UNIQUE SERIES AKTU Syllabus
BP607T AEC6

Active Pharmaceutical Ingredients and Excipient Sciences (Theory)

L-T-P1-0-0 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 6 (AEC – Elective 3)

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Syllabus

5 units · 15 lecture hours
Unit1

Unit 1

3 hrs

Introduction to APIs and Excipients Definitions, classifications, and sources (synthetic, natural, biotech APIs; functional excipients). Physicochemical properties: Solubility, polymorphism, hygroscopicity, particle characteristics. Roles in formulations: Bioavailability enhancement, stability, manufacturability. Industry overview: Global market trends, common examples (e.g., paracetamol API, HPMC excipient).

Unit2

Unit 2

3 hrs

Methodologies for Selection and Pre-formulation Excipient selection criteria: Functionality-related characteristics (FRC). Compatibility studies: Binary mixtures via DSC, FTIR, XRD. Analytical methodologies: HPLC/GC for purity, Karl Fischer titration, laser diffraction for PSD. QbD approach: Risk assessment for API-excipient interactions.

Unit3

Unit 3

3 hrs

Manufacturing Protocols API processes: Synthesis routes, crystallization, drying, milling; lab-to-pilot scale-up. Excipient handling: Sieving, blending, lubrication protocols. GMP essentials: Equipment qualification, process validation. Unit operations: Wet/dry granulation, direct compression.

Unit4

Unit 4

3 hrs

Quality Control and Stability Protocols QC tests: Assay, dissolution, content uniformity (IP/USP methods). Stability studies: ICH Q1A zones, accelerated/forced degradation. Impurity profiling: Genotoxic impurities (ICH M7), residual solvents. In-process controls: Blend uniformity, weight variation.

Unit5

Unit 5

3 hrs

Regulatory Compliance and Industry Practices ICH Q7 guidelines for APIs USP-NF excipient monographs and Schedule M requirements Drug Master File (DMF) for APIs Certificate of Suitability (COS) for excipients Process and cleaning validation protocols Regulatory inspections (USFDA 483, EMA expectations) Emerging trends: green chemistry and bio-based excipients

Course Objectives6 points
  • The objectives of this course are to:
  • Understand the fundamental concepts of Active Pharmaceutical Ingredients (APIs) and excipients in dosage form development.
  • Analyse the physicochemical properties influencing API excipient compatibility and formulation performance.
  • Develop knowledge of industrial methodologies for characterization and quality control.
  • Understand GMP protocols and regulatory frameworks governing API and excipient manufacturing.
  • Explore emerging industrial trends including green chemistry and bio-based excipients.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1To explain the classification, properties and functional roles of APIs and excipients.
  2. CO2To apply analytical and preformulation methodologies for compatibility and stability evaluation.
  3. CO3To understand manufacturing, scale-up and quality control procedures used in industry.
  4. CO4To evaluate regulatory documentation and compliance requirements for API and excipient approval.
  5. CO5To develop awareness of current industrial practices and innovation trends.
Recommended References (Preferably latest edition):8 books
  1. Gibson, M. Pharmaceutical Preformulation and Formulation. Informa Healthcare, London.
  2. Rowe, R. C., Sheskey, P. J., Quinn, M. E. Handbook of Pharmaceutical Excipients. Pharmaceutical Press, London.
  3. Elsevier, London.
  4. ICH Guidelines (Q7, Q8, Q1A). International Council for Harmonisation, Geneva.
  5. Indian Pharmacopoeia (Latest Edition). Indian Pharmacopoeia Commission, Ghaziabad, India.
  6. United States Pharmacopeia National Formulary (USP-NF). USP Convention, USA.
  7. Banker, G. S., Rhodes, C. T. Modern Pharmaceutics. CRC Press, USA.
  8. Allen, L. V., Popovich, N. G., Ansel, H. C. Pharmaceutical Dosage Forms and Drug Delivery Systems. Lippincott Williams & Wilkins, USA. SEMESTER VI Course Title Course Type

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Official AKTU syllabus

This subject is on page 245, 246, 247 of the original AKTU PDF.

Official AKTU syllabus PDF ↗