UNIQUE SERIES AKTU Syllabus
BP806T AEC1

Pharmaceutical Packaging (Theory)

L-T-P2-0-0 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 8 (AEC – Elective 7)

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Syllabus

5 units · 24 lecture hours
Unit1

Unit 1: General Information on Packaging

6 hrs

Introduction: Purpose of packaging, selection of the ideal package (primary, secondary and tertiary), hazards encountered by the package, various types of inner and outer packages, selection of a suitable package.

Unit2

Unit 2: Packaging materials

Detailed study with regard to composition packaging characteristics, advantages, economics and limitations of various packaging materials with special emphasis on glass, plastics, metals and rubber.

Unit3

Unit 3

6 hrs
  • Child resistant package, Tamper Evident Packaging, Anti- Counterfeit Packaging, Environmental considerations of packaging (Recycling). II Pharmaceutical Packaging Design and Development
  • Selection and Design of Packaging during Product Development Process (Parameters).
  • Packaging Process: Significance of Strip, Blister, Pouch Packaging, advantages, economics and limitation, Packing machinery and recent advances, films employed in Packing (Video based learning). III Formulation Packaging Interaction
  • Polymer Chemistry Science and Stability Aspects
  • Extractable and Leachables
  • Methods to study formulation packaging interaction
  • Suitability considerations for pharmaceutical packaging 6 hours
Unit4

Unit 4: Quality Assurance, Control and Regulatory Aspects

6 hrs
  • Total Quality management, Good Manufacturing Practice, Quality Risk Management related to Packaging Department, Specification Testing and Shelf-life testing as per Pharmacopoeial Guidelines for Packaging Material in-process and finished Package Products.
  • Standard Operating Procedures (SOPs)/Documentation for Solid/Semi- Solid/Liquid/Parenteral Formulation Packaging. Packaging waste and Waste policies for packaging materials,
Unit5

Unit 5: Advances in Pharmaceutical Packaging

6 hrs
  • Labelling- Types of label (including Bar code, Hologram, RF, structured program, in- mould and decorative labelling) Use of Software, Legal requirements of Labelling, packaging inserts and outserts. Adhesives and Machinery Employed for Labelling - Pharmacy Accessory Label Printers (PALP), Concept of paperless labelling
  • Logistics Packaging - Block Chain Technology in Supply Traceability, Transparency and Credibility. Review on Automated Packaging System for Oral Solids (Auto-Print), Oral Liquid (Fluidose), and overwrapping (PABS).
Course Objectives6 points
  • The objectives of this course are:
  • Provide students with a comprehensive understanding of pharmaceutical packaging, its principles, materials, processes, and regulatory aspects.
  • Equip students with knowledge of the selection, design, and development of packaging materials for various dosage forms.
  • Educate students on the interaction between packaging and formulation, quality control, and advances in pharmaceutical packaging.
  • Train students in assessing packaging materials for pharmaceutical products in compliance with regulatory guidelines.
  • Prepare students for future roles in pharmaceutical manufacturing, quality assurance, and packaging development.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Understand the purpose and function of packaging in pharmaceuticals, including primary, secondary, and tertiary packaging.
  2. CO2Identify and evaluate the materials used in pharmaceutical packaging and their interactions with dosage forms.
  3. CO3Design and select appropriate packaging materials during product development.
  4. CO4Apply quality control and regulatory principles to packaging processes.
  5. CO5Recognize advancements in packaging technology, including child-resistant packaging, tamper-evident packaging, and automation.
Recommended References (Preferably latest edition):8 books
  1. Brody, A. L., Marsh, K. S. The Wiley Encyclopedia of Packaging Technology. John Wiley & Sons, New York, USA.
  2. Lachman, L., Lieberman, H. A., Kanig, J. L. The Theory and Practice of Industrial Pharmacy. Lea & Febiger, Philadelphia, USA.
  3. KacChesney, T. C. Packaging of Cosmetics and Toiletries. Newness-Butterworth, London, UK.
  4. Allen, L. V. Jr. Remington: The Science and Practice of Pharmacy. Mack Publishing Company, Easton, USA.
  5. Bauer, E. J. Pharmaceutical Packaging Handbook. CRC Press / Informa Healthcare Ltd, USA.
  6. Dean, D. A., Evans, E. R., Hall, I. H. (Eds.) Pharmaceutical Packaging Technology. CRC Press, USA.
  7. Lockhart, H., Paine, F. A. Packaging of Pharmaceuticals & Healthcare Products. Chapman & Hall, UK.
  8. Harburn, K. Quality Control of Packaging Materials in the Pharmaceutical Industry. CRC Press, USA. Course Title Course Type

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Official AKTU syllabus

This subject is on page 274, 275, 276 of the original AKTU PDF.

Official AKTU syllabus PDF ↗