Fluid bed top spray granulation process 3 f cccd rsm model by shivang chaudhary
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FOR SOLID ORAL DOSAGE FORM DEVELOPMENT AS PER QbD OPTIMIZATION OF CPPs OF FLUID BED TOP SPRAY GRANULATION PROCESS RISKS LOWER HARDNESS INADEQUATE DISINTEGRATION QUALITY COMPROMISED EFFICACY COMPROMISED HIGH FRIABILITY INADEQUATE DISSOLUTION SOFT GRANULES HARD GRANULES HIGHER %FINES HIGHER %AGGLOMERATES FACTORIAL MIXTURE BOX BEHNKEN RESPONSE SURFACE CIRCUMSCRIBED CENTRAL COMPOSITE C B A BINDER SPRAYING RATE FLUIDIZATION AIR VELOCITY ATOMIZATION AIR PRESSURE DEVELOPMENT OF DESIGN SPACE ANALYSIS OF RESPONSES DESIGN OF EXPERIMMENTS IDENTIFICATION OF FACTORS CASE STUDY 11 © 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 [email protected]
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Transcript of Fluid bed top spray granulation process 3 f cccd rsm model by shivang chaudhary
FOR SOLID ORAL DOSAGE FORM DEVELOPMENT AS PER QbD
OPTIMIZATION OF CPPs OF FLUID BED TOP SPRAY GRANULATION PROCESS
RISKS
LOWER HARDNESS INADEQUATE DISINTEGRATION
QUALITY COMPROMISED EFFICACY COMPROMISED
HIGH FRIABILITY INADEQUATE DISSOLUTION
SOFT GRANULES HARD GRANULES
HIGHER %FINES HIGHER %AGGLOMERATES
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
CIRCUMSCRIBED CENTRAL COMPOSITE
C
B
A BINDER SPRAYING RATE
FLUIDIZATION AIR VELOCITY
ATOMIZATION AIR PRESSURE
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
11
© 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
DEVELOPMENT OF DESIGN SPACE
IDENTIFICATION OF FACTORS
Factors (Variables) Levels of Factors studied -α -1 0 +1 +α
A Binder Spraying Rate (gm/min) 1.64gm/min 3 gm/min 5 gm/min 7 gm/min 8.36gm/min B Atomization Pressure (bar) 0.32bar 1 bar 2 bar 3 bar 3.68bar C Fluidization Air Velocity (cfm) 32.96cfm 50 cfm 75 cfm 100 cfm 117.04cfm
NO. OF FACTORS
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
ADD. CENTER POINTS
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
5
CIRCUMSCRIBED CENTRAL COMPOSITE RSM for 3 factors
5
8 fp +6 sp +6 cp =20
OBJECTIVE To Optimize CPPs of Fluid Bed Granulation Process
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
DESIGNING OF EXPERIMMENTS
OPTIMIZATION OF CPPs OF FLUID BED TOP SPRAY GRANULATION FOR SOLID ORALS
A BINDER SPRAYING RATE
C
FLU
IDIZ
ATI
ON
AIR
VE
LOC
ITY
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
1
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DEVELOPMENT OF DESIGN SPACE
DESIGN OF EXPERIMMENTS
CQAs CPPs
PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY QUADRATIC MODEL
Agglomerates (%w/w) = +2.27 +1.61A -0.42B -0.61c +0.063AB +0.44AC -0.012BC +0.68A2 +0.82B2 +0.15C2
Fines (%w/w) = +1.63 -0.88A +3.659E-003B +1.52C +0.00AB +0.25AC +0.23BC +0.53A2 +0.16B2 +1.47C2
%Process Efficiency (%) = +95.83 -0.32A +0.42B -1.52C +0.00AB -1.00 AC +0.25BC -1.85A2 -0.78B2 -2.02C2
© Created & Copyrighted by Shivang Chaudhary
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
OPTIMIZATION OF CPPs OF FLUID BED TOP SPRAY GRANULATION FOR SOLID ORALS
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
1
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGN OF EXPERIMMENTS
Responses (Effects) Goal for Individual Responses Y1 Agglomerates (%w/w) Agglomerates should NMT 2.5%w/w Y2 Fines (%w/w) Fines should NMT 2.5%w/w Y3 Process Efficiency (%) To achieve the maximum process efficiency (%yield) NLT 95%w/w
Factors (Variables) Knowledge Space Design Space Control Space A Spraying Rate (gm/min) 3-7 3.75-5.25 4-5 B Atomization Pressure (bar) 1-3 1.25-3 1.5-3 C Fluidization Air Velocity (cfm) 50-100 55-85 60-80
© Created & Copyrighted by Shivang Chaudhary
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF CPPs OF FLUID BED TOP SPRAY GRANULATION FOR SOLID ORALS
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
1
© 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
