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FOR SOLID ORAL DOSAGE FORMS DEVELOPMENT AS PER QbD
OPTIMIZATION OF CMAs & CPPs OF HIGH SHEAR WET GRANULATION PROCESS
RISKS
LOWER HARDNESS INADEQUATE DISINTEGRATION
QUALITY COMPROMISED EFFICACY COMPROMISED
HIGH FRIABILITY INADEQUATE DISSOLUTION
SOFT GRANULES HARD GRANULES
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
FACE CENTERED CENTRAL COMPOSITE
BINDER
DISINTEGRANT
KNEADING TIME C
B
A
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
15
© 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
IDENTIFICATION OF FACTORS
DEVELOPMENT OF DESIGN SPACE
Factors (Variables) Levels of Factors Studied -α = -1 0 +α = +1
A Binder (%w/w) 4% 7% 10% B Disintegrant (%w/w) 1% 3% 5% C Kneading Time (min) 2 min 4 min 6 min
NO. OF FACTORS
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
ADD. CENTER POINTS
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
3
FACE CENTERED CENTRAL COMPOSITE DESIGN
5
8fp + 6sp + 6cp =20
OBJECTIVE To Optimize CMAs & CPPs of Wet Granulation Process
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
OPTIMIZATION OF CMAs & CPP OF HIGH SHEAR WET GRANULATION PROCESS FOR SOLID ORALS
A BINDER
C
KN
EA
DIN
G T
IME
FACE CENTERED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
5
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DEVELOPMENT OF DESIGN SPACE
DESIGNING OF EXPERIMMENTS
CQAs CMAs CPP
PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY QUADRATIC MODEL
HARDNESS =+74.80+11.80A-3.10B+15.10C-1.25AB+3.75AC+1.25BC+0.000A2-0.50B2-6.50C2
FRIABILITY=+0.11-0.050A+0.012B-0.069C+3.750E-003AB-0.016AC-8.750E-003BC+0.021A2+0.011B2+0.036C2
DISINTEGRATION TIME=+8.05+3.40A-2.30B+2.00C +0.50AB-0.25 AC+0.75BC+1.14A2+2.64B2+1.14C2
DRUG DISSOLVED=+93.44-9.20A+2.70B-4.80C+0.000AB+0.75AC-0.50BC-6.09A2-0.59B2-4.09 C2
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
OPTIMIZATION OF CMAs & CPP OF HIGH SHEAR WET GRANULATION PROCESS FOR SOLID ORALS
FACE CENTERED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
5
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
Responses (Effects) Goal for Individual Responses Y1 Hardness (n) To achieve tablet hardness in the range from 65 to 85N Y2 Friability (%) To achieve minimum friability i.e. NMT 0.15% Y3 Disintegration (min) To achieve tablet DT within 10 minutes Y4 Dissolution (%) To achieve maximum dissolution in 30 minutes i.e. NLT 90%
Factors (Variables) Knowledge Space Design Space Control Space A Binder (%) 4-10 5.3-8.8 6.0-8.0 B Disintegrant (%) 1-5 2.2-4.4 3.0-4.0 c Kneading Time (min) 2-6 2.0-5.0 2.5-4.5
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
DESIGN OF EXPERIMMENTS
ANALYSIS OF RESPONSES
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF CMAs & CPP OF HIGH SHEAR WET GRANULATION PROCESS FOR SOLID ORALS
FACE CENTERED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
5
© 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
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