INTRODUCTION TO PHARMACY

Pharmacy is the art, science of compounding, dispensing of medications. It is associated with reading
of prescriptions, compounding, packing in suitable/appropriate container, labelling and dispensing of
drugs. The word "pharmacy" was coined from the Greek word "pharmakon" meaning "medicine" or
"drug".

Pharmacists are healthcare professionals who practice in pharmacy, the field of health sciences
focusing on safe and effective medication use. They are licensed to prepare and dispense
medications, involved in patient care, counsel patients, and monitor outcomes pursuant to a
prescription from a licensed health professional.

HISTORY OF PHARMACY PROFESSION IN INDIA IN RELATION TO PHARMACY EDUCATION

1. Various milestones in the field of pharmacy were achieved during 19th century.
2. The first pharmacy school in the united state was founded in Philadelphia in 1821.
3. The origin of pharmacy profession in India was manifest by the first class of the chemist and
druggist conducted at the Madras medical college in 1870s to train students to gain skills in
pharmacy practice
4. A formal training of the compounders started 1881 in Bengal.
5. The pharmacy profession entered India through "Mahadeva Lal Shroff” known as the Father of
Indian pharmacy.
6. The B. Pharm course at Banaras Hindu University was industry oriented while that at Punjab
University was oriented towards Pharmacy practice.
7. However, the profession was oriented towards pharmacy practice at the introductory stage but
as it grew, it became more industry oriented.

HISTORY OF PHARMACY PROFESSION IN INDIA IN RELATION TO PHARMACEUTICAL INDUSTRY

1. Before 1940: Initially all the drugs were imported from Europe. Later some drugs of this system
began to be manufactured in this country.
2. 1901: Establishment of the Bengal Chemical and Pharmaceutical Works, Calcutta by Acharya P.C.
Ray.
3. 1903: A small factory at Parel (Bombay) by Prof. T.K. Gujjar.
4. 1907: Alembic Chemical Works at Baroda by Prof. T.K. Gujjar.
5. Drugs were mostly exported in crude form and imported in finished form. During World War-1
(1914-1920) the imports of drugs were cut-off Imports of drugs were resumed after the War. In
absence of any restrictions on quality of drugs imported, manufacturer abroad took advantage of
the situation.

The consequences were as follows.

1. Foreign manufacturers dumped inferior quality medicines and adulterated drugs.

2. Markets were full of all sorts of useless and unqualified men sold deleterious drugs.
6. The modern era of the pharmaceutical industry of isolation and purification of compounds,
chemical synthesis, and computer-aided drug design considered to have begun in the 19th
century.
7. The unification of research in the 20th century in fields such as chemistry and physiology
increased the understanding of basic drug-discovery processes.
8. Identifying new drug targets, attaining regulatory approval from government agencies, and
refining techniques in drug discovery and development are among the challenges that face the
pharmaceutical industry today.

HISTORY OF PHARMACY PROFESSION IN INDIA IN RELATION TO PHARMACY PRACTICE

1. Pharmacy practice is the restraint of pharmacy, which involves developing the professional roles
of pharmacists.
2. Disease-state management, Clinical interventions [refusal to dispense a drug].
3. Recommendation to change and add a drug to a patient's pharmacotherapy, dosage
adjustments, Professional development.
4. Pharmaceutical care, Extemporaneous pharmaceutical compounding, Patient care, Drug abuse
prevention, Prevention of drug interactions, including drug-drug interactions or drug-food
interactions, prevention or minimization of adverse events.
5. Incompatibility, drug discovery & evaluation, community pharmacy.

HISTORY OF PHARMACY PROFESSION IN INDIA IN RELATION TO VARIOUS PROFESSIONAL

ASSOCIATIONS

The International Pharmaceutical Federation (FIP) represents Pharmacists internationally. They

represented at the National level by professional organizations such as;

1. Indian Pharmacist Association (IPA).

2. All India Medical Technologists Association.
3. American Pharmacists Association (APA).
4. American Medical Informatics Association.
5. Pharmaceutical Society of Australia (PSA).
6. African Christian Health Association (ACHA).
7. Association of Community Pharmacists of India.
8. Pakistan Pharmacists Association (PPA).
9. Malaysian Pharmaceutical Society (MPS).

PHARMACY AS A CARRIER

Pharmacists are the health professional who dispense medications and provide advice to patients
concerning the use of prescriptions and over-the-counter medications.

For a pharmacist’s career advancement, there are a variety of alternatives.

1. Pharmaceutical industries
2. Retail pharmacy.
3. Drug inspectors.
4. Medical Representatives
5. Production – Manufacturing, packaging, store and purchase quality control & quality assurance.
6. Research & Development
7. Pharmaceutical Marketing
8. Hospital & Clinical Pharmacy
9. Community Pharmacy
10. Regulatory Affairs
11. Academics
12. Consultancy
13. Library Information Service and Pharmaceutical Journalism
14. Opportunities Abroad

Pharmaceutical industries: Pharmaceutical industry, the discovery, development, and manufacture

of drugs and medications (pharmaceuticals) by public and private organizations

Drug Inspectors: The job of a drug inspector includes the inspection of establishment where drugs,
cosmetics, and medical devices are manufactured, handled, stored or sold to enforce legal standards
of purity and grading.

Analytical Chemist: Labs that provides testing and validation about the pharma related products
employ these.

Medical Representatives: These are sales people who are brand ambassador for their respective
companies (both national and multinational companies).

Research and Development: Research creates knowledge and development designs, and builds
prototypes to prove their feasibility.

For example, a computer software company would spend much more on R&D than a retail sales
company would.

Drug Regulatory: The job involves the preparation of drug dossier and its registration in other
countries. Advance knowledge of exports and imports also becomes clever in such cases. The job
also involves travelling abroad for licensing and alliances.

Academics: With many colleges escalating all over India, teaching is a good option for those
interested in academics. As per the A.I.C.T.E. norms, the least entry-level qualification as lecturer is
M. Pharma.

This is a profession allied with job contentment and social status as teaching considered noble
profession. The higher posts in the ladder are Sr. Lecturer, Reader, Asst. Professor, Professor,
Principal etc.
The term pharmacopeia is derived from two Greek words i.e.
pharmakon meaning "A drug" and poiein meaning "To make" Whose
combination means any recipe or any formula or any standards
which are required to make or prepared a drug.

History of British pharmacopoeia: -

1) The term 'pharmacopoeia' was first used in 1580 in a book
written on drug standard in Bergamo, Italy.
2) After that a number of national pharmacopoeias were published
by various European pharmacopoeias The London, The Edinburgh,
and The Dublin pharmacopoeias were official throughout the
kingdom.
3) Each pharmacopeia described different strength and
method of preparation for the same preparation.
4) Hence there was a lot of confusion, to overcome this difficulty
the first British pharmacopoeia came into existence in 1864.

History of Indian pharmacopoeia (I.P):

1) The Government of India through its letter No. 2338 H(C)/43
dated 26 January, 1994, directed the Drugs Technical Advisory Board
to list the drugs in use in India, which are not mentioned in British
pharmacopoeia.
2) The Government of India published the Indian pharmacopoeial
list in 1946, as a supplement to the British pharmacopoeia.
3) The Indian pharmacopoeia list contained about 180
monographs from which approximately 100 works on vegetable
drugs and other Galenical’s.
4) The pharmaceuticals and drug research committee of the
council of scientific and industrial research decided in February 1947
to compile a "Brochure" on the lines of the British pharmacopeial
Codex.
5) After the publication of the Indian pharmacopoeia list, the
Government of India constituted an 11 member Indian pharmacopeial
committee in 1948 for a period of 5 years.
6) The help was taken from British pharmacopoeia, The United
States Pharmacopoeia, The International Pharmacopoeia & Scientific
institutions interested in drugs & pharmaceutical products.
7) The first edition of Indian pharmacopoeia was published in the
year 1955.
Important questions

1) Define pharmacopoeia. Write a note on history of

Indian pharmacopoeia.
2) Write in brief about the Salient features of latest edition of
Indian pharmacopoeia.
3) Explain in detail the history of Indian pharmacopoeia.
After the manufacturing of drugs, it is essential that these should be stored
properly the stability of drug during storage depends on so many factors and
proper packaging is one of them. The pharmaceutical products are in direct
contact with the containers and closures. Improper packing and poor quality of
container may lead to deterioration of the products.

Definition
pharmaceutical container has been defined as a device that holds the drug and it
may or may not be in direct contact with the pharmaceutical preparations.

Closures: closure are the device by means of which containers can be opened
and closed.

Ideal properties of a good container and closure:

1) The container enclosure should not react with the drug packed in it.
2) it should maintain the stability but protecting the drug from an
external environmental factor such as air, heat, light, moisture etc.
3) It should be which stand against the temperature and pressure
during sterilization.
4) It should not wear and tear during handling and transportation.
5) The design of the container should be such that those can be
easily withdrawn.
6) The material used in the manufacturing of the container and closure
should be non-toxic.
7) The container used should be such that it can be labelled easily
8) The closure used for the container should be easily removable
and replaceable.
9) The container must be pharmaceutically-elegant appearance.

Types of containers:
Containers are divided into following types on the basis of their utility:
1. Well-closed containers
2. Single-dose containers
3) Multi dose containers
4) Light resistant containers
5) Air-tight containers
6) Aerosol containers

Materials used for making of container:

The containers used for pharmaceutical products are usually made from the
following basic materials:
a. Glass
b. Plastic
c. Metal
d. Paper and board

a) Glass: glass containers are commonly used in pharmaceutical

packaging because of the following reasons
Advantages:
1. They are transparent.
2. They are available in different shapes and sizes.
3. They can with stand the variation in temperature and pressure
during sterilization.
4. They are economical and readily available.
5. Protect liquid formulation from photosensitivity.
6. Impermeable to moisture and atmospheric gases.
7. They don't deteriorate upon age.
8. Glass container can be easily labelled.
9. They have good protection power.
Disadvantages:
1. Glass is a fragile so it should be handled carefully.
2. Glass containers are heavy which increase the cost of transportation.
3. Glass containers release alkali to liquid preparations.
Types of glass:-
1. Lime soda glass
2. Boro-silicate glass
3. Silicon treated glass
4. Sulphured glass
5. Neutral glass
6. Amber coloured glass
7. Hydrolytic resistance glass

Composition of glass: Glasses composed of sand, soda Ash, lime stone and
cullet. the composition of glass varies and it depends on the specific purpose for
which it is used. silicon, aluminium, boron, sodium, potassium, calcium,
magnesium, zinc and barium are generally used in the preparation of glass.

b) Plastic:
Plastic containers are very commonly used in pharmaceutical packaging
because of the following reasons
Advantages:
1. They are lighting weight and can be handled easily.
2. They are poor conductor of heat.
3. They have sufficient mechanical strength.
4. They can be transported easily.
5. They are unbreakable.
6. They are available in various shapes and sizes.
7. They are resistant to inorganic chemicals.
8. They have good protection power.
9. There are no changes of formation of flakes as it comes in glass container.
Disadvantages:
1. They are permeable to moisture
2. They cannot withstand temperature and pressure during sterilization.
3. They are relatively expensive than glass.
4. They may observe chemical substance such as preservatives.
5. For labelling special type of gums are required.

Types of plastic:
1. Polyethylene (polythene)
2. Polyvinyl chloride (PVC)
3. Poly methyl methacrylate (PMMA)
4. Polystyrene
5. Polytetra fluoroethylene (PTFE)
6. Polypropylene
7. Polyamides (Nylon)
8. Polycarbonate

Composition of plastic:
Plastics are synthetic polymer of high molecular weight.

c) Metals:
Metals are used for the construction of containers, the metals commonly used
for this purpose are aluminium, tin plated Steel, stainless steel, tin and lead.
Advantages
1. They are sturdy.
2. They are impermeable to light, moisture and gases.
3. It can be labelled easily.
4. They have sufficient mechanical strength.
Disadvantages
1. They are expensive.
2. They may shed metal particles into the pharmaceutical products.
d) Paper and board:
Paper
a. It is used to pack solid dosage form such as tablet and capsule.
b. They are weak in nature as they don't have sufficient mechanical strength.
c. a special type of paper is used to pack solid dosage form but now a
day’s papers which are having a thin polythene is used.
d. Paper saw also used to make a "PIL" (patient information list)

Board
a. It is also known as "cartons".
b. it is a thick paper in nature which is used to pack as an outer cover
to a dosage form such as tablet, capsule, syrup etc.

Rubber

Rubber are meant for the construction of closure. Rubber also used in different
dosage forms such as vial and transfusion fluids whether the rubber is
synthetic or natural it should possess the following properties:-
a. It should be soft.
b. It should be quite elastic.
c. Is should not absorb the medicament.
d. It should not react with the product.
e. It should not with stand the pressure and temperature during sterilization.
f. It should have all the properties which led under pharmacopeia.
Pharmaceutical aids: are the drugs or substances which have no or little
pharmacological effect but they are essentially used in the preparation of
pharmaceutical dosage forms like "(tablets, injections, emulsions, ointments.)”
Pharmaceutical aids are also called as an additive which is responsible for
colouring, flavouring, sweetening and texturing of pharmaceutical
formulations.

Organoleptic Agents: Organoleptic Agents are one of the important members

of pharmaceutical aids which help in promoting appearance and palatability of
pharmaceutical dosage forms.
Organoleptic agents used in pharmaceutical dosage forms as colouring,
flavouring and sweetening agents.

I. COLORING AGENTS
Introduction
Colouring agents are one of the important members of any pharmaceutical
formulations products which give colours to pharmaceutical product.
Examples:
1. Caramel colouring, made from caramelized sugar.
2. Annatto, a reddish-orange dye made from the seed of the Achiote
3. A green dye made from chlorella algae.
4. Betanin extracted from beet.
5. Turmeric
6. Saffron

Purpose/need/use
● Colour is a useful tool to help identify a product in its manufacturing and
distribution stages.
● Patients, especially those using multiple products, often rely on colour
to be able recognize the prescribed medication.
 ● The use of different colours for different strengths of the same drug can
also eliminate errors.
● Unattractive medication can be made more acceptable to the patient by
the use of colour.

II. SWEETENING AGENTS

Introduction
1. These are incorporated to pharmaceutical Formulations to improve the
palatability of the product.
2. They have broad application in oral formulations such as syrups.
suspensions, solutions, tablets, chewable oral pharmaceutical
formulations, etc.
3. In all the dosage forms used to make for the paediatric people.
4. It also used to mask the unpleasant taste of the API and or of any other
excipient
5. The generally used sweetening agents are mostly classified into natural
and artificial sweeteners.
Example: Natural sweeteners such as sucrose and dextrose are the most
commonly used sugars for sweetening agents.
Artificial sweeteners are Brilliant Blue E133 (Blue shade), Indigotine,
E132 (Dark Blue shade), Fast Green, E143 (Bluish green shade), Allura
Red AC, E129 (Red shade), Tartrazine, E102 (Yellow shade),Sunset
Yellow, E110 (Orange shade)

Purpose/Need/Use

● To increase the palatability of the dosage form and mask unpleasant

taste of API in formulation.
● The main sweetening agents employed in oral preparations are sucrose,
liquid glucose, glycerol, sorbitol, saccharin sodium and aspartame.
● It is generally used in solid oral and liquid oral formulations.
● It is used in formulations like Chewable tablets, Oral suspension and Oral
solutions.
 Example: Sucrose solution (syrup), Saccharin

III. FLAVORING AGENTS

1. These are one of the generally used pharmaceutical excipients to boost
the aesthetic worth of pharmaceutical preparations to enhance patient
fulfilment and palatability.
2. Flavouring agents are organoleptic agents that impart an intended
characteristic flavour to a formulation, with a concurrent improvement
in the odour of the dosage form.
3. The flavouring agents usually used as pharmaceutical aids.
4. These flavouring agents are used in an excess of pharmaceutical dosage
forms such as syrups, tablets, emulsions, suspensions, and other oral
dosage forms.
5. They are mostly utilized to mask the unlikable odour or taste of the
formulation without causing physical and chemical incompatibility

Purpose of Flavouring agents

● Mask (hide) the unpleasant taste sensation of API by use of blends of

distinctive Flavours
● The specific therapeutic agents are associated with specific flavours in
certain formulations
Example: an orange-mint flavour is especially used in diphenhydramine
expectorant formulation

Types
✓ Salty Butterscotch, vanilla
✓ Bitter Walnut, Chocolate, Mint
✓ Sweet Berry, Mango
✓ Sour: Orange, Raspberry
 PRESERVATIVE

Introduction
It is a substance or a chemical that is added or incorporated to products such
as pharmaceutical drugs, food products, beverages, biological samples,
cosmetics and many other products to prevent disintegration by microbial
growth or by unwanted chemical changes
In common, preservation is implementing in two ways, physical and chemical .
Physical preservation entails processes such as refrigeration or drying
Chemical.
Preservation entails addition of chemical compounds to the product.

