BP502T Industrial Pharmacy Theory

Industrial Pharmacy Theory syllabus

UNIT-I

Preformulation Studies

Introduction to preformulation, goals and objectives, the 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, racemization, 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 the 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.
Equipment and tablet tooling.

b. Tablet coating: Types of coating, coating materials, formulation of the coating composition, methods of coating, equipment employed, and defects in the 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, the 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,
equipment for the manufacture of pellets

UNIT-IV

Parenteral Products

a. Definition, types, advantages, and limitations. Preformulation factors and essential requirements, vehicles, additives, the importance of isotonicity

b. Production procedure, production facilities and controls, aseptic processing

c. Formulation of injections, sterile powders, large volume parenteral 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, toothpaste, 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 the choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests.

  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
  5. Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical
    Science (RPS)
  6. Theory and Practice of Industrial Pharmacy by Liberman & Lachman
  7. Pharmaceutics- The science of dosage form design by M.E.Aulton, Churchill
    livingstone, Latest edition
  8. Introduction to Pharmaceutical Dosage Forms by H. C.Ansel, Lea &Febiger,
    Philadelphia, 5thedition, 2005
  9. Drug stability – Principles and practice by Cartensen & C.J. Rhodes, 3rd Edition,
    Marcel Dekker Series, Vol 107.

Also read: