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

shivaniper@gmail.com

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 shivaniper@gmail.com

https://in.linkedin.com/in/shivangchaudhary

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