qbd for "blister packaging" process
TRANSCRIPT
FOR SOLID ORAL DOSAGE FORM DEVELOPMENT AS PER QbD
OPTIMIZATION OF CPPs OF BLISTER PACKAGING PROCESS
RISKS
EFFICACY & SAFETY COMPROMISED
CHEMICAL & MICROBIOLOGICAL STABILITY COMPROMISED
DEFECT IN BASE FILM CAVITY LEAKAGE IN LIDDING FOIL
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
CIRCUMSCRIBED CENTRAL COMPOSITE
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
21
© 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
C
B
A FORMING TEMPERATURE
MACHINE SPEED
SEALING TEMPERATURE
PRODUCTION COMPROMISED
%SKUs DECREASED
% DEFECTIVES INCREASED
DEVELOPMENT OF DESIGN SPACE
IDENTIFICATION OF FACTORS
Factors (Variables) Levels of Factors studied -α -1 0 +1 +α
A Cavity Forming Temperature (°C) ~110 120 135 150 ~160 B Lid Sealing Temperature (°C) ~120 140 170 200 ~220 C Machine Speed (BPM) ~50 150 300 450 ~550
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 Blister Packaging 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
%Defectives = +0.53-0.017A-0.23B+0.47C+0.000AB+0.000AC-0.050BC+0.036A2 +0.21B2+0.18C2
% Impurities = +0.50+0.60A+0.14B-0.037C+0.038AB-0.012AC+0.013BC+0.34A2+0.041B2-0.012C2
© 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 %Defectives Should not be more than 0.5% to maintain maximum SKU Y2 %Impurities Should not be more than 0.5% to ensure patient safety
Factors (Variables) Knowledge Space Design Space Control Space A Cavity Forming Temperature (°C) 110-160 125-135 130-135 B Lid Sealing Temperature (°C) 120-220 160-190 170-180 C Machine Speed (BPM) 50-550 150-275 175-250
© 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
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