A

Practice School Report on

“FORMULATION DEVLOPMENT’’

Presented
By,
Mr. Yogesh Y. Chavan
Mr.Atharv P.Pore
Mr.Yash B.Vagare
Mr.Aniket S.Vanjari
Ms.Sanika D.Bhosale
Ms.Anuja S.Patil

Final Year B. Pharm Sem–VII

Under the Guidance of
Asst. Prof. Mr. Manohar D. Kengar
(M. Pharm)

Nootan College of Pharmacy,

Kavathe-Mahankal– 416405 , Maharashtra
Academic Year 2024-25
CONTENT
 INTRODUCTION
 CONCEPT OF cGMP
 SOP
 VARIOUS EQUIPMENT,INSTRUMENTS &
HANDLING
 PREFORMULATION STUDIES
 FORMULATION OF CONVENTIONAL OR
NOVEL DRUG DELIVERY SYSTEM
 EVALUATION
 LABELING AND PACKAGING
 REFERENCE
1. INTRODUCTION
 Drug development is a 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 development of their potential new drugs.
 Formulation can determine patentability, lifecycle the success of
a pharmaceutical product.

1.1 DEFINITION
Pharmaceutical formulation development links the discovery of a
new drug substance to the successful development of a
commercial drug product. Formulation development scientists
must determine the most appropriate route to achieving effective
drug delivery Based on patient need, then optimize the
formulation’s characteristics based on a knowledge of the drug
product’s bioavailability and processing requirements.
2. Concept of cGMP
 cGMP refers to current Good Manufacturing Practices
regulations enforced by U.S. Food & drug Administration.
 cGMP provides a system that assure proper design,
monitoring & control Of manufacturing processes & facilities.
 Announced by FDA in Aug 2002.FDA’s cGMP practice
steering committee.
2.1 OBJECTIVES
➢ To provide the quality and strength pharmaceuticals.
➢ To assure that correct procedures have been followed.
➢ To assure that pure,safe, and effective products are
manufactured and distributed
➢ In the manufactured of cosmetic products , overall control
and
monitoring.
 2.2 STEPS IN FORMULATIONS
DEVELOPMENT

 Identification and characterization of

drug
 Excipients Compatibility Study
 Formulation development
 Formulation
 Optimization
Formulation Evaluation
 Stability
Studies
 3 . SOP
 A standard operating procedure (SOP) is a set of written
instruction that document routine or repetitive activity
followed by an organization sop stands for standard
operating procedure.
 Sops are used by most companies that are serious
about process management to manage their day-to-day
3.1 activities
OBJECTIVES .

➢ Ensure uniform and quality output.

➢ Provide clear-cut clarification for employees.
➢ Achieve a consistent and excellent provision of products
and
➢ services.
The risks and reduce the chances of costly errors.
➢ Reduce product recall rates and customer churn.
 4. VARIOUS EQUIPMENT
AND INSTRUMENTS
HANDLING
. 4.1. Tablet Compression machine
Tablet compression process includes the
following stages:

 Filling
 Metering
 Compression
 Ejection

Fig. 4.1. Tablet Compression machine

 4.2 TABLET COATER

Three general types of tablet coater

machine:

A. Standard coating pan.B. Fluidized bed coater C. Perforated PAN System

4.3 CAPSULE FILLING MACHINE

 A type of machine used to fill empty capsules with

pharmaceutical ingredients.
 Industrial capsule fillers are used in
pharmaceutical manufacturing at large scale with
high Capsule filler is efficiency.

Fig. Capsule Filling Machine

4.4 Fluidized bed dryer
 FBD works on the fluidization principle. A high-pressure Hot
air from the supply is passed through the perforated container
containing wet granules.
 As the hot air passes through container granules start to
suspend in the air to become dry (called a fluidized state), the
process is called fluidization.

Fig.Fluidized bed dryer

4.5 EXTRUDER APHERONIZER

 Extruder Spheronizer has wide use in the pelletization,

granulation of spherical particles and granules.

More particularly the sustained release oral solid

dose types.
 Using the extruder spheronizer entails four major
steps:-

 Formulation of the wet mass (granulation)

 Molding the wet mass into cylinders (extruder)
 Disintegrating the extrudate and shaping of the
fragments into spheres (spheronizer)
 Drying of the pellets

Fig.Extruder and
spheronizer
5. PREFORMULATION
STUDIES
5.1 Introduction
 Preformulation is a group of studies that focus
on the physicochemical properties of a New drug
candidate that could affect the drug
performance and the development of a Dosage
form.
 study the physical, chemical, biopharmaceutical
and mechanical properties of a new drug
substance in order to develop a safe, stable and
5.2 dosage form.
effective

Goals
 To establish the physico-chemical parameters of
new drug substance.
 To establish the physical characteristics.
 5.3 Study of physicochemical
characteristics of drugs substance
o Organoleptic properties
o Bulk characterization studies
o Solubility analysis
o Stability analysis

5.4 Physical properties

o Crystalline form
o Amorphous form
o Particle size
o Flow properties
o Solubility profile
 6. Formulation of
conventional drug delivery
6.1system
TABLET FORMULATION
Tablet is defined as a compressed solid dosage form containing
medicaments with Or without excipients.
 There are three methods for granulation:
a. Wet granulation (eg.Acetaminophen tablets)
b. Dry granulation ( eg. Effervescent tablets)
c. Direct compressio(eg.Aspirin)

