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Semester VI · PCI syllabus 2026
Active Pharmaceutical Ingredients and Excipient Sciences
BP607T-E6
1 credit
Elective
Coming soon
Unit 1: Unit 1
- Introduction to APIs and Excipients
- Definitions, classifications, and sources (synthetic, natural, biotech APIs; functional excipients)
- Physicochemical properties: Solubility, polymorphism,
Unit 2: Unit 2
- hygroscopicity, particle characteristics
- Roles in formulations: Bioavailability enhancement, stability, manufacturability
- Industry overview: Global market trends, common examples (e.g., paracetamol API, HPMC excipient). Methodologies for Selection and Pre-formulation
- Excipient selection criteria: Functionality-related characteristics (FRC)
- Compatibility studies: Binary mixtures via DSC, FTIR, XRD
Unit 3: Unit 3
- Analytical methodologies: HPLC/GC for purity, Karl Fischer titration, laser diffraction for PSD
- QbD approach: Risk assessment for API-excipient interactions. Manufacturing Protocols
- API processes: Synthesis routes, crystallization, drying, milling; lab- to-pilot scale-up
Unit 4: Unit 4
- Excipient handling: Sieving, blending, lubrication protocols
- GMP essentials: Equipment qualification, process validation
- operations: Wet/dry granulation, direct compression. Quality Control and Stability Protocols
- QC tests: Assay, dissolution, content uniformity (IP/USP methods)
- Stability studies: ICH Q1A zones, accelerated/forced degradation
Unit 5: Unit 5
- Impurity profiling: Genotoxic impurities (ICH M7), residual solvents
- In-process controls: Blend uniformity, weight variation. Regulatory Compliance and Industry Practices
- ICH Q7 guidelines for APIs
- USP-NF excipient monographs and Schedule M requirements
- Drug Master File (DMF) for APIs
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