Preservatives are mostly use for three reasons:

1. To preserve the natural characteristics of formulations.

2. To preserve the appearance of formulations.
3. To increase the shelf value of formulations for storage.

Ideal Properties of Preservatives:

1) It should not be irritant

2) It should not be toxic
3) It should be physically and chemically stable.
4) Preservative should be compatible with other ingredients
used in formulation.
5) It should be act as good antimicrobial agent
6) It should act as preservative in small concentration.
7) It should maintain activity throughout product manufacturing, shelf life
and Usage.

Classification of Preservatives

There are various classes of preservatives which are described are follow

A. Classification Based On Source

1. Natural Preservatives-These drugs are obtained by natural sources that

are plant, mineral sources, animal etc

✓ Examples Neem Oil, Salt (sodium chloride), Lemon, Honey

2. Artificial Preservatives: These preservatives are man made by

chemical synthesis, active against by various microorganisms in small
concentration.
✓ Examples Benzoates, Sodium benzoate Sorbates, propionates, nitrites

B. Classification Based on Mechanism of Action

a. Antioxidants: The agent which avoid oxidation of Active pharmaceutical

ingredients which or else undergo degradation due to oxidation as they
are sensitive to oxygen
✓ Examples: Vitamin E, Vitamin C, Butylated hydroxy anisole (BHA).

b. Antimicrobial agents: The agent which active against gram -ve & gram
+ve microorganism which causes degradation of pharmaceutical
preparation which are active in small inclusion level.
✓ Examples: Benzoates, Sodium benzoate.

c. Chelating agents: The agents which form the complex with

pharmaceutical ingredient and prevent the degradation of
pharmaceutical formulation.

✓ Examples: EDTA, citric acid etc.

 P

Definition:

It is defined as the process of reducing the size of the drugs either into small
pieces, coarse particles & fine particles.

Importance of particles size reduction:

1. To increase the rate of solution in case of chemical substances.

2. To allow the rapid penetration of the solvent (menstrum), in case of crude drugs.

3. To get a uniform powder because particle size reduction helps in uniform

mixing of drugs.

4. To increase the rate of absorption of drugs. The smaller the particle size,
the greater is the rate of absorption.

5. To improve the stability of certain pharmaceutical dosage forms.

6. To help in the process of separation of solids from liquid by filtration.

Factors affecting size reduction:

1) Hardness- It affects the process of size reduction. It is easier to break soft

material to a smaller size than hard material.

2) Toughness- The crude drugs of fibrous nature or those having higher

moisture content are generally tough in nature.

3) Stickiness- It causes a lot of difficulty in size reduction. It is difficult to

powder drugs of having gummy nature as it sticks to the grinding surface.

4) Material structure- Materials which shows some special structure may

cause problem during size reduction.

Eg-vegetable drugs.
5) Moisture content- It influence number of its properties such as hardness,
toughness, or stickiness which in its turns affects size reduction.

6) Softening temperature- Waxy substance such as stearic acid or drugs

containing oils or fats become softened during the size reduction processes, if
heat is generated this can be avoided by cooling the mill.

7) Physiological effect- Some drugs are very potent. During their particle
size reduction in a mill, dust may produce which may have an effect on the
operator. In such cases, the enclosed mills should be used to avoid dust.

8) Purity Required- Various mills used for size reduction often causes the
grinding surface to wear off & thus impurities come in the powder, hence proper
care should be taken.

9) Ratio of the feed size to product size

10) Bulk Density

Methods of size reduction:

1. Cutting

2. Compression

3. Impact

4. Attrition

5. Combined Impact and Attrition

1. Cutting: The material is cut on a small scale by means of a sharp blade,

knife, root cutter or any other sharp instrument. On a large scale, a cutter mill is
used. Cutting of drug is usually done to hasten the drying of drugs.

2. Compression: In this method the material is crushed by the application

of pressure. On a small scale, size reduction is carried out by using mortar &
pestle, whereas on a large scale Roller mill is used.
 3. Impact: Impact occurs when the material is more or less stationary & is
hit by an object moving at high speed or when the moving particle strikes a
stationary surface. In either case, the material breaks into small pieces.

4. Attrition: In attrition pressure is applied on the material as in

compression, but the surfaces are moving relative to each other.

5. Combined Impact & Attrition: The mechanism of impact & attrition

can be combined in the mill to get better result.

BALL MILL

Principle: It works on the principle of impact and attrition.

Construction: It consists of a hollow cylinder which is mounted on a

metallic frame in such a way that it can be rotated on its longitudinal
axis. The cylinder contains balls that occupy 30 to 50% of the mill
volume. The weightof the ball is kept constant. The ball size depends on
the size of the feed and the diameter of the mill.
Working:
1. The drug to be ground is put into the cylinder of the mill and is rotated.
2. The speed of rotation is very important.
● At a low speed, the mass of balls will slide or roll over each
otherand only a negligible amount of size reduction will
occur.
● At a high speed, the balls will be thrown out to the
walls bycentrifugal force and no grinding will occur.
● At an optimal speed, balls are carried to the top and they
get misbalanced and fall freely, hence maximum size
reduction takesplace by optimal speed.

Advantages:
1. It can produce very fine powder
2. It is suitable for both wet and dry grinding.
3. Toxic substances can be ground because the cylinder contains
closedsystem.
4. Low labor cost.
Disadvantages:
1. It is a very noisy machine.
2. It is a slow process.
3. Soft fibrous material cannot be grind.

HAMMER MILL

Principle: It works on the principle of impact.

Construction:
1. It consists of a stout metal casing, enclosing a central shaft to which
fouror more swinging hammers are attached.
 2. The lower part of the casing consists of a screen through
which fineparticles can pass and collect into a suitable receiver.

Working:
1. The material is put into the hopper which is connected with the drum.
2. Material is powder to desired size, due to fast rotation of hammers
and iscollected under the screen.

Advantages:
● Hammer mill occupies very less space.
● It is a continuous process.

Disadvantages:
● Due to high speed of operation, heat is generated which may
affect thermo labile drugs.
IMPORTANT QUESTIONS

A. SHORT ANSWER QUESTIONS.

1. What are the factors affecting size reduction?

2. Write the importance of size reduction.
3. What are the different methods used in size reduction?

B. LONG ANSWER QUESTIONS.

1. Define size reduction. Write the construction, principle, working,

advantages and disadvantages of Ball mill.
2. Write the construction, principle, working, advantages and disadvantages
of Hammer mill.

C. FILL IN THE BLANKS

1. Ball mill works on the principle of impact and attrition.

2. Hammer mill works on the principle of impact.
3. The process of reduction of particle size is known as size reduction.
4. The method where the as material is crushed by the application of
pressure is known as compression.
 SIZE SEPARATION
Definition:
The process of size reduction is followed by size separation of the powdered material. During
the process of size reduction, it is not possible to obtain the particles of uniform size. Hence a
special technique is used to separate particles of specified size which is known as the
“process of size separation”.

Official standards for powders:

The various grades of powders which are official in I.P. are as follows:
1. Coarse powder(10/44): Coarse powder is defined as ,when the powder is passed
through sieve number 10,all particles passed through sieve number 10 but not more
than 40 percent of particles passed through sieve number 44.
2. Moderately coarse powder (22/60): A powder of which all particles pass
through 22 mesh sieves and not more than 40% through 60 mesh sieves.
3. Moderately fine powder (44/85): Moderately fine powder is defined as, when the
powder is passed through sieve number 44, all particles pass through sieve number 44
but not more than 40 per cent of particles pass through sieve number 85.
4. Fine powder (85): A fine powder of which all the particles passes through 85
mesh sieves.
5. Very fine powder (120): A powder of which all the particles pass through 120
mesh sieves.
Sl. Grades of Sieve Nomina Sieve Nominal
no powder through l mesh throug mesh
which all aperture size h aperture size
particle which
must 40% of
pass particles
pass
1. Coarse 10 1.7mm 44 355
powder
2. Moderately 22 710 60 250
coarse powder

3. Moderatelyfine 44 355 85 180

powder

4. Fine powder 85 180 -----

5. Very fine 120 125 -----

powder
CYCLONE SEPARATOR:

Principle:

● In cyclone separators, the centrifugal force is used to separate solids from fluids .
● The separation depends not only on the particle size but also on density of particles.
● Hence depending on the fluid velocity, the cyclone separator can be used to
separate all types of particles or remove only coarse particles and allow fine
particles to be carried through with the fluid.

Construction:

● It consists of a cylindrical vessel with a conical base.

● In the upper part of the vessel is fitted with a tangential inlet and a fluid outlet and at
the base it is fitted with a solid outlet.

Working:

● The suspension of a solid in a gas (usually air) is introduced tangentially at a very

high velocity, so that rotary movement takes place within the vessel.
● The fluid is removed from a central outlet at the top.
● The rotary flow within the cyclone separator causes the particles to be acted
on by centrifugal force.

● The solids are thrown out to the walls; thereafter it falls to the
conicalbase anddischarged out through the solids outlet.

Uses: Cyclone separators are used to separate the suspension of a solid in a gas (air) .It
can beused with liquid suspensions of solids.
Pharmaceutics-1 Filtration UNIT-04(4)

Filtration: Filtration is defined as a process separation of solid particles from the liquid or gas by
passing it through a porous medium which retains the solid but allows the fluid to pass through it.
Clarification: When solids are present in a very small portion i.e. not exceeding one percent the
process of its separation from liquid is called “Clarification”.

Filter medium:The porous medium used to separate the solid & liquid.
Filter cake: The solid which retains on the filter media.
Filtrate: The clear liquid passing through the filter media.

Factors affecting the rate of filtration:

The rate of filtration depends on the following factors:-
1. Pressure: The rate of filtration of liquid is directly proportional to the rate of pressure.
2. Viscosity: The rate of filtration is inversely proportional to the rate of viscosity.
3. Temperature: The rate of filtration is directly proportional to the rate of temperature.
4. Surface area of the filter media: The rate of filtration is directly proportional to the
rate of surface area of the filter media.
5. Thickness of the cake: The rate of filtration is inversely proportional to the rate of
thickness of the cake.
6. Size of the porous media: The rate of filtration is directly proportional to the rate of size of
the porous media.
7. Particle size: The rate of filtration is directly proportional to the rate of particle size.
8. Nature of the particle: The rate of filtration is directly proportional to the porosity of the
filter cake. The porosity of the filter cake depends upon the nature of solid particles to be
removed.

pg. 1
Pharmaceutics-1 Filtration UNIT-04(4)

Theory of Filtration:The theory of filtration gives an idea about the factors influencing the
rate of filtration through the filtering medium. rather than the mechanism by which the
particles are retained

The factors affecting the rate of filtration were studied by a scientistnamed Darcy
and he expressed it in the form of an equation, which is known as "Darcy's law" The
equation is:

where
V = Volume of filtrate
K= Permeability coefficient and is dependent on the nature of the precipitate to be filtered and
the filter medium
ΔA = Area of filter bed
P= Pressure difference on the liquid and below the filter medium
η = Viscosityof the
fluid l= Thickness of
filter cake

The above equation makes it clear that the rate of filtration not only depends on the nature of
liquid undergoing filtration but also on so many other factors.

Membrane filters:

A membrane is a thin layer of semi-permeable material that separates substances, when a driving
force is applied across the membrane.

Principle: It works on the principle of physical separation.

Construction:

1. These are made up of cellulose acetate & cellulose nitrate.

2. The filters are available in sizes up to 60cm2 and are 50 to 150µ thick.
3. A membrane filter has 400 to 500 million pores per sqcm of filter surface which are
uniform in size.

pg. 2
Pharmaceutics-1 Filtration UNIT-04(4)

Sl No. Pore size (micron) Particles to be removed

01. 0.2 All bacteria

02. 0.45 All coliform group bacteria
03. 0.8 All air borne particles
04. 1.2 All non-living particles which are
dangerous in i.v. fluids
05. 5 All significant cells from body fluids

Working

1. A membrane filter is fixed in a metallic holder before its use.

2. These filters are mainly used for sterilization of both aqueous & oily liquids.
3. The membrane filters cannot be used for filtration of organic solvents such as alchohols,
ketones, esters & chloroform.

Applications

1. These are mainly used to remove microorganism & very fine particles from ophthalmic
solutions & parenteral products.

Sintered glass filters

Principle:

The liquid to be filtered is poured into the sintered glass funnel and drawn through the perforations by
vacuum suction.

Construction:

1. These are made of borosilicate glass.

2. The glass is finely powdered & particles of the required size are separated & is then packed
into disc moulds. These moulds are heated until suitable adhesion has taken place between
the granules.These disc are fused to funnels to suitable shape & size.
3. The sintered glass filters are available in different pore size & numbered accordingly.
4. The filtration is carried out under reduced pressure.

pg. 3
Pharmaceutics-1 Filtration UNIT-04(4)

5. Sintered filters are also available in stainless steel which has a greater mechanical strength.

Working:

Take the mixture to be filter pass it through sintered glass filter under reduced pressure, particles
larger than pore size retain on the surface of the filter disc where as the liquid will be pass-through
sintered glass filter disc which is collected in a suitable container.

Applications:

(1) For separation of viruses from bacteria.

(2) Sterilization of certain thermo-labile material.

pg. 4
Mixing is defined as a process in which two or more substances are combined together.
A perfect mixing is defined as a process in which two components are mixed together in such a way
that each particle of one material comes in contactwith each particle of another material.

Objectives of mixing
The main objectives of mixing are
1) Simple, physical mixing of materials to form a uniform mixture.
2) To promote the chemical reaction to get uniform products.
3) Dispersion of solid in liquid to form suspension or paste.
4) Dispersion of two immiscible liquids to form an emulsion.

MIXING OF POWDERS

The mixing of powder is one of the common Pharmaceutical operations and is used in the preparation
of many types of formulations such as tablets, capsules and compound powders.

Equipment used for mixing of powders:

1. Tumbler mixer
2. Double cone mixer
3. Agitated powder mixer
4. Air mixer

Double cone blender:

Principle: Mixing is due to tumbling and shearing action with blade.

Construction & Working:

● Double cone blender is made up of stainless steel and is available in different capacity
ranging from 5 kg to 200 kg or even more.
● The efficiency of the blender depends mainly on the speed of rotation.
● The rate of rotation should be optimum which depends on the size and shape of the
tumbler as well as nature of material to be mixed. The common range is 30-100 RPM.
● The material to be blended is loaded approximately 50 to 60% of the total capacity of the blender.
● As the Blender rotates the material undergoes tumbling motion and mixes the
material thoroughly.
The double cone Blender is an efficient design for mixing powder of different densities and is
used mainly for small quantities of powder.
 MIXING OF LIQUIDS

Mixing of liquids is done to prepare true solution or emulsions. Mixing is required to dissolve one
miscible liquid into another miscible liquid to form true solution. For making emulsion, the mixing of
two immiscible liquids are done by using shear force.

Equipment used for mixing of liquids

1. Propeller mixer
2. Turbine mixer
3. Paddle mixer

Turbine mixer

Principle: Turbine mixer can create a turbulent movement of the fluids due to the
combination of centrifugal & rotational motion. This combined motion causes effective
mixing of low to medium viscosity fluids.

