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The document provides an overview of different areas of pharmacy including industrial pharmacy, community pharmacy, forensic pharmacy, hospital pharmacy, and clinical pharmacy. It discusses the definitions and goals of pharmacy according to American organizations. The main types of pharmacy specialties described are industrial, community, forensic, hospital, and clinical pharmacy. It also defines key pharmacy terms like pharmacist, assistant pharmacist, therapeutics, drugs, their classification based on sources and sale, and generic vs brand drug names.
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0% found this document useful (0 votes)
179 views131 pages

Pharmaceutics 1.PDF Version 1

The document provides an overview of different areas of pharmacy including industrial pharmacy, community pharmacy, forensic pharmacy, hospital pharmacy, and clinical pharmacy. It discusses the definitions and goals of pharmacy according to American organizations. The main types of pharmacy specialties described are industrial, community, forensic, hospital, and clinical pharmacy. It also defines key pharmacy terms like pharmacist, assistant pharmacist, therapeutics, drugs, their classification based on sources and sale, and generic vs brand drug names.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHARMACEUTICS-I

PUNJAB PHARMACY COUNCIL, LAHORE


PUNJB PHARMACY COUNCIL, LAHORE
1

Chapter 1
PHARMACY

Definition
According to American college of pharmacy the word
pharmacy defines as:
It is the branch of medical science that deals with the
study of discovery, development, synthesis,
manufacturing, action, quality assurance, distributing
regulated affairs, clinical uses, and marketing patterns of
drugs is called pharmacy.

According to American pharmacist association:


Pharmacy is a profession dedicated for the appropriate use
of medication, devices and services to achieve optimal
therapeutic out comes.

Types of Pharmacy (Specialties)

There are different specialties of pharmacy as following:


• Industrial Pharmacy
Retail pharmacy
• Community Pharmacy wholesale pharmacy
• Hospital Pharmacy
• Forensic Pharmacy
• Clinical Pharmacy
• Compounding Pharmacy
• Dispensing Pharmacy

1. Industrial Pharmacy

Industrial pharmacy is the fundamental backbone of pharmacy profession it is an


institution where medicines are manufactured on industrial scale.
Firstly in Pakistan the medicines are prepares manually. Due to recent scientific
advances semi-automatic machines replace the manual work.

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Any pharmaceutical industry mainly contains the following departments.

i. Production Section
It is the section of pharmaceutical industries where medicines are formulated and
manufacture according to specification. Production section can be divided into
following departments
• Tablet section
• Capsule Section
• Injectable section
• Syrup section
ii. Ware House
It is an important section of any industry where raw material and finished products
are stored.
iii. Quality control section
It is the section of any industry where the quality of raw material and finished
product are properly checked.
iv. Research and development Section
The basic function of this section in pharmaceutical industry is to discover,
develop and synthesize new medicines or work on the improvement of existing
medicines.
v. Administration
It is the section which is considers being the back bone of pharmaceutical industry.
This section is responsible of managing all the matters of the industry.

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2. Community Pharmacy
It is one of the pillars of pharmacy profession; in this specialty we provide the
pharmaceutical services at community level.
Goals of any community pharmacy are:
• To provide quality medicine to general public
• Provide guidance and counseling regarding medication and vaccination
• Organized health camps
• Organized health talks and seminars

Community pharmacy divided into following parts

i. Retail Pharmacy
It is the business oriented type of pharmacy where medicines are taken from
distributors or whole sellers and provided to general public on fixed percentage of
profit.

ii. Whole Sale Pharmacy


It is the business oriented type of pharmacy where the medicines are taken from
manufacturer and distribute to the medical stores, pharmacies and hospitals in bulk
on a fixed percentage of profit.

3. Forensic Pharmacy
The branch of pharmacy that deals with the study of drug laws is known as
forensic pharmacy. The forensic pharmacy deals with the legal aspects of
pharmacy practice. The aspects on which forensic stress down are following.
• Duties and responsibilities of all government authorities.
• How to register new drug industry or institute
• How to obtain license to manufacturer purchase and sale drugs/medicine.

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4. Hospital pharmacy
Hospital is an institute where ill patients are treated. The hospital pharmacy is the
department or institution of any hospital where the pharmacy practice has been
done. The pharmacist working in hospital pharmacy is known as hospital
pharmacist.

Pharmacist

Any person that hold B-Pharm or Pharm-D from


Pakistan pharmacy council recognized institution
and furthermore he has a registration certificate
from any provincial council of Pakistan is known
as pharmacist. The provincial council of Pakistan
enters the name of respective pharmacist in
register A.

Assistant Pharmacist or pharmacy technician

Any person who holds diploma in pharmacy from any college or university which
has been registered from Pakistan pharmacy council and furthermore he/she is
registered under register B from provincial pharmacy council of Pakistan.

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As assistant pharmacist the main working area of any hospital pharmacy is:
• Purchasing of quality medicines
• Medicine management
• Dispensing of medicine to in and out patient
• TPN total parental nutrition manufacturing
• Preparation of sterile solution
• Education and training of nurses and paramedics

5. Clinical Pharmacy
According to European society of clinical pharmacy
"Clinical pharmacy is the specialty of pharmaceutical sciences that deals with the
study of drugs or medicines in contrast with their specific diseases."
The pharmacist working in the specialty of clinical pharmacy is known as clinical
pharmacist and the main responsibilities of any clinical pharmacist are
• Medication review in comparison with the diagnosis
• Study about drug interaction for specific prescription
• Drug adverse reaction profiling
• Pharmaco-economic studies
• Drug formulary

Therapeutics

Therapeutics is the branch of medical science that deals with the treatment of
diseases.

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Chapter 2
DRUG

Definition
According to Ansel, the drug can be defined as "an agent intended for use in the
diagnosis, mitigation, treatment, cure or prevention of disease in humans or in
other animals.

Classification of drugs

On the Basis of Sale

1. Over The Counter Drugs

OTC is the group of drug that does not required any prescription for their
dispensing. This group contains the following drugs
• Multivitamin
• NSAIDS (non-steroidal anti-inflammatory drugs) Aspirin, Paracetamol.
• Laxatives
• Oral contraceptives

2. Prescription Drugs

These drugs can only be dispensed on the physician`s prescription.


Following drugs are included:
• Antibiotics
• Steroids
• Benzodiazepines
• Barbiturates
• Hypoglycemic Agents
• Anti-hypertensive

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On The Basis of Sources
The classification of drug on the basis of their source as following
i. Natural sources
ii. Semi synthetic sources
iii. Synthetic sources

i. Natural Sources

Plant source Animal source Microbial source Mineral source

A. Plant sources /drug


This is the group of drug that obtained from
plants e.g.
i. Reserpine is obtained from Rauwolfia
serpentina
ii.Cinamaldehyde obtained from Cinnamomum
loureirii.
iii. Digoxin is obtained from Digitalis lanata

B. Animal Sources /Drugs


Many animals are involved in the production of many important drugs
ii. Insulin
iii. Sex hormones
iv. Thyroxin

C. Microbial Source/drug

This is the group of medicines /drugs that


are synthesized by using different micro-
organisms this group include the following
drug.
• Antibiotics
• Insulin
• Vaccines

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D. Mineral Source
Zinc
Iodine

ii. Semi-synthetic Drugs


Semi synthesis drugs are the group of drugs/ medicines that are synthesized by
using combine sources of natural and synthetic world.
Example
• Amoxicillin
• Cefixim
• Ceftriaxone

iii. Synthetic Drugs


Synthetic drugs are the group of drugs/ medicines that are totally synthesized in
laboratory by using chemicals or substances.
Example
• Paracetamol
• Aspirin
• Ciprofloxacin
• Sulphonamide group

Generic Name.
These are the names of drugs that are given to them on scientific basis. This is the
official name of the drug.
Example
• Paracetamol
• Aspirin
• Ciprofloxacin
Brand Name/Trade Name
These are the names of medicines that are given on the basis of the proprietorship.
These names are given to identify the one product from the other.

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Example
1. Paracetamol
• Panadol
• Calpol
• Disprol
2. Diclofenic sodium
• Dicloran
• Voltral
3. Aspirin
• Dispirin
• Loprin

Chemical Name

These are the names which are given to the drugs on the basis of presence of
different atoms or molecules and their inter-relationship. This name reveals every
part of the compounds molecular structure.
Examples
• Acetylsalicylic Acid (Aspirin)
• Acetyl Para aminophenol (Paracetamol)

Strength
The strength is the amount of drug in the dosage form or a unit of the dosage form
(e.g. 500 mg capsule, 250 mg/5 mL suspension).

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CHAPTER NO. 3
Books in Pharmacy/ Pharmacopoeias and Formularies

The books containing the standards for drugs and other related substances are
known as pharmacopoeias and formularies. They contain a list of drugs and other
related substances regarding their source, tests, formulas for preparation, action
and uses, doses, storage conditions.
Literally it means that it is a list of medicinal substances, crude drugs and formula
for making preparations from them.

There are fundamentally two types of books in


pharmacy
1. Official Books
2. Non Official Books

OFFICIAL BOOKS
These are the books that are written compile and
publish under the strict supervision of
Government agency of respective countries is
known as official book.
Example
• British Pharmacopoeia (B.P)
• British pharmaceutical codex (BPC)
• British National Formulary(BNF)
• United State Pharmacopoeia (USP)
• National Formulary
• Pakistan Pharmacopoeia
• International Pharmacopoeia

NON-OFFICIAL BOOKS
These are the books which are written compile and published locally. Which are
used as secondary reference sources for drugs and other related substances.
Example
• Remington Pharmaceutical sciences
• Merck Index
• Applied and Clinical pharmacology by Katzung
• Tutorial pharmacy

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Official Books

British Pharmacopoeia (BP)


British Pharmacopoeia is the most abundantly used
pharmacopoeia in the world, today it is mostly used
because of their up to date monograph regarding the
drug. .The fundamental responsibility of B.P is on
the General Medical Council which was given to it
in 1858.
This book contain the following data
i. Complete monograph of drugs.
ii. Quality control and quality assurance of
pharmaceutical production sections of pharmaceutical industries.
iii. Quality control test of dosage form
iv. Identification and analytical test of drugs

British Nation Formulary (BNF)


It is the national formulary of medicines that are being
use in United Kingdom. It is written compiled and
published under the co supervision of GMC (General
Medical Council) and Royal Pharmaceutical society of
Great Britain. This book is largely being used as a text
book for registration examination in UAE and in UK
This book contains following information
i. Detail knowledge regarding the clinical and
pharmacological aspects of drugs /medicines
ii. Detail note on prescription policy
iii. Knowledge regarding the refilling and prescription
handling

British Pharmacopoeia Codex


In 1903 first time the Royal Pharmaceutical society of
Great British realized the importance of another Pharmacopoeia which is specially
made for medical practitioners and dispensing pharmacists.
This book contain the knowledge and articles on the following issue of
pharmaceutical sciences
i. Regarding the dispensing method of medicines specific to their nature
ii.The techniques of dispending e.g. unit dose dispensing and multi-dose
dispensing

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iii. A thorough knowledge regarding the Pharmacological aspects of drugs
iv. Manufacturing and formulation techniques of drugs

International Pharmacopoeia (IP)


International pharmacopoeia is the official book that has been written, published
and compiled by the WHO (world Health Organization)
WHO is a sub -office of united Nation that concerned with the health education
and other health problems.
Mainly IP contain following information
i. Pharmaceutical technological techniques for the development of drugs
ii. Drug formulation and manufacturing processes
iii. Controlling the quality of medicines

United States Pharmacopoeia (USP)


This is an official book of pharmacy. It is one of the
leading and important pharmacopoeias of the world.
Firstly written, compiled and published under the
supervision of a government agency of United States,
named United State pharmaceuticals convention. USP
can be used to determine the strength, Quantity,
Quality, Purity and labeling of drug.

United State National Formulary (UNF)


In 1888 the first National Formulary of United States was published under the
supervision of American Pharmaceutical Association. But in 1974 the right of
UNF was given to united state Pharmaceutical Convention so from 1980 the UNF
is published with USP –NF.

(Non-Official Books)

Remington Pharmaceutical Science


This book contain a detail knowledge regarding all the aspects of pharmacy .It is
available in two volumes

Applied and Clinical Pharmacology by Katzung


This book contains a detail knowledge regarding drug and their actions on humans.

Tutorial Pharmacy
This book contains a detail knowledge regarding the physical pharmacy

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CHAPTER NO. 4

HISTORY OF PHARMACY
Regarding the Muslim Scientist

Pharmacy is a word which had been derived from a Greek word "Pharmakon"
which means drug or medicine.
The Muslim scientists play a significant role in the discovery, development,
formulation, manufacturing and the use of drugs in according with the specific
diseases. There are the following Muslim Scientists

1. AL-KINDI (801-873 A.D)

Al-Kindi was a great Muslim philosopher, scientist, physician and psychologist.


He was born in Kufa Iraq. He got his early education from Baghdad.
He plays a significant role in the development of many branches of science e.g.
Pharmaceutical chemistry, medicine, Psychology and cosmetics.
His notable work include:
1. Al Kindi was a first person who uses music for the
treatment of Psychological problems.
2. He describes the isolation process of alcohol to
form pure wine.
3. He describes how to make perfumes.
4. He describes in detail regarding cosmetics
formulation
5. In his book "Treaties of disease caused by phlegm
"he describes the epilepsy.

Phlegm
It is a viscous liquid produce in the living system by the mucous membrane.

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2. IBN-AL-NAFIS (1213-1288 A.D)

Ibn-al-Nafis was the one of the greatest physician, Anatomist, Physiologist,


Pharmacologist, Sociologist and Islamic scholar of his time. He was born in
Damascus, Syria and later he moved to Cairo, Egypt. and done his research work
here. He was renowned for the following work
• He was first person who describe the pulmonary
circulation
• He describe regarding capillary and coronary
circulation
• He describes in detail the anatomy and physiology
of respiratory system, genitourinary system and
GIT.
• He was the first person who writes about pulse rate.
• He has worked in the development of over 100
drugs.

3. IBN-ZUHAR (1091-1161 A.D)

Ibn- Zuhar was the great Muslim scholar, physician, surgeon and pharmacist. He
was a Arab Muslim who was born in Seville (capital of southern Spain) he got his
early education in Spain and done his research work also in Spain.
His scientific work include
• He was the first person who describe experimental
surgery so he was consider to be the father of
experimental surgery.
• He firstly describe the procedure for dissection and
autopsy.
• Ibn-Zuhar was that first person who describe the
use of inhaled anesthetics So, he was consider to be
the pioneer of modern anesthesiology
• He done remarkable work and contribution to
subject neuro-phamacology (Clinical , Neuro,
Cardio ,Cancer, Reproduction ,Medical
,Toxicology)
• Ibn-Zuhar wrote an early pharmacopoeia which was
printed out in 1491.

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4. Abu Ali Sina (980-1037AD)

Abu Ali Sina was a great physician, chemist and astronomer of his time. He wrote
almost 450 treaties on different scientific subjects among them 40 treaties are on
medicine .His book “ The canon of medicine” was used a text book of medicine for
many years Abu Ali Sina was born in Afshana ,Bukhara, Uzbekistan.
His most famous scientific work include
• He firstly describe the procedure of diagnosis
• He was the person who describe the different
psychiatric diseases e.g Depression, Mania,
Insomnia, Dementia etc. in detail
• He was the first person who describes the
paralysis in detail.
• He describes the risk factors of clinical trails
• He was the person who firstly describe steam
distillation

5. Al Biruni (973-1050)

Al-Biruni was a great pharmacist, physician and Geologist. He was born in


Khwarizm.
His famous scientific works include :
• He works in the development and progress of
pharmacy field.
• He wrote a book Al-Saddana fil tibb which
has description of more than 720 herbal
drugs and these are arranged alphabetically
• He has wrote many other treaties on herbal
medicine
• He also describe about the active constituents
of drugs

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6. Jaber Bin Hayan (721-815)

Jabir Bin Hayan was one of the greatest


scientist, chemist and Geologist of his time. He
was born in Iran . He was the first scientist who
introduced experimentation in chemistry.
His greatest scientific works include:
• He invented the practice essence of
chemistry which then lead to the era of
industrialization
• He invented more than 20 laboratory
equipment.
• He firstly describe distillation and
crystallization
• He discover many chemical substance
e.g. Nitric acid, hydrochloric acid,
Sulphuric acid, Acetic acid and oxalic
acid. He invented Aqua-regia the only
solvent that can dissolve gold.
• He describe the purification process of
gold.

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Chapter 5
Surface Tension

The boundary between two phases is generally described as an interface. When one
of the phases is a gas or a vapour and the other a
liquid or solid the term surface is commonly used.
• Surface tension is defined as the force
acting over the surface of the liquid per unit
length of the surface.
Force per unit area (F/A) on surface of liquid.
Its unit is newton per meter (N/m2)

EXPLANATION:
The molecule inside the liquid interacts equally
with other molecule from all sides, whereas the
molecule at the surface is affected only by the
molecule below it. The molecules exposed to air
behave differently.
Surface molecules are compressed more tightly together; forming a sort of skin on
the surface, with less distance between them compared to the molecules below.
The molecules on the surface of a liquid are attracted only sideways and towards
the interior so, surface molecules are being pulled inward the liquid. Liquid surface
is therefore under tension and surface area of the surface molecules is reduced.
Water in particular has a very high surface tension.
This explains the characteristic rounded shape that liquids form when dropping
through the air: The molecules are all being pulled toward the center.

