The purpose of this course is to introduce pharmacy students to the fundamentals of principles, practices and technologies involved in pharmaceutical product development and its exploration from laboratory to global market. The course demonstrates the interrelationships between laboratory scaling of pharmaceutical products, pilot plants and commercial level manufacturing of the various dosage forms. The course explores the basic preparation techniques of emulsions, suspensions, semisolid dosage forms and sterile products. Packaging and basic safety techniques are also part of the course.
COURSE LEARNING OUTCOMES (CLO)
CLO: 1. To describe basic principles, methods, equipments and formulation considerations of dispersions and semisolids.
CLO: 2. To describe basic principles, methods, equipments and formulation considerations of sterileproducts.
CLO: 3. To analyze influence of packaging material on product stability and various hazards encountered during processing of pharmaceutical products.
- Mechanical Equipment, Specific formulation consideration and Emulsion stability.
- Formulation of suspensions, Equipment used in preparation and test methods for pharmaceutical suspensions.
- Equipment used for Ointments, Pastes, Gels and Jellies. Packaging of ointments.
- Sterile area and its Classification, Ophthalmic ointments, Preparation of parenterals (Building, Equipment), Complete Sterility (Aseptic area), air control, (Laminar flow etc.), air locks, Environmental monitoring methods, Sterilization, Filling/Packaging (Plastic and glass containers), Added substances (Preservatives, anti-oxidants, solubilizer, suspending agents, buffers, stabilizers etc.), In-process Quality Control of Parenterals (Sterility, leakage, pyrogens, clarity etc.).
- Influence of Packaging materials, Stability, Packaging Lines, Packaging Area, and Packaging Equipment.
- Mechanical, chemical and fire hazards problems.
- Inflammable gases and dusts.
NOTE: STUDY TOUR: A visit to the pharmaceutical industries will be an integral part of the syllabus and will prepare and submit a report about operations in Pharmaceutical industry that will be evaluated in practical examination.