FOR EMULSION CREAM DEVELOPMENT AS PER QbD

OPTIMIZATION OF OIL WATER EMULGENT RATIO IN SEMISOLID MIXTURES

RISKS

SEPERATION OF OILY PHASE & AQUEOUS PHASE DURING ROUTINE IN-USE STABILITY

PATIENT COMPLIANCE COMPROMISED

SIMPLEX LATTICE

SIMPLEX CENTROID

CONSTRAINED MIXTURE

FACTORIAL RESPONSE SURFACE MIXTURE

OILY PHASE

EMULGENT

AQUEOUS PHASE

1

2

3

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGNING OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

CA

SE

STU

DY

20

© 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

IDENTIFICATION OF FACTORS

Factors (Variables) Actual Levels Constrained Levels A OIL (%w/w) 20-50% 20-40% B WATER (%w/w) 45-75% 45-75% C EMULGENT (%w/w) 5-35% 5-15%

NO. OF COMPONENTS

NO. OF LEVELS

EXPERIMENTAL DESIGN SELECTED

ADD. CENTER POINTS

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

3

3

D-Optimal Constrained Mixture

5

11

OBJECTIVE To Optimize of Oil: Water: Emulgent ratio in Liquid/ Semisolid Emulsion Dosage Form

SIMPLEX LATTICE

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGNING OF EXPERIMMENTS

SIMPLEX CENTROID

CONSTRAINED MIXTURE

OPTIMIZATION OF OIL:WATER:EMULGENT RATIO IN LIQUID/ SEMISOLID EMULSION DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE C

ASE

ST

UD

Y 2

0

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

CQAs CMAs

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

CREAMING RATIO=+0.53A+0.14B+1.69C-0.31AB-3.53AC-2.43BC+0.44ABC

SIMPLEX LATTICE

DEVELOPMENT OF DESIGN SPACE

DESIGNING OF EXPERIMMENTS

SIMPLEX CENTROID

CONSTRAINED MIXTURE

ANALYSIS OF RESPONSES

OPTIMIZATION OF OIL: WATER: EMULGENT RATIO IN LIQUID/ SEMISOLID EMULSION DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE C

ASE

ST

UD

Y 2

0

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

SIMPLEX LATTICE

ANALYSIS OF RESPONSES

SIMPLEX CENTROID

CONSTRAINED MIXTURE

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF OIL:WATER:EMULGENT RATIO IN LIQUID/ SEMISOLID EMULSION DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE C

ASE

ST

UD

Y 2

0

Responses (Effects) Goal for Individual Responses Y1 CREAMING RATIO To achieve minimum creaming ratio NMT 0.1

Factors (Variables) Knowledge Space Design Space Control Space A OIL (%w/w) (20-50%)20-40% 25-35% 28-32% B WATER (%w/w) (45-75%)45-75% 50-70% 55-65% C EMULGENT (%w/w) (5-35%) 5-15% 6-14% 8-12%

© 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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