Construction: A turbine consist of a It consists of a circular disc to which a number of short, straight
or curved blades are attached.
The diameter of the turbine ranges from 30-50% of the diameter of the mixer
vessel. Turbine rotates at a lower speed usually 50-200 RPM.
The turbine mixer is used for mixing of more viscous liquids.
e.g. Syrups, liquid paraffin, glycerin etc.
Working:A mixer is filled through an opening at its top usually, it a pan or drum within which
mixing blade revolve about the vertical axis. The variable speed drills with turbine mixer whip air
into the mixture of materials. The air in mixture yields bubbles contributing mixing.
This type of mixer does not damage product.

Applications:
Used in preparing emulsions, suspensions & syrups.
Used to mix high viscosity liquids, semi solids &
pastes.

Mixing of semi solids

The mixing of semi solids is done for preparing ointments, creams, pill masses and wet mass for
making granules etc.

Equipment used for mixing of semi solids:

In case the quantity is large, the following equipment are used for mixing of semi solids:-
1. Triple roller mill
2. Agitator mixer
3. Planetary mixer

Triple roller mill:

Construction:
● The mill consists of three rollers which are made of a hard abrasion resistant material.
● These rollers are arranged in such a way that they come very close to each other.
● These rollers are rotated at different rates of speed.
 ● The material coming between the rollers is crushed depending on the gap between them
and the difference in rates of moments of the two surfaces.

Working:
1. The material after passing through hopper comes between roller 1 and 2 and is reduced in
size in the process.
2. The gap between roller 2 and 3 is usually less than that between 1 and 2, further crushes
and smooths the mixture which adheres to roller 2.
3. A scraper is arranged in such a way that it can remove the mixed material from roller number
3 and does not allow the material which has not passed between both sets of the rollers to
reach the scraper.

Uses: The triple roller mill is very useful for the

purpose of the mixing of solid powder in an
ointment base.
Homogenization

It is defined as a process in which large particles or globules of a coarse emulsion are broken down
into a small globule by passing under pressure throughan narrow orifice as a result uniform and stable
emulsion is formed. Homogenization is done in an apparatus called homogenizer.

Principle:The homogenizer is based on the principle that the large globules in a coarse emulsion
are broken into smaller globules by passing them under pressure through a narrow orifice.
The commonly used homogenizers are:
1. Hand homogeniser
2. Silverson mixer homogeniser
3. Colloidal mill
Silverson mixer homogenizer:

Construction:
1. It consists of an emulsifier head which is covered with fine meshed stainless steel sieve.
2. The emulsifier head consists of a number of plates which rotate at a very high speed, in
order to produce a powerful shearing action.
 3. The blades are rotated by using an electric motor fitted at the top.

Working:

1. The emulsifier head is placed into a vessel containing immiscible liquid, in such a
way that it gets dipped into it.
2. When the motor is started, the liquids are sucked through the fine holes & the
oil is reduced into fine globules due to the rotation of the blades.
3. So that a fine emulsion is formed which is expelled out.

- -
 EXTRACTIONS

It is defined as the process in which the plant or animal tissues

are treated with suitable solvent. Whereby the medicinally
active constituents are dissolved, and most of the inert matter
remains undissolved.
The solvent used for extraction is known as ‘menstruum.’
The inert insoluble material that retains after extraction is
called ‘marc’.
The liquid extraction process is called
‘Galenicals’. Process used for extraction

1. Infusion
2. Decoction
3. Maceration
4. Percolation
5. Digestion

● Infusion:
● It consists of pouring hot water over the drugs
● Then allow it to stand for 15 minutes with
occasional stirring.
● Filter it and the marc is not pressed.

Apparatus: Coffee pot or a teapot is the simplest form

of Apparatus used for preparing infusion.

Decoction:
1. In this process, the drug is boiled with water
for a stated period of time (usually 15
minutes).
 2. After boiling, the liquid is strained and water is
passed through the content of the strainer to make
the required volume.
3. This process is mainly used for vegetable drugs
of hard and Woody nature having thermostable
water soluble constituents.

● Maceration process:
The various types of maceration processes are:
1. Simple maceration: A process for tinctures
made from organised drugs.
Apparatus:
● A wide bottle or any other container which
can be well stopped is used for the
maceration process.
● A closed container is essential to prevent
the evaporation of menstruum which is
mostly concentrated alcohol.
● Otherwise this may lead to variation in
strength as no adjustment in volume is made.
Method:
● In this process, the drug is placed with the
whole of the menstruum in a closed vessel for
seven days.
● During this period, shaking is
done occasionally.
● The expressed liquid is mixed with
strained liquid.
● It is then filtered to make a clear liquid.
● The final volume is not adjusted.
 Example:
1. Tincture of orange.
2. Tincture of lemon.
3. Tincture of Squill.

2. Maceration process for an organised drug or

Maceration with adjustment: A process for
Tinctures made from unorganised drugs.
Method:
In this process, the unorganised drug is placed with 4/5th of
the menstruum in a closed vessel for a period of 2-7 days.
During this period, shaking is done occasionally.
After the stated period, the liquid is tilted and the final
volume is made up by passing the remaining of the
menstruum through the filter.
The marc is not pressed.
Example:
1. Tincture of tolu.
2. Compound Tincture of benzoin.

3. Maceration process for concentrated

preparation or Multiple Maceration process:

● Multiple maceration processes are carried out in the same

way as a simple maceration process, but the menstruum
used is divided into two parts in the double maceration
process and into three parts in the triple maceration
process.
Double Maceration Process:

In this process, the drug is macerated twice by using

the menstruum which is divided into two parts in such
a manner that the same volume is used for each
menstruum.

One part of the menstruum is kept in contact with the

drug for 2-7 days.
The extract was collected by the filtration.
the marc is collected and remixed with another part
of fresh menstruum then finally combined both the
extract.

Example:
1. Concentrated infusion of orange.
2. Concentrated compound infusion of chirata.
3. Concentrated compound infusion of gentian.

Triple maceration process:

● In this maceration process, the drug is macerated thrice
by using the menstruum which is divided into three
parts in such a manner that the same volume is used for
each maceration

● In this process powder drug is kept in one part of

menstruum for specific period of time with
occasional shaking, filter it and collected
● Similarly, the second and third maceration was done by
using the same marc but with fresh menstruum, mix all
the extract together and separate if necessary.
Example:

1. Liquid extract of Senna

2. Concentrated infusion of quassia

PERCOLATION PROCESSES:
The various percolation processes used for the extraction
of drugs are:-
1. Simple percolation or percolation process for tinctures.
2. Percolation processes for concentrated preparation such
as:- a.Reserve percolation process.
b.Modified percolation process.
3. Continuous hot percolation or Soxhelation.
 1. SIMPLE PERCOLATION PROCESS

Apparatus:- Three types of percolators are used.

1. Conical percolator: The percolator is made of glass
or metal, usually copper, which is tinned inside.
It is conical in shape having the lower diameter not
less than half of the upper diameter.
2. Cylinder percolator.
3. Steam jacketed percolator.
a. Imbibition
b. Maceration
c. Percolation

● Imbibition: The powdered drug is moistened with a

sufficient quantity of menstruum and allowed to stand
for 4 hours in a closed vessel.
Pack the moistened drugs into a percolator and add
sufficient quantity of menstruum to saturate the
material. When liquid starts coming out from the
outlet of the percolator, the outlet is closed.
 Then a sufficient quantity of menstruum is added in
order to leave a layer above the drug.

● Maceration: The moistened drug is left in contact

with menstruum for 24 hours.
During this period, the menstruum dissolves the active
constituent of the drug and becomes almost saturated
with it.

● Percolation:
o It consists of the downward displacement of the
saturated solution formed in maceration and
extraction of the remaining active constituents
present in the drug by the slow passage of the
menstruum through the column of the drug.
o After collecting 3/4th of the required volume of
the finished product or when the drug is
completely exhausted, the marc is pressed.
o Mix the expressed liquid with the percolate.
o Add sufficient quantity of menstruum to produce
the required volume and then filter.
 Example :
1. Tincture of belladonna.
2. Compound Tincture of cardamom.
3. Strong tincture of Ginger etc.

Percolation processes for concentrated preparations :-

Percolation processes for concentrated preparations
are used for preparing liquid extracts and solid
extracts. The various processes used for the preparing
concentrated preparations are :-
a. Reserve percolation process
b. Modified percolation process

Reserved percolation process

In this process, a part of the percolate, generally 3/4th the
volume of the finished preparation, is reserved.

The percolation process is continued till the drug

is completely exhausted.
 The percolate is subjected to evaporation or distillation
(to recover the costly menstruum).

This soft extract is dissolved in the reserve portion

of percolate and then sufficient menstruum is
added to produce the required volume.

The portion of the percolate which is reserved must be

the first percolate because it is more concentrated.

Modified percolation process

In percolation process for preparation of tinctures, the

drug/percolate (d/p) ratio is about 1:4. The d/p ratio is
reduced to 1:3 by modifying the percolation process and
hence there is a lot of savings in heat, time and
menstruum.

Percolation is a displacement process.

The strong solution of active constituents of drug

formed during maceration is displaced by the fresh
menstruum, when the percolation process is started.
 Since the d/p ratio is 1 : 3, test for exhaustion must
be done.
The process is continued in case the drug is not
completely exhausted.

After exhaustion of the drug, the percolate is

evaporated and then mixed with the main percolate.
The final volume is made by adding more of menstruum.

Continuous hot percolation process or Soxhlet extraction

or Soxhelation

● When active constituents of the drug are not freely

soluble in the solvent and are difficult to be
displaced from the cells of the drug, then it
becomes necessary to extract the crude drug by the
action of hot menstruum for a considerable period
of time.
● The fixed oils from seeds and alkaloids from the
drug are extracted by continuous hot percolation
process using benzene, chloroform, petroleum,
ether, etc
Procedure
● The drug to be extracted is packed in a paper
cylinder made from a filter paper and it is placed in
the body of the soxhlet extractor.
● The solvent is placed in the flask.
● The apparatus is then fitted as shown in figure

● When solvent is boiled on heating the flask, it

gets converted into vapours.
● These vapours enter into the condenser through the
side tube and get condensed into hot liquid which
falls on the column of the drug.
● When the extractor gets filled with the solvent,
the level of the syphon tube also rises up to its
top.
● The solvent containing active constituents of the
drug in the syphon tube and run over into the flask,
thus emptying the body of the extractor.
● This alteration of filling and emptying the body of
the extractor goes on continuously until the drug is
exhausted.
● The process is repeated about 15 times for
complete exhaustion of the drug.
Digestion:
In digestion process, the drug is extracted by heating at
a particular pressure. This will increase penetration
power of the menstruum, so that there is complete
extraction of the drug. Precautions should be taken so
that the increased temperature may not harm the active
constituents of the drug.
The apparatus known as “Digestor” is used for
extraction of the drug by this method. It is a vessel
made up of metal. The whole of the drug along with the
menstruum is placed in the body of the digestor. Place
the cover over it & bolt it with the help of nuts. The
drug is treated with menstruum for a definite period
under specified conditions of temperature & pressure.
."Drying" is an important technique used in the pharmaceutical industry.

Drying is defined as the final removal of liquid from solids by vaporisation with the aid of

heat. The equipment used for drying is called a "dryer".

Applications of Drying

1. In the manufacture of granules which can be dispensed in bulk or converted into

tablets or capsules.
2. Drying can also be used to reduce the bulk and weight of the material, thereby lowering
the cost of transportation and storage.
3. It helps in the preservation of crude drugs.
4. It helps in the size reduction of crude drugs, moisture in the crude drug does not allow
it to getpowdered easily.
5. Drying is also used in the processing of materials e.g. the preparation of dried
aluminium hydroxide.
6. Proper drying can prevent deterioration of product.

EQUIPMENT USED IN DRYING PROCESSES =

The equipment used for drying are known as "Dryers" The following are some of the different types
of dryers in common use in the pharmaceutical industry

1. Tray dryers
2. Tunnel dryers
3. Rotary dryers
4. Fluidised-bed dryers.
5. Vacuum dryers
6. Freeze dryers.
 Fluidized Bed Dryer

In a fluidized bed dryer, good contact between hot air and particles to be dried is obtained which
causes rapid drying.

Theory: If a gas is allowed to flow upward through a bed of solid particles at a velocity greater than
the settling velocity of the particles, the particles are partially suspended in the gas stream.

The resultant mixture of solids and gas behaves like a fluid and the solids are said to be fluidized.

Types of Fluidized bed dryer

1 Vertical fluidized bed dryers

2. Horizontal fluidized bed dryers

Vertical fluidized bed dryers

● The fluidizing air stream is induced by a fan which is mounted in the upper part of the dryer.
● The air is heated to the required temperature in air heaters and passed through the
wet material contained in a drying chamber fitted with a wire mesh support at the
bottom.
● The air flow rate is adjusted by means of re-circulation control and fabric filter bags are
provided to prevent the passage of fine particles.
● The fluidized bed dryers are available in different capacities ranging from 5 kg to 200 kg
with an average drying time of about 20-40 minutes.
 Advantages of Fluidised Bed Dryer

1. It gives a high drying rate.

2. The fluidized bed dryer method is 15 times faster than the routine method of a tray dryer.
3. The method is suitable for drying of thermolabile materials.
4. The temperature inside the fluidized bed dryer can be controlled.
5. The fluidized bed dryer has a high output and occupies a small floor space.
6. It can be used for drying any powdered material but it is mostly used for drying of
granules meant for the manufacture of tablets.

Disadvantages of Fluidized Bed Dryers

1. The turbulence produced when hot air is passed through the material may cause
attrition of some material, which leads to the production of fines.
2. The vigorous movement of solid particles in hot air can lead to the generation of an
electric charge. Hence suitable precautions must be taken in this regard.
 Freeze Dryer

Principle: In the freeze-drying process, sublimation process is used for drying (removal of water from
solid without converting into liquid & vice-versa). Therefore, it is also called sublimation drying
process or lyophilization.

Construction Freeze dryers

1. A chamber for vacuum drying

2. A vacuum source
3. A heat sources
4. A vapour removal system as vacuum pump or steam ejector or both

Working

The working of freeze dryer involves the following steps

(1) Pre-treatment:

● This step is done to reduce the volume of the solution to be introduced into
the container which has limited capacity.
● The solution is pre-concentrated under normal vacuum tray drying.
● Sometimes solid or liquid desiccants are also used for this purpose
● This reduces the actual drying by 8-10 times.
(11) Pre-freezing

● It is done to solidify water.

● The ampoules, vials and bottles in which aqueous solution is packed, are frozen in
cold shelves at a temperature below -50°C.

(111) Primary drying

● The material to be dried is spread in order to increase the surface area for sublimation.
● The temperature and pressure is kept below the triple point of water (0.0098 °C and
4.58 mm of mercury) for the sublimation of water.
● Heat is supplied, which transfers a latent heat and ice sublimes directly into vapour
state which are ultimately removed.
● Primary drying help to remove about 98-99 % moisture.

(iv) Secondary drying

● The moisture left in the primary drying is removed by an ordinary vacuum drying.
● The vacuum drying is done at a temperature of 50-60°C. The rate of drying is very
slow and its takes about 10-20 hours.
(v) Packing
● The biological products dried by
freeze drying are usually required to
be in a sterile condition for injection.
● The ampoules are sealed immediately
after drying, whereas the vials and
bottles are closed as such or after
replacement of vacuum by inert gas if
required.
● The containers are labelled and packed in card-board bo

Advantage of Freeze-Drying Process

1. The product obtained is light and porous having excellent solubility.

2. The chances of hydrolysis is minimised as drying takes place at a very low temperature.

3. Drying takes place under vacuum. Hence, oxidation is minimised as there is no contact with air.

4. The heat sensitive materials can be dried.

5. The loss of volatile material is minimum.

6. The freeze-dried material can be stored at room temperature if properly sealed

in an inert atmosphere.

