Industrial Pharmacy-I Book B.Pharm 5th Semester

Syllabus

Module 01                                                                                                                           07 Hours

Pre-formulation Studies

• Introduction to pre-formulation, Goals and Objectives, Study of Physicochemical Characteristics of Drug Substances.
• Physical Properties: Physical form (Crystal and Amorphous), Particle Size, Shape, Flow Properties, Solubility Profile (pKa, pH, Partition Coefficient), Polymorphism
• Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
• BCS classification of drugs and its significant
• Application of pre-formulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.

Module 02                                                                                                                           10 Hours

Tablets

•  Introduction, Ideal Characteristics of Tablets, Classification of Tablets. Excipients,

Formulation of Tablets, Granulation Methods, Compression and Processing Problems. Equipments and Tablet Tooling.

• Tablet Coating: Types of Coating, Coating Materials, Formulation of Coating Composition, Methods of Coating, Equipment Employed and defects in Coating.
• 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.

Module 03                                                                                                                           08 Hours

Capsules

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.

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.

Module 04                                                                                                                           10 Hours

Parenteral Products

• Definition, types, advantages and limitations. Pre-formulation factors and essential requirements, vehicles, additives, importance of isotonicity.
• Production procedure, production facilities and controls, aseptic processing,
• Formulation of injections, sterile powders, large volume parenterals and lyophilized products.
• 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.

 Module 05                                                                                                                           10 Hours

 Cosmetics

• Formulation and Preparation of the following Cosmetic Preparations: Lipsticks, Shampoos, Cold Cream and Vanishing Cream, Toothpastes, 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.