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MP - MPH103T Syllabus

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26 views2 pages

MP - MPH103T Syllabus

Uploaded by

Kanisha Ranpariya
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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GUJARAT TECHNOLOGICAL UNIVERSITY

M.Pharm
PHARMACEUTICS
SEMESTER: I

Subject Name: MODERN PHARMACEUTICS


Subject Code: MPH103T

SCOPE: Course designed to impart advanced knowledge and skills required to learn various aspects and
concepts at pharmaceutical industries

OBJECTIVES: Upon completion of the course, student shall be able to understand


1. The elements of preformulation studies.
2. The Active Pharmaceutical Ingredients and Generic drug Product development
3. Industrial Management and GMP Considerations
4. Optimization Techniques & Pilot Plant Scale Up Techniques
5. Stability Testing, sterilization process & packaging of dosage forms.

Sr.No Course content Total Hrs


1. a. Preformation Concepts – Drug Excipient interactions – different methods, 10
kinetics of stability, Stability testing. Theories of dispersion and
pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS)
preparation and stability Large and small volume parental – physiological
and formulation consideration, Manufacturing and evaluation.
b. Optimization techniques in Pharmaceutical Formulation: Concept and 10
parameters of optimization, Optimization techniques in pharmaceutical
formulation and processing. Statistical design, Response surface method,
Contour designs, Factorial designs and application in formulation
2. Validation : Introduction to Pharmaceutical Validation, Scope & merits of 10
Validation, Validation and calibration of Master plan, ICH & WHO
guidelines for calibration and validation of equipments, Validation of
specific dosage form, Types of validation. Government regulation,
Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
3. cGMP & Industrial Management: Objectives and policies of current good 10
manufacturing practices, layout of buildings, services, equipments and their
maintenance Production management: Production organization, , materials
management, handling and transportation, inventory management and
control, production and planning control, Sales forecasting, budget and
cost control, industrial and personal relationship. Concept of Total Quality
Management.
4. Compression and compaction: Physics of tablet compression, compression, 10
consolidation, effect of friction, distribution of forces, compaction profiles.
Solubility
5. Study of consolidation parameters; Diffusion parameters, Dissolution 10
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors
– f2 and f1, Higuchi and Peppas plot, Linearity Concept of significance,
Standard deviation , Chi square test, students T-test , ANOVA test
REFERENCES:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H.Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total quality control, Second edition;
By Sidney H. Willig.
11. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers, New Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans, Anderson, Sweeney and Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.

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