Optimization of Critical Formulation Variables of “Soft Gelatin Capsule” Dosage Form Development...
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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 CASE STUDY 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 [email protected]
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Transcript of 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
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 [email protected]
https://in.linkedin.com/in/shivangchaudhary
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