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Factors affecting Surface Tension

Intermolecular forces
Surface tension increases with the increase in intermolecular forces and decreases
with the decrease in intermolecular forces.
Hydrogen bonding
Surface tension increases with the increase in hydrogen bonding and decreases
with the decrease in hydrogen bonding.
Temperature
Surface tension decreases with the increase in temperature and increases with the
decrease in temperature.

Applications
• Emulsifying agents reduce the surface tension of oil and water phase which
results in stabilization of emulsion.
• Bile salts reduce the surface tension of fats in duodenum which results in
solubilization of lipids which help in the digestion of lipids.

Viscosity

Viscosity can be described as “ It is the internal


resistance of the molecules of any liquid to flow called
viscosity”.
Viscosity is the fundamental tool to check the internal
friction of any liquid, like water is thin so it has lower
viscosity and on the other hand honey is thick so it has
higher viscosity.

Viscometers

These are the specialized equipment and apparatus used


for the determination of viscosity of different liquids.

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Types of viscometers

There are various types of viscometers the most famous are:

1) Ostwald viscometer or U-Tube viscometer


2) Rotational viscometer
3) Falling ball viscometer

Factors affecting the viscosity

Temperature
Viscosity decreases with the increases in temperature

Size of the molecule


Viscosity increases with the increases in size of the molecule

Molecular shape
More irregular the liquid’s molecular shape greater would be the viscosity of the
liquid. More regular shape of liquid’s molecule lesser would be the viscosity.

Adhesive forces
Stronger the adhesive forces greater would be the viscosity of the liquid.

Cohesive forces
Stronger the cohesive forces lesser would be the viscosity of the liquid.

Application of Viscosity measurement

1) Viscosity determination is the fundamental quality control test for syrups,


suspension thickness and consistency.
2) Viscosity is also given us the indication regarding quality and purity of
liquid raw material
3) Viscosity tell us about the thickness of liquid substances
4) Viscosity determination is also a key quality control test for oil base
injections and suspension.
5) Viscosity enhancers (e.g. Methylcellulose, Hydroxyethylcellulose) are used in
ophthalmic solutions to increase their viscosity. This enables the formulation
to remain in the eye longer and gives more time for the drug to exert its
therapeutic activity or undergo absorption.

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Ionization
ATOM
“ATOM” is derived from Greek word means
“undividable”. it is the smallest particle of an
element which cannot be further divided.It consist
of central nucleus containing protons and neutrons
and outer shells in which electrons are revolving.
Protons carry positive charge neutrons are
neutral particles having no change and
electrons carry negative charge on them.
These are called fundamental particles of
atoms.

ION
Any charged particle is called ion. It may be
positive(+) or may be (-).

Cation(+)
When a atom loses an electron from the
outer most shell, cation (positively charge atom) is produced.

Anion(-)
when a atom gains an electron from the
other atom, anion(negative charge atom) is
produced.

Ionization

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Process by which electrically neutral atoms or molecules by the removal or
addition of electrons . In this process of atom acquires net positive charge on it

Ionization energy
Amount of energy required to remove an electron from an atom.
Ionization experiment

In 1897,J.J. Thomson conducted the famous discharge tube experiment, by passing


electricity at high voltage a gas at very low pressure.
The pressure of air in the discharge tube is reduced to 0.001mm of mercury and a
high voltage is applied to the electrodes.When electric current passes through the
discharge tube ion of given gas produce some ion carry negative charge and some
are neutral creating a condition of ionization.

Applications
Many drugs are either weak organic acids e.g. Acetylsalicylic acid (aspirin) or weak
organic bases e.g. procaine, or their salts. The degree of ionization of a drug has an
important effect on its absorption, distribution and elimination. So ionization is an
important factor which is considered during the manufacturing process of
medicines.
1. Ionization radiations are used in medicines and medical radiography to make
image inside the body.
2. In biology and agriculture radiation is used to induced mutation to produce new
or improved species.
3. Radiation are used in sterilization of tools and equipment used in surgery.

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pH
pH involve taking negative log of hydrogen ions concentration.
pH = -log [H+]
This hydrogen ion concentration is usually expressed in moles per liter.

Calculation of PH
Following formula can be use to determine the value of pH of different solution

For acid
pH = -log [H+]
For base (it is the negative log of hydroxyl ion (OH-) concentration).
pOH = -log [OH-]
Where as
pH + pOH = 14

Explanation
pH of H2O is 7 and it is consider to be neutral If pH is falls down from 7 then the
compound will called acid.
If the pH rises from 7 then the compound is called basic.

Increased Acidity Neutral Increased Basicity


1 7 14
-7
10
Determination of pH
pH of a solution is measured by following methods:
1. By using pH paper
2. By using pH meter
3. By using indicators

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pH Indicators
pH indicators are organic substance which have tendency to change their color
with change of pH of the solution in which they are present.
The aim to use pH indicators are:
• To determine the type of compound
• To determine the pH of different
sample
• To verify the presence of any chemical
substance

Types of pH Indicators
There are three fundamental types of
indicators
i. Acid base Indicators
ii. Redox indicators
ii. Precipitation Indicators
i. Acid base indicators
There are the indicator that change their
color as we change the pH of the solution.
Example :Methyl orange , Phenolphthalein

ii. Redox Indicator


These are the compounds that changing their colors during oxidation and
Reduction reaction e.g.KMnO4

iii. Precipitation Indicators


Those indicators that change their color during precipitation reaction are called
precipitation indicators e.g.
K2CrO4 (potassium chromium oxide)

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pH Meter
it is an electronic instrument used for measuring the pH of a liquid or semi-solid. A
typical pH meter consists of a glass electrode connected to an electronic meter that
measures and displays the pH reading.

Applications
• pH measurements are important in medicine, biology, food science and
many other applications.
• Enzymes work at specific pH, so their preparations must be maintained at
that pH.
• Blood has a specific pH of 7.3-7.4
• pH indicators are used in titrations in analytical chemistry and biology to
determine the pH of different substances.
(A titration is a technique in which a solution of known concentration is used
to determine the concentration of an unknown solution.)

Buffer
Buffer is the compound or mixture of compounds that resist to changing pH of any
solution on slight addition of acidic or basics solution or compound.

Useful Buffer Mixtures

S.No Buffer Mixtures pH Range


1 HCl –Sodium Citrate 1_____5
2 Sodium hydroxide and borax 9.2____11
3 Citric acid /Sodium citrate 2.5_____5.6
4 H2CO3 / NaHCO3

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Theory of buffers
Addition of acid
Hcl is strong acid and it will change H+ concentration when added to a solutionbut
buffer system (H2CO3/ NaHCO3) tends to maintain the pH of solution and
following reaction takes place.
HCl + NaHCO3 H2CO3 + NaCl

NaOH + H2CO3 NaHCO3 + H2O

i. If we add H+ ions to the above mentioned reaction the reaction will shift to the
left side H3O+ + H+
ii. If we add OH- ions to the reaction the reaction will shift to right side

Applications
i. Buffers are most widely used in biological industry to preserve the pH of
biological compounds and fluids
ii. In injection manufacturing buffer are used to maintain their pH.
iii. Buffer are used in fermentation process
iv. Buffers are used to preserved an restored the action of enzymes
v. Buffer are used to maintain the pH of drugs.

Isotonic Solution (Isotonicity)

 If a solution is placed behind a membrane that is permeable only to


solvent molecules and not to solute molecules(semipermeable
membrane) osmosis occurs as the molecules of solvent passes through
the membrane. If a solution filled membrane is placed in a solution of a
higher solute concentrationthan its own the solvent can pass in any
direction, passes into the more concentrated solution until equilibrium is
established on both sides of the membrane. The pressure responsible to
prevent osmosis is termed as osmotic pressure.

 Body fluids including blood and tears have an osmotic pressure equal to

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that of a 0.9% Nacl solution. Or it can be said that 0.9% Nacl solution is
isotonic to body fluids. Isotonic solution can also be defined as “if two
solutions on comparison have same osmotic pressure and ions
concentration are termed as isotonic solution”

The solutions which have less ions and it have less osmotic pressure then
its comparative solution. OR
Solutions with a lower osmotic pressure than body fluids or a 0.9%
sodium chloride solution are commonly called “hypotonic solutions“.

Those are the solution in which the conc. of the ions and osmotic
pressure is greater than its comparative solution . OR
Solutions having greater osmotic pressure than body fluids or a 0.9%
sodium chloride solution are termed as” hypertonic solutions”.

A hypotonic solution added to body`s system will lose water and this
water will be absorbed by body tissues. It may induce hemolysis of red
blood cells.
A hypertonic solution added to body`s system will have a tendency to
draw water from body tissue . so it can cause shrinkage of body tissues
and cause complications.

Solutions for injection, for application to mucous membranes and solutions for
ophthalmic use must be made isotonic with tissue fluid to avoid pain and
irritation. The most widely used isotonicity modifiers are dextrose and sodium
chloride.

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Applications of Isotonic Solution in Pharmacy

• Isotonic solutions are used in physiological experiments and tissue culture


• Isotonic solutions are used to balance the electrolytes
• Isotonic solutions are used to maintain the physiological conditions
• For medical purpose isotonic solution (normal saline) is used to flush wounds
• Normal saline is also used I.V for patients who cannot take fluids orally
• Saline is also used for nasal washes to relieve some of the symptoms of the
common cold.

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Chapter 6
DOSAGE FORM

Pharmaceutics

Pharmaceutics is the branch of pharmacy that deals


with the conversion of (new chemical entity) NCE to
proper dosage form (drug delivery system).
It is also called the science of dosage form design.
 Pharmaceutics converts a drug into a medicine.

Drug Delivery System.


It is the administration of drug or medicine to the living system for their desired
action in body(cure, management or prophylaxis of disease).
Medicines are drug delivery systems, they are means of administering drugs to the
body in a safe, efficient and convenient manner.
Dosage form

Dosage form is the physical form of a dose of


drug. Any Pharmaceutical product which is
ready for the use of patient is known as dosage
form
(OR)
Any pharmaceutical product which has defined
shape and have prescribed amount of APIs
(Active pharmaceutical ingredient) called a
dosage form.

Dosage forms are essentially pharmaceutical


products, typically involving a mixture of active
drug components and nondrug components.

Drug/Active ingredient/Medicament/Medicinal agent

This is a pharmacologically active ingredient in a medicine (Which has


pharmacological action). e.g. Aspirin, Insulin, Digoxin

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Additives/ Excipients

Additives are the substances other than the active medicaments in the formulation
(dosage form), which don’t have any pharmacological action.
They are used for many purposes as:
✓ To give a particular shape to the formulation.
✓ To increase the stability of the product
✓ To increase the palatability and elegance of the preparation.
Additives may include: Surfactants, diluents, vehicles, bases, stabilizers,
preservatives, coloring agents, flavoring agents, sweetening agents.

Vehicles
It may be described as a medium in which the ingredients of a formulation are
dissolved, suspended or dispersed.
The vehicle is a general word may be used for liquids, semisolids or solids. When a
liquid is used to dissolve or suspend the medicament the liquid is known as
vehicle. . Water , Aromatic waters, water for injection, glycerine, propylene
glycol, Oils.
When a semi-solid or solid is used; it is known as base. In which the drug is
incorporated either to increase the bulk or to give a particular shape to the
formulation. Generally these are used for the preparation of ointments and
suppositories. Commonly used ointment bases are soft paraffin, liquid paraffin,
wool fat, wool alcohol, bees wax.
Suppository bases: theobroma oil, glycerogelatin, polyethylene glycols.

Diluents
Diluents are the inert substances which are specially added to increase the bulk of a
drug or to decrease the concentration. The liquids which are used as vehicles may
be specifically used as diluents but for oral preparations water is the most suitable
diluents.
Solid diluents are included in the formulation of powders, granules, tablets,
capsules where they are used to increase the bulk of other materials for easy
conversion into proper dosage form. In potent drugs diluents are incorporated to
increase the bulk so that they can be weighed easily.e.g. Kaolin, lactose, starch,
sorbitol, powdered cellulose.

Binders
Substances used to cause adhesion of powder particles in tablet granulations e.g.
Acacia, sodium carboxymethyl cellulose, gelatin, liquid glucose.

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Tablet Disintegrants
To promote tablet break up into smaller particles after administration. e.g. Starch,
microcrystalline cellulose, carboxymethyl ellulose, sodium alginate, alginic acid.

Lubricants/Anti-adherents
Prevent tablet ingredients from sticking to punches and dies during production and
assist smooth tablet formation. e.g. magnesium stearate, talc.

Glidants
Used in tablet and capsule formulations to improve flow properties of powder
mixture. e.g colloidal silica, corn starch, talc

Surfactants/Surface active agents


Surfactants may be defined as the substances which when added to a liquid, lower
the interfacial tension between two phases, thus make them miscible.
This phenomenon is commonly used to make two immiscible liquids miscible with
each other and to dissolve the drugs.
The molecules of a surfactant consist of two part i.e. a polar part and non-polar
part When such molecules are placed in two phases of different polarities the polar
part moves towards high polarity phase while non-polar part moves toward low
polarity phase and they are absorbed at the interphase.
1. Anionic surfactants

Classification of surfactants 2. Cationic surfactants

3. Non-ionic surfactants
1. Sulphated compounds like sodium lauryl sulphate, sodium cetyl sulphate,
dioctyl sodium sulfosuccinate.
2. Benzylkonium chloride
3.Glyceryl monostearate, spans and tweens.

Hydrocolloids/ Suspending agents


These are high molecular weight solid substances which when added to water
produce high viscous solutions, suspensions or gels. Viscosity increasing agents
used to reduce sedimentation rate of particles in a vehicle. They are also known as
gums and consist of polysaccharides and proteins.
Natural

Classification Semi-synthetic

Synthetic

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Natural: Acacia, Tragacanth, Agar (plant) Gelatin and Casein(animal) Silica,
colloidal alumina, bentonite and veegum (mineral).
Semi-synthetic: Modification of cellulose Methyl cellulose, sodium
carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose.
Synthetic: Only a few are used .e.g. carbopols and polyox.

Stabilizers

Stability: the capability of a formulation in a specific container to remain within


the physical, chemical, microbiological, therapeutic and toxicological
specifications.
The substances used to control these stabilities are known as stabilizers. The most
important are:
1. Antioxidants Prevent deterioration of preparations by oxidation. E.g.
Ascorbic acid. Sodium ascorbate, sodium bisulfite, tocopherols.
2. Chelating agents: substances that form stable water soluble complexes
(chelate) with metals. These metals might promote instability e.g. Edetate
disodium
3.Buffering agents: used to resist change in PH upon dilution or addition of acid
or alkali. e.g sodium citrate, sodium acetate, potassium phosphate.
4. Antimicrobial preservative: used in liquid and semi-solid preparations to
prevent or inhibit the growth of microorganisms. e.g. emulsions and suspension
must be suitably preserved because water and carbohydrates provide very good
medium for the multiplication of bacteria and molds.
Parenteral preparations packed in multi-dose containers must contain a
preservative.

Flavouring agents
Impart a pleasant flavor and often odor to a preparation and to mask specific type
of taste of the preparation, thus make them more palatable. e.g. cherry, banana,
pine-apple, peppermint, lemon, orange, rose, vanilla, menthol.

Sweetening agents: Used to impart sweetness to a preparation, and mask the


objectionable taste of the drug e.g. sucrose is most widely used. Lactose, mannitol,
honey, glycerin, sorbitol, aspartate.

Coloring agents
Substances used to impart color to liquid and solid preparations.
e.g. Caramel, Ferric oxide, chlorophyll, carotenoids, FD&C colors.

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Types of dosage forms


On the Basis of Formulation/ Preparation/Physical form
1. Liquid Dosage Forms
▪ Solutions
▪ Syrups
▪ Elixirs
▪ Spirits
▪ Tinctures
▪ Liniments(liquid or semi-liquid)
▪ Lotions
▪ Sprays
▪ Aerosols (solutions of gases in liquids)

▪ Inhalations Suspensions
▪ Disperse Systems Emulsions
Magmas
▪ Parenteral preparations

2. Solid Dosage Forms


▪ Powders and Granules
▪ Tablets
▪ Capsules
▪ Suppositories

3. Semisolid Dosage Forms


▪ Ointments
▪ Creams
▪ Pastes
▪ Gels

On the Basis of Route of Administration


1.Oral
Oral Solutions
Syrups
Elixirs
Oral Suspensions
Emulsions
Magmas
Powders
Granules Effervescent granules

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Tablets
Capsules
2.Parental
✓ Intracutaneous or intradermal (Beneath the epidermis) 0.1 to 0.2ml
✓ Subcutaneous(Beneath the surface of the skin) 1ml or less
✓ Intravenous(drug directly injected into blood stream) 1ml to 500ml or more
✓ Intramuscular(into the skeletal muscles) upto 2ml
Less commonly used are: Intrathecal, intra-articular, intra-cardiac

3.Transdermal (through skin) / Topical


❖ Lotions
❖ Liniments
❖ Ointments
❖ Creams
❖ Pastes
❖ Topical Powders( Dusting powders)
❖ Transdermal Patches
❖ Gels
❖ Ear drops
❖ Eye drops

Inhalational route
Nasal Decongestant solutions
Inhalers
Sprays
Nebulizer

Pharmaceutical Inserts Rectal

Suppositories Vaginal

Urethral
Ophthalmic inserts

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LIQUID DOGAGE FORMS

S
Os

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SOLUTIONS
Solution may be defined as a mixture of two or more components that form a
single phase which is homogenous and clear.

solutions may be prepared from any combination of


solid, liquid, and gas, the three states of matter. In
pharmacy most of the solutions are prepared by
dissolving a solid , liquid or gas in another liquid

It has two components:

Solvent
Solvent is the liquid portion of a solution in which
another substance (e.g. salt) is dissolved to form a
solution is called solvent.
Solute
A substance that is dissolved in another substance (solvent) to form a solution is
called solute. Or
A solute is a substance that creates a solution when dissolved by a solvent. Solute
can change its physical state, e.g. salt is solid before getting dissolved in water, and
after dissolution it changes from solid to liquid.