7. The sterility of the can be maintained.

Disadvantages of Freeze-Drying Process

1. The process is very expensive because a complicated plant is used.

2. The product obtained by freeze drying process is very hygroscopic.

3. The period of drying is quite long. It is usually not less than 10 hours
Fill in the blanks

1. Fluidised bed dryer method is times faster than that of a tray dryer.
Ans: 15
2. Fluidised bed dryers are available in different capacities ranging ………. from to with an
average drying time of about minutes.
Ans: 5kg-200kg and 20-40 times.
3. Proper drying prevents the Of the product
Ans: detoriation
4. Drying is used to remove …………… and from the solid substances.
Ans: Liquid and Moisture.
5. Vertical fluidised bed dryer is dryer whereas horizontal Fluidised bed dryer is used for
………… drying of material.
Ans: batch type and
continuous 6.Dryer is known as
lyophiliser
Ans: freeze dryer
7. For fixing the effective drying condition processing factor is essential.
Ans: Humidity
8. For drying blood plasma Technique is used.
Ans: freeze drying
9. In a fluidised bed dryer a pre filter is include for filtering …………….
Ans: air
10. In Step of freeze drying most of water is removed during
drying Ans: primarydrying

VERY SHORT ANSWER QUESTIONS

1. Define drying?
Ans-It can be defined as an process in which the liquid, generally water present in a wet solid is
removed by application of heat and finally a liquid free solid product is obtained.

2. is used for drying of food items like mushrooms, prawns, meat products.

Ans-Freeze dryer

3. Tray Dryer is example of …………..

Ans-Static bed dryer

4. Name the dryer which is used for coating of granules.

 Ans-Fluidized bed dryer

5. What are the steps that are involved in the working of freeze dryer.

Ans-Pre-treatment, Prefreezing, Primary drying, Secondary drying, Packing

SHORT ANSWER QUESTIONS

1. Name the various equipment’s used for drying of solid material.

2. Write the advantages and disadvantages of freeze drying.
3. Write Pharmaceutical Applications of Fluidised Bed
dryer. Ans-
● It is used for the drying of the granules in the production of the tablets.
● It is used for coating of granules.
4. Write Pharmaceutical Applications of Freeze
Dryer. Ans:
● It is used in production of injection, solution and suspension.
● It is also used for production of blood plasma and its fractionated products,
bacterial and viral cultures, antibiotics and plant extracts, steroids, vitamins and
enzymes.
● Food items like mushrooms, prawns, meat products can be dried by this method
● Coffee and tea concentrates and citrus fruit juices are also dried by this method.

LONG ANSWER QUESTIONS

Q.1 Define Drying? Write a short note on theory, construction, and working of fluidized bed dryer.

Q2. Discuss the theory, construction, working of freeze-drying apparatus along with advantages
and disadvantages.

Q3. Write a note on applications of drying process in pharmaceutical industry. Write a note on steps
involved in freeze drying process.
Multiple Choice Questions

A. Drying

B. Filtration

C. Mixing

D. Size separation

2) FBD is also called as

A. Size bed dryer

B. Moving bed dryer
C both A & B
D. None

3) The advantages of FBD are

A. Smaller drying period

B. Constant drying

C. Effectively at little temperature

D. All

4) Drying conduction mechanism of heat transfer is involved in

A. Filtration

B. FBD

C. Freeze dryer

D. None
5) Which materials are not used in drying in a freeze dryer

B. Fruits

C. Pharmaceutical

D. Dyes

6) In drying process, the final product is in the form of

A. Slurry

B. Solution

C. Solid

D. Solvent concentrate

7) Condition that is highly critical in drying process.

A. Moisture

B. Pressure

C. Temperature

D. Volume

8) For mixing the effective drying conditions which processing factor is essential.

A. Height

B. Humidity

C Weight

D. Pressure
9) Which the following Dryer is known as “lyophiliser”

A. Fluidized bed dryer

B. Spray dryer

C. Freeze dryer

D. Vacuum dryer

11. The final removal of liquid from solids by vaporation with the aid of heat is known

A. Evaporation

B. Drying

C. Sublimation

D. Desiccation

12. Proper drying can prevent of the product

A. Lose

B. Weight

C. Deterioration

D. Solubility

13. Proper drying improves of the product

A. Solubility

B. Weight

C. Deterioration
Definition:
Mono-phasic liquid dosage form refers to liquid preparation in which there is only one phase.

Classification of Mono-phasic liquid dosage form:

a) Liquids meant for internal use.

b) Liquids meant for external use.

Monophasic liquid dosage form

SYRUPS

A syrup is a concentrated or nearly saturated solution of sucrosein purified water.

The concentration of sucrose is 66.7%w/v.

The syrups are sweet viscous preparations.

The syrups containing medicinal substance is known as “Medicated syrup” and those
containing aromatic or flavoured substance is known as “Flavoured syrups”.

Advantages:

1. Syrups retards oxidation, since it is partly hydrolysed into reducing sugars.

2. It prevents decomposition because it has high osmotic pressure which prevents growth of bacteria.

3. They are palatable.

Disadvantages:

1. Delayed onset of action because absorption takes place.

2. Not suitable for emergency and for unconscious patients.
3. Not convenient for a patient with gastro intestinal disorder such as, diarrhoea,
constipation, ulceration, hyperacidity in stomach.
4. Can’t avoid first pass metabolism.

ELIXIRS

● Elixirs are clear, sweetened, aromatic, hydro-alcoholic liquids intended for oral use. The
main ingredients of elixirs are ethyl alcohol (4-40%), water, glycerin or propylene glycol,
flavouring agents and some suitable preservatives etc. The medicated elixirs contain
some very potent drugs such as antibiotics, antihistamines or sedatives.

Advantages

1. Because of their hydro alcoholic character more preferred than syrup due to stability character.
2. Easy to prepare.
3. It is more effective in masking unpleasant

taste. Disadvantages:

1. Alcohol is not good for children.

2. Because they contain volatile material, it must be stored in a well closed container.

BIPHASIC LIQUID DOSAGE FORM

EMULSION

● An Emulsion is a biphasic liquid dosage form containing two immiscible liquids one of which
is dispersed as a minute globule into the other with the help of an Emulsifying agent.
● The liquid which is converted into minute globules is called dispersed Phase.
● The liquid in which the globules are dispersed is called as continuous phase (Dispersion medium)

Types of Emulsion:

(1) Oil in water type (O/W) Internal use

(2) Water in oil type (W/0) External Use

1. Oil in water type (0/W):

● In this type of Emulsion, the oil is in dispersed phase and water is the continuous phase.
● This type of emulsions is preferred for internal use.

2. Water in Oil type (W/0);

● In this type of Emulsion, the water is in the dispersed phase and oil is in the continuous phase.
● They are preferred for an external use.

Identification tests for Emulsions.

The following tests are done to distinguish between O/W and W/O emulsions.

1. Dilution Test

2. Dye Test (Scarlet red dye)/Staining test.

3. Conductivity test

4. Fluorescence test.

1. Dilution Test:

The Emulsion is diluted with water.

In case the Emulsion remains stable after its dilution, it is O/W Emulsion.

In case the Emulsion breaks after the dilution with water, but remains Stable when diluted
with oil, then it is w/o emulsion.

2. Dye test (or) Staining test:

The Scarlet red dye (oil soluble dye) is mixed with the Emulsion.

Place a drop of the Emulsion on a microscopic slide; cover it with a Cover

slip & examine under the microscope.
If the disperse globules appear red and the ground colourless, the Emulsion is o/w type.

In case the dispersed globules appears colourless and the ground is in red colour then
the Emulsion is w/o type.
 3. Conductivity Test:
Water is a good conductor of electricity, whereas oil is Non-conductor (or) bad
conductor of electricity.
Place a sample of Emulsion in a beaker, dip a pair of electrodes connected through a
low voltage bulb in the Emulsion.
If the bulb glow on passing the electric current the Emulsion is oil in water (o/w) type.

In case the bulb does not glow then the Emulsion is water in oil (w/o) type.

4. Fluorescence Test:
Certain fixed oil possesses the physical properties of fluorescing in the presence of UV radiation.

On microscopic observation of Emulsion under ultra violet radiation, the whole field
fluorescence indicates that oil is present in continuous phase i.e., water in oil type of
Emulsion.
If the droplet fluorescence indicates that oil present in dispersed phase i.e., Oil in water
type of Emulsion.

Emulsifying agents (or) Emulsifiers (or) Emulgents:

1. These are the agents which reduces interfacial tension between two phase i.e., oily phase
and aqueous phase and make them miscible with each other and formed a stable
Emulsion.
2. Each globule of the dispersed phase is covered by a layer.
3. The Emulsifying agents are also called as Emulsifiers (or) Emulgents.

Ideal properties of emulsifying agents:

1. It should be capable of reducing the interfacial tension between the two immiscible liquids.
2. It should be compatible with other ingredients of the preparation.
3. It should be non-toxic.
4. It should be chemically stable.

Preparation of Emulsion:

The following methods are commonlyEmulsions, namely –

1. Dry gum method (0: G:W)

2. Wet gum method (G: W:0)
3. Bottle method,
4. Other method
1. Dry Gum method
Measure the required quantity of oil and transfer it into a dry mortar.

Add the calculated quantity of gum acacia into it and triturate rapidly to form uniform
mixture, maintain the same speed and same direction while triturating.
Add required quantity of water in small proportion with continuous mixing till a clicking
sound is produce and the product became white (or) nearly white, the emulsion produced at
this stage is known as primary emulsion.
Add more water to produce required volume.

Transfer the emulsion to a bottle, cork, label and dispensed.

2. Wet Gum method:

Calculate the quantity of oil, water and Gum required for the preparation of primary Emulsion.

Powder the gum acacia in a mortar, add water and triturate it with gum to form mucilage.

Add required quantity of oil in small proportion with rapid trituration in one direction and
same speed untill a clicking sound is produced and the product becomes white (a) nearly
white, at this stage the primary emulsion is produced.
Add more amount of water in small portion to the primary emulsion with trituration to
produce the required volume.
Transfer the Emulsion to a bottle, cork, label and dispense.

3. Bottle method:
Bottle method is used for the preparation of Volatile oil and other non-viscous oils.

The proportion of Oil: Water: Gum is 2:2:1.

Measure the required quantity of oil and transfer into a large bottle.

Add the required quantity of powdered gum acacia.

Shake the bottle vigorously, unit the oil and gum are mixed thoroughly.

Add the calculated amount of water all at once.

Shake the mixture vigorously to form a primary Emulsion.

Add more water in small portions with constant agitation to produce the required volume.
 Primary emulsion formula

SL NO: TYPE OF OIL EXAMPLE RATIO OFOIL: WATER:

GUM
01. Fixed oil Castor oil, Almond oil, Palm oil, 4:2:1
Ground nut oil, Arachis oil, Cod
liver oil, Shark liver oil
02. Volatile oil Turpentine oil, peppermint oil, 2:2:1
Cinnamon oil, Clove oil, Fennel oil
03. Mineral oil Liquid paraffin 3:2:1

Stability of Emulsions/ Instability problems ofEmulsion:

An Emulsion is said to be stable if it is remains as such after its preparation i.e., the dispersed
globules are uniformly distributed throughout the continuous phase (dispersion medium)
during its storage.
The emulsion should be chemically stable and there should not be any bacterial growth
during its shelf life.
The following three changes (or) instability problems occurs during the storage of an Emulsion.

1. Cracking
2. Creaming and Sedimentation.
3. Phase Inversion.

1. Cracking:
Cracking means the separation of two layers i.e., dispersed phase and continuous phase,
due to the coalescence (small particles combine to form large particle) of disperse Phase
globules which are difficult to redisperse by shaking.
Cracking may occur due to the following reasons.
a. By addition of emulsifying agent of opposite type.
● Soap of monovalent metals produce 0/w type of Emulsions whereas
soap of divalent metals produces w/o type of Emulsion.
● But the addition of monovalent soap to a divalent soapEmulsion
(or) divalent soap to a monovalent soap Emulsion leads to
cracking.
 b. By decomposition (or) Precipitation of Emulsifying agents:
● When an acid is added to an alkali Soap Emulsion (Turpentine
Liniment), it causes the decomposition of an emulsifying agent leads
to cracking of Emulsion.
c. By addition of a common Solvent:
● When a solvent is added to an emulsion which is either miscible or
dissolved with the dispersed phase, emulsifying agent and continuous
phase.
● There will be a formation of one phase (or) a clear solution. This
leads to cracking of an Emulsion.
● Ex: Addition of alcohol to turpentine liniment lead to the formation of
clear solution because turpentine oil, soft soap and water are soluble in
alcohol..
d. By microorganisms:
● If emulsions are not stored properly, they may develop bacterial and
mould growth, fungus growth.
● This may lead to destruction of Emulsifying agent and cause
cracking of Emulsion.

e. Changes in temperature:
● When emulsions are stored in high temperature for a long period of time
may reduce the viscosity of Emulsion, this lead creaming and cracking of
emulsion.

2. Creaming and sedimentation :

● Creaming may be defined as the upward movement of

dispersedGlobules to form a thick layer at the surface of the Emulsion.
● Creaming is a temporary phase because it can be redistributed by mild shaking
(or) stirring to get again a homogenous mixture of emulsion.
● Creaming should be avoided because it may lead to cracking with complete
separation two phases.
● Sedimentation is defined as the down word movement of dispersed globules
towards the bottom to form a layer at bottom and forms Sedimentation of
Emulsion.

3. Phase Inversion:
It is a process of conversion of OlW type of Emulsion into W/O type of emulsion (or) vice
versa is called as phase inversion.
It may due to following reasons.

1. Addition of an Electrolyte.
2. By changing the phase -volume ratio.
3. By temperature change.
4. By changing the Emulsifying agent.
 SOLUTIONS AND SUSPENSION
DEFINITION:

Solutions are liquid dosage forms prepared by dissolving the

active ingredient(s) in an aqueous or non-aqueous solvent.
A solution is a homogeneous mixture of two substances.

These two substances or components are the solute and the solvent.

The solute is the substance that gets dissolved. It is present

in a smaller quantity.
On the other hand, the solvent is the substance that dissolves
the solute. It is present in a comparatively larger quantity

Advantages of Solutions:

Solutions can be easy to swallow, especially for paediatric

and geriatric patients.
In solutions dissolved drug is immediately available for GI
tract absorption, thus onset of therapeutic response is fast.
They can be immediately diluted in the GI tract fluids and
avoids irritation.
Solutions can be easily measured if accurate devices are used.

Disadvantages of Solutions:

Solutions are inconvenient for transport and storage.

Solution stability is poor due to hydrolysis.

Active drug and excipients may chemically interact more

readily in solution than in solid dosage form.
Solution is suitable medium for microbial growth.
 Suspensions

Suspensions are the biphasic liquid dosage form of medicament

in which the finely divided solid particles ranging from 0.5 to 5
micron are dispersed in a liquid or Semi solid vehicle with the
help of a suspending agent.
The solid particles act as dispersed phase whereas liquid vehicle
acts as the continuous phase. Generally suspensions are taken
orally (or) by parenteral route.
They are also used for external application.

Qualities (or) Ideal characteristics Good Suspension

It should be settle slowly and should be re-dispersed-on gentle

shaking of the container. The suspension should pour readily
and evenly from its container.
It should be chemically Inert.

The suspended particles should not form a cake.

It should be free from large particles which spoils its

appearance, give a gritty taste to oral suspensions and also
cause irritation to sensitive tissues when appliedExternally.

Types

Suspensions based on physico-chemical properties. The suspensions

are divided into two types.
1) Flocculated Suspension: The suspensions are said to be
flocculated, when the individual particles are in contact with
each other and form a network like structure.
2) Non flocculated Suspension: In case of non-flocculated
suspensions, the individual particles exists as a separate
entity.
 Advantages of Suspensions...

1. Majority of the modern drugs are insoluble in the solvent,

hence they can be formulated as suspension.
2. Suspensions are more stable compare to solution type of
dosage form.
3. Bulk drugs can be conveniently consumed as a suspension
e.g. Antacid
4. Unstable drugs particularly in an aqueous medium can
be formulated as powder for suspensions.
5. Suspensions are available as oral use, external use as well
as parenteral use.

**********************************************************
 Processing of capsules

Capsules are solid dosage form in which the drug substance is

enclosed in a water-soluble shell or an envelope.
Capsule shell is made from gelatin.
The capsules are available both as hard capsules and soft gelatin
capsules.

