5th Sem Industrial Pharmacy 1 Syllabus

  UNIT-I  (View PDF)

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  (View PDF)

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  (View PDF)

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  (View PDF)

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  (View PDF)

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.