Lovely Professional University,Punjab

Format For Instruction Plan [for Courses with Lectures and Labs

Course No PHR418T

Cours Title DOSAGE FORM DESIGN

Course Planner 13053 :: Rahul Bhaskar

Lectures Tutorial Practical Credits 3 0 0 3

Text Book:

1 1. Aulton, M. E. Pharmaceutics: The science of Dosage form Design. 3rd ed. Edinburg, London.

Other Specific Book:

2 1. Lachman, L. Lieberman, H.A. Kanig, J.L. The Theory & Practice of industrial Pharmacy, 4th ed. Lea & Febiger, Philadelphia. 3 Ali, J., Khar, R.K., Ahuja, A. Dosage Form Design. 4th edition. Birla Publications. Delhi 4 Nash, R.A., Wachter, A.H. 2005. Pharmaceutical process validation. Vol 129. Marcel Dekker Inc. New York

5 Wise, D.L., 2008. Handbook of pharmaceutical controlled release technology. Marcel Dekker Inc. New York 6 Jain, N.K., 2008. Controlled and novel drug delivery. CBS Publisher and Distributors 7 Martin, A.N., 2008. Physical pharmacy and pharmaceutical sciences. Wolters Kluwer New Delhi. 8 Subramanyam, C.V.S., 2008. Text book of physical pharmaceutics. Vallabh Prakshan New Delhi. 9 Robinson, R.J., Lee, V.H.L. 2005. Controlled drug delivery fundamental and application. Marcel Dekker Inc. New York. 10 Bramankar, D.M., Jaiswal, J.B. 2008. Biopharmaceutics and pharmacokinetics a treatise. Vallabh Prakshan

Other Reading

Approved for Spring Session 2011-12

Sr No

Jouranls atricles as compulsary readings (specific articles, Complete reference) 11 Federal Register. 25 September 2001. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Vol. 66, No 186, Pages 49028 to 49029 12 Federal Register. 21 November 2003. Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision) Vol, 68, No. 225, pages 65717-18, 13 Federal Register. 9 May 1997. Q1C: Stability Testing for New Dosage Forms. Vol. 62, No. 90, pages 25634-25635 14 Federal Register. 16 January 2003. Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products Vol 68, No. 11, pages 2339-2340 15 Federal Register. March 1, 1995. Q2(R1): Validation of Analytical Procedures: Text and Methodology Vol. 60, pages 11260 16 2. Guidance for industry: dissolution testing of Immediate release solid oral dosage forms. 17 3. Guidance for Industry: Bioavailability and bioequivalencestudies for orally administered drug products general considerations. 18 Guidance for Industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms 19 Guidance for Industry, Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

Relevant Websites Sr. No. (Web adress) (only if relevant to the courses) Salient Features

20 http://google2.fda.gov/search? For various industry related FDA guidance q=guidance&client=FDAgov&site=FDAgov&lr=&proxystyleshe et=FDAgov&output=xml_no_dtd&getfields=* 21 http://www.ich.org/products/guidelines/quality/article/qualityguidelines.html For stability, quality related aritcles

Detailed Plan For Lectures

Week Number Lecture Number Lecture Topic Chapters/Sections of Pedagogical tool Textbook/other Demonstration/case reference study/images/anmatio n ctc. planned

Part 1
Week 1 Lecture 1 Study of physical properties of drugs like physical ->Reference :1,Ch 8 form, particle size, shape, density, wetting, dielectric ->Reference :2,Ch 8 constant. ->Reference :3,Ch 1 Study of physical properties of drugs like physical ->Reference :1,Ch 8 form, particle size, shape, density, wetting, dielectric ->Reference :2,Ch 8 constant., ->Reference :3,Ch 1 Solubility, dissolution and organoleptic property and ->Reference :1,Ch 8 their effect on formulation, stability and ->Reference :2,Ch 2 bioavailability. ->Reference :3,Ch 1 NA

Lecture 2

NA

Lecture 3

NA

Approved for Spring Session 2011-12

Week 2

Lecture 4

Solubility, dissolution and organoleptic property and ->Reference :1,Ch 8 their effect on formulation, stability and ->Reference :2,Ch 2 bioavailability. ->Reference :3,Ch 1

NA

Lecture 5

Study of chemical properties of drugs like hydrolysis, ->Reference :1,Ch 8 NA ->Reference :2,Ch 8 oxidation and their influence on formulation and ->Reference :3,Ch 1 stability of products. ->Reference :7,Ph 420 Study of chemical properties of drugs like reduction, ->Reference :1,Ch 8 NA racemization, polymerization etc., and their ->Reference :2,Ch 8 influence on formulation and stability of products. ->Reference :3,Ch 1 ->Reference :7,Pg 420 ->Reference :8,Ch 2 Study of pro-drugs in solving problems related to ->Reference :10,Pg stability, bioavailability and elegancy of formulation. 159 Study of pro-drugs in solving problems related to ->Reference :10,Pg stability, bioavailability and elegancy of formulation. 159 General discussion on validation Analytical method validation ->Reference :3,Ch 3 ->Reference :3,Ch 3 ->Reference :4,Ch 15 ->Reference :15,. NA NA Images NA

