CAREER POINT UNIVERSITY HAMIRPUR

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Course Name: FORMULATIVE PHARMACY (Theory)

Course Code: BP502T

Credits Points: 4 (One credit is equivalent to 11 hours of lectures / organized classroom
activity / tutorials, contact hours; 5 hours of practical work / seminars/ assignment work/field
work / teacher-led activity and 15 hours of other workload such as independent individual/ group
work; obligatory/ optional work placement; literature survey/ library work; data collection/ field
work; writing of papers/ projects ; seminars, etc.)
Total Course Hours: 45 hours
Scope: Course enables the student to understand and appreciate the influence of pharmaceutical
additives and various pharmaceutical dosage forms on the performance of the drug product.

Objectives: Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

Course Content:
UNIT-I 07 Hours

Preformulation Studies: Introduction to preformulation, goals and objectives, study of

physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.

UNIT-II 10 Hours

Tablets:
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation
of tablets, granulation methods, compression and processing problems. Equipments and tablet
tooling.
b. Tablet coating: Types of coating, coating materials, formulation of coating composition,
methods of coating, equipment employed and defects in coating.
c. Quality control tests: In process and finished product tests

Liquid orals: Formulation and manufacturing consideration of solutions, suspensions and

emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia
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UNIT-III 08 Hours
Capsules:
a. Hard gelatin capsules: Introduction, Extraction of gelatin and production of hard gelatin
capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard
gelatin capsules. In process and final product quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules,importance of base
adsorption and minimum/gram factors, production, in process and final product quality control
tests. Packing, storage and stability testing of soft gelatin capsules

Pellets: Introduction, formulation requirements, pelletization process, equipments for

manufacture of pellets

UNIT-IV 10 Hours

Parenteral Products:
a. Definition, types, advantages and limitations. Preformulation factors and essential
requirements, vehicles, additives, importance of isotonicity
b. Production procedure, production facilities and controls.
c. Formulation of injections, sterile powders, emulsions, suspensions, large volume parenterals
and lyophilized products, Sterilization.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids.
Quality control tests.

Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops,

eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of
ophthalmic preparations

UNIT-V 10 Hours

Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks,

shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens.
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems;
formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability
studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors
influencing choice of containers, legal and official requirements for containers, stability aspects
of packaging materials, quality control tests.
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LECTURE PLAN
FORMULATIVE PHARMACY (Theory) BP502T

Lectu Topic to be covered Web Link

rer
No.

1 Preformulation Studies:
Introduction to preformulation,
goals and objectives.
2 Study of physicochemical
characteristics of drug
substances.
3 Physical properties: Physical
form (crystal & amorphous),
particle size, shape, flow
properties, solubility profile
(pKa, pH, partition
coefficient), polymorphism
4 Chemical Properties:
Hydrolysis, oxidation,
reduction, racemisation,
polymerization
5 BCS classification of drugs
6 Application of preformulation
considerations in the
development of solid, liquid
oral
7 Parenteral dosage forms and its
impact on stability of dosage
forms.
8
Introduction, ideal
characteristics of tablets,
classification of tablets.

9
Excipients, Formulation of
tablets, granulation methods,
compression and processing
problems.

10 Equipments and tablet tooling.

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11 Tablet coating: Types of

coating, coating materials.
12 Formulation of coating
composition.

13
Methods of coating, equipment
employed and defects in
coating.

14
Quality control tests: In
process and finished product
tests

15 Liquid orals: Formulation and

manufacturing consideration of
solutions
16 Suspensions and emulsions;
Filling and packaging
17 Evaluation of liquid orals
official in pharmacopoeia
18
Hard gelatin capsules:
Introduction, Extraction of
gelatin and production of hard
gelatin capsule shells.

19
Size of capsules, Filling,
finishing and special
techniques of formulation of
hard gelatin capsules.

20
In process and final product
quality control tests for
capsules.

21
Soft gelatin capsules: Nature
of shell and capsule content,
size of capsules
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22
importance of base adsorption
and minimum/gram factors,
production, in process

23
Final product quality control
tests.

24
Packing, storage and stability
testing of soft gelatin capsules

25 Pellets: Introduction,
formulation requirements,
pelletization process,
equipments for manufacture of
pellets.
26 Parenteral Products:
Definition, types, advantages
and limitations.

27
Preformulation factors and
essential requirements,
vehicles, additives, importance
of isotonicity.

28
Production procedure,
production facilities and
controls.

29
Formulation of injections,
sterile powders.
30
Emulsions, suspensions.

31 Large volume parenterals and

lyophilized products,
Sterilization.
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32
Containers and closures
selection, filling and sealing of
ampoules.

33
Vials and infusion fluids.
Quality control tests.

34 Ophthalmic Preparations:
Introduction, formulation
considerations; formulation of
eye drops, eye ointments and
eye lotions
35 Methods of preparation;
labeling, containers; evaluation
of ophthalmic preparations
36 Cosmetics: Formulation and
preparation of the following
cosmetic preparations:
lipsticks, shampoos, cold
cream and vanishing cream
37 Tooth pastes, hair dyes and
sunscreens.
38 Pharmaceutical Aerosols:
Definition, propellants,
containers, valves.
39 Types of aerosol systems.
40 Formulation and manufacture
of aerosols
41 Evaluation of aerosols Quality
control and stability studies.
42 Packaging Materials Science:
Materials used for packaging
of pharmaceutical products.
43 Factors influencing choice of
containers.
44 Legal and official requirements
for containers
45 Stability aspects of packaging
materials, quality control tests.
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Course Name: FORMULATIVE PHARMACY (Practical)

Course Code: BP506P

Credits Points: 2 (One credit is equivalent to 20 hours of practicals / organized

practical activity / contact hours; 5 hours of practical work / seminars/ assignment work/field
work / teacher-led activity and 15 hours of other workload such as independent individual/ group
work; obligatory/ optional work placement; literature survey/ library work; data collection/ field
work; writing of papers/ projects ; seminars, etc.)

Scope: Course enables the student to understand and appreciate the influence of pharmaceutical
additives and various pharmaceutical dosage forms on the performance of the drug product.

Objectives: Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

BP 506 P. FORMULATIVEPHARMACY (Practical)

4 Hours/week
1. Preformulation study for prepared granules
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Preparation of Paracetamol Syrup
9. Preparation of Eye drops
10. Preparation of Pellets by extrusion spheronization technique
11. Preparation of Creams (cold / vanishing cream)
12. Evaluation of Glass containers

Recommended Books: (Latest Editions)

1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman
&J.B.Schwartz
2. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman
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3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman

4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science(RPS)
6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill livingstone,
Latest edition
8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger, Philadelphia,
5thedition, 2005
9. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel
Dekker Series, Vol 107.