6.2 CAPSULE
o Capsule are solid dosage forms in which the active
medicament are enclosed in either a hard or soft soluble
container or shell of a suitable form of gelatin.
o There are two types of capsule
A. Hard gelatin capsule(eg. Amoxicillin )
B. Soft gelatin capsuule(eg. Vitamin capsule)
6.3 ORAL LIQUID
 Oral liquids are homogeneous liquid preparations,
usually consisting of a solution, an Emulsion, or a
suspension, of one or more active ingredients in a
o suitable liquid
eg. Syrups, base.
elixirs

6.4 SEMI SOLID (like ointment,creams, lotions)

 Semi solids are the topical dosage form used for the
therapeutic, protective or cosmetic Function. They may be
applied to the skin, or used nasally, vaginally, or rectally.
 Internal semisolid dosage forms- (ex- suppositories, pessaries)
 External Semisolid Dosage Form-(ex.-Ointments,Creams)
6.5 PARENTERAL
 Parenteral drug delivery systems are the preparations that
are given other than oral route (Para-outside, enteric–
intestine).
Types of parenteral dosage form
 With injections: - E.g. Intravascular, Intramuscular,
Subcutaneous
 Without injections:. E.g. Inhalations
7.Evalution
7.1 SOLID DOSAGE
FORM
 Dissolution test
The USP APPARATUS II was used to
measure the release characteristics of
the Formulation at 50 and 100 rpm in
0.1 M HCL or pH 6.8 phosphate buffer
kept at 37°c. Six tablets were Fig.Dissolution test
subjected to dissolution tests, and the
amount of medication released Was
measured spectrophotometrically
 Disintegration test at a
238 nm
For a wavelength.
drug to be absorbed from a Solid
dosage form after oral administration, it
must First be in solution, and the first
important step toward this condition is
usually the Break-up of the tablet; a
process known as disintegration.
Fig.Dissolution test
 Fribiality test
The friability test, which measures a tablet’s resistance to abrasion
during handling, Packaging, and shipping, is closely connected to
the hardness test. Utilizing Roche Friabilitor, it is measured. Max
Weight Loss NO more than 1% Is considerd.

 Hardness test
it is a laboratory technique used by the pharmaceutical industry
The following are the different apparatus used into
Hardness testing.
a. The Monsanto tester
b. The Strong-Cobb tester
c. The Pfizer tester
 Weight variation
According to USP, weight variation test is run by weighing 20
tablets individually Calculating the average weight and
comparing the individual tablets weights to the Average the
value of weight variation test is expressed in percentage
Formula: weight variation= (IW-AW)/AW X 100

Where , IW- individual weight

AW- average weight Not more than 2 individual tablet weight
devite from the average weight by more then the deviation
stated in phramcopoeia.
7.2 LIQUID DOSAGE FORM
o Leakage test

o Clarity test

o Sterility test

7.3 SEMISOLID DOSAGE

FORM
 Viscosity
Creams are marketed in tubes or containers so Viscosity is very
important. The viscosity Should remain constant. The viscosity
can be measured using viscometers for nonNewtonian products.
With a concentric cylinder spindle, A brookfield viscometer can
Used to identify the viscosity of the different topical formulations.
The tests were Carried out at 21°C. The spindle was rotated at
various rpm such as on 0, 0.5, 1, 2, 2.5, 4, 5, 10, 20, 50, and 100
rpm values. All measurements were made in triplicate.
8.Labelling and packaging
Packaging of drugs is a crucial aspect of the pharmaceutical industry
to ensure the safety, Efficacy, and stability of medications.
Types of packaging
i. Blisters
ii. Bottles and containers
iii. Ampoules
iv. Vials
v. Syringes
vi. Parenterals bags
vii. Pouch dose packaging
 Packaging material
i. Glass
ii. Plastics
iii. Rubbers
iv. Paper/card boards
 Metals Evaluation tests for
Packaging materials
i. Edge crush test (ECT)
ii. Bursting strength test (BST)
iii. Puncture resistance test
iv. Climate conditioning for different environments.
 Labelling of different dosage form
o Labelling plays a crucial role in the identification of active
ingredients or excipients of a known drug, as well as
providing guidance for patients to ensure safety and
appropriate administration of medicine.
o It is an essential component of pharmaceutical quality
assurance, which assures that every dose is safe and
effective, free of contamination and defects.
9. Conclusion
The formulation development studies along with preformulation
studies various test and SOP handling are important aspect of
pharamceutical industries can’t work properly Formulation
development is a dynamic process that transforms APIs into
effective pharmaceutical products. This intricate science plays a
pivotal role in addressing diverse patient needs, from improving
drug solubility to enhancing patient acceptability. By seamlessly
merging scientific expertise with patient-centered design,
formulation development stands as a comerstone of the
pharmaceutical industry, driving innovation, and enhancing
healthcare outcomes. Preformulation work is the foundation of
developing efficacious and economical formulations
10. Reference:
1.International journal of creative research thoughts (IJCRT)
2.Industrial pharmacy textbook by nirali by Dr.Ashok Hajare pg.no 1.1
to 1.40
3. Preformulation Studies: An Integral Part of Formulation Design By
Pinak Patel Submitted: July 16th 2018 Reviewed
4. December 3 rd 2018 Published:June 9 th 2019 DOI:
10.5772/intechopen .8 2868 5. Various disintegration test dissolution
test usp pharmacopeia stage 4 harmonization Official may 1, 2020
( 701-1 to 703-25)
6. PYROGEN TESTING Indian pharmacopeia 2007 volume-1 appendices
-1British Pharmacopeia 2007 Remington science .
7. practice of pharmacy