Advantages:
✓ They are homogenous, therefore the medicament is uniformly distributed.
✓ They are more quickly effective than tablets or capsules because they are
already in solution form and absorption starts quickly.
✓ They can easily colored, flavored and sweetened.
✓ Children or patients who cannot swallow tablets or capsules can easily
ingest solutions.

Disadvantages:
 They are less stable as compared to solid dosage forms because
deterioration is faster in solutions.
 In some medicaments their unpleasant taste and flavor is difficult to
mask.

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Solubility :The amount of substance that passes into solution in order to


establish equilibrium at constant temperature and so produce a saturated
solution is known as the solubility of the substance.

BP defined the solubility in an approximate manner that ‘the no of parts of


solvent required to dissolve one part of solute”.

TABLE.1 RELATIVE TERMS OF SOLUBILITY

Descriptive Term Parts of solvent required


For 1 part of solute
Very soluble <1

Freely soluble 1–10

Soluble 10–30

Sparingly soluble 30–100

Slightly soluble 100–1000

Very slightly soluble 1000–10000

Practically insoluble >10000


or insoluble

Solubilization: is the process in which the water insoluble substances are


dissolved in aqueous solutions in the presence of surfactants.

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ORAL SOLUTIONS

According to the British Pharmacopoeia (BP)


Oral solutions are oral liquids containing one or more active
ingredients dissolved in a suitable vehicle.

DRY MIXTURES FOR SOLUTION

A number of medicinal agents, particularly certain


antibiotics, e.g., penicillin V, have insufficient
stability in aqueous solution. Manufacturers of these
products provide them to the pharmacist in dry
powder or granule form for reconstitution with a
prescribed amount of purified water immediately
before dispensing to
the patient. The dry powder mixture contains all of
the formulative components, including drug,
flavorant, colorant, buffers, and others, except for
the solvent.

ORAL REHYDRATION SOLUTIONS

Oral rehydration solutions are usually effective in treatment of patients with mild
volume depletion, 5% to 10% of body weight. These are available OTC and are
relatively inexpensive, and their use has diminished the incidence of complications
associated with parenterally administered electrolyte solutions.

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SYRUPS
Definition
Syrups are sweet, viscous, concentrated aqueous solutions of a sugar(sucrose) or
sugar-substitute in water or any other suitable vehicle. With or without added
flavoring agents and medicinal substances.

TYPES:
1. Simple syrup.
2. Medicated syrup
3. Flavoured syrup

1.SIMPLE SYRUP:
:When purified water alone is used in
making the solution of sucrose ,the preparation is known as syrup or simple
syrup. It is used as flavouring agent and vehicle for drugs. According to BP it
is 66.7% (w/w)and USP 85%(W/V).

2.MEDICATED SYRUP:
When aqueous preparation contains some medicinal agent ,the syrup is called
as medicated syrup. OR
Solution of medicated substance in which sufficient sucrose is dissolved to
produce a syrup liquid .
These are prepared by combining each of the individual components of the syrup.
Such as sucrose, purified water, flavors, coloring agents, therapeutic agent and
other desirable ingredients. They are employed in therapeutics.
The medicated syrup consist of sucrose mixed with solutions of other
substances.

3.FLAVOURED SYRUP/ NON-MEDICATED SYRUP:


Syrups not contain medicinal substances but contains various pleasantly flavored
substances are called flavored syrups.
These syrups are added in the preparation of medicated syrup and used for masking
the disagreeable taste of medicinal substances.
Examples are: Coca syrup , orange syrup , raspberry syrup etc .

USES AND SIGNIFICANCE:


1.Syrups are used as vehicle for drug substances.
2.Syrups are used as flavouring agents.
3.Syrups are used as sweetening agents.
4.Syrups are used as demulcents.

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5.Syrups are used as diluting vehicles for water soluble drugs.
6.As masking agents for nauseous and irritative drugs.

Syrups are significant because:


✓ Easy to administer to children and old
people.
✓ Sucrose retards oxidation because it
is partly hydrolyzed into reducing
sugars laevulose and dextrose.
✓ Strong solution of sucrose prevent
decomposition by bacteria , fungi and
mold because of strong osmotic
pressure which results in dehydration
of these organisms.
✓ Contain little or no alcohol.

COMPONENTS OF SYRUP
Most syrup contain the following components in addition to the purified
water and any medical agent present.

1.Sugar and sugar substitutes


2.Antimicrobial preservatives.
3.Flavourants
4.Colourants
5.Special solvents ,solubilizing agents ,thickness , and stabilizers.

1.Sugar Or Sugar Substitutes


Sucrose is the sugar most frequently employed in syrups. It may be replaced by
other sugars or substances such as sorbitol , glycerin, propylene glycol. Artificial
sweetening agents: methylcellulose, hydroxyethyl cellulose. These non-sugars are
used for syrups of diabetic patients.
Dilute solutions of sucrose support mold, yeast and other microbial growth
whereas the growth of such microorganisms is usually retarted when the
concentration of sucrose is 65% W/W or more but a saturated solution may lead to
crystallization of sucrose. Sucrose and other sugars give proper viscosity to
formulation and also sweetness. A syrup contain as much as 60 to 80%
sucrose.

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2.Anti microbial Preservatives
Sucrose concentration of syrup is itself antimicrobial because it exerts a
great osmotic pressure on microbes to draw water out of them thus
dehydrating them.
Commonly used preservatives with their effective concentration are
Benzoic acid-----------------0.1 ---0.2%
Sodium benzoate-------------0.1---0.2%
Various combination of methyl, propyl and butyl parabenes totally about----0.1%
3.Flavourants
Most syrups are flavoured with synthetic flavorants or naturally occurring
materials to render the syrup pleasant tasting. Such as Volatile oils, Vanillin.

4.Colourants
To enhance the appeal of the syrup ,a colouring agent is generally used.
which correlates with the flavorant employed.i.e .green with mint ,brown with
chocolate etc .
The colores used should be :
➢ Water soluble
➢ Non -reactive with other components
➢ Colour stable at PH range and under light intensity.

5.Miscellaneous
Special solvents ,solubilizing agent ,thickness and stabilizers are used
according to formulation needs.

Methods of preparation of syrups

1. Solution with the aid of Heat


2. Solution by agitation without aid of Heat
3. Addition of sucrose to a medicated liquid
4. Percolation

Storage
Syrups should be stored in a well closed container and at a temperature not
exceeding 300C.

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ELIXIRS
Elixirs are clear, sweetened hydro-alcoholic solutions intended for oral
administration and are usually flavoured to enhance their palatability.

The BPC describes elixirs as ‘ being usually sweet ,aromatic preparations


frequently containing alcohol and requiring dilution before use or
administration’.
The main ingredients of elixirs are ethanol and water but
glycerin, sorbitol, propylene glycol, flavoring agents, sugar
and preservatives may be incorporated to the preparation.
Elixirs containing agents will low water solubility.

TYPES OF ELIXIRS:
These are of two types
1. Non-Medicated Elixirs.
2. Medicated Elixirs

1. Non Medicated Elixir:-


The elixirs having no medicament are termed as non-
medicated elixirs.

Non medicated elixirs are used as:


. Flavouring agents
.Vehicles for medicaments (Addition of a therapeutic agent)
. Diluting agent (Dilution of an existing medicated elixir)
It should have approximately the same alcoholic concentration as the elixir being
diluted. Examples are aromatic elixir, orange-spirit elixir.

2.MEDICATED ELIXIRS:-
When medicinal agents are incorporated into hydro-alcoholic vehicles ,called
medicated elixers.
Medicated elixirs are used for the therapeutic effect of the medicinal
substances they contain. A medicated elixir may have only a single
therapeutic agent or more than one . They usually contain very potent
drugs such as antibiotics, anti-histaminic and sedatives.

Elixir having single medical agent are advantageous than those having more
than one ,on the behalf of their dosage variability i.e when one medicinal
agent is required to be varied in dosage. Most official and commercial elixirs
contain a single therapeutic agent.

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COMPONENTS OF ELIXIRS

1.Alcohol 2. Water 3.Glycerol


4.Flavoring agent 5. Preservative 6.Sorbitol, propylene glycol syrups etc.

• The proportion of alcohol in elixirs varies widely. These can be low as


5-10% and as high as 30—35%. Elixirs containing more than 10 to 12% of
alcohol are usually self-preserving.
• Alcoholic contents on one hand increases the solubility of certain
ingredients and at the same time have preservative action.
• Glycerin and syrup may be added to increase the solubility of
medicinal agent and for sweetening purposes.
• Propylene glycol may be used as substitute for both alcohol and
glycerine.

PREPARATION OF ELIXIRS
Elixirs are usually prepared by:
1.Simple solution with agitation and/or
2.By Admixture of two or more liquid ingredients.

By Admixture of two or more liquid ingredients:


Alcohol soluble and water soluble components are generally dissolved
separately in alcohol and in purified water respectively.
Then aqueous sol. is added to the alcoholic solution, rather than the reverse
in order to maintain the highest possible alcoholic strength at all times so
that minimal separation of the alcohol-soluble components occurs.
When two solutions are completely mixed the mixture is made to volume
with specified solvent or vehicles.They are also called as isoalcoholic elixir

PEDIATRIC ELIXIRS:-
In pediatric elixirs alcohol contents are very small. Sometimes syrups do
contain alcohol contents up to 10% on the basis of which they are difficult to
be differentiated from elixirs. e.g. Ephedrine Syrup USP.

Important Official Elixirs:-


Chloral hydrate Elixir .
Paracetamol Elixir .

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Ephedrine Elixir.
Digoxin Elixir (10%alcohol)

Packaging And Storage


➢ Because of their usual contents of volatile oil and alcohols, elixir
should be stored in tight, light resistant containers.
➢ Should be protected from excessive heat.

COMPARISON BETWEEN ELIXIR AND SYRUPS


ELIXIRS SYRUPS
1. Alcohol is necessary component. Alcohol is not necessary component.

2. Less sweet than syrup. More sweet than elixir


3. Less viscous than syrup. More viscous than elixir.

4. Low proportion of sugar. High concentration of sugar

5. Because of their hydro alcoholic This ability of syrup is less than elixirs
character, elixirs are better able to due to their only aqueous nature.
maintain both water soluble and alcohol
soluble components in solution.
6. More stable Less stable

7. Easy to formulate than syrup. Difficult to formulate than elixirs.

8. Less effective in masking the taste More effective in masking the taste of
of medicinal agents medicinal agents

9.Cannot be used as such for NO such disadvantage.


children and Alcohol prohibited
patients.
10. Can be used for diabetic patients Sucrose syrup can not be used for
easily diabetic patient.
11. These are clear formulation . May not be clear.

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TINCTURES
These are alcoholic or hydro-alcoholic solution of non-volatile drug of vegetable
and chemical origin.
Tinctures contain 15-80% alcohol. Tinctures contain one part by weight of drug in
four parts of product.
Internally
These are mostly used
Topically

Types of Tinctures
• Medicated tinctures
Oral tinctures :
They are taken orally. They are becoming a thing of past, because of bad taste.
Example :Belladonna tincture, digitalis tincture.
Topical tinctures : They prepared by solution. Majority are applied to the skin for
the anti-infective activity of their main chemical component. Due to high alcoholic
content provide additional antiseptic effect.Example: iodine tincture

• Non-Medicated tinctures
Flavouring tinctures : In the flavoring of other types of preparations.

PREPARATION
Tinctures can be prepared by following processes.
 By maceration (latin word macerare meaning “to soak”).
 By percolation
 By simple solution

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Disperse Systems

These are the types of preparations containing undissolved or immiscible drug


distributed throughout a vehicle.

In these preparations, the substance distributed is referred to as the dispersed


phase(discontinuous phase), and the vehicle is
termed the dispersing phase or dispersion
medium(continuous phase). Together, they
produce a dispersed system.

The particles of the dispersed phase are usually solid


materials that are insoluble in the dispersion medium.
In the case of emulsions, the dispersed phase is a
liquid.
In the case of an aerosol, the dispersed phase may be
small air bubbles. Dispersions also consist of droplets
of a liquid in air.

The particles of the dispersed phase vary widely in size.


Colloidal dispersions: the colloidal range,(1.0 nm to 0.5 μm)
Fine dispersions: particles of smaller size (0.5 to 10 μm)e.g magmas & gels
Coarse dispersions; Dispersions containing coarse particles, usually (10 to 50 μm)
For example Suspensions ,Emulsions.

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SUSPENSIONS

Suspensions may be defined as preparations containing finely divided drug


particles (the suspensoid) distributed somewhat uniformly throughout a vehicle in
which the drug exhibits a minimum degree of solubility.
These are biphasic liquid dosage form. The solid particles constitutes the
discontinuous phase whereas the liquid vehicle as continuous phase. Particle size
range falls between 10-15µm.
Suspensions are mainly used for:
Oral administration
Topical use (Ophthalmic suspensions)
Parenteral use

Qualities of Good suspension

A well formulated suspension should have the following properties:


✓ The dispersed particles should not settle readily and the settled particles
should re-disperse immediately on shaking
✓ The particles should not form cake on settling
✓ The viscosity should be such that the preparation can be easily poured
✓ Suspension for internal use must be palatable and for external use must be
free from gitty particles.
✓ The particle size of the suspensoid should remain fairly constant throughout
standing period.

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TYPES OF SUSPENSIONS
Extemporaneous suspensions
▪ Such suspensions are prepared just before
dispensing to the patients i.e. infants who are
unable to swallow solid dosage forms (tab&cap)
and no other liquid dosage form is available.
▪ When preparing an extemporaneous suspension
the contents of the capsule are emptied into
mortar, OR the tablet is crushed in a mortar with
a pestle. The selected vehicle is then slowly
added to and mixed with powder to form a paste
and then diluted to desired volume.
▪ For preparation of such suspensions good
quality suspending agents are used which are less liable to microbial attack.
▪ Extemporaneous suspension cannot be stored for a long time.

Dry powders for oral suspensions OR Reconstituted suspensions


▪ These are powders or granules which are intended to
be suspended in water or some other vehicle prior to
oral administration.
▪ In official title these are designated as “For oral
Suspension”.
▪ The dry products containing active agent,
sweeteners, colorants, stabilizers, suspending agents
and preservatives
▪ The powders should be provided in a slightly
oversized container to permit the adequate shaking
of the contents after the entire amount of water has
been added.
Examples of official drugs for reconstituted suspension are:
 Antibiotic drugs .e.g. Tetracycline suspension, Amoxicillin, Ampicillin.
 Barium sulphate for oral suspension
Packaging and storage of suspensions
 All suspensions should be packaged in wide mouth containers having
adequate airspace above the liquid to permit adequate shaking and ease of
pouring.
 The label should have statement SHAKE WELL BEFORE USE
 For reconstituted suspensions, the bottle should have a clear mark to show
the level of water addition.
 Suspension should be protected from freezing, excessive heat and light.

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EMULSIONS
An emulsion is a dispersion in which the dispersed
phase is composed of small globules of a liquid
distributed throughout a vehicle in which it is
immiscible.
These are biphasic dosage forms. The two immiscible
liquids are made miscible by the addition of a third
phase an emulsifying agent. In emulsion terminology
the dispersed phase is internal phase and the
dispersion medium is the external or continuous
phase.
Emulsions are of two types
Oil in water (o/w) : oil is dispersed in the water.
Water in oil (w/o) : water is dispersed in the oil.

Liquid Orally, Parentally, Topically


They may be
Semi-solid Topically

Liniments
Two classes of liquid external preparation o/w or w/o
Lotions

Oily creams (w/o) cold cream


Semi-solid emulsions are
Aqueous creams (o/w) vanishing cream

Choice of Emulsifying agents

To get an emulsion of required properties, the selected emulsifying agent have the
following qualities
➢ Should be capable of reducing interfacial tension between two immiscible
liquids
➢ Should be capable of keeping the dispersed liquid globules distributed
indefinitely throughout the dispersion medium
➢ It should be non-toxic.
➢ Chemically compatible with other ingredients of the preparation
➢ Able to produce and maintain the required consistency of the preparation.

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PREPARATION OF EMULSIONS

 Continental or Dry gum method


 English or Wet gum method
 Bottle or forbes bottle method

Dry gum method

The emulsifying agent (usually acacia) is mixed with the oil before the addition of
water, that is, dry gum. The continental method is also referred to as the 4:2:1
method because for every 4 parts by volume of oil, 2 parts of water and 1 part of
gum are added in preparing the initial or primary emulsion. Other formulative
ingredients that are soluble in or miscible with the external phase may then be
mixed into the primary emulsion. When all necessary agents have been added, the
emulsion is transferred to a graduate and made to volume with water.

