Industrial Pharmacy I (Theory) | STUDY MATERIAL | BOOK | NOTES | PDF FREE DOWNLOAD | B pharmacy 3rd year - 5th sem
Industrial Pharmacy I (Theory) - STUDY MATERIAL - NOTES PDF | B pharmacy 3rd year - 5th sem
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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:
3 hours/ week
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, solubilityprofile (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 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 syrups and elixirs suspensions and
emulsions; Filling and
packaging; evaluation of
liquid orals official in pharmacopoeia
UNIT-III 08 Hours
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 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, 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 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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