Advantages of capsules

1. The drugs having unpleasant odour and taste can be

administered by enclosing them in a tasteless shell
2. They are smooth, become very slippery when moist and can
be easily swallowed.
3. They are economical.
4. They are easy to handle and carry.
5. The capsules release the medicament as and when
desired in gastrointestinal tract.
6. The capsules are made from gelatin and hence they
are therapeutically inert.
7. They are attractive in appearance.
8. Capsules are available in various sizes.

Disadvantages of capsules

1. The hygroscopic drugs cannot be filled in capsule.

2. The concentrated preparations which need previous dilution
are unsuitable for capsule because it may lead to irritation in
stomach.
Capsules are available in two types

1. Hard gelatin capsule

2. Soft gelatin capsule

Hard gelatin capsule

➔ This are used for administration of solid Medicaments.

➔ The capsule shell is prepared from gelatin, colour and
titanium dioxide to make it opaque.
➔ It consists of two parts i.e body and cap.
➔ The powdered material is filled into the cylindrical body of
the capsule and then the cap is placed over it.
➔ The empty capsules are available in various sizes.
➔ They are numbered according to the capacity of the capsule.
➔ The number starts from 000 and goes up to 5.
➔ The approximate capacity of a capsule with respect to its
number is given in the following table.

CAPSULE NUMBER AND ITS APPROXIMATE CAPACITY

Capsule number Approximate capacity in
mg
000 950

00 650

0 450

1 300

2 250

3 200

4 150
Methods of filling the hard gelatin capsule : The capsule can be
filled either by hand or by a semi-automatic filling machine

Capsule filling machine (hand operated) It consists of:-

● A bed having 200 to 300 holes.
● A loading tray having 200 to 300 holes.
● A powder tray.
● A pin plate having 200 to 300 pins.
● A sealing plate having a rubber top
● A lever.
● A cam handle.

❖ The empty capsules are filled in the loading tray and it is

placed over the bed.
❖ The cam handle is operated to separate the capsule cap from their
bodies.
❖ The Powder tray is placed in a proper position and filled with
an accurate quantity of powder with scraper.
❖ The excess of powder is collected on the platform of the
Powder tray.
❖ The pin plate is lowered and the filled powder is pressed by

moving the pin downwards..

❖ After pressing, the pin plate is raised and the remaining
powder is filled into the bodies of the capsule.
❖ The Powder tray is removed after its complete filling.
❖ The cap holding tray is again placed in position.

❖ The plate with the rubber top is lowered and the lever is
operated to lock the caps and bodies.
❖ The loading tray is then removed and the filled capsules are

collected.
❖ With a 200 hole machine, about 5,000 capsules can be filled in
one hour, where as in a machine having 300 holes about 7,500
capsules can be filled in one hour.

Soft gelatin capsule

● These are used for administration of liquid medicaments.

Soft gelatin capsules are available in round, oval and tube
like shapes.
● They are made from gelatin.
● The gelatin is plasticized by the addition of glycerin
and sorbitol etc.
● The soft gelatin shell may contain a preservative to
prevent the growth of fungi.
● They are used to enclose liquid medicaments such as :
oils, suspensions, food concentrates and ophthalmic
products.
 Methods of filling of soft gelatin capsule

Soft gelatin capsules are generally filled mechanically.

The manufacturing of the capsule shell and the filling of the
medicament takes place simultaneously.
Now a days rotary machine is used for this purpose.

Rotary machine : In a rotary die machine, the soft gelatin capsule are
prepared and then filled immediately with the liquid
medicaments.

● The machine consists of two hoppers.

● Liquid gelatin mixture is placed in one Hopper and the
liquid medicaments in the other Hopper.
● There are two rotating dies which rotate in
opposite directions.
● When fluid gelatin mixture enters into the machine from
the Hopper it produces two continuous ribbons.
● These ribbons come over the rotating dies from
opposite directions and enter in between the dies.
● Thus, half the shell of the capsule is formed.
● At this stage the measured quantity of the
medicaments is filled into it with the stroke of a pump.
● With the subsequent movement of the dies, the other half
of the capsule is formed.
● The two halves of the capsule are sealed together by the
heat and pressure of the rotating dies.
● The capsules formed are washed thoroughly and dried..
● This rotary machines are capable of producing
between 25000 to 30000 capsules in an hour.
Semisolid dosage forms are dermatological products of semisolid consistency and applied to skin for
therapeutic or protective action or cosmetic function.

They can be applied topically to the skin, cornea, rectal tissue, nasal mucosa, vagina, buccal tissue,
urethral membrane, and external ear lining. E.g.: Ointments, creams, jellies and paste etc.

Advantages of semi-solid dosage form:

1. It is used externally.
2. The probability of side effects can be reduced.
3. First, pass gut and hepatic metabolism is avoided.
4. Local action and site-specific action of the drug on the affected area.
5. Convenient for unconscious patients
6. Suitable dosage form for bitter drugs.
7. More stable than a liquid dosage form.

Disadvantages of semi-solid dosage form:

1. The accuracy can’t be measured for semisolid dosage form.

2. They are bulky to handle.
3. Application with a finger may cause contamination.
4. May cause irritation or allergy to some patients

Ideal properties of semisolid dosage forms:

1. Smooth texture
2. Elegant in appearance
3. Non dehydrating
4. Non greasy
5. Non hygroscopic
 Ingredients needed for semisolid dosage form

1. Bases
2. Preservatives
3. Humectants
4. Antioxidant
5. Emulsifiers
6. Gelling agent
7. Permeation enhancer
8. Buffers

Ointment

Ointments are the semi-solid preparations meant for applications on Skin (or)
mucous membrane.
They usually contain a medicament dissolved, suspended (or) emulsified in an ointment base.

They may contain a suitable antimicrobial preservative.

The ointments are mainly used as protective (or) Emollient for the skin

Types of ointment:

1. Dermatological ointment (Applied on the skin)

2. Ophthalmic ointment (introduce into ophthalmic cavity)
3. Rectal Ointment (Applied on the Rectum).

Ointment base

The ointment base is a substance (or) a part of ointment which acts as a carrier (or) vehicle for the
medicament
 Ideal properties of the ointment base:

✔ It should be inert, odorless and smooth.

✔ It should be physically and chemically stable.
✔ It should be compatible with the skin and with the incorporated medicaments.
✔ It should be of such a consistency that it spreads and Softens when applied to the skin
with stress.
✔ It should be easily washable.
✔ It should not produce irritation (or) sensitization of the skin.

Classification of ointment Bases

They are four types of ointment bases.

1. Oleaginous bases

2. Absorption bases.

3. Emulsion bases

4. Water soluble bases.

1. Oleaginous bases:

These bases consist of water insoluble hydrocarbons, vegetable oils, animal fats and

waxes. The constituents of hydrocarbon bases are Soft paraffin, hard paraffin and liquid

paraffin.

2. Absorption Bases:

These bases are generally anhydrous substances which have the property of absorbing considerable
quantities of water but still retaining their ointment base consistency.
→ Ex: wool fat, wool alcohol, Hydrous wool fat etc.
 3. Emulsion Bases:
These bases are semisolid (or) having cream like
consistency. Both o/w type and w/o Emulsion are used as
ointment bases.

4. Water soluble Bases

These are commonly known as “grease less ointment bases".
The water soluble bases consist of water soluble ingredient such as polyethylene glycol
popularly known as Carbowaxes.
Ex: Tragacanth, Gelatin, Bentonite.

Method of preparation of Ointments,

The Ointment methods can be prepared by any o one of the following

1) Trituration method
2) Fusion method
3) Chemical reaction method
4) Emulsification method

Trituration method

It is the most commonly used method for preparation of ointments.

This method is used when the base is soft and the medicament is insoluble in base.

The following procedure is used to get a uniform ointment.

Finely powder solid medicaments

Weigh the required quantity of an ointment base

Triturate the solid medicament with a small amount of base in an ointment slab with the
help of stainless steel ointment Spatula until a homogenous product is formed

Add remaining quantities of base until the medicament Is uniformly mixed with it. Ex: Sulphur ointment.
2. Fusion method:

When an ointment base contains a number of solid ingredients of different melting points such as
whitebees wax, stearic acid, hard paraffin and cetyl alcohol

It is necessary to melt them in decreasing order to their melting point & mix with each other.

CREAMS
● Creams are formulated to provide preparations that are essentially miscible with the
skin secretion.
● They are intended to be applied to the skin or certain mucous membranes for
protective therapeutic or prophylactic purposes especially where an occlusive effect
is not necessary.

TYPES OF CREAMS

1. Water-in-oil creams (oily creams) as bases: These are produced by emulsifying

agents of natural origin, e.g. beeswax, wool alcohols or wool fat.
These bases have good emollient properties.
They are creamy white or translucent and rather stiff

2. Oil-in-water creams (aqueous creams) as bases: These are produced by synthetic waves,
E.g. macrogol and cetomacrogol. They are the best bases to use for rapid absorption
and Penetration of drugs.
They are thin, white and smooth in consistency

PASTE
✔ Pastes are semisolid preparation intended for external application to the skin.
✔ They are generally thick and stiff.

Types of Bases:

I. Hydrocarbon bases
Ex: Soft paraffin, liquid paraffin.
 II. Water miscible
bases Ex.
Glycerine.

III. Water soluble

bases Ex.
Polyethylene
glycol

Method of preparation:

The following methods are used to prepare the paste and they are similar to method of preparations
of ointments.

? Trituration method
? Fusion method

Difference between pastes and ointments

Pastes

They contain large amount of finely powdered solids such as starch, zinc oxide, calcium

carbonate. They are very thick and stiff.

They are less greasy.

They are generally applied with a spatula (or) Spread.

They form a protective coating to the area where it is applied.

They are less macerating in action.

Paste contains a large amount of Powder which is porous in nature hence perspiration can escape.

Ointments
They contain medicaments which are generally dissolved (or) Suspended (or) Emulsified in the

base. They are soft and semisolid Preparation.

They are more greasy.

They are simply applied on the skin.

They are used for the protective of lesion (or) emollient for the skin.

They are more macerating in action.

They are used for the protection of lesions.

Storage of pastes:

The pastes should be stored in well closed container and keep in a cool place so as to prevent
evaporation of moisture present In the Paste.

JELLIES
Jellies are transparent, translucent, non-greasy semisolid preparation meant for external application
to the skin (or) mucous membrane.
They are prepared from,

(i) Natural gums:-Tragacanth, pectin, Sodium alginate.

(ii) Synthetic derivatives:-Methyl cellulose, Sodium carboxyl methyl cellulose.

Types of Jellies:

There are three types of Jellies:

(1) Medicated jellies

(2) Lubricating Jellies
(3) Miscellaneous Jellies..
Medicated jellies:
● The Jellies meant for medication purpose are called medicated jellies.
● These are chiefly used on mucous membrane and skin.
● These jellies contain sufficient water after evaporation of water, jellies provide a local
cooling effect and residual gum gives protection.
● The drugs which are added in medicated jellies are local anaesthetics, antiseptics,
lubricating. Ex: Ephedrine sulphate jelly is used as a vasoconstrictor to arrest the bleeding
of nose.

Lubricating jellies
● These jellies are used for the lubrication of diagnostic equipment’s such as surgical
gloves, cystoscopies, catheters, rectal thermometers etc.
● These jellies should be thin, transparent and water soluble.
● These Jellies should be sterilized.

LINIMENT
● Liniments are semi liquid, liquid or semisolid preparations meant application on the skin.
● They may be alcoholic or oily solutions or emulsions.
● Liniments are commonly used to relieve pain and stiffness caused by sore muscles, aches,
and strains, or Arthritis.
● Most of them are rubbed/massaged onto the skin e.g. Counter-irritant type.
● Some are applied on warm dressing or with the help of brush.
E.g. Analgesic liniments and soothing type.
● Alcohol is the main vehicle used in liniments to increases the penetration effect of
Counter- irritant and rubefacient action of molecules through skin.
● In oily liniments, oil is commonly used which spreads more easily on the skin.
● Liniments must not be applied to broken skin because it may cause excessive Irritation on
the skin.
E.g. Soap Liniment BPC, Camphor liniment BP, Methyl salicylate liniment BPC.
 LOTIONS
● Lotions are less viscose liquid dosage form mainly meant for external or topical
application without friction.
● They are either dabbed on the skin or applied on a suitable dressing with the help of
cotton wool and gauze socked in it to reduce evaporation.
● Lotions may be used for local action as cooling, soothing or protective purposes.
● They are generally applied for antiseptic action.
● Alcohol sometimes mixed in aqueous lotions for its cooling and soothing
action Examples of lotions:
a. Copper and Zinc sulphate lotion have astringent action.
b. Salicylic acid lotion for dandruff.
 Difference between liniments and lotions:

❖ Liniments are liquid or semi-liquid preparations that are generally applied to the skin by rubbing
and friction on the skin.
❖ Liniments are not applied to damaged skin because it causes excessive irritation.
❖ Liniment has higher viscosity than the lotion.
❖ Liniment is applied to relieve pain, and swelling of joints..
❖ Liniment is applied after taking a bath as pain relief.
❖ Liniments are suitable for unbroken skin.
❖ Liniments are alcoholic or oleaginous solutions are emulsions.

❖ Lotions are liquids that are intended for external application without friction.
❖ Lotions are applied directly to the skin.
❖ Lotion has a lower viscosity than liniment this is why they need to be rubbed.
❖ Lotion is used to moisturize the skin and is used as a treatment for superficial injuries.
❖ Lotion is ideal for use during the day and during summer
❖ Lotions are suitable for mild to slightly dry skin.
❖ Lotions are aqueous or sometimes alcoholic preparation.
 SUPPOSITORIES
Suppositories are semi-solid dosage form of medicament meant for insertion into body
cavities other than mouth.
They may be inserted into rectum, vaginal or nasal cavity.

The medicament is incorporated into the suppository base and product is formulated in such a
way that they will either melt or dissolve in the body cavity.
Suppositories are available in different shapes, sizes and weights.

Suppositories are used to produce local, systemic and mechanical action.

Advantages of suppositories

1. Suppositories are the unit dosage form of drug.

2. They can be easily administered into the children, old person & unconscious
patients who cannot swallow the drug easily.
3. They are inserted into the body cavities to produce local & systemic effect.
4. Drugs in suppositories are slowly absorbed giving sustained action.

Disadvantages of suppositories:

1. The irritant drugs cannot be administered by this route.

2. The suppositories cause embarrassment (rectal & vaginal) in most of
the patients.
3. Suppositories cannot be prepared easily.
4. Large quantity of suppositories cannot be administered in the body cavities.

TYPE OF SUPPOSITORY

i. Rectal Suppository-Into the rectum.

ii. Vaginal Suppository-into the vagina.
iii. Urethral Suppository-into male urethra.
iv. Nasal suppositories (Nasal bougies)
v. Ear cones (aurinaria)
 1. Rectal suppositories are meant for introduction into the rectum for their systemic
effect. They are available in various sizes & either in cone or torpedo weighs about 2 gm.
The rectal suppositories meant for children are smaller in size and Weigh is 1 gm.

2. Vaginal suppositories are meant for introduction into vagina. They are larger than rectal
suppositories and vary in weight from 3 to 6 gm or more. They may be conical, rod-shaped or
wedge shaped.
They are exclusively used for their local action in vagina
3. Urethral Suppositories (or Urethral bougies) are meant for insertion into the
urethra. Their weight varies from 2 to 4 gm and length from 2 to 5 inch. Urethral suppositories
are very rarely used.
4. Nasal suppositories (Nasal bougies) are meant for insertion into nasal cavity.
They are similar in shape compare to urethral bougies. Their weight is about 1 gm and length 9-10
cm. They are always prepared with glycero-gelatin base.
5. Ear cones (aurinaria) are meant for insertion
into the ear. Generally theobroma oil is used as a base.
They are prepared in a urethral bougies mould and cut according to the required size.

PESSARIES
✔ Pessaries are semi-solid medicated preparations meant for insertion into the vagina, with
the provided applicator.
✔ They melt or dissolve at a site of insertion.
✔ The pessaries may be conical, wedge shaped or rod shaped.
✔ They are used mainly for vaginitis (unpleasant vaginal discharge). Vaginitis may be caused
by a variety of micro-organisms or key old age.
✔ Pessaries are intended for local effects are employed mainly as contraceptives,
antiseptics in feminine hygiene (Trichomonas vaginalis, Candida Monilla)
✔ The pessaries are also available as tablets and capsules and are known as vaginal tablets
and capsules respectively.
✔ Pessaries should be stored in cool place.
✔ Now days special shaped suppositories are manufactured & are supplied with
applicator to facilitate insertion into vagina.
 Tablets
Tablets are the solid unit dosage form containing medicament or medicaments usually circular or flat
in shape. Tablets are prepared by the compression method and are hence called as compressed
tablets.