Wet gum method


The emulsifying agent is added to the water (in which it is soluble) to form a
mucilage, and then the oil is slowly incorporated to form the primary emulsion,
that is wet gum. Should the mixture become too thick, additional water may be
blended into the mixture before another portion of oil is added, the other
formulative materials are added, and the emulsion is transferred to a graduate and
brought to volume with water.

Bottle method
The bottle method is used for the preparation of emulsions of volatile oils or less
viscous oils and is a variation of the dry gum method. Because of low viscosity the
volatile oils require greater amount of gum for emulsification therefore the
proportion for oil, water and gum for primary emulsion are 4:4:2.
Oil and powdered dry gum are shaken vigorously in a large bottle until mixed
thoroughly. Then water is added to form primary emulsion. More water is added in
small portions with constant agitation to produce final volume.

STABILITY OF EMULSION
Stability of emulsion means that a formulated emulsion should retain its original
characters i.e. as the size of globules and their uniform distribution throughout the
continuous phase.

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1.Coalescence
Coalescence means to grow together, to fuse. The dispersed phase fuse to form
large globules.

2.Creaming and sedimentation


Upward (creaming) or downward (sedimentation) movement of dispersed globules
in the continuous phase. In creaming they form a thick layer at the surface of
emulsion.

3.Cracking/Breaking
Separation of the internal phase from the emulsion is called breaking. The
coalescence of the dispersed globules take place and the two separate layers of the
dispersed phase and continuous phase are formed which are difficult to re-disperse
by shaking or stirring to get the original product.

4.Flocculation
The individual particles of dispersed phase come in contact with each other to form
loose aggregates and create a network like structure.

➢ Many molds, yeasts, and bacteria can decompose the emulsifying agent,
disrupting the system.

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LOTIONS
Lotions are liquid aqueous preparations intended for external application to the
skin without rubbing with the help of some absorbent material such as cotton wool
or gauze soaked in the lotion, applied to the affected part.

Lotions contain finely powdered substances that


are insoluble in dispersion medium and are
suspended by the use of suspending agents. If
liquids are used as dispersed phase then they
dispersed by emulsifying agents.

Lotions may be employed for:


Protective action
Local cooling and soothing action: The
inclusion of alcohol in a lotion hastens its
drying and produces cooling effect.
Whereas the addition of glycerin keeps the
skin moist for sufficiently long time and
have soothing effect.
Therapeutic action of their constituents
from sun burn, skin disorders, insect bite, acne etc.

Examples
Calamine lotion
Salicylic acid lotion
Zinc sulphate lotion

Precautions
 Bacteria and molds grow in certain lotions if no preservative is added to the
preparation.
 On long standing the lotions have a tendency to separate out. So container
must be labeled “Shake before Use”.
 The container should be labeled “For External Use Only”.

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LINIMENTS
These are alcoholic or oleaginous preparations of various medicinal substances
intended for external application to the skin generally with friction and rubbing.
These are liquid or semi-liquid preparations and can be solution, suspension or
emulsion.

Uses
• They are used for their rubefacient action:
Produce congestion or redness to the area to
which they are applied.
• Irritant: not directly affect the tissues but cause
inflammation of area to which applied.
• Counter-irritant: Irritate intact skin thus reducing or
relieving another irritation or deep seated pain.
• Penetrating action
Two types of vehicles

1. Alcoholic or hydro-alcoholic vehicle is useful when


rubefacient, counter-irritant or penetrating action is
desired.
2. Oleaginous vehicles are employed when massage is desired. They are less
irritating than alcoholic liniments

Precautions
 Liniments are not to be applied to the broken skin because they may produce
excessive irritation.

Storage and Labeling


 The bottle should be labeled: ”For external use only”.
 They should be stored in tightly closed containers
 The container must bear a label “Shake the bottle well before use”

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Aerosols
Aerosols are pressurized dosage forms containing
one or more than one active ingredients which
upon actuation emit a fine dispersion of solid and
liquid in gaseous form.
The liquid or solid drug particles are dissolved or
suspended in gas. The gas used for this purpose is
known as propellant.

Components of Aerosols are:


1. Propellant 2.Container
3.Valve assembly and actuator
4. Product concentrate

1.Propellants
These are chemical substances which are responsible for developing pressure
within a container and expel the product when valve is open.
Commonly used propellants
Butane, isobutane, Chlorofluorocarbons( difluoroethane, dichlorotetrafluoroethane)

2.Containers
Containers are available in tin plate, aluminum, stainless steel and glass material.

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3.Valve Assembly
Function of valve assembly is to permit the expulsion of contents of containers:
 In desired form
 In proper amount or dose
It has following parts
1. Mounting cup
Used to attach the valve properly to the
container, made of tin. Aluminum can also be
used.
2. Housing
It contains an opening at the point of
attachment of dip tube. It is made of nylon.
3. Stem
It supports actuator and delivers the product
in proper form. Made of nylon, brass and
steel.
4. Gas kat
It is used to prevent leakage of formulation
from container. Made of rubber.
5. Spring
Used to hold gas kat in plate. When actuator
is depressed and released it returns the valve
to its close position again.
6. Dip tube
It is used to bring formulation from container.
Its diameter vary from formulation to formulation.
7. Actuator
Its function is to deliver the aerosol product in proper and desired form.
 Spray actuator (Dispersing product into relatively small particles)
 Foam actuator (Large orifice)
 Solid actuator (Relatively large orifice used for semi-solid products)
 Specially designed actuator ( For appropriate site as nasal, throat, eye)

Metered Valve
These are valves which allow specific amount of product to come out and then stop
automatically. Such valves contain reservoir of specific volume which on actuation
empties all the contents present in it on single push of actuator.
e.g. metered dose inhaler (MDI)
4.Product Concentrate
It consist of: Active ingredient, Solvent system, Preservative/ Anti-oxidant,
surfactants.

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INHALATIONS
Inhalations are drugs or solutions of drugs administered by the nasal or oral
respiratory route. OR
Inhalations are liquid preparations containing volatile ingredients and are used for
local or systemic action (Absorption from the lungs) on the nasal or respiratory
tract.
Inhalations are used to relieve nasal congestion and inflammation of the respiratory
tract. Inhalations are used in various ways:
➢ If the ingredients are volatile at room temperature, they may be placed on an
absorbent pad and inhaled thereof.
➢ In other cases they may be added to warm water, the vapours are inhaled for
five to ten minutes.
➢ Another group of products known as inhalants are drugs or combination of
drugs that carried into nasal passages by their high vapour pressure. The
device in which drug is contained and by which inhalants are administered is
known as inhaler.

In order for the inhaled drug substance or solution to reach the bronchial tree, the
inhaled particles must be just a few microns in size. A widely used instrument
capable of producing fine particles for inhalation is nebulizer.
This apparatus consists of:
1.An atomizing unit
2.A rubber bulb

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Inhalation Aerosols
1.Humidifier: To provide a cool mist to the air in room, it may be ultrasonic.
2.Vaporizer: A device producing a fine mist of steam to humidify the room.

Uses
Inhalations are used to relieve nasal congestion and inflammation of the respiratory
tract.

SPRAYS

These are aqueous or oleaginous solutions in


the form of coarse droplets or as finely divided
solids to be applied topically usually to nasal
pharyngeal tract or to the skin.
They are sprayed into mouth for their laryngitis,
pharyngitis and tonsillitis action. But mainly
they are used to produce their action on the
lungs for which they are sprayed with a special
type of atomizer known as nebulizer.

Powder blowers or Insufflators may be


employed to produce a spray powder. This
divides the powder into a stream of finely
divided particles.

INJECTIONS/ PARENTERAL PREPARATIONS


Parenteral preparations or injectable are the sterile, pyrogen free solutions or
suspensions of drugs in aqueous or oily vehicles meant for introduction into the
body by means of an injection (parentally).
Since they are introduced into internal body parts they must be:

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 Sterile, free from all types of microorganisms and microbial products such
as toxins, pyrogens etc.
 Must be free from particles like dust, fibers.
 Should be isotonic with body fluids.
 Multi-dose injections must contain preservatives

Advantages
✓ Rapid onset of action in emergency situations (IV route)
✓ Most suitable route for non-cooperative and unconscious patients
✓ Prolonged action of a drug can be produced by this route (IM route)
✓ The route is preferred when the drug is not absorbed or inactivated
in the GIT.
✓ Solutions in volumes from mililitres to 4 litres can be introduced by
parenteral route

Disadvantages
 The administration of drug through wrong route may prove fatal.
 Mode of treatment is expensive as expertise is required

Formulation of parenteral products


Vehicles: The most suitable vehicle for dissolving or suspending the
medicament is water.
Oily vehicles are used when medicament is insoluble in water, prolong the
duration of action of drug. Cotton seed oil, peanut oil, sesame oil, olive oil.
Added substances
1. Solubilizing agents
2. Stabilizers
3. Buffers
4. Antibacterial agents
5. Isotonicity adjusters
6. Wetting, suspending and emulsifying agents
The use of coloring agents is strictly prohibited.
Manufacturing of parenteral preparations
➢ Washing and cleaning of containers, closures and equipment
➢ Collection of materials
➢ Compounding the preparation
➢ Filteration
➢ Distributing the preparation in final containers

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➢ Sealing the containers
➢ Sterilization
➢ Labelling and packaging
➢ Evaluation of parenteral preparations

Packaging and storage of injections


Single-dose container or ampoule
The container holding a quantity of sterile drug intended for parenteral
administration as a single dose and which when opened can not be re-sealed.

Multi-dose container or Vial


The container permits withdrawal of successive portions of the drug without
changing the strength, quality or purity of the remaining portion.

Intravenous fluids (Large volume


parenteral) / IV Infusions
1. Dextrose injection
2. Dextrose and sodium chloride injection
3. Mannitol injection
4. Ringer`s injection
5. Lactated Ringer`s injection
6. Sodium chloride injection

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SOLID DOSAGE FORMS

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POWDERS
Powders are the solid dosage form of medicament that is homogenous, finally
divided, dry materials.
Medicated powders intended to be as:
• Internal use
• External use

According to mode of dispensing powders are of two types:


1. Bulk powders
Generally less-potent drugs are supplied in the form of bulk powders. These are
packed in bulk containers. These are used internally and externally
Internal use: They are supplied in wide-mouthed containers in which a teaspoon
is entered for easy removal of the contents.e.g. Antacids, laxatives
External use (Dusting powders): these are meant for external application to the
skin for their antiseptic, protective and lubricant purposes. These are dispensed in
sifter type containers or pressure aerosols.

2. Divided powders
Powder is divided into individual dosing units based upon the dose to be
administered at a single time. These are simple (one ingredient) or compound (two
or more ingredient) powders for internal use. Divided portion of powder is placed
on a small piece of paper which is then folded.
e.g.Analgesics, ORS.

GRANULES

Granules are prepared from powdered substances, the particles of which are made
to aggregate by additions of solvents or binding agents or by some other means.
They are generally irregular shaped but may be prepared to be spherical.They are
used in the manufacturing of tablets.

Effervescent Granules
They contain a medicinal agent in a dry mixture usually composed of sodium
bicarbonate, citric acid and tartaric acid. When added to water the acids and base
react to liberate carbon dioxide resulting in effervescence.

Citric acid + sod. Bicarbonate sod. Citrate + CO2


Resulting carbonated solution masks the saline or undesirable taste of medicinal
agent present.

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TABLETS
Tablets are the solids dosage forms of medicinal
substances usually prepared with the aid of
pharmaceutical adjuncts (excipients). Intended for
oral, buccal, vaginal or rectal route of administration.

Advantage of tablets
✓ Ease of administration (easy to swallow)
✓ Surety of accurate dose
✓ Unpleasant taste can be masked by coatings.
✓ They are dry so more stable than liquid
preparations
✓ The deterioration of medicaments due to
environmental factors (oxygen and light) is less in tablet form

Disadvantage of tablets
 Children and elderly people cannot swallow the tablets
 The manufacturing cost is high.

DIFFERENT TYPES OF TABLETS


1. Compressed tablets

These are the tablets that are made up of single compression and in addition to
medicinal agent contain lubricant, binder disintegrant, diluents colorant and
flavorant.
Example
i. Paracetamol tablet
ii. Aspirin Tablets

2.Multiple Compressed Tablets

These are the tablets that are manufactured by multiple compression resulting in
I. A multiple layered tablet
ii. A Tablet within a tablet

3.Film Coated Tablets

To mask the unpleasant taste of drug and to prevent the tablets from external
conditions, a coating of polymer is applied. This coat ruptures in GIT. e.g. Maxit

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4.Sugar coated tablets

These are the tablets that are coated by colored or uncolored sugar solution
intended to make the bitter taste of tablets e.g. Brufen

5.Enteric coated tablets


These are the tablets which are required to be disintegrated in the intestines and not
in the stomach. They are coated which makes the tablet to pass the stomach as such
and breaks in alkaline medium of intestines.e.g Loprin

6.Buccal/Sublingual Tablets

These tablets are required to be placed below the tongue (sublingual) or in the side
of the cheek (buccal) e.g. Angised (nitroglycerine)
Generally these types of tablets contain those drugs which are destroyed,
inactivated or not absorbed in the GIT.

7.Effervescent Tablets

These tablets along with active medicament contain


other ingredients like sodium bicarbonate, citric acid
and tartaric acid which react in the presence of water
and liberate carbon dioxide, producing effervescence
leading to disintegration. e.g. Disprin, Cac 1000.

8.Chewable tablets
These are the tablets which are required to be broken and chewed in between the
teeth before ingestion. These are given to children and adults who have difficulty
in swallowing. E.g antacids, multivitamin tablets

8.Sustained Release Tablets

These are the tablets which after oral administration have prolong action duration
of drug e.g. Dicloran or Voltral

Formulation of tablets

Compressed tablets usually consists of active medicaments mixed with a number


of inert substances known as excipients or additives

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According to the functions which these additives play in the preparation of tablets
may be classified as follows:
1. Diluents
2. Binders
3. Disintegrating agents
4. Lubricants
5. Coloring agents
6. Flavoring agent
7. Sweetening agents
Methods of preparation of tablets
➢ Direct compression
➢ Dry granulation/ Slugging
➢ Wet granulation

TABLETS COATING
Deposition of any desired material on tablets to impart characteristics
properties to tablets.

OBJECTS OF TABLETS
COATING :-
1. For pharmaceutical elegance by
improving their appearance, taste
and stability.
2. Protection against environmental
factors (air, humidity)
3. To mask the taste of drug
Most recently coating has been used:
To control the site of drug release
(enteric coating)
Delay or prolong the release of drug
from dosage form (sustained release)
Coating pan

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TYPES OF TABLET COATING

1.Sugar Coating
Sugar coating is used to mask the unpleasant taste and odor, to improve the
appearance and to protect the ingredients
The various stages involved in sugar coating are:
1.Water Proofing and Sealing Coat: is applied for tablets that may absorb
moisture and are adversely affected on contact with moisture. i.e. shellac

2.Sub -coating :- 3-5 coats using sugar based (heavy syrup)containing gelatin
/acacia.
3.Smoothing and final rounding:- 5-10 coats using thick simple syrup

4.Finishing and coloring :-several coats of a thin syrup containing the


desired colour are applied to attain final rounding smoothness and colour.
5.Polishing:- with fabrics / carnauba wax.

2. Film Coating
Sugar coating makes the tablets bulky and is time consuming. These
disadvantages can be overcome by using film coating. Which places a thin, skin
tight coating of a plastic like material(polyethylene glycol, carbowax, cellulose
polymers) on the compressed tablets. Film coating tablets are far more resistant
to destruction by abrasion than are sugar coated tablets.

3. Enteric Coating
It is done when tablets are required to disintegrate in intestine but not in stomach
Among material used in enteric coating are:
>Shellac and shellac derivative >Hydroxypropyl methylcellulose phthalate
>Polyvinyl acetate phthalate >Cellulose acetate phthalate

4. Air Suspension Coating


Hot air is passed into the coating chamber from lower which keep the
tablets somewhat suspended. Coating solution also enters the system at bottom; it
is rapidly placed on the suspended, rotating tablets.

5.Compression Coating
This method is also known as press coating or dry coating as no water or any
solvent is used in the coating. Only the dried granules are compressed around the
precompressed tablets.

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6.Dip Coating
The tablets to be coated are placed in a basket and then dipped in coating
solution.

7.Gelatin Coating
Gelatin coated tablets are called as GELCAPS. Gelcaps are easier to
swallow.

8.Electrostatic Coating
An ionic charge is imparted to the substance and an opposite charge to coating
solution.To apply films to conductive materials.

9.Laminated Coating
It is marely a coating that provides a second action or layer of medicament for
tablet as in :An enteric coated tablet in which on drug may be made
available for gastric absorption and another is released in the intestine.
CAPSULES
Capsules are solid unit dosage form in which the medicaments are enclosed in a
particularly tasteless, hard or soft gelatin shell and are intended for oral use.
The basic empty capsule shells are made from a mixture of gelatin, sugar and
water.

TYPE OF CAPSULES

There are two types of capsules


• Soft Gelatin Capsules
• Hard Gelatin Capsules

Hard Gelatin Capsules


These are the capsules that have hard shell of
Gelatin around its medicaments this Gelatin can be
prepared by reacting sugar ,water and gelatin .
There are two halves of hard Capsule shells:
• Cap (slightly large in diameter but shorter in length)
• Body (shorter in diameter and longer in length)
The drug is filled in the longer half (body) and other half is fitted as a cap.
Hard gelatin capsules intended for human medicine are manufactured in eight
sizes.

