GANPAT UNIVERSITY

FACULTY OF PHARMACY
Program Bachelor of Pharmacy Branch/Spec. [Link].
Semester VI Version [Link]
Effective from Academic Year 2020-21 Effective for the batches admitted onwards 2018-19
Subject code BPH605 Subject Name Industrial Pharmacy I
Teaching scheme Examination scheme
Le Tu Pr Total Marks CE SE ES Total Duration SE ES
Hours 3 1 4 8 Theory 10 15 75 100 Theory 1 hr. 3 hr.
Credit 3 1 2 6 Practical 10 15 75 100 Practical 4 hr. 4 hr.
Pre-requisites
Nil
Scope and Objectives:
This subject is intended to give the knowledge on various aspects related to design, development, evaluation
and applications of different types of dosage forms.
Course outcome:
CO1 Know various pharmaceutical formulations and their manufacturing techniques.
CO2 Understand considerations in preformulation and formulation development with respect to the
pharmaceutical industry.
CO3 Apply theoretical concepts in order to develop lucid ideas about the use of various equipment in laboratory
relevant to pharmaceutical products.
CO4 Compare different dosage forms on the basis of their merits and demerits for their selection according to
drug.
CO5 Perform preformulation evaluation as well as evaluation of formulations, such as tablets, capsules, parenteral
products and cosmetics.
CO6 Formulate dosage forms, such as tablets, capsules, injections, ophthalmic products, creams, etc.
Syllabus- Theory
Unit Contents Hrs
1. Preformulation Studies: Introduction to preformulation, goals and objectives, study of physicochemical 06
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 & its significant. Application of preformulation considerations in the development
of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.
2. Tablets: 12
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 syrups and elixirs suspensions and
emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia.
3. Capsules: 07
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. Size of capsules,
Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects.
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 minim/gram factors, production, in process and final product quality control tests.
Packing, storage and stability testing of soft gelatin capsules and their applications.
c. Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of
pellets.
4. Parenteral Products: 10
a. Definition, types, advantages and limitations. Preformulation factors and essential requirements,
vehicles, additives, importance of isotonicity.
b. Production procedure, production facilities and controls, aseptic processing.
c. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
d. Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality
 control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye
ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic
preparations.
5. Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, 10
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.
Syllabus-Practical
1. Preformulation studies on paracetamol/asparin/or any other drug.
2. Preparation and evaluation of Paracetamol tablets.
3. Preparation and evaluation of Aspirin tablets.
4. Coating of tablets- film coating of tables/granules.
5. Preparation and evaluation of Tetracycline capsules.
6. Preparation of Calcium Gluconate injection.
7. Preparation of Ascorbic Acid injection
8. Qulaity control test of (as per IP) marketed tablets and capsules.
9. Preparation of Eye drops/ and Eye ointments.
10. Preparation of Creams (cold / vanishing cream).
11. Evaluation of Glass containers (as per IP)
Text books
1. Pharmaceutical dosage forms - Tablets, volume 1 -3 by H.A. Liberman, Leon Lachman &[Link].
2. Theory and Practice of Industrial Pharmacy by Liberman & Lachman.
3. Cosmetic Science & Technology Volume 1-3 by M.S. Balsam.
4. Cosmetics Formulation Manufactoring & Quiality Control by P.P. Sharma.
5. Handbook of Pharmaceutical Technology by L. K. Ghosh.
6. Handbook of Cosmetics by B.M. Mithal.
7. Introduction to Pharmaceutical Dosage Forms by H. [Link], Lea &Febiger, Philadelphia, 5thedition, 2005.
Reference books
1. Pharmaceutical dosage form - Parenteral medication vol- 1&2 by Liberman & Lachman.
2. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman.
3. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition.
4. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS).
5. Pharmaceutics- The science of dosage form design by [Link], Churchill livingstone, Latest edition.
6. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition, Marcel Dekker Series, Vol
107.

Mapping of CO with PO and PSO

PO PO PO PO PO PO PO PO PO PO PO PO PS PS PS PS
1 2 3 4 5 6 7 8 9 10 11 12 O1 O2 O3 O4
CO1 3 2 2 0 0 0 0 0 0 0 0 0 3 2 0 0
CO2 3 2 2 0 0 0 0 0 0 0 0 0 3 2 0 0
CO3 3 2 2 0 1 0 0 0 0 0 0 0 3 2 1 0
CO4 3 3 3 2 1 0 0 0 0 0 0 0 3 3 1 0
CO5 3 3 3 3 1 0 0 0 0 0 0 0 3 3 1 0
CO6 3 3 3 3 2 0 0 0 0 0 0 0 3 3 2 0