Lecture 6

Week 3

Lecture 7 Lecture 8 Lecture 9

Week 4

Lecture 10

Part 2
Week 4 Lecture 11 Validation of tablet dosage form ->Reference :3,Ch 3 Images ->Reference :4,Ch 5 ->Reference :7,Pg 420 ->Reference :8,Ch 2 ->Reference :3,Ch 3 ->Reference :3,Ch 4 ->Reference :21 ->Reference :3,Ch 4 ->Reference :14,. ->Reference :21 ->Reference :3,Ch 4 ->Reference :12,. ->Reference :13,. ->Reference :21 ->Reference :16,. ->Reference :20 NA NA Images

Lecture 12 Week 5 Lecture 13 Lecture 14

Valiation of suspension General guidelines for stability testing Bracketing and matrixing

Lecture 15

Protocol for new drug and new dosage form

NA

Week 6

Lecture 16

In vitro dissolution studies for solid oral dosage forms, Federal perspectives on Immediate Release (IR) and Extended Release (ER) products.

Images

Approved for Spring Session 2011-12

Week 6

Lecture 17

In vitro dissolution studies for solid oral dosage forms, Federal perspectives on Immediate Release (IR) and Extended Release (ER) products. Brief Concepts of Biopharmaceutics Classification Scheme (BCS), in-vitro in-vitro correlation Biowaiver Bioavailability and bioequivalence studies and clinical trial conduct Statistics related to Bioavailability and bioequivalence studies

->Reference :16,. ->Reference :20 ->Reference :1,Ch 15 ->Reference :19,. ->Reference :20 ->Reference :4,. ->Reference :18,. ->Reference :1,CH 17 ->Reference :17,. ->Reference :1,Ch 18 ->Reference :17,.

Images

Lecture 18

NA

Week 7

Lecture 19 Lecture 20 Lecture 21

NA NA NA

MID-TERM Part 3
Week 8 Lecture 22 Lecture 23 Lecture 24 Week 9 Lecture 25 Lecture 26 GMP GMP quality assurance Quality audit ->Reference :11,. ->Reference :11,. ->Reference :4,Ch 21 ->Reference :3,Ch 4 NA NA NA NA

General classification of controlled release systems ->Reference :3,Ch 4 Images ->Reference :5,Pg 431 ->Reference :6,. General classification of controlled release systems ->Reference :3,Ch 4 Images ->Reference :5,Pg 431 ->Reference :6,. General considerations for design of controlled release systems Design, development, production and evaluation of oral controlled released formulations ->Reference :1,Ch 19 ->Reference :3,Ch 7 ->Reference :6,. Images

Lecture 27

Week 10

Lecture 28

Lecture 29

->Reference :1,Ch 20 Images ->Reference :3,Ch 7 ->Reference :9,Pg 373 ->Reference :10,Pg 347

Part 4
Week 10 Lecture 30 Design, development, production and evaluation of oral controlled released formulations ->Reference :1,Ch 20 Images ->Reference :3,Ch 7 ->Reference :9,Pg 373 ->Reference :10,Pg 347 Approved for Spring Session 2011-12

Week 11

Lecture 31

Design, development, production and evaluation of oral controlled released formulations

->Reference :1,Ch 20 Images ->Reference :3,Ch 7 ->Reference :9,Pg 373 ->Reference :10,Pg 347 ->Reference :1,Ch 20 ->Reference :3,Ch 7 ->Reference :1,Ch 20 ->Reference :3,Ch 7 ->Reference :1,Ch 20 ->Reference :3,Ch 7 ->Reference :1,Ch 20 ->Reference :3,Ch 7 Images Images Images Images

Lecture 32 Lecture 33 Week 12 Lecture 34 Lecture 35 Lecture 36

Design, development, production and evaluation of parenteral controlled released formulations Design, development, production and evaluation of parenteral controlled released formulations Design, development, production and evaluation of parenteral controlled released formulations Design, development, production and evaluation of parenteral controlled released formulations Design, development, production and evaluation of transdermal controlled released formulations Design, development, production and evaluation of transdermal controlled released formulations Design, development, production and evaluation of transdermal controlled released formulations Design, development, production and evaluation of transdermal controlled released formulations

->Reference :1,Ch 33 Images ->Reference :3,Ch 7 ->Reference :6,Pg 100 ->Reference :1,Ch 33 Images ->Reference :3,Ch 7 ->Reference :6,Pg 100 ->Reference :1,Ch 33 Images ->Reference :3,Ch 7 ->Reference :6,Pg 100 ->Reference :1,Ch 33 Images ->Reference :3,Ch 7 ->Reference :6,Pg 100

Week 13

Lecture 37

Lecture 38

Lecture 39

Spill Over
Week 14 Lecture 40 Lecture 41 Bracketing and matrixing Analytical method validation ->Reference :14,. ->Reference :15,. NA NA

Approved for Spring Session 2011-12