optimization of cpps of “softgel capsule encapsulation” process using circumscribed central...
TRANSCRIPT
WEIGHT VARIATION
FOR SOFT GELATIN CAPSULE DEVELOPMENT AS PER QbD
OPTIMIZATION OF CPPs OF SOFT GELATIN CAPSULE ENCAPSULATION PROCESS
IN-PROCESS IMPURITIES
QUALITY COMPROMISED PATIENT SAFETY COMPROMISED
IMPROPER MACHINE SPEED HIGHER TEMPERATURE
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
CIRCUMSCRIBED CENTRAL COMPOSITE
MELTING/ HEATING TEMPERATURE
GELATIN LAYER THICKNESS
ROTARY DIE SPEED
3
2
1
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
12
RISKS
INADEQUATE DRUG RELEASE
EFFICACY COMPROMISED
THICKENED SOFTGEL LAYER
© 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
Factors (Variables) Levels of Factors studied -α -1 0 +1 +α
A Melting/ Heating Temperature (°C) 52.9 55.0 60.0 65.0 67.1 B Gelatin Layer Thickness (mm) 0.46 0.50 0.60 0.70 0.74 C Rotary Die Speed (RPM) 1.59 2.00 3.00 4.00 4.41
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 WITH FRACTIONAL FACTORIAL (SCALE DOWN CCD)
4
4 ffp + 6sp + 5cp =15
OBJECTIVE To Optimize CPPs of Encapsulation Process for Soft Gelatin Capsule
© Created & Copyrighted by Shivang Chaudhary
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
IDENTIFICATION OF FACTORS
DESIGN OF EXPERIMMENTS
OPTIMIZATION OF CPPs OF SOFTGEL CAPSULE ENCAPSULATION PROCESS
A MELTING TEMPERATURE
C
RO
TAR
Y D
IE S
PE
ED
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
2
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DEVELOPMENT OF DESIGN SPACE
CQAs CPP
PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY QUADRATIC MODEL
DISSOLUTION AT 30 MINS=+96.56-2.12A-7.78B+2.12C+1.87AB-2.03AC+0.63BC-3.97A2-5.97B2-3.47C2
%TOTAL IMPURITIES =+1.40+0.81A-0.035B-0.28C-0.033AB+0.015AC+0.063BC+0.54A2+0.044B2+0.22C2
WEIGHT VARIATION =+1.28-0.21A+0.035B+0.60C+0.13AB+0.010AC-0.44BC+0.28A2+0.31B2+1.01C2
© Created & Copyrighted by Shivang Chaudhary
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
DESIGN OF EXPERIMMENTS
ANALYSIS OF RESPONSES
OPTIMIZATION OF CPPs OF SOFTGEL CAPSULE ENCAPSULATION PROCESS
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
2
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGN OF EXPERIMMENTS
Responses (Effects) Goal for Individual Responses Y1 Weight variation (%) Weight variation should not be more than i.e. NMT 1.5%RSD Y2 Drug Dissolved at 30 min %Drug dissolved should not be less than 90% Y3 Total Impurities (%) Total Impurities should not be increased more than 1.5%w/w
Factors (Variables) Knowledge Space Design Space Control Space A Melting/ Heating Temperature (°C) 53-67 57-60 58-60 B Gelatin Layer Thickness (mm) 0.46-0.74 0.52-0.62 0.54-0.60 C Rotary Die Speed (RPM) 1.6-4.4 2.25-3.25 2.50-3.00
FACTORIAL MIXTURE
BOX BEHNKEN
RESPONSE SURFACE
ANALYSIS OF RESPONSES
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF CPPs OF SOFTGEL CAPSULE ENCAPSULATION PROCESS
CIRCUMSCRIBED CENTRAL COMPOSITE C
ASE
ST
UD
Y 1
2
© 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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