optimization of “sweetener: flavor: color” ratio in liquid oral mixtures using {3,3} simplex...
TRANSCRIPT
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
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 [email protected]
https://in.linkedin.com/in/shivangchaudhary
facebook.com/QbD.PAT.Pharmaceutical.Development