Advantages

I. Tablets are easy to be administered.

II. They are easy to be dispersed.
III. They are most stable dosage form.
IV. They maintain accuracy of dosage.
V. Bitter and nauseous substances can be given in tablet form with suitable coating.
VI. They are economical.
VII. They are easy to pack and transport.

Disadvantages

I. Tablets cannot be used in case of emergency or unconsciousness patient.

II. Bioavailability of some drugs may be low compared to solution and parenterals.
III. Some of drugs cannot be compressed into tablet form due to their amorphous nature.

CLASSIFICATION OF TABLETS

They are classified in 4 different types

A) Tablets are ingested orally
❖ Compressed tablets
❖ Multiple compressed tablets or press coated tablets
❖ Multilayered tablets
❖ Sustained action tablets
❖ Enteric coated tablets
❖ Sugar coated tablets
❖ Film coated tablets

B) Tablets used in oral cavity

❖ Buccal tablets
❖ Sublingual tablets
❖ Lozenges tables
❖ Dental cones

C) Tablets administered by other routes

❖ Implants
❖ Vaginal
D) Tablets use to prepare solution

❖ Effervescent tablets
❖ Dispersing tablets
❖ Tablets triturates
Coated Tablets

Coated tablets are a cover with one or more layer of mixtures of substances such as natural or
synthetic polymers, sugars, gums, coloring matter or flavoring agents.

The substance used for coating is usually applied as a solution or suspension. The tablets may be
coated for variety of reasons such as

❖ To make the unpleasant odour and taste.

❖ To improve the appearance of tablets.
❖ To protect the drug from atmospheric effect.
❖ To control the site of action of drugs. (Enteric coating)

Sugar Coated tablets

A sugar coated tablet is coated with sugar to mask unpleasant flavor & taste of tablet. The hard
coating on a sugar coated tablets is similar to the sweat coating on some cardies.

Film coated tablets

In this process the tablets are coated by a single or mixture of film such as thin layer of polymers like
methyl cellulose, carbowaxes etc

The polymers are dissolved in some of volatile organic solvents and are sprayed over the tablets until
a uniform good film is formed over the tablets.

It is done to protect the tablet from atmospheric changes such as light, air and moisture. It is also
used make the tablet water proof.

Enteric coating

Enteric coating is given to the tablets in order to ensure that these tablets will not disintegrate in the
stomach but pass through it as they are and get disintegrated in the intestine.

This is done due to the following reason

I. Medicaments produce severe irritation in the stomach

II. The action of medicament is required in the intestine eg: Anthelmintics
III. Medicaments get decomposed or destroyed by the acidic medium of the stomach
IV. Drug absorption is better in the intestine

Uncoated tablets

Uncoated tablets are generally single layer or multi-layer tablet prepared by compression of
granules.

Soluble tablets

Soluble tablets are uncoated tablets that are intended to be dissolved in water before
administration.
Dispersible tablets

Dispersible tablets are uncoated tablets intended to be dispersed in water before administration.

Effervescent tablets

Effervescent tablets are uncoated tablets containing (Citric acid and Tartaric acid) and carbonates
(base) that react quickly in the presence of water to release carbon dioxide. They are intended to be
dissolved or dispersed in water before administration.

Chewable tablets

These tablets are usually uncoated they are intended to be chewed before being swallowed.

Sublingual tablets

Sublingual are the uncoated tablets which are placed under the tounge where they dissolve or
disintegrate quickly and are absorbed directly without passing into GIT.

Buccal tablets

These are the tablets which are placed in the buccal pouch or between the gums and lips or cheek
where they dissolve or disintegrate slowly and are absorbed directly without passing into alimentary
canal.

Various modified tablets are

1) Sustained release tablets / Extended release tablets

Sustained release, prolonged action, controlled release or extended release tablet these are
the terms used to recognize drug delivery systems that are intended to attain a prolonged
beneficial effect by constantly release of medication over extended period of time
subsequent to administration of a single dose of drug.
The aim in designing sustained release delivery system is to decrease frequency of dosing or
to enhance efficacy of the drug localization at the site of the action.
The technologies used to compound SR tablets are wet granulation technique, Dry
granulation technique and sintering technique.

Advantages
I. Reduction in dosing frequency.
II. Enhanced patient convenience and compliance.
III. Reduction in adverse effects.
IV. Impaired efficiency of treatment.
V. Better drug absorption.
VI. Maximum bioavailability with a minimum dose.

Disadvantages

i. Cost is more for processing.

ii. Toxicity due to dose dumping
iii. Bigger possible for first pass clearance.
 iv. Need additional patient learning and counseling( Not to chew or crush
before swelling)
v. Delayed onset of action, hence sometimes not useful in acute condition.

Fast dissolving Tablets

Fast dissolving tablets are disintegrating and or dissolve rapidly in the saliva without the need of
water. Some tablets are designed to dissolve in saliva remarkably fast with in few records and known
as True fast dissolving tablets.

Fast or mouth dissolving tablets have been formulated for pediatrics, geriatric, bed ridden patients
who are busy and travelling and may not have access to water.

The technologies used for manufacturing fast- dissolving tablets are freeze drying, spray – drying,
tablet molding, sublimation, sugar -based excipients, tablets compression and disintegration
addition.

The European pharmacopeia used the term “Oro dispersible tablet” as a tablet that to be placed in
the mouth where it disperse rapidly before swallowing. According European pharmacopeia the ODT
should disperse/disintegrate in less than 3 minutes. The basic approach in development of FDT is the
use of super disintegrants like cross linked caboxymethyl cellulose, Sodium starch glycolate etc.
Which provide instant disintegration of tablet after putting on tongue.

Advantages

I. No need of water to swallow the tablet.

II. FDT’s can be easily administered to pediatric, elderly & unconscious patients.
III. Accurate dosing as compared to liquids.
IV. Dissolution & absorption of the drug is fast offering rapid onset of action.
V. Fast pass metabolism is reduced, thus offering improved bioavailability & thus reduced dose
& side effects

Disadvantages
I. The major disadvantages of FDT’s are related to the mechanical strength of tablets.
II. Bad tastes drug are difficult to formulate as FDT.
III. Dryness of mouth due to decreased saliva production.

Multi-layered tables

These tablets consist of two or more layers of material compressed successively in the same tablets.
The color of each layer may be same or different. The tablets having layers of different colors are
known as “Multi colored tablets” They are usually prepared for effective treatment of disease.

General properties

I. They should have sufficient mechanical strength

II. They should not have any manufacturing defects like chipping, capping etc.
III. They should have physical & chemical stability

Advantages

I. Cost is lower compared to all other oral dosage form.

 II. Light & compact.
III. Easy to swallow.
IV. Objective odour& bitter taste drug can be masked by coating techniques.
V. Suitable for large scale production.

Disadvantages

I. Some drug resists compression into dense compacts.

II. Drugs with poor wetting, slow dissolution properties are difficult to formulate as multi
layered tablets.
III. Bitter tasting drugs, drugs with an objectionable odour or drugs that are sensitive to oxygen
may require special coating.
 Ear preparations
These are the solutions which are instilled into the ear cavity with the help of a dropper
(Prepared in Water, Glycerine, and Propylene glycol and dilute alcohol as vehicles)
Ear drops are mainly used for
● Cleaning the ear
● Softening the wax
● Treating the ear infections
Advantages
❖ Stopping the growth of bacteria and fungus.
❖ Treating the infection.
❖ Self administration is possible.
Disadvantages
❖ Loss of hearing on application.
❖ Allergic reaction
❖ Itching
Ear drops mainly used for the following action
❖ Antibacterial
❖ Softening the wax
❖ Mild infections
Storage: Store in a cool
place
Labelling: For External use only
Example: Sodium Bicarbonate ear drop, Boric acid Ear drop

Nasal preparations
Nasal preparations meant to be instilled in the nasal cavity & are usually available in the form
of solutions or suspensions administered in the form of nasal drops or nasal spray.
They are available as
1) Nasal drops
2) Nasal sprays
3) Nasal gel
4) Nasal powers
Advantages
❖ Rapid drug absorption.
 ❖ Quick onset of action.
❖ Convenient route when compared with parenteral route for long term therapy.
Disadvantages
❖ Nasal irritation.
❖ Absorption surface area is less compared to GIT.
❖ Once the drug is administered cannot be removed.
Storage : Store in a cool place
Labelling : For External use only
Example : Ephedrine nasal drop
Solid dosage form

The solid dosage forms are mostly available in unit (single) dosage form, such as tablets, capsules,
pills, cachets or powder.
Classification of solid dosage form

Powders:
? Pharmaceutical powder is defined as a mixture of finely divided drug and chemicals in
a dry form.
? They are available in crystalline (or) amorphous form they are meant for both internal
and external use.
? The particle size of a powder plays an important role in dissolution distribution and
absorption.
Advantages
❖ Self medication is possible.
❖ Large quantity of drug can be administered (by dissolving or mixing the powder in a
suitable liquid)
❖ Onset of action is fast compared to other solid dosage forms such as tablet, capsule and pill.
❖ Incompatibility is less compared to liquid dosage form.
❖ Easy to prepare pack and store.
❖ The formulation of powders does not require any machines and techniques.

Disadvantages

❖ Drugs having bitter nauseous and unpleasant taste cannot be dispensed in powder form.
❖ The minimum weighable quantity of powder is 100mg.
❖ The dispensing of powder is time consuming.
❖ Deliquescent and hygroscopic drugs cannot be dispensed in powder form.
❖ Onset of action is slow when compared to liquid dosage form and parenterals.
Classification of powder

1. Bulk powder for internal use

2. Bulk powder for external use
a. Dusting powder
i. Medicated dusting powder
ii. Surgical dusting powder
 b. Insufflations
c. Snuffs
d. Dentifrices or tooth powder
3. Simple and compound powder for internal use
4. Powder enclosed in cachets and capsule
5. Compressed powder/ tablet triturates/ moulded tablet
6. Special powders
a. Eutectic mixture or powders
b. Explosive powder
c. Potent drug
d. Hygroscopic powder
e. Effervescent granules
7. Granules
a. Special granules
b. Effervescent granules
8. Powder for suspensions

Bulk powder for external use

? This is the powders which are used externally.
? This powder has to be supplied in a glass or plastic container with perforated top.
? Bulk powders for external use again classified into:-

Dusting powder

✔ These are the powders which are used to apply on the broken skin (or) body surface.
✔ They contain one or more active ingredients along with diluents such as magnesium
sterate, purified talc, kaolin etc.
✔ The particle size of powder should be very fine for the following reasons):-
a. For better absorption, adherence.
b. To cover large surface area
c. To prevent irritation.
✔ Dusting powders are of two types
namely –
● Medicated dusting
powder
● Surgical dusting powder.
∙
Medicated dusting powder (body surface)

? There are the non sterilized dusting powders which contains one (or) more
active ingredientsalong with diluents.
? They are used in the treatment of super facial skin disorders such as
antiseptic, astringent etc.

Surgical dusting powder (broken skin)

? These are sterilized dusting powders which are used in case of burn, cuts and upon
the umbilical cord of new born baby.
? These powders after the preparation should be sterilized in a hot air oven at 160 0c for 2
hours because inert diluents like magnesium sterate, kaolin, purified talc contains micro
organism.
Insufflations

? These are the medicated (non-sterilized) dusting powder which is used to apply in the
body cavities such as ear, nose, throat, vagina etc. which is applied with an applicator
(or) instrument known as insufflators in the form of spray or fine powder.

Effervescent granules

? There are special granules which are meant for oral administration
? They contain two carboxylic acids, base and drug.
a. Citric acid
b. Tartaric acid
c. Base (sodium bicarbonate)
d. Drug along with organoleptic agents

? Granules dispersed in the water before its administration, an acid-base reaction takes
place andcarbon dioxide is liberated.

C6 H8 O7 .H2 0 + 3NaHCO3 C6 H5 Na3 O7. + 3H20 + 3CO2

Citric acid Sodium bicarbonate Sodium citrate

C4 H6 O6 + 2NaHCO3 C4 H4 Na2 O6 + 2H20 + 2CO2

Tartaric acid Sodium bicarbonate Sodium tartrate.

Method preparation of effervescent granules.

i. Heat method (or) heat granulation method

ii. Wet method (or) wet granulation method

Heat granulation method

? Place large porcelain (on) stainless steel (or) evaporating pan (or) dish on a boiling water bath.
? The dish must be sufficiently heated before transferring the powder.
? Place a citric acid and tartaric acid over the pan and heat sufficiently till it releases the
water of crystallization from the acid.
? Add sodium bicarbonate to the mixture and mix with the help of spatula until a coherent
mass is formed.
? Pass the coherent mass through the sieve no. 22 by which wet granules are obtained.
? The wet granules are dried in hot air oven at the temperature not exceeding 600 c
? The dry granules are again passed through a sieve no. 22 to break the lumps which
maybe formed during drying.
? The drug granules are packed in a wide mouth bottles and dispensed.

Wet granulation method

? Place all the powder in a mortar and triturate then add a granulating agent such as alcohol and
mix
 it well until a damp mass (or) coherent mass is formed.
? Pass the coherent mass through the sieve no. 22 by which the wet granules are obtained.
? The wet granules are dried in oven at the temperature not exceeding 600c.
? Then the dried granules are passed through a sieve no 22 to break the lumps which may be
formed during drying.
? The dried granules are packed in a wide mouth bottle and dispensed.
 Sterile dosage form is the pharmaceutical formulation which is completely free from micro
organisms including spores and pyrogen.

The Sterile dosage forms includes:-

1) Injections
2) Eye formulation
3) Dialysis fluids (Dextrose and Electrolytes)

Parenterals

❖ It is derived from two Greek

words i.e. Para→ Beside (or) other than

Enteron→ Intestine

❖ Parenterals are the sterile pharmaceutical products that are given other than oral route,
which are used to administer into the body tissues with the help of Syringe and needle.
❖ They are administered by Intravenous, Intra muscular, intra dermal route etc
Advantages
1. Onset of action is fast compared to oral route.
2. Bioavailability is greater than other route.
3. Suitable in Emergency cases.
4. No Gastro Intestinal side effects.
5. It can be given to uncooperative and unconscious patients.
Disadvantages
1. Injection causes pain at the site of administration.
2. Self medication is not possible.
3. The trained person (or) skilled persons is required to administer the drugs.
4. Withdrawal of drug in not possible in case of over dose.

General requirements for parenterals Dosage

Forms:

1. Stability
2. Sterility
3. Free from pyrogens
4. Free from foreign particles
5. Purity
6. Isotonicity

❖ Stability:
It is a very important factor, the physical and chemical stability of parenterals preparation must be
maintained till it’s shelf life (or) during storage.
❖ Sterility:
They should be free from all types of micro-organisms.
Aseptic conditions are required to be maintained during the preparation of parenterals
products and its administration.
Sterility test of the product is done to remove all types of micro organisms.

❖ Free from pyrogen:

The parenterals products should be free from Pyrogens (or) toxin.
They should undergo test for pyrogens before its sealing.

❖ Free from foreign particles:

They should be free from foreign particles such as dust, fibers, crystals
etc. They should undergo test for clarity after its manufacturing.

❖ Purity:
The drug used for the manufacturing of parenterals should be of high quality or of purest
form. They should not contain impurities.
If impurities are present it should be under certain limits as prescribed in the individual monographs.

❖ Isotonisity :
Isotonisity of the parenterals preparation should be same with as blood pressure and body
fluids.They are two types of:-
a.Hypertonic Solutions

b. Hypotonic Solutions

Hypertonic solution
This has high degree of osmosis which causes shrinkage of blood cells.
Hypotonic Solutions
This has low degree of osmosis which cause haemolysis of blood cell and produce pain at the site of
injection.

