Pharmaceutics

PHARMACEUTICS – THEORY

Course Code: ER20-11T

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

1. Basic concepts, types and need

2. Advantages and disadvantages, methods of preparation / formulation

3. Packaging and labelling requirements

4. 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

1. Describe about the different dosage forms and their formulation aspects

2. Explain the advantages, disadvantages, and quality control tests of different dosage forms

3. Discuss the importance of quality assurance and good manufacturing practices

1.

• 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

2.

Packaging materials: Types, selection criteria, advantages and disadvantages of glass, plastic, metal, rubber as packaging materials

3.

Pharmaceutical aids: Organoleptic (Colouring, flavouring, and sweetening) agents

Preservatives: Definition, types with examples and uses

4.

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

5.

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.

6.

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 5

7.

Novel drug delivery systems: Introduction, Classification with examples, advantages, and challenges