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FOR HARD GELATIN CAPSULE DEVELOPMENT AS PER QbD
OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN ENCAPSULATION PROCESS
Factors (Variables) Knowledge Space Design Space Control Space A Glidant (%) 0.10-0.50 0.20-0.40 0.20-0.40 B Lubricant (%) 0.50-2.00 0.70-1.80 0.90-1.60 C Filling Rate (SPM) 50-80 56-68 58-66
Responses (Effects) Goal for Individual Responses Y1 Weight Variation Relative Standard Deviation in WV test should NMT 2.0% Y2 Content Uniformity Acceptance Value in CU test should NMT 4.0 Y3 Hardness Force required to break the plug should NMT 2N Y4 Disintegration To achieve complete disintegration (no residue) within 5 minutes Y5 Dissolution To achieve at least 90% drug release within 30 minutes
ANALYSIS OF RESPONSES
FACTORIAL MIXTURE
CENTRAL COMPOSITE
RESPONSE SURFACE
BOX BEHNKEN
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF CMAs & CPPs OF HARD GELATIN CAPSULE ENCAPSULATION
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