Practice school

report on

“Formulation
Development”
Submitted to

Dr. Babasaheb Ambedkar Technological University,

Lonere, Maharashtra
In partial Fulfillment of the requirement for the Degree of

Bachelor of Pharmacy
by
Miss. Gayatri Chandrakant Shelake
Final Year B.Pharm Sem – VII
Under the Guidance of
Mr. Umesh T. Mali
Nootan College of Pharmacy,Kavathe-Mahankal – 415111,
Maharashtra
Academic Year 2024-2025

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 National Health Law Research Institutes

NOOTAN COLLEGE OF PHARMACY

Narsinhagaon, Tal-Kavathemahankal, Dist-Sangli (Maharashtra)

CERTIFICATE

This is to certify that, the Project entitled “Formulation Development”

submitted by Miss.Gayatri Chandrakant Shelake, Final Year B.Pharm Sem

– VII (Exam Seat No. 2168861823109)under the guidance of Mr. Umesh T.

Mali Sir.

in partial fulfillment of the requirement for the award of the Degree of

Bachelor of Pharmacy under Dr. Babasaheb Ambedkar Technological

University, Loneri.

This work has been carried out under our supervision at Nootan College

of Pharmacy,Kavathemahankal by the above student during Academic Year

2024-2025

Date: Dr. R .S jagatap

Place: Kavathemahankal

Nootan College of pharmacy KM

 National Health Law Research Institutes

NOOTAN COLLEGE OF PHARMACY

Narsinhagaon, Tal-Kavathemahankal, Dist-Sangli (Maharashtra)

CERTIFICATE

This is to certify that, the Project work report entitled, “Formulation

Development” submitted by, Miss.Gayatri Chandrkant Shelake , Final Year
B.Pharm Sem – VII (Exam Seat No. 2168861823109) in partial fulfillment for the
award of degree of Bachelor of Pharmacy under Dr. Babasaheb
Ambedkar Technological University, Lonere.

This work has been carried out under my supervision and guidance by the above

student during Academic Year 2024-25

Date: Mr.U.t.Mali
Place: Kavathe Mahankal

Nootan College of pharmacy KM

 National Health Law Research Institutes

NOOTAN COLLEGE OF PHARMACY

Narsinhagaon, Tal-Kavthemahankal, Dist-Sangli (Maharashtra)

DECLARATION

I hereby declare that the project work report entitled, “Formulation

Development” has been submitted by me under the guidance Mr. Umesh .T. Mali
Nootan College of Pharmacy, Kavathe-Mahankalin partial fulfillment oF the
requirement for the award of the degree of Bachelor of Pharmacy under Dr.
Babasaheb Ambedkar Technological University, Loneri.

I further declare that this is an original work and not submitted this report

previously.

Date: Miss. Gayatri Chandrakant Shelake

Final Year B. Pharm, Sem – VII .
Place: Kavathemahankal

Nootan College of pharmacy

KM
 ACKNOWLEDGEMENT

With great pleasure, I acknowledge my sincere gratitude to my guide Mr.

Umash .T .Mali Sir for his active guidance, innovative ideas, constant
inspiration, continuous supervision, valuable suggestions and support
to complete the project work effectively and successfully.

I express my sincere gratitude to Dr. R. S Jagtap (Principal, Nootan College of

Pharmacy, Kavathemahankal) for his constant encouragement and for making
the requisite arrangement to enable me to complete my work.

I am grateful to my family members, and my friends for their lovable and

moral support and constant inspiration without which this work would not
have been possible.

I sincerely thank all.

Miss . Gayatri Chandrakant Shelake

Date:
Final Year B. Pharm, Sem – VII
Place:Kavathe Mahankal

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 INDEX

Sr.no. Content Page number

1 Abstract 07

2 Introduction 08

Objective
3 09-10

Preformulation Parameters
4 10-13

Drug Delivery System

5 14 – 16

Evaluation Test Of Dosage Form

6 16-17

Packing and Labelling

7 18-19

8 Conclusion 23

9 Reference 24

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 Formulation dovelopment

Abstract :
The formulation development is important part of pharmaceutical development and essential
for therapeutic and commercial success of product by providing quality, safety and efficiency.
The main parts of formulation development are product development methods like drug
discovery, research etc. It is an essential factor not only in the starting stage of drug
development, but also in later marketing success of drug product. It ties the exploration of a
new drug substance to the successful development of a drug product. Formulation can
determine patentability, lifecycle the success of a pharmaceutical product.