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Soft Gelatin Capsule
These are prepared from gelatin and water to which glycerin, sorbitol or propylene
glycol are added to make them elastic or plastic like. Soft Gelatin Capsules are
found in different shapes e.g.
• Oval
• Tube Shape
• Round
These are used for filling liquids and
semi-solids. Vitamin preparations such as
vitamin A, D and multivitamins

Advantages of Capsules

✓ Capsules may be used for dispensing solid, semi-solid and liquid drugs.
✓ Easy to swallow as they are tasteless and odorless.
✓ In capsule manufacturing less adjuncts are required as compare to tablets
✓ Capsules can be colored to protect from light.
✓ They are easy to handle and carry

Disadvantage of Capsule

 Capsules cannot be used for aqueous and alcoholic preparation as they will
attack the shell.
 Hygroscopic substances are not suitable to capsulate, they absorb moisture
and make shell brittle.

SUPPOSITORIES

Suppositories are solid dosage form of medicament intended for insertion into
body cavities other than mouth. They may be inserted into rectum, vagina or
urethra, where suppositories soften or melt at body temperature which releases the
medicament and exert local and systemic actions.

Suppositories vary in shapes, sizes and weights.


✓ These are convenient for administration of drugs which irritate GIT, cause
vomiting, destroyed by stomach PH.
✓ Easily administered to children, old people, and unconscious patients.
✓ Suppositories are used for local actions(rectal: relieve constipation),
(vaginal: antibacterial, local anesthetic, analgesic)

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✓ For systemic effects, mucous membrane of rectum and vagina permits
absorption of many soluble drugs

CLASSIFICATION OF SUPPOSITORIES

1.Rectal suppositories
Shape: They are tapered at one or both ends
Size: 32mm in length
Weight: 2g ----------------------------Adult
1g ---------------------------children

2.Vaginal suppositories or pessaries


Shape: Oval, rod or cone shaped.
Size: They are larger than rectal
suppositories.
Weight: is about 5g and varies depending upon the base used and purpose.

3.Urethral suppositories or bougies


Shape: long, thin, pencil shaped rounded from both sides
Size: Male 3-6mm----------------- diameter
140mm ----------------length
Female 70mm ---------------length
Weight: Male 4g
Female 2g

4.Nasal suppositories
Also known as nasal bougies meant for introduction into the nasal cavity
Shape: similar in shape to urethral bougies
Size: 32 mm ------------length
Weight: 1g

5.Aural suppositories (Ear cones)


Shape: These are also pencil shaped like bougies
Size: 32mm ----------------length

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Type Shape Size Weight


Rectal Tapered on one or 32mm Adult: 2g
both ends Children: 1g
Vaginal Oval, rod, cone Larger than rectal
shaped 5g
Urethral Long, thin, pencil M: 140mm M: 4g
shaped F: 70mm F: 2g
Nasal ---------------- 32mm 1g

Aural ---------------- --------

SUPPOSITORY BASES

These play very important role in release of medication. They remain solid at room
temperature but melt at body temperature and made drug available. Commonly
employed bases are cocoa butter (Theobroma oil), glycerogelatin base,
polyethylene glycols.

1. Fatty or oleaginous bases: Cocoa butter


It is a fat obtained from the roasted seed of theobroma cocoa. Its melting point is
30-350C. it melts at body temperature and release the medicament. It’s a very good
base for rectal suppositories. It is not suitable for pessaries, urethral or nasal
bougies because immiscible with mucous secretions and after melting leaks out of
the cavities.

2. Water miscible bases:


1.Glycero-gelatin base
It is a mixture of glycerin and water which is made stiff by addition of gelatin. The
base being hydrophilic slowly dissolves in aqueous secretions and slow release of
medicament. It may be used to prepare all types of suppositories particularly
vaginal suppositories.

2. Polyethylene glycols
These are polymers of ethylene oxide and water. They are commonly known as
carbowaxes. They don’t melt but dissolve in body fluids and release medicament.

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SEMI-SOLID DOSAGE FORMS

OINTMENTS
Ointments are soft and greasy semi-solid preparations intended for application on
the skin or mucous membrane.
Types of Ointments
i. Medicated Ointment: contains a medicament dissolves, suspended or
emulsified in the base.
ii. Non-Medicated ointment : are used as vehicles for preparation of medicated
ointments or can be used for their emollient and protective action to the skin.

Classification Of Ointment Bases


1. Oleaginous bases
These bases consist of water insoluble hydrophobic oils and fats. The most
important are hydrocarbons e.g. petrolatum (soft paraffin), liquid paraffin (liquid
petrolatum or white mineral oil)
These bases are greasy and difficult to remove from skin. They prevent drainage
on oozing areas and evaporation of cutaneous secretions.
2. Absorption Bases
The term absorption is used to show the hydrophilic character of the base. They
absorb large amount of water but still retain their ointment like consistency.
Wool fat (anhydrous lanolin) obtained from wool of sheep
Hydrous wool fat (lanolin)
Bees wax it obtained from honey comb of bees.
3. Emulsion bases
These are semi-solid emulsions. These are of two types: o/w and w/o
The additional amount of water can be incorporated in both the types. These bases

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contain both water soluble and water insoluble components. These have
emulsifiers and because of their surface active property may facilitate contact
between medicament and skin.
Hydrophilic ointment, rose water ointment, vanishing creams.
4. Water soluble bases
These contain only the water soluble ingredients but not the greasy substances.so
also known as greaseless bases. These are water washable.
Polyethylene glycols (carbowaxes)
Certain other substances that are used as water soluble bases include tragacanth,
gelatin, pectin, cellulose derivatives.

Other additives in ointments


Preservatives: bases having high water contents support the microbial growth as
compared to that having no water. So preservatives such as methyl parabene or
propyl parabene, benzoic acid may be incorporated if they are intended to be stored
for a long time.
Antioxidants
Chelating agents

Preparation of ointments
1. Trituration method
2. Fusion method
Packaging
• Should be packed in well closed container
• These are packed in ointment jars and collapsible tubes
• Should be so packed that there are no air spaces in container
Storage
• Store at cool place to avoid softening and liquification of the base.
• They must be protected from air, light and moisture.
Labeling
It should be labeled
“FOR EXTERNAL USE ONLY”
OPTHALMIC OINTMENTS
Ophthalmic ointments are sterile dispersions of
medicaments in a base meant for application into the
eye. They should be sterile and free from irritation. The
base selected for an eye must be non-irritating and
permit the diffusion of drug throughout the secretions
of the eye and must melt close to the body temperature.
The preparation must be carried out under aseptic

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conditions.
CREAMS
Creams are non-greasy viscous liquid or semi-solid preparations (emulsions)
intended for the application on skin and mucous membrane.

Creams may be:


i. Medicated creams (for specific action)
ii. Non -Medicated creams (as emollients:
to soften the skin)

Creams contain a water soluble base due


to which they can be easily removed
from skin.
They are of softer consistency

TYPES
Water in oil (oily creams)
Oil in water (aqueous creams)

Preservation
The aqueous creams have a tendency to bacterial and mold growth, therefore a
preservative must be added.

Containers and storage


 Creams should be supplied in well closed containers, which should prevent
evaporation and contamination.
 They should be stored in a cool place.
 The collapsible tubes made of metals or plastic are most suitable for packing
the creams.
 Aluminum tubes are not suitable for packing creams.

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PASTES

Pastes are semi-solid preparations, used for application to the skin. They are
dispersions of high concentration of insoluble powdered substances in a fatty or
aqueous base.

 They are less greasy and stiffer than ointments due to high solid
concentration.
 They are more absorptive than ointments
 As they are stiff so don’t melt at ordinary temperatures and forming a
protective covering over the areas to which they are applied.
 They are difficult to remove so not suitable for application to hairy area.

Zinc and salicylic acid paste which is also known as Lessar`s paste is the most
commonly used paste. It is used as an anti-septic paste.

Storage and labeling


❖ They should be stored in air tight containers. So as to prevent evaporation of
moisture present in the paste.
❖ Pastes which contain water must be suitably preserved by adding anti-
microbial preservatives.
❖ They must be labeled “FOR EXTERNAL USE ONLY”

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Chapter 7
Compounding and dispensing
DISPENSING: In dispensing, medicines are
supplied to the individual patient usually in
response to prescription. It concerned with
proper distribution of medicines.
It requires the extensive knowledge of___
 The stability of medicines and their
ingredients
 Principles of compounding
 Dosage
 Physical, chemical and therapeutic
incompatibilities
 Packaging methods
 Labeling procedures
 Legal requirements for storage, containers, labeling, supply (drug sale) and
records.

General dispensing procedure


➢ Wear a freshly laundered overall coat. It should be spotless and clean.
➢ Provide yourself with clean glass-cloth and a duster or sponge. It is used for
cleaning the dispensing area.
➢ Work in a clean and tidy manner. Don’t accumulate stock bottles and
equipment in the working area.
➢ Read the prescription carefully
➢ If necessary, find the formula of preparation in an appropriate source of
information (official books: BP,USP etc)
➢ Check the doses of internal preparations
➢ Confirm that there are no incompatibilities in the preparation or between
different preparations on the prescription.
➢ Look up the storage conditions for the preparation
➢ Check the calculations
➢ Collect the correct container and closure
➢ Write the main label and collect any special labels that are required
➢ Make the preparation, pack it in container
➢ Check the labels and fix them to container
➢ Check the finished preparation
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➢ Wrap the container and write the patients name and address on the wrapper
➢ Make the appropriate records
The prescription
Prescription is a written order from a physician, dentist or any other registered
medical practitioner to compound and dispense a specific medication for the
patient.
The order is accompanied by directions for the pharmacist that what type of
preparation is to be prepared and how much is to be prepared. It is also
accompanied with the directions for the patient.

Parts of a Prescription
A complete prescription should have following parts.
✓ Name, age sex and address of the patient
Age and sex helps the pharmacist in checking the medication and the dose,
especially in the case of children. The address is recorded to help for any
reference at later stage.
✓ The date prescribed
It helps pharmacist to find out the cases where prescription is brought for
dispensing long time after its issue. The prescription should be filled
within suitable time after it is written.
✓ Superscription
This part is represented by a symbol Rx which is always written at the
beginning of the prescription. This is an instruction to the pharmacist. It
is an abbreviation for the Latin world “recipe” meaning you take.
✓ Inscription
This is the main part of prescription. It contains the names and quantities of the
prescribed ingredients. The medicament may be prescribed as:
a) An official preparation
b) A proprietary product
c) A special formula with the description of the type of preparation i.e. lotion,
tablet.
✓ Subscription
This part contains prescriber’s directions to the pharmacist regarding the dosage
form to be prepared and number of doses to be dispensed.
✓ Signatura
It is usually abbreviated as” Sig” and consists of directions to the patient regarding:
administration, quantity of medicament, number or dosage units to be taken, how
many times in a day and at what time drug to be taken.
✓ Refill status
Prescription can be used for refill or not.

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✓ Name, address and signature of prescriber

EXAMPLE OF TYPICAL PRESCRIPTION

GENERAL HOSPITAL MULTAN

NAME: SHAHID SEX: M AGE: 45


ADDRESS: VEHARI CHOWK, MULTAN

Rx
LINCOCIN - 500mg
Disp. 20 tabs
One T I D
REFILL –
LABEL-
Dr. SIGNATURE AND REGISTERATION NUMBER

HANDLING OF PRESCRIPTION
The manner in which a pharmacist handles a prescription can enhance his image in
the eyes of both physician and patient.

Handling of prescription comprises of following steps:


1 .Receiving 2.Dosage calculation 3 .Compounding
4 .Finishing 5 .Pricing 6.Delivering

1 .RECEIVING THE PRESCRIPTION:


Pharmacist should receive the prescription from the patient in a professional
manner .If a verbal order is received, the pharmacist has to transcribe it into written
form.
Receiving include:
A: READING THE PRESCRIPTION;
The prescription order first should be completely and carefully read from top to
bottom .There should be no doubt as to the ingredients and quantities prescribed.
There should not be any “guess work” regarding the spelling etc .as this may
lead to serious consequence
B.CHECKING THE PRESCRIPTION:
Prescription is also checked for any incompatibility, likely to exist and should be
removed after consulting physician.
2. DOSAGE CALCULATION:

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The dose of each ingredient should be calculated and its safety is verified by the
pharmacist .Age is important for dose administration .A child’s dose is calculated
as a function of adult dose and is calculated by following formula.
A.YOUNG’S RULE:
Child dose =child’s age in years× adult dose /child’s age in years +12.
b. COUNTING ‘S SCALE :
Child dose=age+2/24 × adult dose
c. CLARK’S RULE:
Child dose=Childs weight in pounds(lb)/150 x adult
dose
d. FRIED’S RULE:
Child dose= child’s age (month)/150 ×adult dose.
3. COPMPOUNDING:
After reading and checking, pharmacist should follow
the procedure forcompounding the medicine.
Materials to be used in compounding the prescription
should be collected on the left hand side of the balance.
After weighing the ingredients are shifted to the right.
The ingredients should be accurately weighed and after
being used, should be placed in their proper sites. A
white paper should be placed on table while
compounding, use electric machine for correct and accurate weighing.
4. FINISHING THE PRESCRIPTION:
Finishing the prescription includes”
a. Packaging b. Labeling c. Rechecking d. Filing /Recording
a. PACKAGING:
After compounding the prescription the drug is transferred to a container which is
by the pharmacist choice, best suited considering the drug container interactions
and drug stability .
1. Syrup in glass bottles
2. Tab. in glass or plastic bottles
3. Cream in jar
4. Ointments and emulsion in collapsible tubes

b. LABELING:
The container should be applied with appropriate label which reflect neatness
and professional attitude of pharmacist .A carelessly made dirty label will
destroy the reputation of the pharmacy. The following information should be
written on the label.
1. Type of preparation (mixture, emulsion, powder etc.) and their strength.

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2. Patient bio data
3. Date of dispensing
4. Direction for use
5. Storage condition
6. Precaution
7. Name and address of pharmacy
c. RECHECKING:
Every prescription should be checked against preparation order. After labeling,
the container should be thoroughly polished to remove the finger prints and
then dispense.
d. FILLING/RECORDING:
A variety of prescription files are available which serve to maintain and
preserve original prescription orders in numerical order .A clean and concise
record of all the prescription is maintained.
5. PRICING OF PRESCRIPTION:
The prescription should be priced immediately after receiving it and informed
the patient about it. This should be done before starting the compounding of
prescription so that there will not be any dispute cost is evaluated by
considering following
1. Cost of ingredient
2. Cost of container
3. Cost of overhead coverage
4. Personal fee
5. Net profit.
System 1: some pharmacist use coding system
e.g. P H A R M A C I S T
1 2 3 4 5 6 7 8 9 10
If patient is poor than code P is used i.e. 1% net profit
System 2: some formula have also been evaluated
Price =cost of ingredients + (cost of ingredients multiply %markup)
If cost of ingredient is Rs .8 and mark up is 10%than price =8+ (8 ×10/100) =
Rs 8.8
System 3: Price=cost of ingredients + (cost of ingredients × markup) +main fee
If cost of thing is Rs 8, markup is 10 %and main fee is 0.2

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Than price is=8 + (8multiply10/100) + 0.2=Rs .9
PRICE VARIATION:The unfavorable attitude of public towards prescription
prices is due to large variation in prices charged in different stores for filling the
same prescription. It also occurs in same store when prescription is filled by
different pharmacist.
THEORY OF PRICE
The price charged for filling a prescription must be sufficient to cover the cost
of ingredients container, time required for compounding and dispensing,
professional services fee and in addition to yield a net profit.
6. DELIVERING THE PRESCRIPTION:
Delivering the prescription to the patient is of three types
a. Store Delivery :
Most prescriptions are delivered in the store to customer .In this type of
delivery, the pharmacist personally deliver prescription medication .By doing so
pharmacist assures himself that patient understands how to assure medication.

b. Home Delivery:
Home delivery of prescription is offered by many pharmacies in large cities.
Telephoned order for refill to be delivered, especially frequent delivery charges
may be added and special instructions are also added in the box.
C .Main delivery:
In mailing the finished prescription to patient, it is necessary to observe all postal
and legal restrictions. Packing and labeling requirements should be checked by
first class mailing.

REFILLING OF PRESCRIPTION;
The refilling of prescription is governed by Federal Law which divided the drug
into two categories.
1. Those drugs which are potentially toxic or dangerous causes harmful effects
These can’t be dispensed without a prescription .These can also be divided into
three groups.
GROUP A:
Very dangerous drug cannot be refilled .e.g. .morphine
GROUP B:
These drugs are dispensed with prescription which can be refilled .e.g.
Apomorphine
GROUP X:
These drugs contain very small amount of dangerous ingredients and can be issued
without prescription but its record is kept .e.g. Corex
1. Syrup contain very small amount of codeine .Drugs containing 2 gram of opium
1 gram of codeine or ¼ gram morphine in this group.

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2. Those drugs which are not harmful and can be dispensed without a prescription
such OTC cover Rx counter drugs .These are common drugs such as NSAID; s etc.

