FOR TABLET DEVELOPMENT AS PER QbD

OPTIMIZATION OF CPPs OF TABLET COMPRESSION PROCESS

LOWER HARDNESS INADEQUATE DISINTEGRATION

QUALITY COMPROMISED EFFICACY COMPROMISED

WEIGHT VARIATION

SAFETY COMPROMISED

HIGH FRIABILITY INADEQUATE DISSOLUTION CONTENT NONUNIFORMITY

RISKS

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

CIRCUMSCRIBED CENTRAL COMPOSITE

COMPRESSION FORCE

TURRET SPEED B

A

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGN OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

CA

SE

STU

DY

10

© 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 -α -1 0 +1 +α

A COMPRESSION FORCE (kN) 1.17 2.00 4.00 6.00 6.83 B TURRET SPEED (RPM) 3.79 10.00 25.00 40.00 46.21

NO. OF FACTORS

NO. OF LEVELS

EXPERIMENTAL DESIGN SELECTED

ADD. CENTER POINTS

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

2

5

CIRCUMSCRIBED CENTRAL COMPOSITE RSM FOR 2 FACTORS

5

4 fp +4 cp +5 cp =13

To Optimize CPPs of Tablet Compression Process OBJECTIVE

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

OPTIMIZATION OF CRITICAL PROCESSING PARAMETERS OF TABLET COMPRESSION PROCESS

A COMPRESSON FORCE

B

TUR

RE

T SP

EE

D

CIRCUMSCRIBED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

0

© Created & Copyrighted by Shivang Chaudhary

CPPs

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

HARDNESS =+73.80+25.97A-10.09B-2.25AB+2.47A2-1.78B2 FRIABILITY =+0.080-0.055A+0.022B-0.010AB+0.033A2+0.018B2

DISINTEGRATRION TIME =+8.20+5.72A-1.38B-0.50AB+1.71A2+0.46B2

% DRUG DISSOLVED IN 30 MIN =+93.40-9.84A+3.26B+4.25AB-3.51A2-1.51B2

%RSD in WV=+1.62+0.22A+1.07B+0.12AB+0.053A2+0.43B2 AV in CU =+4.02+0.23A+1.16B+0.072AB+0.091A2+0.48B2

CQAs

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

DEVELOPMENT OF DESIGN SPACE

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

ANALYSIS OF RESPONSES

OPTIMIZATION OF CRITICAL PROCESSING PARAMETERS OF TABLET COMPRESSION PROCESS

CIRCUMSCRIBED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

0

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGN OF EXPERIMMENTS

ANALYSIS OF RESPONSES

Factors (Variables) Knowledge Space Design Space Control Space A Compression Force (kn) 2-6 2.4-4.6 3.0-4.0 B Turret Speed (RPM) 10-40 10-35 15-30

Responses (Effects) Goal for Individual Responses Y1 Hardness To achieve tablet hardness in the range from 60 to 90N Y2 Friability To achieve tablet friability NMT 0.2%w/w Y3 Disintegration To achieve tablet disintegration within 10 minutes Y4 Dissolution Drug release should NLT 90% in 30 minutes Y5 Weight variation Relative Standard Deviation in WV test should NMT 3.0% Y6 Content uniformity Acceptance Value should in CU test should NMT 5.0

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF CRITICAL PROCESSING PARAMETERS OF TABLET COMPRESSION PROCESS

CIRCUMSCRIBED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

0

© 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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