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Introduction:

Drug development high trend in the pharmaceutical and Biotechnology industries.

With growing responsibilities to study drugs candidates from discovery to human
Clinical Trials as soon as possible, most pharmaceutical and biotech companies are
providing a portion of the developement of their potential new drugs. Outsourcing
decreases the timeline of product development and cost-effective alternative.
Changing needs of the people can be consider and fast solution can be provided to
the company and people is necessary outsourcing gives a multiple cost structure,
increasing resources and spending and decreasing when demand subsides.
Formulation can determine patentability, lifecycle the success of a pharmaceutical
product. Companies use this formulation developmem rules and regulations and
personnel into their product development to grow better. In large pharmaceutical
companies, specific departments may exist as the physical Characterization of drug
substances and formulation. issues. In many cases, various department are work at
deferment places so there handling is very much inmportant by single authority so
that the development get speed up and the formulation development timeline
decreases.

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Preformulation
Studies:

Defination:
This is an investigation of physical and chemical properties of drug substance alone and
when combined with expecients that affect drug performance

Objective:
 To generate information useful to formulator
 To increase drug stability
 To reduce excipient incompatibility
 To improve drug bioavailability
 To develop the elegant, stable effective and safe dosage form by establishing kinetic rate
profile and establish physicochemical parameter of new API
 To generate useful data needed in developing safe dosage forms that can be manufactured
on a commercial scale

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Performulation
parameters:
BULK CHARACTERS
 Crystallinity and
Polymorphism
 Hygroscopicity
 Fine particle
characterization
 Powder flow properties

SOLUBILITY ANALYSIS
 Ionization constant-PKA
 PH solubility profile
 Common ion effect-Ksp
 Thermal effect

Solubilization
 Partition co-efficient
 Dissolution
 STABILITY ANALYSIS
 Stability in toxicology formulations
 Solution stability
 pH rate profile
 Solid-state stability
 Bulk stability
 Compatibility

 Polymorphisim- (Poly-many, morph-form)

Defination :
“It is the ability of any compound or element or crystallize
as one or more distinct crystal species with different
internal lattice is called polymorphism.”

Types –
 Enantiotropic– One polymorph reversibly changed into Another by varying temperature &
pressure e.g. Sulphur
 Monotropic- One polymorph form is unstable at all temp & pressure e.g. Glyceryl stearate

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  Hygroscopicity – “Hygroscopicity is a term used to describe the ability of a
substance to absorb moisture From its surroundings is known as hygroscopicity.”

Hygroscopicity can be classified as :

a. Deliquescent
b. Very hygroscopic
c. Hygroscopic
d. Non-hygroscopic

 Powder flow properties

Flow property is an important factor that determines the fate of drug molecule.Sufficient
flow is required for uniformity of dosage form. So it is necessary to judge the flow of
material in preformulation stage of the dosage form.However extreme increase in flow may
improve weight uniformity but may reduce content uniformity through increased
segregation.

Methods of determination :
i. Angle of repose
ii. Density measurement
iii. Carr’s index
iv. Hausner’s ratio

i. Angle of Repose-Indirect method of quantifying powder flowability, because of their

relationship With inter particle cohesion.
“It is a maximum angle between the surface of a pile of powder & horizontal plane.”

Angle of repose is measured by the equation:

Tan θ= h/r
Here,
h-height of conical heap
r-radius of horizontal plane of powder

ii. Density measurement – “It is defined as mass per unit volume

(weight/volume) at fixed temperature and pressure.” It is expressed in g/cm3 or
kg/m3

Types of density :
a. Bulk density-Weight of powder/Bulk volume is known as bulk density
b. Tapped density-Powder weight /Tapped volume is known as tapped density
c. True density – Mass/True volume is known as true density.