Total Parenterals Nutrition (T.P.N):

? In case of several ill patient, when oral administration of nutrition supplement is not
Possible and alone dextrose by I. V cannot full fill the nutrition requirement of body.
? Thus it becomes necessary to supply the essential amino acid through I.V route to prevent
the nitrogen loss and to provide the building blocks of protein for active synthesis of cell
and their metabolism.
? This admixture of emulsion contains the egg phospholipids, hydrogenated
triglycerides, essential amino acids and glycerin along with combination of
dextrose.
? To the above ingredients when dextrose is added and sterilized “Millard’s reaction” takes
place, which convert the preparation to brown color which is unfit for use.
? Ingredients are mixed with dextrose has to be pre sterilized and can be administered by
I.V route.
 Formulations of parenterals

These are the following formulation of parenterals preparation:

a. Vehicle
b. Buffers.
c. Tonicity modifier
d. Solubilizing agent
e. Preservatives
f. Viscosity builders
g. Stabilizers
h. Chelating agents (EDTA)

Vehicle

It is a solvent (or) liquid which is used to dissolve, disperse (or) suspend a medicament.

It is of two types
(a) Aqueous liquid
(b) Non aqueous liquid.

a) Aqueous liquid:
Most of the parenterals preparation are prepared by using aqueous vehicle. They have good solvent
property as well as compatibility.

It consists of two types:-

Water for Injection:
? It is clear, colorless, odourless, pyrogens free water prepared by either distillation
(or) reverse osmosis process and having PH 5 to 7.
? It is used as a solvent when the medicament is either soluble (or) stable in aqueous medium.
? The solution which are prepared by using water for injection are sterilized & packed in a
final container.

Sterile Water for Injection:

? It is pre-sterilized water which is used to pack in single dose container.
? The parenterals product are prepared under aseptic condition but are not sterilized.
? It is used as for a re-constituent injections, where sterile water is mixed with powder just
before it’s use.
b) Non aqueous liquids:
These vehicles are used
? When the medicaments are not soluble in the aqueous medium. Eg:
Hormone Steroids etc
? When the drugs (or) medicaments gets hydrolysed (or) decomposed in aqueous
medium. Eg: Vitamins
 ? When modern formulations are prepared such as sustained release, control release etc.

Solubilising agent.

? When the medicaments are not completely soluble in vehicle (or) medicaments gets
crystallized after some time, thus it becomes necessary to add a solubilising agents.
Eg: Alcohol, Benzene, Ether liquid polyethylene glycol, ionic surfactants etc.

Buffers:

? Buffers solutions are the solutions which can tolerate the slightly changes in the pH
when included in parenteral preparation.
? They are used for following reasons:-
a. To provide stability for drug substances.
b. PH of parenterals preparation is same as PH of blood which can be
adjusted by adding the buffer solution.
Eg: Acetate buffer, phosphate buffer, citrate buffer, glutamide buffer.

Preservatives

It includes anti oxidants and antimicrobial agents:

a) Anti-oxidants: These are the chemical substances which are reducing
agent in naturewhich prevents the oxidative decomposition of some drug.
Anti oxidants are drugs which get self oxidized to prevent the oxidation of other
drug. Eg: Sodium Meta bisulphate, Ascorbic acid, sodium ascorbate.
b) Anti-microbial agents:- Indian pharmacopoeia recommends the
addition of an antimicrobial agent is not necessary for a single dose
container.
E.g. Benzalkonium chloride

Tonicity modifiers

Isotonic solutions are the solutions which have the same degree of osmosis as that of blood
pH/ plasma otherwise it may leads to shrinkage (or) haemolysis of blood.
Eg. Sodium Chloride 0.9%, Dextrose, Boric acid.
Hence the solution should be made isotonic by adding tonicity modifier.

Suspending agent/ Thickening agent/ viscosity

builders:

? Suspension type of infection contains insoluble solid particles, which may get settled
down at bottom and form a cakes of sediment particles.
? This may leads to inaccuracy in dose syringibility and injectibility.
? Hence the viscosity of preparation is increased by which the particle can evenly
distributed throughout the solution upon gentle shaking and the particle does not
form cake.
 Immunity & immunological product

Immunology: it is a branch of biological science that deals with the study

ofimmunity.

Immunity:- It is a power of the body to resist the effects of the invasion of

microorganisms called immunity.

Factor responsible for immunity:-

1. Phagocytosis: It is a process of engulfment or ingestion

of bacteria by certain cells of the body, which make them
harmless.It is caused by two types of body cells
● Cells of reticulo-endothelial system
● White blood cells (W.B.C)

2. Antibody formation:-
Anti bodies may be defined as substances formed in the body in
response to the presence of foreign proteins and certain other
materialsin the tissues. The production of antibodies in the body is
stimulated by the invasion of pathogenic microorganisms.

Immunological product:-

These are the preparations which are meant for the prevention of disease such as,
Vaccine.
(or)
For the treatment of disease, such as antitoxin and antiserum
(or)
For the diagnostic purposes, such as bacterial toxin.
Almost all immunological preparations are administered by parenteral
route,except poliomyelitis vaccine, which is administered by oral route.

Different between Active immunity and Passive immunity

Active Immunity Passive immunity

It is produced due to contact with It is produced due to antibodies

pathogen or antigen. obtained directly.

It lasts for a long time. It lasts for few days.

E.g. Small pox,polio etc. E.g. Diphtheria, chicken pox.

Antibodies areproduced by the body Antibodies are obtained from other

against the antigen. sources.
Immunity is not immediate there is a Immunity develops immediately.
time lapse for thedevelopment.

There are no or little side effects. The introduction of anti sera can
cause serum sickness.

The person isexposed to theagent. The person isnot exposed tothe agent
but is given the antibodies.
 Difference between serum and vaccine

Vaccine Serum
It containsdead bacteria orweak It does not contain bacteria or toxins.
bacteria or toxins.
Stimulates the body to make Contains serum formed in another
antibodies. animal.
Gaining immunityafter a Acquired immunity immediately.
Period.
Remain immune for long time. Remain for short time.

Vaccine
Vaccines are preparations containing antigens which stimulate the body to produce
antibodies. These antibodies make the person or animal immune to that disease for
which the vaccine is given.

Bacterial vaccines are either sterile suspension of live or killed bacteria or

sterile extracts of derivatives of bacteria. They may be simple vaccine
prepared from one species or may be mixed vaccines prepared by mixing two
or more simple vaccinesfrom different species or varieties.

Bacterial vaccines may be prepared from cultures grown on suitable solid or liquid
media. The bacteria are then suspended in normal saline solution or freeze dried.
The bacterial vaccines must be free from any substance known to cause toxic,
allergicor other undesirable immunological reactions in man. E.g. B.C.G.
vaccine.

Vaccines containing killed organisms may be prepared by killing the organism by

chemical or physical means provided the antigenic potency of the vaccine is
preserved
e.g. Cholera vaccine, pertussis vaccine and typhoid vaccine.

BCG vaccine (Bacillus Calmette-

Guerin)
BCG Vaccine is in the form of white pellet which when reconstituted yields an
opalescent suspension.
It is a freeze dried preparation containing live culture of the bacillus of Calmette & Guerin strain
of Mycobacterium tuberculosis.
 Preparation of BCG vaccine
● It is prepared by growing bacillus tuberculosis in suitable culture
media for not more than 14 days.
● Culture media is then transferred in a sterile liquid which
prevents further growth but preserves the antigenicity and
viability of the vaccine.
● The prepared vaccine is then transferred into sterile
glass containersimmediately in aseptic condition.
● BCG vaccine is available in liquid or freeze dried form.
● Liquids deteriorate even at low temperatures therefore it must be
used within14 days from the date of manufacturing.

Storage: Store in hermetically sealed light resistant glass container at a

temperature between 20 and 80 C. The reconstituted vaccine should be used
immediately after its preparation.

Uses: BCG vaccine is used as an immunizing agent which provides

protectionagainst tuberculosis.
Dose: Prophylactic: 0.1ml as a single dose by Intra cutaneous injection.

Typhoid vaccine

Typhoid vaccine is white or creamy white turbid liquid free from clumps.

It is a sterile suspension prepared from one or more strains of Salmonella typhi

that aresmooth and have the full components of O, H and VI antigens.

Preparation: Salmonella typhi organisms are grown on a suitable culture media.

Thebacteria are killed by heat or by a bactericide such as phenol, formaldehyde
or by a chemical such as acetone.

It is then standardized, so that 1.0 ml of the typhoid vaccine contains not less
than 1000million bacteria (S typhi).
The vaccine must comply with tests for sterility and the test for undue toxicity
forvaccine.

Storage: Store at a temperature between 20 and 8°C. The vaccine must not be
frozen.
Uses: It is used for immunization against infections caused by typhoid bacilli.
Dose: Prophylactic, Initial dose 0.5 ml followed by second dose of 1.0 ml
bysubcu taneous injection after an interval of 4 to 6 weeks.

Smallpox vaccine (freeze-dried)

Small pox vaccine (freeze-dried) is almost white powder which reconstitutes to

yield aviscid, straw colored liquid.
It contains living attenuated Vaccinia virus.

Preparation of smallpox vaccine:-

The vaccine is prepared by two methods.
A. By using animals.
B. By using eggs.

By using animals:-

➢ Smallpox vaccine is prepared by using calves or sheep.

➢ The method of preparation can be divided into followingsteps.

I. Selection of animal free from disease:-

Healthy calves or sheep are used for the production of vaccines and are
keptfor 10 -14 days in isolated areas under the observation.

II. Preparation of animal for scarification:-

The abdomen and flanks (the side of the body between ribs and
ilium) arethoroughly scrubbed, washed and disinfected in a special
room.
III. Inoculation:-
Light incisions are made in the cleared skin without drawing blood with
the helpof scarifier. The scarified area is then rubbed with some of the
seed vaccine of known potency.

IV. Incubation:-
During the next 7-9 days pustules or vesicles form along the line of
scarification. During the incubation period, every precaution is taken to
keep the animals as clean and aseptic as possible. Any animals showing
 V. Collection of virus:-
The animal is taken to the operation table and killed. A post mortem on
the animal is made to check the absence of disease. The abdomen and
flanks then wash with sterile water. The materialpustules are withdrawn
with the help of a sharp edged spoon under the asepticcondition.

VI. Purification:-
The contents of pustules are mixed with equal volume of glycerin, cooled &
then finely grounded to form homogenous mixtures. It is stored for a long
time at -10°C to remove impurities.

VII. Filling, sealing and storage:-

It is filled into the final container under aseptic conditions and freeze-
dried. Thecontainer is sealed to avoid contamination.

By using eggs:-

1. The eggs of hen are incubated for 12 days.

2. On the 13 days a small portion of the shell of the egg is removed and
the chorio-allantoic membrane is inoculated with seed vaccine of
known potency.
3. The portion of the shell is replaced and sealed in position with a
little meltedparaffin wax and incubated for 72 hours (3days).
4. Using aseptic precautions the shell is removed and the Chorio-allantoic
membrane is separated. It is placed in a sterile solution at 0°C, 50% of
glycerin is added. The product is ground to produce homogenized
suspension and transferred intothe final container freeze-dried &
sealed.
Storage:- Store between 20 - 8°C for 7 days.
Uses:- For active immunization against

smallpox. Dose:- For prophylaxis of smallpox

Toxoid

The pathogenic bacteria during their growth in a liquid media release a toxic
substance known as “toxins”.
These toxins are disease producing and are antigenic in nature. These toxins cannot
beused for immunization purposes because of their toxicity.
When these toxins are treated with chemicals, such as, formaldehyde, their
toxic properties are destroyed without causing any significant loss of antigenic
properties.These are called “toxoids”
The following are some of the immunological products containing toxoids.

Diphtheria Toxoid

It is a modified form of exotoxin of Corynbacterium diphtheriae.

Preparation:
A suitable strain of Corynbacterium diphtheriae is grown on a liquid medium at
37°C for7-10 days or until the required toxin concentration is obtained.
Phenol is added to kill the microorganism and filtered through bacteria proof
filters.The filtrate is a crude toxin.
It is antigenic but highly toxic. So, the toxin is converted into toxoid which is less
toxic innature and has an equal number of antigenic properties as the parent
toxin.

Four types of diphtheria toxoids are official, which are:

1. Formol Toxoid (FT): It is prepared by adding about 1% formaldehyde
into toxinand incubated at 37°C for 2-3 weeks. Due to undesirable
reactions produced with this vaccine, it is not commonly used these
days.
2. Toxoid Anti toxin Floccules (T.A.F.): It is prepared by adding Diphtheria
antitoxin to formol toxoid and the floccules or precipitates thus obtained
are suspended in normal saline solution. It has weaker antigenic properties
but is free from harmfulallergic reactions. Due to this reason it is useful for
sensitive persons.
3. Alum Precipitated Toxoid (APT): It is prepared by treating formal toxoid
with anadequate quantity of potash alum which precipitates the
diphtheria toxoid. Theprecipitates are separated, washed and suspended
in normal saline solution containing some preservative.
4. Purified Toxoid Aluminum Phosphate (PTAP): It is prepared by treating
formoltoxoid with hydrated aluminium phosphate.

Tetanus toxoid

This is prepared from the exotoxin of Clostridium tetani, the specific toxicity
of which has been completely removed by the action of chemical substances in
such a way thatit retains its antigenic properties.
Tetanus toxoid is available in the following forms
1. Formol Toxoid (F.T.) It is prepared by treating the sterile culture
filtrate ofClostridium tetani with formaldehyde solution.
2. Alum Precipitated Tetanus Toxoid: It is prepared by adding alum to
tetanus toxoid in simple solution in the proportion which is necessary to
produce a suitable precipitate. The precipitates are separated, washed
and suspended innormal saline solution.

Serum/ Antitoxin

When a person or animal has been actively immunized either by natural or

artificialmeans, the blood contains a large number of antibodies.
If blood is withdrawn and allowed to clot, the antibodies are found in the
serum.The serum is called antitoxin.
If the antibodies it contains are antitoxin. The serum is called
antiserum.If the antibodies in it are antibacterial antibodies.
Similarly, if the antibodies are antiviral, the serum is known as antiviral serum.

Diphtheria Antitoxin
It is almost colorless, very faintly yellow or a slightly opalescent Liquid.

Preparation: The method of preparation of diphtheria antitoxin is divided into the

following stages:

1. Preparation of toxin for active immunization of the horse:

A pure culture of Corynbacterium diphtheriae is grown in a suitable

culturemedia at 37°C for 4-7 days.
After incubation, 0.5% phenol is added and the culture media is filtered
throughbacteria proof filters.
The filtrate is a crude toxin. It is converted into toxoid.

2. Selection of the horse:

Horses are selected because:
(a) They are easy to handle.
(b) They readily produce antitoxins because a horse resembles man
in having a natural immunity against diphtheria.
(c) R.B.C of horse’s blood settles quickly and packs tightly. This
propertyhelps in the separation of the serum.
(d) Considerable volume of blood can be taken without any i’ll effects.
 Note: The horse selected must be free from disease.

3. Active immunization of the horse: To the

selected horsesDiphtheria toxoid is given for active
immunization.
The toxoid is given by i/m route in the gradually increasing
doses.The first dose is of about 5 ml.
Further injections are given at the interval of 2-3 days by doubling the
volume of the injection each time.
In this way the volume of the last dose is about 600 ml.

4. Separation of serum from the horse: After a period of about 10 days

from thefinal dose, the blood is collected under aseptic conditions to see if
the adequateantitoxin has been obtained.
Eight liters of blood is collected three times during a period of 8 days.
After a rest of about 2 weeks, further injections of diphtheria toxoids are
given asper the past schedule to stimulate the production of antibodies.
Again 24 liters of blood is collected in three batches of 8 liters each.
The process is again repeated, but it should not be more than 4 or 5
times.After the collection of the blood, it is allowed to clot to separate
the serum.
The serum contains antitoxin along with other proteins, such as,
beta- globulins,gamma-globulins and albumins
Antitoxins are largely associated with beta-globulin

5. Concentration and refinement: Horse serum contains a high

concentration ofseveral other proteins which may cause
undesirable reactions, such as, anaphylactic shock or serum
sickness.
So these undesirable proteins are separated by the following methods
i. Concentration by fractional precipitation
ii. Concentration by fractional proteolytic digestion

Storage: It is stored in containers protected from light at a temperature

between 20and 8°C. It should not be allowed to freeze.

