Modern Pharmaceutics (M Pharm, Pharmaceutics)

Teacher

Dr Amulyaratna Behera

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Course Name : Modern Pharmaceutics

CODE(Credit) : CUTM1583(4-0-0)

Course Objectives

To impart advanced knowledge and skills required to learn various aspects and concepts at pharmaceutical industries

Learning Outcomes

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

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

Course Syllabus

Module I.

a. Preformation Concepts – Drug Excipient interactions - different methods, 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 parameters of optimization, Optimization techniques in pharmaceutical formulation and processing. Statistical design, Response surface method, Contour designs, Factorial designs and application in formulation.

Module II.

Validation : Introduction to Pharmaceutical Validation, Scope & merits of 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.

Module III.

cGMP& Industrial Management: Objectives and policies of current good 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.

Module IV.

Compression and compaction: Physics of tablet compression, compression, consolidation, effect of friction, distribution of forces, compaction profiles. Solubility.

Module V.

Study of consolidation parameters; Diffusion parameters, Dissolution 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.

Session Plan

Session 1

Drug excipient interaction,methods, kinetics of stability, Stability testing. Theories of dispersion and pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS)

https://www.youtube.com/watch?v=mRJvss9bMVc

https://www.youtube.com/watch?v=L_pnw_1xyQk

https://www.youtube.com/watch?v=cfaz-olLQVY

Session 2

Preparation and stability Large and small volume parental –physiological and formulation consideration, Manufacturing and evaluation.

https://youtu.be/R0EBmAVp8yk

Session 3

Concept and parameters of optimization, Optimization techniques in pharmaceutical formulation and processing.

https://youtu.be/aJKuM4U-eYg

Session 4

Statistical design, Response surface method, Contour designs, Factorial designs and application in formulation

Session 5

Introduction to Pharmaceutical Validation, Scope & merits of Validation.

https://www.youtube.com/watch?v=WW6kxpATTD0

Session 7

ICH & WHO guidelines for calibration and validation of equipments

https://www.youtube.com/watch?v=hTFh17WJ4m8

Session 8

Validation of specific dosage forms

https://www.youtube.com/watch?v=Dz6HiL7QuDI

Session 9

Types of validation. Government regulation

https://www.youtube.com/watch?v=Dz6HiL7QuDI

Session 10

Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.

https://youtu.be/TWjFi4oP0js

Session 11

cGMP& Industrial Management

https://youtu.be/mdHnMsUuXjw

Session 12

Objectives and policies of current good manufacturing practices

https://youtu.be/mdHnMsUuXjw

Session 13

Layout of buildings, services, equipment and their maintenance

https://youtu.be/DjlK11hS2F8

Session 14

Production management: Production organization

https://youtu.be/5--KdyzONjg

Session 15

Materials management, handling and transportation

https://youtu.be/5z3dNfiLMws

Session 16

Inventory management and control, production and planning control

https://youtu.be/X1jPQoxW5AQ

Session 17

Sales forecasting, budget and cost control, industrial and personal relationship

https://youtu.be/vlFOF9kSZmk

Session 18

Concept of Total Quality Management.

 

https://youtu.be/Ktga-OnBJlk

Session 19

Compression and compaction

https://youtu.be/PbrQIM3U8Dw

Session 20

Physics of tablet compression

https://youtu.be/ZqKvV67ntaQ

Session 21

Session 22

Session 23

Effect of friction

https://youtu.be/ybpFEB6Mt88

Session 24

Distribution of forces

 

https://youtu.be/M83mEAaAhw

Session 25

Compaction profiles.

https://youtu.be/_CnxBWQuNlw

Session 26

Session 27

Study of consolidation parameter

https://youtu.be/VIoucBnjDGs

Session 28

Diffusion parameters

https://youtu.be/jeIBeGf3W4A

Session 29

Dissolution parameters and Pharmacokinetic parameters

https://youtu.be/px9Yy_4gjTI

Session 30

Session 31

Similarity factors – f2 and f1

https://youtu.be/X0_xNTFc7v0

Session 32

Higuchi and Peppas plot

https://youtu.be/SLR8CHvm-Mw

Session 33

Linearity Concept of significance

https://youtu.be/lzGKRSvs5HM

Session 34

Standard deviation

https://youtu.be/R8soFAO5b4c

Session 36

Session 37

Case Studies

Case Studies

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