BP 502 T. Industrial Pharmacy (Theory)
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
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 & 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.
UNIT-II
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 syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals
official in pharmacopoeia
UNIT-III
Capsules:
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
UNIT-IV
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,
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
UNIT-V
Cosmetics:
Formulation and preparation of the following cosmetic preparations: lipsticks,
shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and
sunscreens.
Formulation and evaluation of shampoo
Lipsticks
Ingredients in Cosmetics
Evaluation of Cream and Powder
Classification of Cosmetics
Cosmetics for face
Hair Dyes
Tooth Paste
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.
SOP for Analysis of Packaging Materials
BP 506 P. Industrial Pharmacy (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)
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