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 d. Granule density -It is determined by mercury displacement
method.
iii.
Carr’s index = (Tapped density – Bulk density)×100 /
(Tapped density)

iv. Hausner’s ratio = (Tapped density) / (Bulk density)

 Stability Analysis
Stability of formulation dictate shelf life of marketed product, so to achieve this
preformulation is performed. Drugs degraded during storage via hydrolysis, oxidation, or
photochemical reaction. Formulation of a stable dosage form is essential for the patients
safety and drug efficacy ,hence stability studies become an integral and important part of
the drug development program.

Drug formulation
“The process through which a variety of substances combined with the drug active
pharmaceutical ingredients to finally produce a drug product that can be given to patient is
called drug formulation.”

Dosage Form = Active Pharmaceutical Ingredients (API) +

Expecients

= +

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 DRUG DELIVERY SYSTEM

Drug delivery is the method of administering pharmaceutical compound to achieve a

therapeutic effect in humans or Animals. Most common methods of drug delivery includes
the oral (through the mouth), topical (skin), trans-mucosal (nasal. Buccal, sublingual, vaginal,
ocular, rectal),parenteral(injection into systemic circulation) and inhalation routes.
Drug delivery system is the absorption of the drug across a biological membrane, whereas
the targeted release system releases the drug in a dosage form Ex. Tablets, Capsules, Oral
liquids Semisolids like Ointments, creams, lotions , Parenteral etc.

The drug delivery system can further be divided into two Main types:
1. Conventional drug delivery system.
2. Novel drug delivery system.

1. Conventional drug delivery system

“Conventional Drug Delivery System is the Classical methods for the delivery of Drug into
the body.”

The Examples of these systems includes:

 Oral Delivery – it includes tablets, capsules, syrups etc. taken directly through
Mouth and travels through GIT.
 Buccal/Sublingual Delivery - Here tablets or chewing gums are placed under
tongue (sublingual) and between cheeks (buccal).
 Intramuscular Delivery – The liquid drug is administered in the muscle tissue by
injecting with injector.
 Rectal delivery – Here suppositories are placed inside rectum and it melts at
body temperature to give quick effect.
 Subcutaneous delivery – Here liquid drug is administered in subcutaneous tissue
by Injecting with injector.
 Intravenos delivery – Drug in liquid form is administered directly into blood by
injecting in vein with the help of sterile injector

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 2. Novel drug delivery system
“Novel Drug delivery System (NDDS)
refers to the approaches, formulations,
technologies, and systems for
transporting a pharmaceutical
compound in the body as needed to
safely achieve its desired therapeutic
effects.”

NDDS is a system for delivery of drug other than conventional drug delivery system.
NDDS is acombination of advance technique and new dosage forms which are far
better than conventional dosage forms. Is a novel approach to drug delivery that
addresses the limitations of the traditional drug delivery systems.

Aim Of NDDS:

 Novel Drug Delivery System is to provide therapeutic amount of drug to the

appropriate site in the body to accomplish promptly and then maintain the desired
drug concentration.
 For drugs to reach the targeted site with little or no Side effects
 To minimize drug degradation and loss.
 To increase bioavailability of the drug and the fraction of the drug absorbed in the
required site.

Characteristics of ideal NDDS:

 Increase the bioavailability

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  Provide controlled delivery of drug
 Transport the drugs intact to the site of action avoiding the non diseased tissue Stable and
delivery be maintained under various Physiological variables
 Easy to administer, safe and reliable
 Cost effective Medical-optimum

NOVEL DRUG DELIVERY SYSTEM INCLUDES :

 Controlled Drug delivery system
 Nano carriers
 Vesicular Drug delivery system
 Gastro retentive Drug delivery system
 Nose brain Drug delivery system

 Controlled Drug delivery system: Controlled drug delivery is one which delivers
the drug at a predetermined rate , for locally or systemically, for a specified period of time.

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 Nano carriers – Nanocarriers are useful in the drug delivery process because they
can deliver drugs to site-specific targets, allowing drugs to be Delivered in certain
organs or cells but not in others
TYPE: liposomes, phytosomes, nanoparticles, microsphere

 Liposomes –
Liposomes are vesicle of lipid bilayer which encloses an aqueous compartment. Liposomes are
phospholipid-based colloidal vesicular structures in which hydrophilic core is entirely enclosed
by membranous lipid Bilayers.

