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Semester III · PCI syllabus 2026
Pharmaceutical Dosage Forms I
BP306T
3 credits
Theory
Coming soon
Unit 1: 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)
Unit 2: 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
Unit 3: 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
Unit 4: 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
Unit 5: 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
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