FOR HARD GELATIN CAPSULE DEVELOPMENT AS PER QbD

OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN ENCAPSULATION PROCESS

INADEQUATE DISINTEGRATION

QUALITY COMPROMISED EFFICACY COMPROMISED SAFETY COMPROMISED

RISKS

WEIGHT VARIATION & CONTENT NON UNIFORMITY

INAPPROPRIATE FLOW PROPERTY & FILLING RATE

INADEQUATE DISSOLUTION

FACTORIAL MIXTURE

CENTRAL COMPOSITE

RESPONSE SURFACE

BOX BEHNKEN

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGN OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

A GLIDANT

B ANTIADHERANT

C FILLING RATE

CA

SE

STU

DY

17

© 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 -1 0 +1

A Glidant (%w/w) 0.10%w/w 0.25%w/w 0.40%w/w B Lubricant (%w/w) 0.50%w/w 1.25%w/w 2.00%w/w C Filling Rate (SPM) 50SPM 65SPM 80SPM

NO. OF FACTORS

NO. OF LEVELS

EXPERIMENTAL DESIGN SELECTED

ADD. CENTER POINTS

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

3

3

BOX BEHNKEN DESIGN

2

12 + 3CP =15

To Optimize CMAs & CPPs of Hard Gelatin Capsule Encapsulation. OBJECTIVE

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

FACTORIAL MIXTURE

CENTRAL COMPOSITE

RESPONSE SURFACE

BOX BEHNKEN

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN CAPSULE ENCAPSULATION

A GLIDANT

C

FIL

LIN

G R

ATE

CA

SE

STU

DY

17

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

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

Weight Variation =+1.53-0.34A-0.10B+0.49C-0.00AC-0.075AC-0.00BC+0.37A2+0.30B2+0.92C2

Content Uniformity=+1.80-0.44A-0.14B+0.58C+0.075AB-0.050AC+0.100BC+0.44A2+0.29B2+1.11C2

Plug Breaking Force =+1.53+0.025A-0.26B-0.76C-0.13AB-0.075AC-0.050BC+0.058A2 -0.017B2+0.18C2

Disintegration Time =+3.17+0.000A-0.50B-1.78C-0.22AB+0.025AC-0.075BC+0.054A2+0.054B2+0.40C2

CMAs CPP

%Drug Dissolved in 30 minutes =+95.67+0.37A-2.13B+7.75C+0.000AB-1.25AC-3.75BC-3.08A2-5.58B2-4.83C2

CQAs

DEVELOPMENT OF DESIGN SPACE

FACTORIAL MIXTURE

CENTRAL COMPOSITE

RESPONSE SURFACE

DESIGN OF EXPERIMMENTS

BOX BEHNKEN

ANALYSIS OF RESPONSES

OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN CAPSULE ENCAPSULATION

CA

SE

STU

DY

17

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGN OF EXPERIMMENTS

Factors (Variables) Knowledge Space Design Space Control Space A Glidant (%) 0.10-0.50 0.20-0.40 0.20-0.40 B Lubricant (%) 0.50-2.00 0.70-1.80 0.90-1.60 C Filling Rate (SPM) 50-80 56-68 58-66

Responses (Effects) Goal for Individual Responses Y1 Weight Variation Relative Standard Deviation in WV test should NMT 2.0% Y2 Content Uniformity Acceptance Value in CU test should NMT 4.0 Y3 Hardness Force required to break the plug should NMT 2N Y4 Disintegration To achieve complete disintegration (no residue) within 5 minutes Y5 Dissolution To achieve at least 90% drug release within 30 minutes

ANALYSIS OF RESPONSES

FACTORIAL MIXTURE

CENTRAL COMPOSITE

RESPONSE SURFACE

BOX BEHNKEN

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN CAPSULE ENCAPSULATION

CA

SE

STU

DY

17

© 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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