The size ranges from 25-500nm.

 Phytosomes-

Phytosomes are complex

of phospholipids and
natural active
phytochemicals, bound in
their
structures, by the
obtained reaction between
phosphatidylcholine (or any
hydrophilic polar head
groups) and plant extracts in
an aprotic solvent.

 Nano particles – Nanoparticles are defined as particulate dispersion, or solid particles

having the size range 10-100 nm

Biocompatible , Biodegradable, offer complete drug protection

 Microspheres – Microspheres are small spherical particles , with diameters in in the

micrometer range 1mm to 1000 mm
Microspheres are sometimes referred to as microparticles .

 Vesicular Drug delivery system - Vesicular drug delivery system is one of the
systems that can improve the bioavailability of the drug and the reduction in toxicity By drug
targeting to the specific site. Bingham pioneered the biologic origin of vesicular systems in
1965, and hence named them Bingham bodies.

 Gastro retentive Drug delivery system – Gastro rentetive delivery system

are designed to be retained in the stomach for a prolonged time and release their active
ingredients

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 and thereby enable sustained and prolonged input of the drug to the upper part of
the gastrointestinal tract .

Ex. Bioadhesive drug , Expandable drug ,high density drug delivery

 Nose brain Drug delivery system –

The target region for effective nose-to-brain drug delivery is the olfactory epithelium
in the upper nasal cavity. This region contains olfactory nerve cells which bypass the
BBB & provide direct access to the brain & CSF.

 Transdermal Drug delivery system – Transdermal Drug delivery system also

known as patches .are dosage forms designed to deliver a therapeutically effective
amount of drug across a patients skin. The ashesive of the transdermal Drug delivery
system is critical to the safety, efficacy and quality of the drug.

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 EVALUATION TEST OF DOSAGE FORMS

1. SOLD DOSAGE FORMS

Solid dosage forms are substances having definite shape and volume manufactured for the
administration of active and/or inert ingredient. Solids include tablets, capsules,
granules,Powders etc…
The solid dosage for needs various tests of evaluation so that it shows proper properties of
drug.

i. Dissolution Test -The assembly consists of the following: vessel, which may be
covered, made of glass or other inert, Transparent material, which should not sorb,
react or interfere with the preparation to be tested; a motor; a drive shaft; and a
Cylindrical basket (stirring element). The vessel is partially immersed in a suitable
water-bath of any convenient size or heated by a Suitable device such as a heating
jacket. The water-bath or heating device permits maintaining the temperature inside
the vessel at 37 ± 0.5 ºC during the test.

ii. Disintegration Test – To carry out a disintegration test for tablets, we use a basket
which holds 1 to 6 tablets. This is Then raised and lowered into a beaker of water,
which is used to simulate conditions in the stomach at 3737 ± 0.5 ºC. If the tablets or
Capsules float, perforated plastic disks are placed on the top of the tablets to keep
them under the water level. The tablet disintegration Time is taken when no residue
is left in the mesh.

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iii. Friability Test – Friability testing is a laboratory technique used by the
pharmaceutical industry to test the durability of tablets during transit. This testing
involves repeatedly dropping a sample of tablets over a fixed time, using a rotating
wheel with a baffle.

iv. Hardness Test – Monsanto hardness tester used to determine the hardness of
solid dosage forms .

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 v. Weight Variation Test – To find out the uniformity in the weight, 20 tablets
average weight is calculated of solid dosage forms.

2. LIQUID DOSAGE FORMS

A solution is a liquid preparation that contains one or more soluble chemical substances
dissolved in a specified solvent.
The liquid dosage for needs various tests of evaluation so that it shows proper properties of
drug:
 Leakage Test – 10 containers filled with liquid dosage form and inverted for 24
hours, also check for leakage in case of rubber Closure

3.DYE BATH TEST: to check ability of empty

container or container with product , the container
is deep in dye bath and pressure And vacuum
applied to it and than after estimated time check
for the dye marks.

 CLARITY TEST: dilute the preparations and check for

cloudiness with control that is clean water In this test transparent particles Or white
particles observed against the black background and the black or dark particles
observed against the white background.

