optimization of “sweetener: flavor: color” ratio in liquid oral mixtures using {3,3} simplex...

FOR SOLUTION SUSPENSION EMULSION DOSAGE FORM DEVELOPMENT AS PER QbD

OPTIMIZATION OF SWEETENER FLAVOR & COLOR RATIO IN LIQUID ORAL MIXTURES

RISK

UNACCEPTABLE TASTE OF LIQUID ORAL MIXTURE

PATIENT ACCEPTANCE COMPROMISED

CONSTRAINED MIXTURE

SIMPLEX CENTROID

SIMPLEX LATTICE

FACTORIAL RESPONSE SURFACE MIXTURE

FLAVOR

SWEETENER 1

2

3 COLORANT

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

DESIGNING OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

CA

SE

STU

DY

18

© 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 2 3 4

A SWEETENER (%w/w) 0% 0.333 0.667 1% B FLAVOR (%w/w) 0% 0.333 0.667 1% C COLOR (%w/w) 0% 0.333 0.667 1%

NO. OF COMPONENTS

EXPERIMENTAL DESIGN SELECTED

TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)

3

{3,3} SIMPLEX LATTICE MIXTURE

10

OBJECTIVE To Optimize Sweetener: Color: Flavor ratio of Liquid Oral Dosage Form

DEVELOPMENT OF DESIGN SPACE

ANALYSIS OF RESPONSES

CONSTRAINED MIXTURE

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

SIMPLEX CENTROID

SIMPLEX LATTICE

OPTIMIZATION OF SWEETENER: COLOR: FLAVOR RATIO IN LIQUID ORAL(SOLUTION/ SUSPENSION/ EMULSION) DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE

A

SWE

ETE

NE

R

A

CA

SE

STU

DY

18

© Created & Copyrighted by Shivang Chaudhary

CQAs CMAs

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

PATIENT ACCEPTANCE SCORE =+8.30A+4.50B+2.70C+8.32AB+5.40AC+3.15BC+42.08ABC+2.92AB(A-B)-9.90AC(A-C)+1.35BC(B-C) (MIX ORDER SCHEFFE MODEL) [SIGNIFICANT TERMS: AC, BC]

DEVELOPMENT OF DESIGN SPACE

CONSTRAINED MIXTURE

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

SIMPLEX CENTROID

SIMPLEX LATTICE

ANALYSIS OF RESPONSES

OPTIMIZATION OF SWEETENER: COLOR: FLAVOR RATIO IN LIQUID ORAL(SOLUTION/ SUSPENSION/ EMULSION) DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE C

ASE

ST

UD

Y 1

8

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

Responses (Effects) Goal for Individual Responses Y1 PATIENT ACCEPTANCE

SCORE To achieve maximum Patient Acceptance Score as maximum as possible out of 10. & NLT 7.0

Factors (Variables) Knowledge Space Design Space Control Space A SWEETENER (%w/w) 0-1.00% 0.2-1.0 0.4-0.8 B FLAVOR (%w/w) 0-1.00% 0.1-0.6 0.2-0.4 C COLOR (%w/w) 0-1.00% 0.0-0.4 0.1-0.2

ANALYSIS OF RESPONSES

CONSTRAINED MIXTURE

SIMPLEX CENTROID

SIMPLEX LATTICE

DEVELOPMENT OF DESIGN SPACE

OPTIMIZATION OF SWEETENER: COLOR: FLAVOR RATIO IN LIQUID ORAL(SOLUTION/ SUSPENSION/ EMULSION) DOSAGE FORM

FACTORIAL RESPONSE SURFACE MIXTURE C

ASE

ST

UD

Y 1

8

© 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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