FOR NON-AQUEOUS PARENTERAL DEPOT DOSAGE FORM DEVELOPMENT AS PER QbD

OPTIMIZATION OF CPPs OF DRY HEAT STERILIZATION PROCESS

RISKS

INADEQUATE EXPOSURE HIGH TEMPERATURE

SAFETY COMPROMISED

MICROBIAL LOAD INPROCESS IMPURITIES

FACTORIAL MIXTURE

BOX BEHNKEN

FACE CENTERED CENTRAL COMPOSITE

RESPONSE SURFACE

EXPOSURE TIME

STERILIZATION TEMPERATURE A

B

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGN OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

CA

SE

STU

DY

13

© 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

DEVELOPMENT OF DESIGN SPACE

IDENTIFICATION OF FACTORS

Factors (Variables) Levels of Factors studied -1 0 +1

A Sterilization Temp ( ͦC) 120 ͦC 150 ͦC 180 ͦC B Exposure Time (min) 30 min 60 min 90 min

NO. OF FACTORS

NO. OF LEVELS

EXPERIMENTAL DESIGN SELECTED

ADD. CENTER POINTS

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

2

3

FACE CENTERED CENTRAL COMPOSITE RSM for 2 factors

4

4 fp +4 cp +5 cp =13

OBJECTIVE To Optimize CPPs of Dry Heat Sterilization Process for Non-Aqueous Parenteral Depots

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

ANALYSIS OF RESPONSES

DESIGNING OF EXPERIMMENTS

OPTIMIZATION OF CPPs OF DRY HEAT STERILIZATION PROCESS FOR PARENTERALS

A STERILIZATION TEMPERATURE

B

EX

PO

SUR

E T

IME

FACE CENTERED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

3

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DEVELOPMENT OF DESIGN SPACE

CQAs CPPs

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

%REDUCTION IN MICROBIAL LOAD=+99.69+0.53A+0.38B-0.18AB-0.25A2-0.20B2

% DEGRADATION (TOTAL IMPURITIES) =+1.31+0.35A+0.25B-0.043AB+0.28A2+0.12B2

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

design of experimments

ANALYSIS OF RESPONSES

OPTIMIZATION OF CPPs OF DRY HEAT STERILIZATION PROCESS FOR PARENTERALS

FACE CENTERED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

3

© Created & Copyrighted by Shivang Chaudhary

Responses (Effects) Goals for Individual Responses Y1 % REDUCTION IN MICROBIAL LOAD Should Not Less Than 99.5% Y2 % DEGRADATION (TOTAL IMPURITIES) Should Not More Than 1.5%

Factors (Variables) Knowledge Space Design Space Control Space A Sterilization temp ( ͦc) 120-180 128-172 135-165 B Exposure Time (min) 30-90 35-85 40-80

IDENTIFICATION OF FACTORS

FACTORIAL MIXTURE

BOX BEHNKEN

RESPONSE SURFACE

design of experimments

ANALYSIS OF RESPONSES

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF CPPs OF DRY HEAT STERILIZATION PROCESS FOR PARENTERALS

FACE CENTERED CENTRAL COMPOSITE C

ASE

ST

UD

Y 1

3

© 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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