optimization of critical formulation variables of “soft gelatin capsule” dosage form development...

FOR SOFT GELATIN CAPSULE DEVELOPMENT AS PER QbD

OPTIMIZATION OF CRITICAL FORMULATION VARIABLES OF SOFT GELATIN CAPSULE

RISKS

LONGER DISINTEGRATION TIME

DRUG RELEASE SUSTAINED

ACTION DELAYED

PLACKETTE BURMAN

2 LEVEL FACTORIAL

MIXTURE RESPONSE SURFACE FACTORIAL

WATER : DRY GELATIN RATIO 1

2 GLYCERINE : DRY GELATIN RATIO

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSE

DESIGNING OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

CA

SE

STU

DY

8

3 LEVEL FULL FACTORIAL

© Created & Copyrighted by Shivang Chaudhary

SHIVANG CHAUDHARY Created & Copyrighted by:

Quality Risk Manager & Intellectual Property Sentinel- CIIE, IIM Ahmedabad, INDIA MS Pharm (Pharmaceutics)-NIPER, PGD (Patents Law)-NALSAR

shivaniper@gmail.com

Factors (Variables) Levels of Factors studied 0 1 2

A Water: Dry Gelatin Ratio 0.70 1.00 1.30 B Glycerine: Dry Gelatin Ratio 0.30 1.05 1.80

NO. OF FACTORS

NO. OF LEVELS

EXPERIMENTAL DESIGN SELECTED

ADD. CENTER POINTS

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

2

3

32 FULL FACTORIAL DESIGN

2

32 FP =9

OBJECTIVE To Optimize Critical Formulation Variables of Soft Gelatin Capsule Shell

OPTIMIZATION OF CRITICAL FORMULATION VARIABLES OF SOFT GELATIN CAPSULE DOSAGE FORM

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSE

PLACKETTE BURMAN

2 LEVEL FACTORIAL

IDENTIFICATION OF FACTORS

3 LEVEL FULL FACTORIAL

DESIGNING OF EXPERIMMENTS

MIXTURE RESPONSE SURFACE FACTORIAL

A WATER : GELATIN

B

WA

TER

: G

LYC

ER

INE

CA

SE

STU

DY

8

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

CQA CMAs

PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY QUADRATIC MODEL

DISINTEGRATION TIME=+11.22 -7.67A +4.83B -0.50AB +3.67A2 +1.17B2

DEVELOPMENT OF DESIGN SPACE

DESIGNING OF EXPERIMMENTS

PLACKETTE BURMAN

2 LEVEL FACTORIAL

ANALYSIS OF RESPONSE

OPTIMIZATION OF CRITICAL FORMULATION VARIABLES OF SOFT GELATIN CAPSULE DOSAGE FORM

MIXTURE RESPONSE SURFACE FACTORIAL C

ASE

ST

UD

Y 8

3 LEVEL FULL FACTORIAL

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

DISINTEGRATION TIME Goals for Individual Responses Y1 Disintegration Time To achieve disintegration of soft gelatin capsule within 10 minutes

© Created & Copyrighted by Shivang Chaudhary

Factors (Variables) Knowledge Space Design Space Control Space A Water: Dry Gelatin Ratio 0.70-1.30 0.90-1.30 1.00-1.20

B Glycerine: Dry Gelatin Ratio 0.30-1.80 0.30-1.45 0.75-1.25

ANALYSIS OF RESPONSE

PLACKETTE BURMAN

2 LEVEL FACTORIAL

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF CRITICAL FORMULATION VARIABLES OF SOFT GELATIN CAPSULE DOSAGE FORM

MIXTURE RESPONSE SURFACE FACTORIAL C

ASE

ST

UD

Y 8

3 LEVEL FULL FACTORIAL

© Created & Copyrighted by Shivang Chaudhary

THANK YOU SO MUCH FROM

DESIGN IS A JOURNEY OF DISCOVERY…

© Created & Copyrighted by Shivang Chaudhary

SHIVANG CHAUDHARY

© Copyrighted by Shivang Chaudhary

Quality Risk Manager & Intellectual Property Sentinel- CIIE, IIM Ahmedabad MS (Pharmaceutics)- National Institute of Pharmaceutical Education & Research (NIPER), INDIA

PGD (Patents Law)- National academy of Legal Studies & Research (NALSAR), INDIA

+91 -9904474045, +91-7567297579 shivaniper@gmail.com

https://in.linkedin.com/in/shivangchaudhary

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