Dose It is administered by s/c or i/m injection in the following dose schedule:

(i) Prophylactic: 500 to 2000 international units

(ii) Therapeutic: not less than 10,000 international units

Tetanus Antitoxin
 It is almost colorless or a very faintly yellow liquid.

Preparation; It is prepared in the same way as diphtheria antitoxin.

The toxin is obtained from Clostridium tetani which is used for active
immunization ofthe horse.

Tetanus antitoxin has a potency not less than 1000 international units Per ml
when intended for prophylactic use and not less than 3000 International units
per ml whenintended for therapeutic use.

Storage: Same as diphtheria antitoxin.

Dose: It is administered by s/c or i/m injection in the following dose Schedule.
(i) Prophylactic: not less than 1500 international units.
(ii)Therapeutic: not less than 50,000 international units.

*********************************************************************
● A pharmaceutical manufacturing plant is an industry which manufactures and
sells pharmaceutical products such as medicines, cosmetics and drugs.
● The basic requirement of any manufacturing plant is personnel and their functions.
● All the jobs and departments together are responsible for the success and profit of the
organization.
● The organization structure of a “Typical” Pharmaceutical plant is categorized as functional
structure, product-oriented structure and matrix structure.
● The basic functional structure is presented in Fig 6.1 whereas a detailed organizational structure is
presented in Fig. 6.2. The description of the hierarchical structure followed within a
pharmaceuticals industry.
 QUALITY CONTROL

Definition

Quality control can be defined as “part of quality management focused on fulfilling quality
requirements.” QC can also be defined as “the operational techniques and activities used to fulfill
requirements for quality”

IS0 9000 defines quality control as “A part of quality management focused on fulfilling quality
requirement.

Concepts
QC involves establishment of quality standards and installation of systems to ensure that these
standards are maintained and practiced.
QC analysis regularly checks various quality parameters at each step to produce good quality
products.
In order to implement an effective QC program, an organization first decides which specific
standards the product service must meet.
Then, the extent of QC actions is determined, for example, the percentage of units to be tested
from each lot.
The types of quality control include process control charts product quality control and process
control.
The data such percentage of units that fail at testing is collected and the results are reported to
Manager.
After this, corrective action is decided and implemented.
Steps in Quality Control:
1) Establishing quality standards
2) Selecting the manufacturing process
3) Development of measurement techniques
4) Monitoring product quality
5) Taking

corrective action Significance of

Quality Control:

1. Cost reduction and profit maximization

2. Increase in operational efficiency
3. Maximum profit and customer satisfaction
4. Image of the organization
5. Insurance against heavy losses
6. Promotes employees' productivity
7. Morale of employees
 QUALITY ASSURANCE

Definition

QA also called QA testing, is defined as a procedure to ensure the quality of pharmaceutical

products or services provided to the customers by an organization.

Concepts
QA is any systematic process of determining whether a product or service meets specified
requirements. It helps to give high-quality product that builds trust and loyalty with customers.
The standards and procedures defined by a QA program help to prevent product defects before
they arise QA approaches are employed during every stage of a drug’s development. The QA
process includes reviewing documents, approving equipment, calibration, reviewing training
records, reviewing manufacturing records and investigating market returns

QA process has a defined cycle called PDCA cycle. The phases of this cycle are plan, do, and
check and act (PDCA). These steps are repeated to ensure that processes followed in the drug’s
development and manufacturing are evaluated and improved periodically

(a) Plan: In this phase, organizations plan and establish the

product, process and Service-related objectives and
determine them to deliver a high-quality end product
(b) Do: In this phase, product, process and services are developed
and tested and Necessary changes are made (do).
(c) Check: In this phase, product, process and services are
monitored and modified do check whether it meets the
predetermined objectives.
(d) Act: In this phase necessary actions implemented to
achieve improvements in the product, process and
service

An organization uses QA to ensure that the product, process and services are designed and
implemented with correct procedures This helps reduce problems and errors, in the final product.

Functions of QA:

(1) Technology transfer: Product design document is prepared and trial and error
data collected and evaluated. The documents are distributed, checked and
approved.
(2) Validation: In validation validations master plan (VMP) for the entire system is
prepared and resource planning for execution is done. Test criteria for approval
ofValidating product and process are set.

(3) Documentation: It controls the distribution and archiving of documents. Any change
in a document is made by adopting the proper change control procedure. It also
involves approval of all types of documents.

(4) Assuring product quality. It prevents mistakes and defects in manufactured

products and avoids problems when delivering process, products or services to
customers

(5) Quality improvement plans: Organizations makes to its stakeholders to improve

quality through focused targets and actions.
CURRENT GOOD MANUFACTURING PRACTICE

Definition
The CGMP is defined as the regulations enforced by the FDA that provides for systems to assure proper
design, monitoring and control of manufacturing processes and facilities.

Concepts
Currently, the FDA is the sole national authority mandated and tasked with the responsibility to issue
policies on cGMPs.

As a rule of thumb, a drug is deemed adulterated if the facilities used to manufacture it and the
packaging, and processing do not conform to CGMP’s.

a) The Outline of GMP:

GMP constitutes the license to operate in pharmaceutical manufacturing GMP guidelines

are a series of general principles that must be applied during manufacturing.
There are many ways to comply GMP while setting up of pharmaceutical quality system,
manufacturing processes and control in an organization.

(b) Parts of GMP

❖ Part I: Good manufacturing practices for premises and materials.

❖ Part IA: Specific requirements for manufacture of sterile parenteral and
ophthalmic preparations.
❖ Part IB: Specific requirements for manufacture of oral solid dosage form.
❖ Part IC: Specific requirements for manufacture of oral liquids.
❖ Part ID: Specific requirements for manufacture of topical products.
❖ Part IE: Specific requirements for manufacture of metered dose inhalers.
❖ Part IF: Specific requirements of premises, plant and materials for manufacture of drugs
❖ Part II: Requirements of plant and equipment.

(C) Importance of cGMP:

Testing of products alone is not adequate to detect contamination, error, etc, to ensure quality,
efficiency and safety.
cGMP requirements that help to assure the safety and efficacy of drug products Poor quality
drugs can be a disaster for both patients and governments from a health and a cost
perspective.
Therefore, manufacturers must produce appropriate quality products by following GMP
guidelines.
 INTRODUCTION TO CONCEPT OF CALIBRATION
DEFINITION
According to ICH calibration can be defined as “The Demonstration that a particular instrument or
device produces results within specified limits by comparison with those produced by a reference or
traceable standard over an appropriate range of measurements.
Calibration of instruments and processes is essential for checking their performances against known
standards.

(a) Important Definitions:

i. Calibration procedure: A documented, verified, and validated process that describes a
set of operations in accordance with a given method.
ii. Calibration provider: Laboratory or facility including personnel that performs calibration
in an established location.
iii. Errors: Result of a measurement minus the true value of the measured.
iv. Reference standard: Measurement standard having the highest metrological quality available
in an organization.
v. Uncertainty of measurement: Dispersion of values that can be attributed to the measured.

(b) Calibration procedure:

The calibration procedure involves comparison of the instrument against primary or secondary
standards.

Sometimes, it is sufficient to calibrate a device against another device of known accuracy.

After the calibration of a device or a process, future operation is considered to be error bound for a
given period of time under similar operational conditions.

The process of calibration is carried out in a hierarchical order.

i. Highest level: At this level, primary reference standard is assigned a value by direct
comparison with the reference base of S1 units. The primary standards are designated and
widely acknowledged as having the highest metrological quantities that have values
without reference to other standards of the same quantity.
ii. Second level: In this level, the secondary reference standards are calibrated against
primary standards of the same quantity using a high precision comparator and making
appropriate corrections.
iii. Third level: At this level, working standards are routinely used to calibrate instruments
and processes against the secondary reference standards or their representatives

(c) Advantages of Calibration:

i. It determines validity of measurements before the calibration.

ii. It assures consistency and compatibility with those made elsewhere.
iii. It helps to test repeatability and reproducibility features of the instruments processes.
iv. It provides confidence that products meet their specifications and are of desired Quality,
thus reducing costs and legal liability.
 v. It increases process and product efficiency through correct measurements.
vi. Calibration of devices in the process industry help to assure that the processes are well
controlled and that the products meet set specifications.
vii. It generates documentation of performance of instruments and processes to meet ISO 9000,
ISO 1400, and QS-9000 standards.
viii. A frequent calibration provides a graphical view of the equipment uncertainty over time as
well as reliability of equipment performance.
ix. Measurements made within international standards promotes global acceptance.

(d) Calibration services:

All the testing and measuring instruments are calibrated at reputed laboratories which have a
set of precise reference standard, instruments and facilities backed up with well qualified and
experienced personnel.
These institutes provide good, most accurate and reliable calibration services with due traceability.
Some of them provide facilities such as identification of instruments for calibration, at site
calibration, single window calibration service, calibration of special instruments and after calibration
service.
In order to calibrate instruments through outsourcing details such as name and type of the instruments,
make, model and the year of manufacturing, operational range with least count and accuracy.
Relevant standards or calibration procedure (specialized and critical instruments) and general
information about customer organization must be provided.
INTRODUCTION TO CONCEPT OF
VALIDATION DEFINITION:
Validation is the procedure which authorizing documentary evidences that prove, the following
process/ method or activity will consistently produce the product which leads to the expected result
(predetermined requirements).

● The concept of validation was first introduced by two US FDA officials Ted Byers and Bud
Loftus, during 1970’s to enhance the standards in order to improve the quality of
pharmaceuticals.

a. Scope of Validation: Pharmaceutical validation is a vast area of work that practically

covers every aspect of pharmaceutical processing activities Various areas for pharmaceutical
validation includes analytical, instrument calibration, process utility services, raw materials,
packaging materials, equipment, facilities, manufacturing operations, product design, cleaning
operation, etc.

b. Planning for Validation:

All validation activities are planned and the key elements of a validation programmed are clearly
defined and documented in a Validation Master Plan (VMP) or equivalent documents
The VMP is a summary document, which is brief, concise and clear. The VMP contains data on
validation policy, organizational structure of validation activities, summary of facilities and systems,
equipment and processes to be validated, documentation formats to be used for protocols and
reports, planning and scheduling, change control, reference to existing documents, etc.

c. Validation Team and Its Responsibilities:

A multidisciplinary team of qualified, trained and experienced personnel, in a relevant discipline, is
employed to execute validation studies Its responsibilities are to;

(1) Create, update and review/approve individual project validation plans and
validation deliverables.
(2) Ensure validation compliance with the industry’s VMP and project validation plan.
(3) Coordinate, implement and verify elements of VMP.
(4) Consult, evaluate and approve changes.
(5) Review and approve 1Q/OQ/PQ procedures and plans.
(6) Review test results and makes recommendations regarding release.
(7) Assess risks and develop contingency plan.

(d) The Importance of Validation:

Validation has significance in pharmaceutical industries which includes assurance of quality, process
optimization and reduction of quality cost, minimal batch failures, improved efficiently and
productivity, reduction in rejections and increased output.

In addition, it is of great value in avoiding capital expenses and reduction of complaints about process
 failures.

It is important in reduced in-process and finished goods testing It is significant in more rapid and
reliable start-up of new equipment’s, easier scale-up form development work and maintenance of
equipment.
It helps to improve employee awareness and more rapid automation.

It helps to reduce batch to batch variations achieve reproducible products of same quality, purity
and strength, and assure safety and efficacy and to minimize hazardous effects and reduce the
chance of product recall from market.

Last but not the least it is crucial in terms of government regulation

(e) Types of Validation:

(1) Process validation

(2) Equipment validation
(3) Facilities validation
(4) HVAC system validation: Heating, ventilation, and air conditioning (HVAC)
(5) Cleaning validation
(6) Analytical method validation
(7) Computer system validation (CSV)

************************************************************************************
Drugs are administered with the main aim of curing a patient of his or her disease. Drugs are never
administered in their pure form but are converted into a suitable formulation.

With the advancement of pharmaceutical sciences, new concepts have evolved various modern
dosage forms and methods of their administration.

Some of the modern dosage forms are:

1. Implants
2. Films and strips
3. Liposome drug carriers
4. Controlled drug delivery modules
5. Erythrocytes
6. Nanoparticles
7. Prodrugs

IMPLANTS

● The hypodermic tablets are placed under the skin by a minor surgery in order to release drugs
over prolonged periods of time.
● Now the magnetically controlled implants have been developed which can be opened or closed
at will in order to release or stop the drug.
● The implants which are in capsule form, consist of a body and a cap. It can be opened by placing
a magnet on the skin and moving it in the desired direction.

FILMS AND STRIPS

These are meant for topical application for slow release of drug over predetermined period of time.
The films and strips which are becoming popular these days are:

1. Zero order release films

2. Buccal strips

3. Spray bandages

Zero Order Release Films

● These films are called “laminates”, and are meant for topical applications.
● Such laminates release the drug slowly into circulation for about 12 hours.

Buccal Strips
● The buccal and sublingual tablets are now replaced with buccal strips. These strips consist of a
thin absorbent base of fabrics, filter paper and cotton etc.
● The buccal strip is made in contact with buccal mucosa for about 15 minutes and then it is
removed and discarded.

Spray Bandages
● These bandages are prepared by spraying the solution of drug in polylactide (polymer of lactic
acid anhydride).
● When this solution is sprayed, it will be comfortable bandage which can be simply washed off
with warm water.

LIPOSOME DRUG CARRIER’S

● There are several carriers in our body which transport bio-chemicals from one part of the body
to another e.g. proteins, enzymes etc.
● Liposomes are phospholipids, which can transport both hydrophilic and hydrophobic drugs.
● Large Multilamellar Vesicles (LMV), Small Unilamellar Vesicles (SUV) and Large Unilamellar
Vesicles (LAV) are some of the liposomes which are known today.

Application’s
Liposomal drugs have wide therapeutic applications, some of which are as follows:

1. Used in diseases caused by intracellular parasites e.g. malaria, tuberculosis and amoebiasis.
2. Liposomes can be used to transport functional DNA/RNA molecules into cells.
3. Liposomes can be used to transport radio-pharmaceuticals and immunological products.

CONTROLLED DRUG DELIVERY MODULES (CDDM)

● Controlled drug delivery modules are devices which are formed by embedding the drug within a
polymeric matrix, so that it gets released slowly to the body over a very long period of time.
● The drug-polymer complex may be formulated into tablet, capsule or any other suitable
formulation.
● These controlled drug delivery modules are punctured before administration with laser beam to
make a small orifice of a few microns in diameter for the release of the drug.

ERYTHROCYTES

Erythrocytes have also been tried in order to achieve controlled release of drugs.

The life span of an erythrocyte is about 120 days.

 Erythrocytes can allow a drug to circulate in the body for a long time which helps in the slow
release of drug in serum.
When the drug is encapsulated in erythrocytes, the drug gets leaked out of its cell over to
prolonged period of time.
Moreover, it can be sent to the specified sites.

Resealed erythrocytes technique as drug carrier is very promising but it is difficult to arrange
a large quantity of these erythrocytes.

Eg. Resealed erythrocytes of urease have been used in kidney failure to degrade
serum urea.
Resealed erythrocytes of methotrexate and adrianycin have been tried in cancer
therapy. It has shown good results.

NANO PARTICLES

● It is based on colloidal drug delivery system. The particle size of this system is in nanometre
range i.e. 200-500 mm. That is why they are called nanoparticles.
● The system consists of a drug and a carrier to deposit the drug at the target site

PRODRUGS

● The compounds which undergo biotransformation before showing desired pharmacological

activity are called as prodrugs or proagents.
● Prodrugs are generally the esters or amides of parent drugs.
● Prodrugs are useful in improving the solubility, stability, bioavailability of drugs, masking the
unpleasant taste and odour of the parent drug and reducing the drug toxicity.
Eg. Chloramphenicol palmitate, the prodrug of chloramphenicol is used in the
preparation of paediatric suspension because it has no bitter taste.