UNIQUE SERIES AKTU Syllabus
BP306T

Pharmaceutical Dosage Forms I (Theory)

L-T-P3-0-0 Credits3 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 3 (Core)

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Syllabus

5 units · 45 lecture hours
Unit1

Unit 1: Fundamentals of Dosage Form Development

7 hrs

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).

Unit2

Unit 2: Compressed Solids

12 hrs

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.

Unit3

Unit 3: Finely Divided and Filled Solids

12 hrs

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.

Unit4

Unit 4: Modified-Release Solids

7 hrs

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.

Unit5

Unit 5: Microencapsulation

7 hrs

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.

Course Objectives6 points
  • The objectives of this course are to:
  • 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 (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Describe pre-formulation principles and evaluate key physicochemical parameters critical to solid dosage-form development.
  2. CO2Apply formulation and manufacturing processes and perform quality control tests for tablets, including coated tablets, and troubleshoot common formulation and processing defects.
  3. CO3Formulate 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. CO4Design and evaluate modified-release solid dosage forms by selecting suitable polymers and mechanisms to achieve sustained and controlled drug release.
  5. CO5Analyze various microencapsulation methods, select suitable techniques for specific drug-delivery needs, and evaluate microcapsules based on physicochemical and performance parameters.
Recommended References (Preferably latest editions):9 books
  1. Allen, L. V., Popovich, N. G. and Ansel, H. C. Forms and Drug Delivery Systems. Lippincott Williams & Wilkins.
  2. Aulton, M. E. and Taylor, K. M. G. Manufacture of Medicines. Elsevier.
  3. Lachman, L., Lieberman, H. A. and Kanig, J. L. The Theory and Practice of Industrial Pharmacy. CBS Publishers & Distributors.
  4. Troy, D. B. and Beringer, P. Remington: The Science and Practice of Pharmacy. Pharmaceutical Press.
  5. Robinson, J. R. and Lee, V. H. L. Controlled Drug Delivery: Fundamentals and Applications. CRC Press.
  6. Sinko, P. J. Lippincott Williams & Wilkins.
  7. Indian Pharmacopoeia. Indian Pharmacopoeia Commission.
  8. United States Pharmacopeia. United States Pharmacopeial Convention.
  9. British Pharmacopoeia. British Pharmacopoeia Commission. Course Title Course Type

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Official AKTU syllabus

This subject is on page 79, 80, 81, 82 of the original AKTU PDF.

Official AKTU syllabus PDF ↗