CONTAINERS AND CLOSURES


Packaging: it is the art and science in preparing a
product for transport, storage, display and use.
Pharmaceuticals are suitably packed so that they
should retain their therapeutic effectiveness from the
time of their packaging till they are consumed.
A package may consist of:
Container: In which the drug is placed and is in direct
contact with the drug.
Closure: This seals the container to exclude oxygen,
carbon dioxide, moisture, microorganisms and prevent
the loss of volatile substances. It also prevents the loss
of medicament during transport and handling.
Factors selecting container for packaging
The selection of container for packaging of pharmaceuticals product is depended
on following factors:
I. Nature of product:
• Its chemical activity, sensitivity to moisture and oxygen, compatibility with
packaging material.
II. Type of patient:
• Is it to be used by an elderly or arthritic patient or by a child?
III. Dosage form
• Either solid or liquid or gas.
IV. Method of administrating the medication.
V. Required shelf-life.
VI. Product use
• Such as for dispensing or for an over the counter product.
VII Cost of container.
VII. Type of container
• Child resistant closure and temper evident seals.

Desirable feature of containers:


1-Container must be rigid enough to prevent damages to the contents.
2-The materiel of construction must not react with the content.
3-Closure must prevent.
• Access of moisture to tablets and capsules.
• Loss of moisture from cream ointment and paste.

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• Unintentional escape of the content.
4-Closer must be easily removed and replaced.
5- It must not be difficult to abstract the content or to empty the container
completely.
6-Medicament must not be absorbed by container material nor must diffusion
through the wall be possible.
7-It must be easy to label the container correctly.
8-It must have a pharmaceutically elegant appearance.

TYPES OF CONTAINERS
According to method of closure and use
1. Well closed containers
To protect the preparation from contamination and to prevent the loss of potency of
active constituents during transport, storage and handling.

2. Air-tight containers
To protect preparation from atmospheric contamination of liquids, solids or
vapours. Prevent loss of drug due to efflorescence or evaporation.

3. Light resistant containers


Protect drugs which undergo decomposition in the presence of light. These drugs
may be enclosed in amber colored or opaque containers.

4. Hermetically sealed containers


Which does not allow the air and other gases to pass through it. Generally used for
injectable. A glass ampoule sealed by fusion is most common example.

5. Single dose containers


They are used to supply only one dose of the medicament. e.g ampoules

6. Multi-dose containers
This type of container hold a number of doses. It is sealed in such a way that
successive doses can be withdrawn easily. e.g.multidose vials

7. Aerosol containers
Containers for aerosol must be strong enough to withstand the pressure evolved at
the time of use of the preparation.

8. Temper-Evident Container

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These are closed containers fitted with a device that irreversibly
indicates if the container has been opened .
According to their shapes
1.Glass / polyethylene bottles
a) Narrow mouth
Liquid oral preparations intended to be
swallowed like syrups, elixirs, emulsions,
suspensions are required to be dispensed in
narrow mouthed bottles.
b) Wide mouth
Semi-solid preparations like ointments, creams,
pastes are dispensed in wide mouth containers.
On manufacturing scale collapsible tubes are
preferred.
Bulk powders and granules for internal
use, and dusting powders are dispensed in
air tight, wide mouthed glass or plastic
jars.

2.Dropper bottles
Eye drops, Ear drops, Nasal drops should
be dispensed in amber colored glass bottles
fitted with a dropper.

3.Collapsible tubes
4.Ampoules
5.Vials
6.Polythene packets for intravenous fluids
7.Envelops, strips, blister packs, cartons, boxes.
Solid dosage forms like tablets, hard and soft
capsules are generally packed in strips. Individual
powders are dispensed in paperboards or plastic
boxes.

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MATERIALS USED FOR CONTAINERS


1. Glass
2. Plastics
3. Metals
4. Paper
They are used either singly or sometimes in combination with each other.

Glass
It is hard, brittle and transparent and is composed of a network of silicon and
oxygen atoms. Special types of glass e.g. colored glass or heat resistant glass can
be produced by adding certain other substances.
Various types of glass used for pharmaceutical purposes.
➢ Type-I Borosilicate glass
➢ Type-II Treated soda lime glass
➢ Type-III Soda lime glass
➢ Type NP Non parenteral glass
➢ Colored glass
➢ Neutral glass

Plastics
Plastics are high molecular weight polymers possessing long carbon chains.
The various polymers used for the manufacture of containers are:
➢ Polyethylene
➢ Polyvinyl chloride (PVC)
➢ Polystyrene
➢ Polypropylene
➢ Polyamides (Nylons)

Metal
Metal containers are not very
popular for packing the
pharmaceutical products because
they react with the preparations.

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However they are used for packing aerosols, powders and tablets.
Metals used for pharmaceuticals:
➢ Tin
➢ Aluminum
➢ Lead
➢ Iron
Collapsible tubes made from aluminum, tin and lead are used. They are used for
packing semi-solid preparations i.e. ointments, creams, pastes, toothpastes and
cosmetics. They are attractive containers. Lead should never be used alone for
anything taken internally due to risk of lead poisoning. They are used with internal
linings.
Paper
It has an insignificant role in primary packaging but it remains the predominant in
secondary and tertiary packaging material
TYPES OF CLOSURES
Closures are available in five basic designs:
1. Screw-on
These are of two types
a) Threaded screw cap
When screw cap is applied its threads engage with the corresponding threads
moulded on the neck of bottles. Fig 1
b) Lug cap
It is similar to threaded screw cap and operates on same principle but it has
interrupted thread on closure instead of a continuous thread .it is widely used
in food industry. i.e. jam bottle caps. Fig 2

Fig 1 Fig 2
2. Crimp-on
These are crown type closures used as crimped closures for
beverage bottles and remain unchanged for more than fifty years.
3. Press-on
a) Snap seals : these are used in Cac 1000

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b) Bung seals: they are conical and can be inserted for about half their length
into the neck of container. Rubber is excellent material for bung closure i.e.
closure of vials of penicillin powders. Fig 5
4. Roll-on
The aluminum roll on cap can be sealed securely, opened easily and resealed
effectively. Pilferproof types of roll on closures are available for glass and plastic
bottles. These are thread less straight –sided shells.
Materials used for closures
1. Cork
It is wood obtained from bark of oak tree. Used as stoppers for narrow mouth
bottles. Fig3
2. Glass
As compared to cork glass is ideal material for making the stoppers. But they don’t
provide leak-proof closure. Fig 4. F

3. Plastics
Plastic closures are more popular than other closure materials. They are
unbreakable and easily moulded into various sizes and shapes. Fig 1
4. Rubber
Rubber closures are mainly used for vials, multi-
dose containers and IVfluid

Fig 3 Fig 4
Fig 5

bottles, because it can withstand sterilization


temperatures. Fig 5

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5. Metals
Tin plate and aluminum are most commonly used. To make the closures pilfer-
proof they may be sealed with aluminum cap.

Unit Dose Packaging


The unit dose package for oral solids is made from some flexible material or may
be the strip type package.
Blister packaging
The package
consists of a
transparent
plastic
material and a heat
sealable
backing
material.( Fig a)
Strip
packaging
In strip
packaging the tablets and capsules are packaged in a
flexible film or foil that are connected in a continuous film. i.e. aluminum foil( Fig
b)

Fig a Fig b

Child-Resistant Containers (CRCS)and Closures:

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Any container and closure system should provide
an effective seal to retain the container contents
and exclude external contamination, in response
to demands for greater protection of children
against accidental poisoning is known as child-
resistant containers &closures (CRCS).
They take advantage of the greater strength of
adults for ease of opening and generally
incorporate a locking mechanism.The commonly
consist of a glass or plastic vial or bottle with a
specially designed closure e.g. palm and turn
tablet and capsule container is replaced by
pressing down on the lid with palm of the hand
and turning at the same time.
The closure in common use with dispensed
medicines are the snap-safe closure and push
down turn clic-locR closure.

Chapter8
Total parenteral Nutrition
(parenteral hyperalimentation)
It is a method of administering enough basic nutrients to achieve active tissue
synthesis and growth via parenteral route.

It is characterized by the long-term IV feeding of protein solutions containing high


concentrations of dextrose (approximately 20%), electrolytes, vitamins, and in
some instances insulin. The individual components and amounts vary with the
patient’s needs.
Components of TPN formulation:
It contain following components
 Water
 Protein source: lack of nitrogen cause poor
wound healing interfere with body defense
mechanism. Amino acid is included in TPN
as a source of nitrogen.
 Energy source : Carbohydrates and fats
The carbohydrate of choice is dextrose in
the form of 5-70% w/v solution. if
required in large quantities insulin can be

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administered in TPN to increase uptake of dextrose.
Fat is administered in the form of oil in water emulsion. They provide
high calorie source in low volume.
 Electrolytes : Sodium, potassium, magnesium, chloride, calcium,
phosphate
 Trace elements: These act as metabolic cofactors and essential for
proper functioning of several enzymes in body. These are zinc, copper,
manganese
 Vitamins/ Minerals: Fat soluble and water soluble vitamins are
essential they act as co-enzymes in carbohydrate metabolism and DNA
synthesis.
ADULTS CHILDREN
Water 30-40ml/kg/day 30- 40ml/kg/day
Energy 30-60kcal/kg/day 20- kcal/kg/day
Amino Acid 1-2gm/kg/day 2.5-3.5gm/kg/day

TPN/HPN Bags
Bags should be sterile. In past polyvinyl chloride bags were used. Now ethyl
vinyl acetate bags are commonly used.
Addition Of Components To TPN
Amino acid solutions and glucose added into the bag first. Followed by any fat
emulsion if required. To prevent precipitation of vitamins, they are added
immediately before administration.
Labeling And Packaging Details on label are:
▪ Patient Name (ward and unit no)
▪ Components of bag
▪ Total volume(ml)
▪ Energy content (kcal)
▪ Nitrogen (g)
▪ Infusion rate (ml/h)
▪ Expiry date and storage conditions
Packaging
TPN bag is sealed into dark colored outer plastic bag. Outer label identical to inner
is placed. It is refrigerated until required to maintain stability.
Administration of TPN
The formulation is administered via catheter. The solution is administered slowly
through a large vein, such as the superior vena cava(central vein). The superior
vena cava is accessed through the subclavian vein immediately beneath the clavicle
and near the heart. This permits rapid dilution of the concentrated fluid and

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minimizes the risk of tissue or cellular damage due to the hyper-tonicity of the
solution. Generally, final concentrations of dextrose (not greater than 10%) can be
given peripherally. Solutions containing more than 10% dextrose should be given
via the superior vena cava.
The following abbreviations may be used in hospitals in describing the desired
order for parenteral nutrition:
CVTPN (central vein TPN)
TPN (total parenteral nutrition)
PPN (peripheral parenteral nutrition)
HPN (Home parenteral nutrition)
INDICATIONS
GIT diseases: ulcerative colitis, pancreatitis, malabsorption syndrome
Trauma: severe burn, acute renal failure
Abdominal surgery
ROLE OF PHARMACIST
➢ Pharmacist can provide information on aseptic techniques
➢ Handling & setting TPN bags
➢ Formulation requirements
➢ Stability problems
➢ Storage conditions

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Aseptic Dispensing
Aseptic dispensing is the preparation and supply of sterile medical products, which
require some dilution or other handling before administration. The preparation is
carried out in the pharmacy by trained pharmacy technicians, assistants and
pharmacists.
The preparations are aseptically dispensed in response to a prescription/ order for a
patient, under the supervision of a pharmacist.

Sterilization
Sterilization is a process that eliminates (removes) or kills all forms of microbial life
such as fungi, bacteria, viruses, spore forms, etc.

Basic Approaches for Sterile Preparation


1.Terminal Sterilization
2.Aseptic Process
(Aseptic: the complete absence of living microorganisms)

1.Terminal Sterilization
Terminal sterilization is a more traditional method of sterilizing products. In
terminal sterilization, we fill a container, seal it and then sterilize it.
Whenever possible, products intended to be sterile should preferably be terminally
sterilized by heat in their final container.

2.Aseptic Process
Aseptic processing is the process by which a sterile product is packaged in a sterile
container in a way that maintains sterility. Aseptic processing is a simple idea.
Sterilize a container, sterilize its cap, sterilize its contents and put them together.

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Where it is not possible to carry out terminal sterilization by heating due to the
instability of a formulation, a decision should be taken to use filtration and/or
aseptic processing.

In order to maintain the sterility of the components and the product during aseptic
processing, careful attention needs to be given to the environment, personnel,
container & closure sterilization and transfer procedures.

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Chapter 9
INCOMPATABILITIES
Incompatibility is defined as:
“The change which occur in the quality of a preparation” as a result of prescribing
or mixing the substances which antagonize (opposite) each other and an
undesirable product is formed which may affect the safety, purpose or appearance
of the preparation.
Incompatability may be classified as follows

Pharmaceutical incompatibility Therapeutic incompatibility


1. Physical
2. Chemical

1.PHARMACEUTICAL INCOMPATIBILITY
It is a type of incompatibility which results during the process of compounding or
preparation of pharmaceutical dosage form. Primarily they affect the appearance of
products. Occasionally they can lead to therapeutic incompatibility if not corrected.
It is of two types:
a) Physical incompatibility
It is a result of direct physical interaction between two or more components of a
preparation. It is due to
➢ Insolubility (incomplete solution)
When two or more substances are combined they may not give a homogenous
product due to insolubility.
➢ Immiscibility (separation of immiscible liquids: salting out)
Separation of a liquid from solution upon addition of another solvent takes place
with which liquid is immiscible. e.g oils dissolved in alcohols separates on addition
of water.
➢ Precipitation
A substance is precipitated from its solution upon addition of another solvent in
which substance is insoluble.
➢ Liquefaction
Mixtures of solids sometimes liquefy due to absorption of water or release of water
of hydration.
➢ Gelatinization
Solutions may form a gel when combined with certain substances

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Physical incompatibility usually causes non-uniform dosage (difficult to measure
accurate dose), unpalatable mixtures.

CORRECTION
✓ Change the vehicle
✓ Modify the mixing order
✓ Addition of suspending agent, emulsifying agent, solubilizing agents.
✓ Add adsorbents
✓ Remove the troublesome ingredient
✓ Change the dosage form

b) Chemical incompatibility
It may be result of chemical interactions between the ingredients of a prescription
and a harmful or even dangerous product may be formed. These generally result
from:
❖ Hydrolysis
It is addition of water. Aspirin (acetyl salicylic acid) upon hydrolysis converts into
salicylic acid and acetic acid.
❖ Oxidation-reduction reaction
• Sugars are oxidized by Cu++& Ag+ in alkaline PH.
• Oils and fats are oxidized by light to become rancid. All organic compounds
are oxidized by oxidizing agents Fe+3 (ferric) is an oxidizing agent.
• Silver compounds are reduced to metallic silver by light and reducing agent.
❖ Acid-base reactions
These may be indicated by: i. Evolution of gas (carbonates react with acid and
release carbon dioxide)
ii. change in color (reaction causes change in color indicating change in PH.
iii.precipitation (when soluble compounds react with hydroxyl (OH- ) ion or
strong acids they form insoluble compounds).
❖ Combination reactions
In these reactions ions of one compound reacts with ions of other compound to
form precipitates.
AgNO3 + NaCl AgCl + NaNO3

CORRECTION
✓ Complete the reaction before packaging
✓ Protect from air, light and moisture.
✓ Add desiccants.
✓ Addition of anti-oxidants, buffering agents and chelating agents.

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2.THERAPEUTIC INCOMPATIBILITY

When the effect produced by one or more drugs is different in nature and intensity
from that intended by the prescriber.

It is due to administration of:

➢ Overdose and under dose of a drug( Improper dose)


Excessive single dose
Over dosage may results from Excessive daily dose
Synergistic combination

Under dosage may be due to Antagonistic combinations


Prescription writing errors
➢ Incorrect drug
Trademark error: it may be due to products with very similar names. Error in
prescription handling may be due to difficult hand writing.

➢ Wrong dosage form


Toxic external preparation is prescribed internally. Skin preparations are
prescribed for eye.

➢ Contraindicated drugs
Prescription calls for a drug to which patient is allergic. Patient is still taking a
previous prescription which may be contraindicated with new one.

CORRECTION
✓ Review prescription for possible errors
✓ Educate patient about proper use of drug. (Time, frequency and dose)
✓ Enquire patient about other prescription and OTC drugs.

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Chapter 10

INTRODUCTION AND APPLICATION OF VARIOUS


PROCESSES IN PHARMACY

1. Adsorption

When a solid surface is exposed to gas or liquid molecules then gas or liquid
molecules accumulate at the surface it is called adsorption.
The substance that deposits at the surface is called adsorbate. And the solid on
whose surface the adsorption occurs is called adsorbent.

Attachment of Particle
The solid particles have more compact molecules
than liquid or gases. So, it acts as a foundation in
adsorption for liquid or gas particles. On surface
they can join by the following ways
• Ionic bonding
• Physical interactions
• Chemical Interaction

Difference between adsorption and absorption


Adsorption means deposition on surface only
while absorption means penetration into the body
of solid.

Types of adsorption

Adsorption fundamentally divided into two main


categories
1. Physical Adsorption
It is the interaction of liquid or gas particles with
solid particles surface and there is physical
characteristics are involved
Example
Many drugs are absorbed from GIT and skin through
physical adsorption mechanism.

