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MQA104T Syllabus

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36 views4 pages

MQA104T Syllabus

Uploaded by

Sandip Sandip
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Course Title PRODUCT DEVELOPMENT AND TECHNOLOGY TRANSFER

Course Code MQA104T

Course Credit Lecture :4


Tutorial :0
Total :4

Course Objectives

Upon completion of this course the student should be able to


• To understand the new product development process
• To understand the necessary information to transfer technology from R&D to actual
manufacturing by sorting out various information obtained during R&D
• To elucidate necessary information to transfer technology of existing products
between various manufacturing places

Detailed Syllabus

Sr. Hours
Name of Chapter & Details
No. Allotted

1 Principles of Drug discovery and development: Introduction, Clinical 12


research process. Development and informational content for
Investigational New Drugs Application (IND), New Drug Application
(NDA), Abbreviated New Drug Application (ANDA), Supplemental New
Drug Application (SNDA), Scale Up Post Approval Changes (SUPAC) and
Bulk active chemical Post approval changes (BACPAC), Post marketing
surveillance, Product registration guidelines – CDSCO, USFDA.

2 Pre-formulation studies: Introduction/concept, organoleptic properties, 12


purity, impurity profiles, particle size, shape and surface area. Solubility,
Methods to improve solubility of Drugs: Surfactants & its importance, co-
solvency. Techniques for the study of Crystal properties and
polymorphism. Pre-formulation protocol, Stability testing during product
development.

3 Technology transfer: Development of technology by R & D, Technology 12


transfer from R & D to production, Optimization and Production,
Qualitative and quantitative technology models.
Documentation in technology transfer: Development report, technology
transfer plan and Exhibit.

4 Pilot plant scale up: Concept, Significance, design, layout of pilot plant 12
scale up study, operations, large scale manufacturing techniques
(formula, equipment, process, stability and quality control) of solids,
liquids, semisolid and parenteral dosage forms. New era of drug
products: opportunities and challenges.

5 Pharmaceutical packaging: Pharmaceutical dosage form and their 12


packaging requirments, Pharmaceutical packaging materials, Medical
device packaging, Enteral Packaging, Aseptic packaging systems,
Container closure systems, Issues facing modern drug packaging,
Selection and evaluation of Pharmaceutical packaging materials.
Quality control test: Containers, closures and secondary packing
materials.

Instructional Method and Pedagogy:


▪ Lectures will be conducted with the aid of multi-media projector, black board, OHP etc.
▪ Assignments based on course content will be given to the students at the end of each
unit/topic and will be evaluated at regular interval.
▪ Surprise tests/Quizzes/Seminar/Tutorials will be conducted which carries 5% component
of the overall evaluation.
▪ The course includes language practices such as Group Discussion, Interviews etc to
develop the communication skills of the students.

Reference Books:

1. The process of new drug discovery and development. I and II Edition (2006) by Charles
G. Smith, James T and O. Donnell. CRC Press, Group of Taylor and Francis.
2. Leon Lac Lachman, Herbert A. Liberman, Theory and Practice of Industrial Pharmacy.
Marcel Dekker Inc. New York.
3. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of
pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house
Mumbai.
4. Tablets Vol. I, II, III by Leon Lachman, Herbert A. Liberman, Joseph B. Schwartz, 2nd
Edn. (1989) Marcel Dekker Inc. New York.
5. Text book of Bio- Pharmaceutics and clinical Pharmacokinetics by Milo Gibaldi, 3rd
Edn, Lea & Febriger, Philadelphia.
6. Pharmaceutical product development. Vandana V. Patrevale. John I. Disouza.
Maharukh T.Rustomji. CRC Press, Group of Taylor and Francis.
7. Dissolution, Bioavailability and Bio-Equivalence by Abdou H.M, Mack Publishing
company, Eastern Pennsylvania.
8. Remingtons Pharmaceutical Sciences, by Alfonso & Gennaro, 19th Edn.(1995)OO2C
Lippincott; Williams and Wilkins A Wolters Kluwer Company, Philadelphia.
9. The Pharmaceutical Sciences; the Pharma Path way ‘Pure and applied Pharmacy’ by D.
A Sawant, Pragathi Books Pvt. Ltd.
10. Pharmaceutical Packaging technology by D.A. Dean. E.R. Evans, I.H. Hall. 1st
Edition(Reprint 2006). Taylor and Francis. London and New York.

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