optimization of “glidant: lubricant: antiadherant” ratio in solid oral mixtures using {3,3}...
TRANSCRIPT
SIMPLEX LATTICE
FOR TABLET/ CAPSULE DOSAGE FORM DEVELOPMENT AS PER QbD
OPTIMIZATION OF GLIDANT LUBRICANT ANTIADHERANT RATIO IN SOLID ORAL MIXTURES
RISKS
INADEQUATE GLIDANT INADEQUATE LUBRICANT
QUALITY COMPROMISED
INADEQUATE ANTIADHERANT
POOR FLOW OF GRANULES FROM HOPPER TO DIE
EJECTOION OF COMPLETE TABLET FROM DIE
ADHESION OF GRANULES TO PUNCES & DIES
WEIGHT VARIATION & CONTENT NONUNIFORMITY
STICKING CAN BE OBSERVED ON TABLET PERIPHERALS
PICKING CAN BE OBSERVED ON TABLET SURFACE
CONSTRAINED MIXTURE
SIMPLEX CENTROID
FACTORIAL RESPONSE SURFACE MIXTURE
ANTIADHERANT
LUBRICANT
GLIDANT 1
2
3
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGNING OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
19
© 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 Low High
A GLIDANT (%w/w) 0% 2% B LUBRICANT (%w/w) 0% 2% C ANTIADHERANT (%w/w) 0% 2%
NO. OF COMPONENTS
EXPERIMENTAL DESIGN SELECTED
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
SIMPLEX CENTROID
10
OBJECTIVE To Optimize Glidant: Lubricant: Anti-Adherant ratio of Solid Orals
SIMPLEX LATTICE
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
CONSTRAINED MIXTURE
SIMPLEX CENTROID
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
OPTIMIZATION OF GLIDANT: LUBRICANT: ANTIADHERANT RATIO IN SOLID ORAL DOSAGE FORM
FACTORIAL RESPONSE SURFACE MIXTURE
GLID
AN
T
A
CA
SE
STU
DY
19
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY MIXED ORDER SCHEFFE CUBIC MODEL
Angle of Repose = +41.27A +44.63B +41.18C -25.97AB -24.88AC -22.15BC (MIX ORDER SCHEFFE CUBIC MODEL)
CQAs CMAs
SIMPLEX LATTICE
DEVELOPMENT OF DESIGN SPACE
CONSTRAINED MIXTURE
DESIGNING OF EXPERIMMENTS
SIMPLEX CENTROID
ANALYSIS OF RESPONSES
OPTIMIZATION OF GLIDANT: LUBRICANT: ANTIADHERANT RATIO IN SOLID ORAL DOSAGE FORM
FACTORIAL RESPONSE SURFACE MIXTURE C
ASE
ST
UD
Y 1
9
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
SIMPLEX LATTICE
ANALYSIS OF RESPONSES
CONSTRAINED MIXTURE
SIMPLEX CENTROID
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF GLIDANT: LUBRICANT: ANTIADHERANT RATIO IN SOLID ORAL DOSAGE FORM
FACTORIAL RESPONSE SURFACE MIXTURE C
ASE
ST
UD
Y 1
9
Responses (Effects) Goal for Individual Responses Y1 Angle of Repose To achieve angle of repose in the range from 30˚ to 35˚ (GOOD Flow property)
Factors (Variables) Knowledge Space Design Space Control Space A GLIDANT (%w/w) 0-2% 0.30-1.20 0.60-0.90 B LUBRICANT (%w/w) 0-2% 0.00-0.90 0.35-0.65 C ANTIADHERANT (%w/w) 0-2% 0.25-1.25 0.60-0.90
© 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]
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