BP502T – Industrial Pharmacy I

Unit I: Pre-formulation Studies

• Introduction to pre-formulation: goals and objectives.
• Study of physicochemical characteristics of drug substances.
• Physical Properties:
• Physical forms (crystal & amorphous).
• Particle size, shape, flow properties.
• Solubility profile (pKa, pH, partition coefficient).
• Polymorphism.
• Chemical Properties:
• Hydrolysis, oxidation, reduction, racemization, polymerization.
• BCS Classification of Drugs & Its Significance.
• Application of pre-formulation considerations in solid, liquid oral, and parenteral dosage forms.
• Impact on stability of dosage forms.

Unit II: Tablets & Liquid Orals

Tablets

• Introduction and ideal characteristics.
• Classification and excipients.
• Formulation, granulation methods, compression, and processing problems.
• Equipment and tablet tooling.
• Tablet Coating:
• Types of coating and materials used.
• Formulation, coating methods, equipment, defects.
• Quality control tests: in-process and finished product tests.

Liquid Orals

• Formulation and manufacturing considerations:
• Syrups, Elixirs, Suspensions, and Emulsions.
• Filling and packaging.
• Evaluation of liquid orals as per pharmacopoeia.

Unit III: Capsules & Pellets

Hard Gelatin Capsules

• Introduction and production.
• Shell sizes, filling, finishing, special formulation techniques.
• Manufacturing defects and quality control tests.

Soft Gelatin Capsules

• Shell composition, capsule content.
• Importance of base adsorption, minim/gram factors.
• Production, in-process, and final quality control tests.
• Packing, storage, stability testing, and applications.

Pellets

• Introduction, formulation requirements.
• Pelletization process and equipment.

Unit IV: Parenteral Products

• Definition, types, advantages, and limitations.
• Pre-formulation factors and essential requirements.
• Vehicles & Additives:
• Importance of isotonicity.
• Production Procedure:
• Facilities, controls, aseptic processing.
• Formulation of injections, sterile powders, large volume parenteral, lyophilized products.

Unit V: Cosmetics, Aerosols, and Packaging

Cosmetics

• Formulation and preparation:
• Lipsticks, shampoos, cold creams, vanishing creams.
• Toothpastes, hair dyes, sunscreens.

Pharmaceutical Aerosols

• Definition, propellants, containers, valves.
• Types of aerosol systems.
• Formulation and manufacturing.
• Evaluation, quality control, and stability.

Packaging Materials Science

• Materials used in pharmaceutical packaging.
• Factors influencing choice of containers.
• Legal and official requirements.
• Stability considerations and quality control tests.