Shree Sahkar Education Trust
SHREE DHANVANTARY PHARMACY COLLEGE, KIM
(An Autonomous College U/s UGC Act 1956)
NBA-UG & NAAC Accredited, Accorded Status under UGC Sec 2 (f) of UGC Act 1956, Recognized
as SIRO by DSIR, Govt. of India. Awarding University GTU, Ahmedabad, Approved by PCI,
AICTE, New Delhi
Bachelor of Pharmacy
Sub Code: BP504T
SEMESTER: V
Subject Name: Industrial Pharmacy-I
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.
Course Outcomes: Upon successful completion of this course, the student should be able to:
CO 1: Study of physicochemical characteristics of drug substances.
CO 2: Know the various pharmaceutical dosage forms and their manufacturing
Techniques
CO 3: Know various considerations in development of pharmaceutical dosage forms
CO4: Formulate solid,liquid and semisolid dosage forms and evaluate them for their quality.
Teaching Scheme and Examination Scheme
Teaching Scheme Evaluation Scheme
Theory Tutorial Practical Total Theory Practical
External Internal External Internal
3 1 - 4 75 25 - -
Unit Course Content Hours
1 Preformulation Studies: Introduction to preformulation, goals 07
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 & 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: 10
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 test
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: 08
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.
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: 10
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.
Total 45
Recommended Texts/Reference books/web resources:
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
3. Pharmaceutical dosage form disperse system VOL-1 by Liberman & Lachman
4. Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition Remington:
TheScience and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)
5. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
6. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill
livingstone,Latest edition
7. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger,
Philadelphia,5thedition, 2005
8. Drug stability - Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition,
MarcelDekker Series, Vol 107.