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2. Chemical Adsorption

It is the process in which liquid or gas particle binds to solid particle surface
through chemical interaction is known as chemical adsorption
Example Accumulation of O2 on the surface of iron

Factors affecting adsorption

Surface area
Increase in surface area leads to increase in the amount of gas adsorbed

Nature of gas
More liquefiable gases adsorbed more readily e.g SO2

Temperature
Adsorption decreases by increasing temperature.

Application of Adsorption

1. Adsorption is the mechanism of absorption through skin and GIT.


2. Adsorption is the fundamental mechanism of antidotes.
3. Removal of access acid from stomach by using weakly basic adsorbents.
4. It is used in discoloration of different substances. Activated charcoal remove
color from solution.
5. It is the main mechanism to combat with intestinal toxin Example etox-P
6. Removal of poisonous gases from atmosphere.

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2. Calcination

Calcination is the process in which the inorganic substances are strongly heated
so as to remove their volatile components and fixed component are preserved.

Mechanism of Calcination

On laboratory scale we use silica or platinum crucibles, china dishes and glass
dishes for this process. Firstly we add the chemical substance to respective
apparatus, now heat this chemical substance until volatile components are
evaporated and fixed components remain in apparatus. On industrial scale
rotary kilns are used in the process of calcination.

Examples

CaCO3 Cao + CO2


ZnCO3 ZnO + CO2

Application in Pharmacy

1. Calcination is used in the separation and


purification of certain inorganic
substances e.g. calcium oxide Zinc oxide
and red mercuric oxide.
2. It is used in the conversion of carbonates
to oxides.
3. Calcinations is used in Gravimetric
analysis which is used widely in
pharmaceutics and chemical industries

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3. Centrifugation

“Centrifugation is the process of separating lighter portions of a solution, mixture


or suspension from the heavier portions by centrifugal force”.
The rate of centrifugation is specified by the angular velocity measured
in revolutions per minute (RPM).

Microcentrifuges

Microcentrifuges are used to process small


volumes of biological molecules, cells, or nuclei.
Microcentrifuge tubes generally hold 0.5 - 2.0
mL of liquid, and are spun at maximum angular
speeds of 12,000–13,000 rpm.

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High-speed centrifuges
High-speed or superspeed centrifuges can handle larger sample volumes, from a
few tens of millilitres to several litres. Additionally, larger centrifuges can also
reach higher angular velocities (around 30,000 rpm). The rotors may come with
different adapters to hold various sizes of test tubes, bottles, or microtiter plates.

Ultracentrifuges
Ultracentrifugation makes use of high
centrifugal force for studying properties of
biological particles. Compared to
microcentrifuges or high-speed centrifuges,
ultracentrifuges can isolate much smaller
particles, including ribosomes, proteins, and
viruses. Ultracentrifuges can reach maximum
angular velocities in excess of 70,000 rpm.

Applications
Industrial centrifuges are used:
• For separating solids from liquids, liquid-liquid separation, and liquid-solid
separation.
• Removing fat from milk to produce skimmed milk
• Separation of urine components and blood components in forensic and
research labs.
• In laboratories performing biochemical analyses on body fluids, centrifuges
are routinely used: To separate blood cells from serum/plasma.
• To separate sediment from urine
• To measure the volume fraction of erythrocytes in blood (the hematocrit)

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4. Crystallization

It can be defined as highly specific method which is used to convert liquid into
solids by using evaporation, cooling or precipitation method is known as
crystallization.

Basic steps of crystallization


➢ Make supersaturated solution
➢ Formation of crystal nuclei
➢ Initiation of crystal growth
➢ Complete growth of crystals in mother liquor (liquid left behind after
getting crystals is called mother liquor).

Methods of crystallization

1. Evaporation
In this method the temperature of the liquid raised and the liquid evaporate so
finally we get a solid crystals of compounds.

2. Cooling
In this method we use cooling procedure to form solid crystals it is a very selective
method for heat sensitive materials. Supersaturated solution is cooled and then by
filteration of solution, crystals can be obtained on filter paper.

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The cooling method is divided into two subclasses


I. Slow cooling crystallization : large sized crystals can be obtained.
i. Rapid cooling crystallization: small sized crystals can be obtained.

3. Precipitation
In this method two chemical liquids are mixed together and precipitates are
formed and then separate out the solid material. It is very rarely used method of
crystallization

Factors affecting Crystallization


1. Temperature
2. Cooling rate
3. Precipitation rate
4. Rate of growth of crystals
5. Nature of solvent
6. Nature of substance
7. Impurities
Pharmaceutical application of crystallization

i) It is important purification mechanism used in pharmaceutical industries


to get pure solid drugs e.g. insulin, sulphur, cortisone acetate purified by
crystallization.
ii) Penicillin –G is solidify by this process
iii) Crystallization process is used to get proteinaceous drugs in solid form.
iv) Stability of drug is enhanced by crystallization.
v) It is very simple and less time consuming method to get extremely pure
drugs.
5. Decantation

It is a process used in pharmacy to separate out the impurities from the soluble
portion of the solution

Process
Decantation involves following steps
1. washing of the Solids
2. Adding the Solids in solvents and stir it
3. After the Solution formed separate all the
impurities After the removal of impurities we
will get a pure solution

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Applications

ii. This method is used to purify the solids.


iii. This process is also used to separate the solids from liquids.
iv. It is also use in the separation of gels and magmas.

6. Deliquescence

It is chemical process in which any anhydrous compound catch up the water


from its surrounding environment and convert itself into hydrated form. It is
also known as hygroscopicity.

The compound have the tendency to convert itself from anhydrate to hydrated
form are known as hygroscopic or deliquescence compound.

Mechanism

In deliquescence the humidity level of


product as compare of the humidity level of
atmosphere if this kind of material directly
interact with the atmosphere. The humidity
from atmosphere moves inside the product
and convert it from anhydrous form to
hydrous form.

Precautions

1. These products should not be kept open.


2. These products should be kept in well closed containers.
3. We add silica gel packet to absorb the humidity that is enclosed in
container.

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7. Dessication

It is drying procedure which is widely used in


pharmacy to remove the admixed water from the
product. The term dessicated is applied to those
substances or product that have undergone the
Dessication procedure.
The admix water is completely remove from the
substances or products. These are also termed as
dried products.

Mechanism

In Dessication the dessicant (silica gel) is used to remove the extra or


admixed water from the substance or product and term dry is usually used for those
products that do not have the noticeable quantity of moisture.

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Desiccants
The chemical used for desiccation are called desiccant. These are also called
dehydrating agents. They include:
1. P2O5
2. Silica gel
3. Exsiccated CaCl2
4. Conc. H2SO4
5. NaOH

Applications

1. Aid in preservation
Vegetable and animal drugs soon undergo decomposition by the bacteria and fungi
due to the presence of moisture. Desiccation process remove moisture from drugs.
It preserves them for longer period of time.

2. Reduce bulk weight


It reduced the bulk weight of drug by removing moisture, in the way reduce the
cost of transportation.

3. Increase the stability of drugs


Stability of drugs is increase by desiccation.

4. To facilitate communition
Desiccation process makes the drugs less elastic and more brittle. Brittle drugs are
triturated more easily as compared to elastic drugs.

1. Increase shelf life of crude drugs.


Shelf life of crude drugs is increased by desiccation.

Application

1. By using Dessication the stability of pharmaceutical product enhances


2. Dessication is a renowned process for drying
3. All the hygroscopic drugs are dried through Dessication process.
4. For Dessication dried silica gel and alumina is used in the bottles of
hygroscopic medicine.

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8. Distillation

It is the method of separating the constituents of a liquid by vaporizng the liquid.


The different componenets separate on the basis of their volatilities.

Principle

It is a purification as well as separation process in which a chemical substance is


boiled up to their boiling point until it convert into vapors then these vapors are
converted back into liquid and collected in the receiver, it is called distillate.

Apparatus

1. Still : the vessel or the container in which the liquid is hated.


2. Condenser : through which cold water is circulated to carry out
condensation
3. Receiver : vessel in which the condensed liquid is collected

Types of distillation.

1. Simple distillation (Distillation under atmospheric pressure)


2. Steam distillation
3. Fractional distillation
4. Vaccum distillation (Distillation under reduced pressure)

1. Simple distillation

The apparatus generally used for simple distillation consists of still, the condenser
and the receiver. Flask should be filled not more than half or two third of its size.
The liquid is converted into vapors which are passed through cooling surface to
condense the vapors.

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Simple Distillation Apparatus

2.Fractional distillation

This process is used to separate miscible volatile liquids having different boiling
points.i.e. mixture of alcohol and water. Miscible liquids can be separated by using
fractionating columns in between the still and the condenser. Fractionating column
condensing vapors of the less volatile component of the mixture and return it to the
still. The vapors of more volatile component pass through the condenser and
collected in receiver.

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3.Steam distillation

Steam distillation is used for the distillation of two immiscible liquids one of which
is water. The distillation apparatus consists of steam generator fitted with a tube
which carries the steam to the flask containing the liquids. When steam is passed
through a mixture of these liquids, it boils at a much lower temperature than the
boiling point of pure water. The vapors are allowed to pass through condenser and
distillate forms two layers which are separated from each other as completely as
possible.
This method is used for distilling heat-sensitive compounds as volatile oils i.e.
clove oil, eucalyptus oil.

4.Vaccum distillation
The liquids which are decomposed at their boiling point under atmospheric
pressure can be distilled at a much lower temperature when pressure is reduced on
the surface of liquid.

This process is carried out in claisen


flask(has two necks). Through one
inserted thermometer and attached to
condenser and other hold fine
capillary. Side tube of receiver
connected to vaccum pump, a
pressure guage(manometer) is
inserted b/w receiver and vaccum
pump.

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APPLICATIONS

✓ Distilled water, rose water and other pharmaceuticaly active ingredients are
obtained by distillation.
✓ Steam distillation is used for extraction of volatile oils from their crude
drugs i.e. clove, anise,eucalyptus oil.
✓ Petrol, kerosene, fuel oil, lubricant oil produced from fractional distillation
of crude oil
✓ For purification and separation of miscible and immiscible liquids.

9. Exsiccation

“Exsiccation is the process of removing the water of crystallization from the


hydrated crystalline substances by heat” and making them anhydrous.
After removing water molecules the abtained material is called “exiccated
material”.

➢ EXAMPLES:
The examples of exsiccated substances include
1. Exsiccated magnesium sulphate
2. Exsiccated ferrous sulphate
3. Exsiccated magnesium sulphate
4. Exsiccated sodium sulphate
5. Exsiccated sodium carbonate
6. Exsiccated alum
7. Anhydrous sodium arsenate

➢ Method:
In the laboratory, exsiccation may be carried out by taking a weighed
amount of the substance in a tarred dish which is heated on water bath,
Sand bath as or in an over, with continuous stirring until a constant weight
is obtained or until the calculated loss in weight has taken place.

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➢ THE TEMPERATURE REQUIRED TO REMORE WATER OF
CRYSTALIZATION IS VERY IMPORTANT:

➢ Examples:
1. Copper sulphate, CuSO4 .5H2O, when heated at about 30oC loses two
molecules of water of crystallization at 100oC it loses two more water molecules
and the last water molecule is removed when it is heated at 200 oC thus forming
CuSO4 .5H2O, CuSO4 .3H2O and CuSO4 respectively.

2. Ferrous sulphate FeSO4. 7H2O when heated on water bath lose six molecules
of water of crystallization but when further heated to remove last water molecule,
decomposition take place. Hence ferrous sulphate with one molecule of water of
crystallization FeSO4. H2O is called exsiccated ferrous sulphate.

➢ STORAGE OF EXSICCATED SALTS:


Since the exsiccated salts are very hygroscopic, so must be stored in well closed
containers.

➢ APPLICATIONS
1. To increase the shelf life of drugs and prevent from microbial
contamination.
2. It is also carried out to reduce the bulk and weight of certain drugs so that
they can be easily administered.
3. To obtain fine powder of the substance.

10. Ellutriation

This is a process of separating a substance into powders of different degrees of


fineness by stirring the substance with a large volume of liquid in which it
insoluble and withdrawing the liquid at different heights. The upper layers of liquid
contain suspension of the finer particles, while the lowers layers contain the
coarser or heavier particles.

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Explanation
Elutriation on large scale is carried out in elutriation tank consisting of vessels of
large capacity having taps placed at different intervals from top to bottom.
So that liquid can be draw at different levels. On small scales it is carried out in
elutriation jar it is made of glass and usually only as three taps.

Example
Chalk is prepared from native CaCO3 by elutriation. The CaCO3 is first levigated
with water then large volume of water is added to the mixture and it is stirred
briskly, after which different layers of liquid with different size of particle can be
separated. Upper layers is decanted containing with it finer particles while the
lower layers contain heavier or coarser particles.

Application
1. Calamine may be produced in the same manner from native Zinc Carbonate.
2. Kaolin is also prepared from pharmaceutical purposes by elutriation.
3. Chalk is produced from native CaCO3 by elutriation.

11. Evaporation

Evaporation is a phase transition from the liquid phase to gas phase that occurs at
temperature below the boiling temperature at a given pressure. It is a type of
vaporization of a liquid that occurs only on the surface of a liquid. Evaporation
produced cooling effect. In summers when sweat evaporates it produces cooling
effect on skin.

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Thus practically evaporation may be defined as removal of liquid from a
solution by boiling the solution is a suitable vessel.

Factors influencing the rate of evaporation

1. Flow rate of air


Higher the flow rate greater will be the rate of evaporation.

2. Inter-molecular forces
The stronger the inter-molecular forces lesser would be the rate of evaporation.

3. Surface area
Large the surface area greater will be the rate of evaporation.

4. Temperature of the substances


Greater the temperature greater will be the rate of evaporation.

5. Density
Higher the density slower a liquid will evaporate.

6. Agitation
The process of agitation increases the rate of evaporation.

7. Atmospheric pressure
Rate of evaporation will increase with decrease in atmospheric pressure.

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8. Concentration of other substances in air


If the air is already saturated with other substances then substance will evaporation
more slowly.

DIFFERENCE B/W Boiling Point AND Evaporation:


“Evaporation differs from boiling that evaporation takes place at all
temperature whereas boiling takes place only at one temperature at a given
pressure.
DIF B/W Evaporation AND Distilation:
“Evaporation differs from distillation that is evaporation the solvent which
is generally water is not condensed and collected whereas is distillation the
solvent vapors are condensed and are collected in a receiver .

EVAPORATORS

SMALL SCALE METHODS


A fixed maximum temperature can easily be attained by employing different types
of baths as a source of indirect heathing. A water bath is most suitable when the
liquids are to be heated up to 100oc. or soft paraffin may up to 150oc to prevent
decomposition.

LARGE SCALE METHODS

1. Evaporating pans
On a manufacturing scale, liquid
extracts containing water as a menstrum
are evaporated in open pans called
evaporating pans. They consist of
hemispherical or shallow pans made of
copper, stainless steel, aluminum,
enameled iron or other metal and
surrounded by a steam jacket. These
pans may be fixed or made to tilt to
remove the product.

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Advantages
1. They are simple, easy and cheap to construct.
2. They are easy to use and clean.
3. Stirring of the evaporating liquids can be done easily.
Disadvantages
1. The whole of the liquid is heated all the time which may lead to
decomposition of the components.
2. On the evaporating surface, scum is rapidly formed which decreases
evaporation. Solids may be deposited at the bottom which makes the
stirring necessary.
3. The pan can only be used for evaporating aqueous and thermo-stable
liquid extracts. They cannot be used for evaporating extracts
containing organic solvents like alcohol etc.

2. Evaporating stills
Evaporating stills are quite similar to evaporating pans, it consists of a
vessel made from copper condenser so that the solvent is condensed
and collected in a receiver. At the lowest point of the pan, a tube fitted
with a tap is connected for the removal of the product from the pan.
The pan is surrounded by a steam jacket. For cleaning the pan or easy
removal of the product the cover of the vessel may be fitted with
quick-release system of clamps.

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Advantages
1. They are very simple to construct and are quite easy to clean and
maintain.
2. The still can be used for evaporating liquids containing aqueous
and other organic solvent.
Disadvantages
1. The whole of the liquid is to be heated all the time which may
lead to deterioration of the product.
2. The heating surface is very limited.
3. This methods of evaporation is widely used in pharmaceutical
industries when small batches of liquids are to be evaporated.

Applications of evaporation
1. Evaporation is one of the most important processes in the
manufacture of pharmaceuticals.
2. It is used in the preparation of liquid extracts, soft extracts and
dry extracts and in the concentration of blood plasma and serum.
3. It is also used in the manufacture of drugs containing antibiotics,
enzymes, hormones and many other substances.

12. Fusion

Fusion process is commonly called “melting”. It is the process by which the solids
get converted into liquids without adding any solvent. It may also be defined as the
process of heating the solids until they melt.

Process of fusion
All the substances are melted together and then cooled slowly with constant
stirring until a uniform product is obtained. To avoid overheating substances with
higher melting points are heated first to which substances with lower melting
points are added. Heat-labile substances and any volatile components are added in
last when temperature of the mixture is low enough not to cause decomposition or
volatilization of components.

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Explanation
Fusion process is employed only when components are stable at fusion
temperatures.

Application

1. Fusion is done to purify certain solid and semi-solid substances e.g bees
wax, wool fat, soft paraffin are heated to melt and filtered while hot to
remove the dissolved impurities.
2. This method is used for preparation of ointments.
3. It is used in pharmacy for incorporating drug components into base.
4. Creams, pastes and gels are also formulated through fusion process.

