PHARMACEUTICS – THEORY
Scope: This course is designed to impart basic knowledge and skills on the art and science of formulating and dispensing different pharmaceutical dosage forms.
Course Objectives: This course will discuss the following aspects of pharmaceutical dosage forms
Basic concepts, types and need
Advantages and disadvantages, methods of preparation / formulation
Packaging and labelling requirements
Basic quality control tests, concepts of quality assurance and good manufacturing practices
Course Outcomes: Upon successful completion of this course, the students will be able to
Describe about the different dosage forms and their formulation aspects
Explain the advantages, disadvantages, and quality control tests of different dosage forms
Discuss the importance of quality assurance and good manufacturing practices
Chapter 1: (7 hours)
History of the profession of Pharmacy in India in relation to Pharmacy education, industry, pharmacy practice, and various professional associations.
Pharmacy as a career
Pharmacopoeia: Introduction to IP, BP, USP, NF and Extra Pharmacopoeia. Salient features of Indian Pharmacopoeia
Chapter 2: (5 hours)
Packaging materials: Types, selection criteria, advantages and disadvantages of glass, plastic, metal,
rubber as packaging materials
Chapter 3: (3 hours)
Pharmaceutical aids: Organoleptic (Colouring, flavouring, and sweetening) agents
Preservatives: Definition, types with examples and uses
Chapter 4 (9 hours)
Unit operations: Definition, objectives/applications,
Principles, construction, and workings of:
Size reduction: hammer mill and ball mill
Size separation: Classification of powders according to IP, Cyclone separator, Sieves and standards of sieves
Mixing: Double cone blender, Turbine mixer, Triple roller mill and Silverson mixer homogenizer
Filtration: Theory of filtration, membrane filter and sintered glass filter
Drying: working of fluidized bed dryer and process of freeze drying
Extraction: Definition, Classification, method, and applications
Chapter 5 (8 hours)
Tablets – coated and uncoated, various modified tablets (sustained release, extended-release, fast dissolving, multi- layered, etc.)
Capsules - hard and soft gelatine capsules
Liquid oral preparations - solution, syrup, elixir, emulsion, suspension, dry powder for reconstitution
Topical preparations - ointments, creams, pastes, gels, liniments and lotions, suppositories, and pessaries
Nasal preparations, Ear preparations
Powders and granules - Insufflations, dusting powders, effervescent powders, and effervescent granules
Sterile formulations – Injectables, eye drops and eye ointments
Immunological products: Sera, vaccines, toxoids, and their manufacturing methods.
Chapter 6 (5 hours)
Basic structure, layout, sections, and activities of pharmaceutical manufacturing plants
Quality control and quality assurance: Definition and concepts of quality control and quality assurance, current good manufacturing practice (cGMP), Introduction to the concept of calibration and validation
Chapter 7 (5 hours)
Novel drug delivery systems: Introduction, Classification with examples, advantages, and challenges