 STERILITY TEST: It is done for detecting the presence of viable forms of bacteria,
fungi and yeast in parenteral products he test for Sterility must be carried out under
strict aseptic conditions in order to avoid accidental contamination of the product
during test.

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  PYROGEN TEST: Pyrogen testing determines the presence or absence of pyrogens
in parenteral pharmaceutical products.It is part of the mandatory release tests to
avoid life-threatening fever reactions induced by pyrogenic substances.

i. LAL TEST -The LAL (limulus amebocyte lysate) testing, also known as bacterial
endotoxin testing, is an in vitro assay used to detect the presence and concentration
of bacterial endotoxins in drugs and biological products, and is an important part of
pharmaceutical microbiology.

PACKAGING AND LABELING :

Defination – “ Packaging is the science, art and technology of enclosing
or protecting products for distribution, storage,sale and use .”

Productio Marketin
n g

TYPES OF PACKAGING :
 Primary Packaging – Primary Packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of distribution or use and is the
package which is in direct contact with the contents.

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 Secondary Packaging – Secondary Packaging is outside the primary
packaging perhaps used to
group primary packages together.

Example: Paper and board , box

 Tertiary Packaging -

Tertiary Packaging is used for bulk handling, warehouse storage and transport
shipping.

Example: wood Pallet

EVALUATION TEST FOR PACKAGING MATERIALS :

•IDENTIFICATION: appearance of packaging material alone and combination of

the product content is checked

•PHYSICAL TEST: appearance light absorption, ph., non volatile matter, residue on
ignition ,heavy metals, buffering capacity, Oxidisable substances are check.

•CHEMICAL TEST: test include ph. Materials chloride sulphates, paper or board,
alkalinity of glass, compatibility test for Containers.

• MECHANICAL TESTs: to check working and strength

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• BIOLOGICAL TEST: usp. Provides procedure for it implantation test, systemic
injection test ,intracutaneous test,

• ENVIRONMENTAL TEST : materials test in environment

LABELLING OF DIFFERENT DOSAGE FORM:

DEFINITION:

The term “labelling” designates all labels and other written, printed, or graphic matter
upon an immediate container of an article or Upon, or in, any package or wrapper in
which it is enclosed, except any outer shipping container.

Drug labelling is also referred to as prescription labelling, is a written, printed or graphic

matter upon any drugs or any of its container, Or accompanying such a drug. Drug
labels seek to identify drug contents and to state specific instructions or warnings
for Administration, storage and disposal.

For labelling of dosage form one should follows all the godliness given Product Name,
Drug Facts, Table, Active Ingredients, Purpose And Use, Warnings, Directions, Allergic
Reactions active Ingredients, expiry date, date of manufacturing, various type of
drugs Properly should be mentioned .

Conclusion:

The formulation development studies along with the pre-formulation studies

various tests and the sop handling are the important aspects of the pharmaceutical
industries without this the indusries cannot work properly and the quality efficiany
and the new solution of the problems occurring during development cannot be solve
one can know that the large amount efforts required with knowledge required for
formulation development because “ small mistake big consequences’

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 REFERENCE:
i. Azhar Chand Shaikh,Simran Sallubhai Shaikh,Dr.A.M.Shaikh,Mrs.Mangal S.Gaikwad, Ms.
Priti B.Shinde 2022 INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS
(IJCRT)Review - Formulation Development Studies Volume-10,page 1-1

ii. Preformulation Studies: An Integral Part of Formulation Design by Pinak Patel

Submitted: July 16th 2018 Reviewed

iii. MVP samaj's college of pharmacy (2020) international journal of science and research (IJSR)
review on preformulation study of drug volume -9 page 1

iv. Trevino JT , Quispe RC ,Khan F ,Novak V 2020 Non-Invasive Strategies for Nose-to-Brain
Drug Delivery figure 1

v. https://www.mdpi.com/1420-3049/26/19/5905

vi. Preformulation Studies: An Integral Part of Formulation Design by Pinak Patel Submitted:
July 16th 2018 Reviewed

vii. Mohammad mudassar , Department for Quality control of packaging material page 1-7

viii. Industrial pharmacy 1 textbook by nirali by dr.ashok hajare page no.1.1to 1.40

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