13. Ignition

Ignition is also called incineration. Ignition is a process used in pharmacy in


which the organic substances are strongly heated until its carbon part burn and
converted into ash.
The temperature is maintained at 200oC to 300oC. The temperature is provided by
putting platinum crucibles in furnace.

Application in pharmacy

1. Ignition process is used as a standardization test to


evaluate the quality and purity of organic
compounds
2. Ignition is also used as sterilization process.
3. This process is used in combustion analysis.

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14. Levigation

Levigation also called “wet grinding” .The incorporation of small quantities of


drugs by using spatula is also known as
levigation.

Method of Levigation

In levigation solid is first converted into paste.


The solvent used should be somewhat viscous
such as mineral oil or glycerin. Levigation is a
process of mixing throughly or grinding to
make a smooth paste.

Levigation is performed for two functions


• Grinding technique for making the fine powder.
• For mixing of various ingredients

Application of Levigation

1. It is the leading method that is used in dispensing pharmacy to mix up the


medicaments with the fat or water soluble base.
2. Levigation process can be used in the formulation of ointments creams pasts
and gels.
3. Levigation used for the mixing and blending of various ingredients of drugs.

15. LYOPHILIZATION (Freeze drying)

Freeze drying is the process in which water is removed from liquid prroducts by
sublimationThe material is first frozen to ice then reducing the surrounding
pressure(by vaccum) to allow the frozen water in the material to sublimate directly
from solid to gas phase.

Freeze drying process carried out in various stages.


1. Pre treatment
2. Freezing
3. Drying

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1. Pre treatment
It is stage product is prepared for freezing. It may be include concentrating the
products or addition of components to increase the stability.

2. Freezing
In laboratory it is done by placing the material in the freeze drying flask and
rotating the flask in the shell freezer bath which is cooled by dry ice, methanol or
mechanical refrigeration etc. On large scale it is down by using freeze drying
machine. To produce large size crystals products should be frozen slowly.
3. Drying
At this stage vaccum is applied to the chamber which has been previously chilled.
Pressure is lowered and enough heat is supplied to material for sublimation of
water. At this stage 95% of water in the material is sublimed. The process is
continued till the product is dry and spongy solid material left behind. Freeze dried
products are sealed to prevent the re-absorption of moisture.

Applications
1. This process is used for the manufacture of certain pharmaceutical and
biological product which are thermolabile. It is used for drying blood
plasma, enzymes, hormones, antibiotics and vitamins.
2. Freeze dried products remain protected from spoilage for many years.
3. It increases the shelf life of pharmaceutical products like vaccines and other
injections.
4. It is used to preserve food and resulting products is low and light weight.

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16. SUBLIMATION

Sublimation is the process in which, on heating, a solid directly gets converted to


vapours without passing the liquid state and vapors get converted back to the solid
state.The product so obtained is known as sublimate (sublimed material).

METHOD OF SUBLIMATION:
On laboratory scale sublimation may be carried out by using a very simple
apparatus consistiong of;

APPARATUS:
❖ China dish
❖ Perforated filter paper
❖ Funnel
❖ A plug of cotton wool.

The material to be sublimed is put in the


china dish which is covered with a perforated
filter paper. A glass funnel the open end of
sublimed product; is placed in the inverted
position over the filter paper. The china dish
is heated over sand bath and vapours pass
through the perforations of the filter paper
which are collected on the inner surface of
the glass funnel which is kept cool from
outside bay wrapping a wet filter paper or
cotton wool. The vapours on cooling are
converted into a solid which is collected a

afterwards.

Applications

✓ Used in the purification of many pharmaceutical substances such as iodine,


camphor, sublimed sulphur.
✓ It is also used in the manufacture of iodine, ammonium chloride and
naphthalene.

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17. Trituration

Word trituration comes from “triturate” which means “rub to pieces”. It is a


process of reducing the particle size by grinding.

Mechanism of Trituration

In Trituration pestle and motor is used for size reduction of different organic and
inorganic substances. Trituration is the production of a homogenous material
through mixing. It is a dry process and is different from levigation. It is the
continous rubbing or grinding of the powder in a mortar with a pestle. To avoid
complication we use only one direction of movement either clockwise or
anticlockwise

Application in Pharmacy

1. Use for the size reduction of


different substances
2. Use for the mixing of different
pharmaceutical components
3. It is used in the formation of
creams lotion and ointments
4. It is used in pharmacy for the
dispensing of different drugs
18. Efflorescence
Efflorescence is the loss of water of crystallization from hydrated substances into
the atmosphere.
Explanation
In hydrated form the water molecules attached to the compound. The surrounding
atmosphere also has vapours and definite vapour pressure due to water vapours
present in atmosphere. If the vapour pressure of hydrated substance is greater than
the surrounding atmosphere then hydrated substance loses water molecules to
become less hydrous and finally become anhydrous this phenomenon is known as
efflorescence.
Prevention of Efflorescence
• By closing the container immediately after use
• By filling the container completely so that no space for air storage is
available in the container

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• Dispensing portion
Types of dispensed pharmaceutical products
1. Elixir.

Storage:
Since elixir contain alcohol and usually some volatile ingredients which deteriorate
in the presence of air and light so should be stored in tightly closed containers and
in cool place.

2.EAR DROPS
Ear drops are the liquid preparation in which the drugs are dissolved or suspended
in a suitable vehicle like water, dilute alcohol, Glycerin , propylene glycolor any
other suitable solvent and are intended for instillation the ear with dropper.

Commonly Used Vehicles:


=> Propylene glycol, Polyethylene glycol Glycerin are commonly used vehicles
=> Water is disfavored bcz it would face difficulty in mixing with the secretions
of ear which are mainly fatty.

Uses:
Ear drops are generally used for cleaning the ear, drying weeping surfaces,
softening the wax and for treating the mild infections.

Method Of Dispening
Ear drops are dispensed in colured fluted bottles attached with a dropper or in
suitable plastic containers . label on container is for external use only

3. NASAL DROPS
Nasal drops are usually aqueous solutions intended for instillation into the nostrils
by means of dropper.

Uses:
They are commonly used for their antiseptic, local analgesic or vasoconstrictor
properties

Vehicles For Nasal Drops


At one time , oily preparation containing liquid paraffin or vegetable oils as vehicle

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were used prolong the action of the drug but now the use of oily vehicle in the
preparation of nasal drops discouraged because on prolonged use the oil retards the
colliery action of the nasal mucosa of drops of oil may enter the trachea and cause
lipoid pneumonia .so aqueous vehicles are preferred .

Dispensing Of Nasal Drops :


1. Nasal drops should be made isotonic with 0.9% Nacl
2.Ph Natural
3.Viscosity similar to nasal secretions achieved by the addition of 0.5%methyl
cellulose.

4.Should be dispensed in colored fluted bottles attached with a dropper.

4.PASTES

Pastes are semisolid preparation They differ from ointments and creams in
containing a high proportion of finely powdered medicaments

=> The base may be anhydrous (liquid soft paraffin)


=> Or water soluble (glycerol or mucilage)
=> They contain a high proportion of fine powder Example. Starch
=>This makes them very stiff and means they do not spread readily over the
skin’s surface
=> Corrosive drugs such as dethrone are often formulated as pastes .
=> Paste is applied to the lesions But will not spread onto healthy skin and
compromise it’s integrity

5.GELS
Def: It is dosage form for topical use.
=> They are usually transparent or translucent and have a variety of uses.
=> Spermicides and lubricants are often presented in gel form.
=> Preparation containing coal tar or other drug used in the treatment of psoriasis
and eczema are also presented in this from .
=> Many patients prefer this formulation

(Gels are also used to describe aqueous colloidal suspensions of the hydrated forms
of insoluble medicaments Examples. ( Aluminum hydroxide gel, used as
antacids)

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Cachets..
Enclosure in cachets provides a means of administering nausious or
disagreeable powders in a tasteless form.
Definition.
Cachets are moulded from rice paper, a material made by pouring a mixture of rice
flour and water between two, hot polished, revolving cylinders; the water
evaporates and a sheet of water is formed.
There are two kinds; wet seal’, so called because water is used to seal them, and
dry seal. the wet seal type consists of two halves, both alike, convex in shape and
having a broad flange that is used for sealing. The dry seal type has a shallow
cylindrical base and a slightly larger, slip over cap. Both are made in a variety of
sizes holding from 0.2 to 2 g of a powder of medium density. They are softened by
immersion in water for few seconds and then taken with a draught of water.
Collodions.
Collodions are fluid preparations use. They are applied
with a brush or rod. The vehicle is volatile and evaporates on application to
the skin, leaving a flexible protective film covering the site. The volatile
solvents are ether and alcohol, the film producing in gradient is pyroxylin
(nitrocellulose) and the substance having the flexibility is castor oil.
Unmedicated and medicated forms are available, the former are useful for
protecting small cuts while the later provide prolonged contact between the
skin and a medicament.
Draughts.
Draughts are liquids oral preparations of which only one or
two rather large doses, of the order of 50ml are prescribed. Each dose is
issued in a separate container lpecacuanha Emetic draught, paediatric, is
exceptional, the normal dose is 10 or 15 ml and therefore, a multiple dose
volume is prescribed.
Enemas.
Enemas are solutions, suspensions, or oil in water
emulsions of medicaments intended for rectal administrations.
Gargles.
Gargles are aqueous solutions used to prevent or treat throat
affections. Usually they are dispersed in concentrated form with directions
for dilution with warm water before use.
Gels.
Gels are aqueous colloidal suspensions of the hydrated
form of insoluble medicaments eg, aluminium hydroxide gel, used as an
antacid also see jellies).
Granules.

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Granules are a comparatively unusual means of
administering drug that process an unpleasent taste. The drug is mixed with
sugar, a flavouring agent and inert adjuncts, moistened to produce a coherent
mass, granulated by passage through a sieve and dried. The resultant small
irregular particles, ranging from 2 to 4 mm in diameter are often supplied in
single dose sachets the contents of which are stirred in water before taking.
Insufflations.
Insufflations are medicated dusting powders that are
blown by an insufflator (a device similar to an atomizer) into regions, such
as the nose, throat, body cavities and ear, to which it would be difficult to
apply the powder directly. Occasionally, insufflations intended for the nose
(eg, pituitary (posterior lobe) insufflation) are used as the same way as snuff.
Irrigations.
Irrigations are solutions of medicaments used to treat
infections of the bladder, vagina and less often, the nose. They are
administered via a thin, soft, rubber or a plastic tube known as catheter
(bladder) a vulcanite or plastic pipe (vagina) or a specially designed glass
irrigator (nose). Solutions and equipment used for bladder irrigations must
be sterile.

Jellies (Gels).
Jellies are translucent, non-greasy, semisolid
preparations mainly used externally. The gelling agent may be gelatin, or a
carbohydrate such as starch, tragacanth, sodium alginate or cellulose
derivative.
Linctuses.
Linctuses are viscous, liquid oral preparations that are
usually prescribed for the relief of cough. They are simple solutions or
admixtures containing a high proportion of syrup and sometimes, glycerin
which as well as giving a sweet taste, have a demulcent effect on the mucous
membranes of the throat. The dose is small (5 ml).
Lozenges (troches).
These are solid preparations consisting mainly of sugar
and gum, the later giving hardness and cohesiveness and ensuring slow
release of the medicament. They are used to medicate the mouth and throat
and for the slow administration of indigestion and cough remedies.
Mouthwashes.
These are similar to gargles but are used for oral
hygiene and to treat infections of mouth.
Nasal drops.

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Nasal drops are solutions of drugs that are instilled
into the nose with a dropper. They are usually aqueous because oily drops
inhibit movement of cilia in the nasal mucosa and, if used for long periods,
may reach the lungs and caused lipoidal pneumonia.

Pills.
Pills are oral dosage forms that are largely be
replaced by tablets and capsules. They are spherical, or less often, ovoid, and
usually sugar coated.
Poultices.
Poultices are paste like preparations use externally to
reduce inflammation because they retain heat well. After heated the
preparation is spread thickly on a dressing and applied, as hot as the patient
can bear it, to the affected area.
Solutions.
Solutions are used for many purposes. For some of
these sterility necessary, eg. Parenteral, peritoneal, dialysis and
anticoagulant solutions, bladder irrigations and dermatological solutions for
application to broken surfaces. Unsterile solutions are used orally, either
alone or as ingredient for medicine, or externally, on unbroken surfaces.

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Chapter 11

Weights and Measures

Weight
It is a measure of the gravitational force acting on a body and is directly
proportional to its mass. Or
The weight of an object is usually taken to be the force on the object due to gravity

Measures
Finding out the size, amount, or degree of (something) by using an instrument or
device marked in standard units is called measures. Or
A standard unit used to express the size, amount, or degree of something.

System of Measurement
A system of measurement is a set of units of measurement which can be used to
specify anything which can be measured
There are two Systems of weights and measures
1. The Imperial System
2. The Metric System

1.Imperial System
A system of weights and measures originally developed
in England.
Example of Imperial measures:
Length: inches, feet, yards
Area: square feet, acres
Weight: pounds, ounces,

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Volume: fluid ounces, gallons

The Imperial System has been replaced by the Metric System in most countries
(including England). We will discuss only metric system in detail

2.Metric System
The most commonly used system of weights and measures in pharmacy is the metric
system. Understanding of the metric system is important to perform calculations in
the pharmacy.

Values of Prefixes in the Metric System


The three basic units of the metric system are the meter, the gram, and the liter.
The names of the other units are formed by adding a prefix to one of the basic
units. Each prefix has a numerical value as indicated below:

Prefix Values
Micro - (mc) = 1/1,000,000
Milli - (m) = 1/1,000
Centi - (c) = 1/100 times the basic unit.
Deci - (d) = 1/10
Deka - (dk) = 10
Hecto - (h) = 100 times the basic unit.
Kilo - (k) = 1000

Standard Unit of Weight in the Metric System Used in the Pharmacy


Common measures of weight in metric system
(a) 1 kg = 1000 g
(b) 1 g = 1000 mg

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(c) 1 mg = 1000 mcg

Whereas
Kg = kilogram
g = gram
mg = milligrams
mcg = microgram

The gram (g or gm) is the basic unit of weight used to weigh solids in the pharmacy.

1 kilogram (kg) = 1000 gm


1 hectogram (hg) = 100gm
1 decagram (dag) = 10gm
1 gram (gm) = 1000 milligrams (mg)
1 decigram (dg) = 0.1gm or 100mg
1 centigram (cg) = 0.01gm or 10mg
1 milligram (mg) = 0.001gm or 1mg

Standard Unit of Volume in the Metric System


1 kiloliter (kl) = 1000 liters
1 hectoliter (hl) = 100 liters
1 decaliter (dal) = 10 liters
1 liter (l) = 1,000 milliliters (ml)
1 deciliter (dl) = 0.10 L or 100ml
1 centiliter (cl) = 0.01 L or 10ml
Domestic measures
1 drop = 0.06ml
1 tea spoonful = 4ml

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1 desert spoonful = 8ml
1 table spoonful = 15ml
1 tea cupful = 120ml
1 fluid ounce = 30ml

Measurement of Temperature
Centigrade or Celsius temperature scale
Celsius temperature scale also called centigrade
temperature scale, is the scale based on 0 for the
freezing point of water and 100 for the boiling
point of water.

Fahrenheit temperature scale


Fahrenheit temperature scale is a scale based on 32
for the freezing point of water and 212 for the
boiling point of water.

Conversions of Temperature
The following formula works for converting both ways; that is, conversions can be
made from Fahrenheit to Centigrade or from Centigrade to Fahrenheit using this
formula:
5F = 9C + 160

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Calculation

Density
Density is defined as the mass of a substance per unit volume. Or

Density is defined as mass divided by volume

Density = mass/volume
Or
Density = mass divided by volume
or

The unit of density is kg/m3 (kg per cubic meter)

Mass
A measure of how much matter is in an object is called mass

Mass = density x volume


The unit of mass is kg (kilogram)

Volume
Volume is the measure of space occupied by an object.

Volume = weight /density

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In metric system unit of volume is liter (L), on the other hand, one liter is the
volume of a 10-centimetre cube, 1 liter = (10 cm)3

Percentage
Percent means "parts per hundred" and is expressed in the following manner.
Or
Percentage is the rate, number, or amount in each hundred.

Percentage = number of parts/ 100 parts

Percentage Preparations
There are three types of percentage preparation
1. Weight in volume (W/V)
2. Weight in weight (W/W)
3. Volume in volume (V/V)

Weight in Volume (W/V)


W/V of Weight/Volume percent is defined as the number of grams in 100 milliliters
of solution.

Example
(10% w/v solution of NaCl)
A 10 percent (w/v) sodium chloride (NaCl) solution would contain 10 grams of
sodium chloride in every 100 milliliters of water.

Weight in Weight (W/W)


W/W percent or Weight/Weight percent is defined as the number of grams in 100
grams of a solid preparation.

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Example
(5% w/w boric acid ointment)
A 5 percent (w/w) boric acid ointment would contain 5 grams of boric acid in each
100 grams of boric acid ointment.

Volume in Volume (V/V)


V/V percent or Volume/Volume percent is defined as the number of milliliters of a
liquid in every 100 ml of solution.

Example
(70% v/v solution of alcohol)
A 70% (v/v) alcoholic solution would contain 70 milliliters of alcohol in every 100
ml of solution.

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