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AKTU Pharmaceutical Dosage Forms I (Theory) (BP306T) Syllabus PDF – B.Pharm 3rd Semester
Pharmaceutical Dosage Forms I (Theory) BP306T
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Official AKTU syllabus of Pharmaceutical Dosage Forms I (Theory) (BP306T) for B.Pharm 3rd Semester – 3 credits, L-T-P 3-0-0. Read the unit-wise course content, course outcomes, evaluation pattern and recommended books online, or download the PDF.
Syllabus — Pharmaceutical Dosage Forms I (Theory)
Download PDFBP306T · 3 credits · L-T-P 3-0-0
Course Objectives
- Understand the fundamentals of dosage form development, including pre-formulation studies, drug excipient compatibility, and stability considerations as per ICH guidelines.
- Acquire knowledge of formulation and manufacturing of compressed solid dosage forms, including tablets and coated tablets, along with quality control and packaging.
- Develop competence in the formulation and evaluation of finely divided and filled solid dosage forms, such as powders, granules, and hard and soft gelatin capsules.
- Understand the principles and formulation strategies of modified-release solid dosage forms, including sustained-release and controlled-release systems.
- Gain knowledge of microencapsulation techniques, their applications, advantages, limitations, and evaluation of microcapsules in pharmaceutical products.
Course Outcomes
| CO | Upon successful completion of this course, the students will be able to: |
| No. | |
| 1 | Describe pre-formulation principles and evaluate key physicochemical parameters critical to solid dosage-form development. |
| 2 | Apply formulation and manufacturing processes and perform quality control tests for tablets, including coated tablets, and troubleshoot common formulation and processing defects. |
| 3 | Formulate and evaluate finely divided and filled solid dosage forms such as medicated powders, granules, hard capsules, and soft gelatin capsules using appropriate materials, equipment, and quality control procedures. |
| 4 | Design and evaluate modified-release solid dosage forms by selecting suitable polymers and mechanisms to achieve sustained and controlled drug release. |
| 5 | Analyze various microencapsulation methods, select suitable techniques for specific drug-delivery needs, and evaluate microcapsules based on physicochemical and performance parameters. |
Course Content
| Unit | No. of Topics Lectures | |
|---|---|---|
| I | Fundamentals of Dosage Form Development: Pre-formulation studies: concept, need, and parameters including solubility, pKa, physical nature (amorphous and crystalline), polymorphism, particle size and shape, and powder flow parameters. Drug excipient compatibility studies. Packaging selection for various dosage forms. Drug product and container-closure interaction. Introduction to stability guidelines of new drug substances and products (ICH Q1). | 07 Hours |
| II | Compressed Solids: Tablets Excipients (roles and examples); tooling (types and specifications); manufacturing methods and equipment; tablet defects and remedies; in-process quality control (IPQC); finished-product tests; packaging. Tablet Coating Types of coating (sugar, film, compression, enteric); need, advantages, and limitations; polymers, process specifications, and equipment; coating defects; quality control of coated tablets. | 12 Hours |
| III | Finely Divided and Filled Solids: Medicated powders and granules: formulation considerations, manufacturing processes (mixing, granulation), quality control, and packaging. Gelatin and non-gelatin shells: composition, empty shell manufacturing, quality control, and capsule sizes. Hard gelatin capsules: formulation design; filling methods (manual, semi-automatic, automatic); IPQC and finished-product tests; packaging. Soft gelatin capsules: shell composition and plasticizers; fill materials; manufacturing methods (rotary die and others); defects; quality control and stability. | 12 Hours |
| IV | Modified-Release Solids: Types of tablets: sustained-release and controlled-release tablets. Concept, need, advantages, and disadvantages. Formulation design and drug-release mechanisms. Polymers used for sustained and controlled release. Evaluation of modified-release dosage forms. | 07 Hours |
| V | Microencapsulation: Concept, need, advantages, and disadvantages. Methods of microencapsulation: spray drying, spray congealing, extrusion and spheronisation, fluidized bed coating, and phase-separation coacervation. Evaluation of microcapsules. | 07 Hours |
Recommended References
- Allen, L. V., Popovich, N. G. and Ansel, H. C. Forms and Drug Delivery Systems. Lippincott Williams & Wilkins.
- Aulton, M. E. and Taylor, K. M. G. Manufacture of Medicines. Elsevier.
- Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
- Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
- Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
- Sinko, P. J. Lippincott Williams & Wilkins.
- Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
- United States Pharmacopeia. United States Pharmacopeial Convention.
- British Pharmacopoeia. British Pharmacopoeia Commission.
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