Course Code: ER20-11T 75 Hours (3 Hours/week)
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.
Syllabus:
|
Chapter |
Topic |
Hours |
Marks |
|
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. |
7 |
12 |
|
2 |
· Packaging materials: Types, selection criteria, advantages and disadvantages of glass, plastic, metal, rubber as packaging materials. |
5 |
7 |
|
3 |
· Pharmaceutical aids: Organoleptic (Colouring, flavouring, and sweetening) agents. · Preservatives: Definition, types with examples and uses. |
3 |
5 |
|
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. |
9 |
26 |
|
5 |
Tablets: Coated and uncoated, various modified tablets (sustained release, extended-release, fast dissolving, multi-layered, etc). |
8 |
25 |
|
Capsules: Hard and soft gelatine capsules. |
4 |
||
|
Liquid oral preparations: Solution, syrup, elixir, emulsion, suspension, dry powder for reconstitution. |
6 |
||
|
Topical preparations: Ointments, creams, pastes, gels, liniments and lotions, suppositories, and pessaries. |
8 |
||
|
Nasal preparations, Ear preparations. |
2 |
||
|
Powders and granules: Insufflations, dusting powders, effervescent powders, and effervescent granules. |
3 |
||
|
Sterile formulations: Injectables, eye drops and eye ointments. |
6 |
||
|
Immunological products: Sera, vaccines, toxoids, and their manufacturing methods. |
4 |
||
|
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 |
8 |
|
7 |
· Novel drug delivery systems: Introduction, Classification with examples, advantages, and challenges. |
5 |
5 |
|
TOTAL |
75 |
88 |