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API PARTICLE SIZE 1
2 POLYMER CONTENT
FOR HARD GELATIN CAPSULE DEVELOPMENT AS PER QbD
EFFECT EVALUATION OF FORMUALATION VARIABLES FOR SUSTAINED RELEASE ENCAPSULATED DOSAGE FORM
RISKS
INADEQUATE OR EXCESS DRUG RELEASE WITH RESPECT TO TIME
EFFICACY OR SAFETY COMPROMISED
DRUG PLAMA LEVEL BELOW MINIMUM EFFECTIVE CONC. OR ABOVE MAXIMUM SAFE CONC.
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
MIXTURE RESPONSE SURFACE FACTORIAL
EVALUATION OF CRITICAL FACTORS
ANALYSIS OF RESPONSE
DESIGNING OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
5
© 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
EVALUATION OF CRITICAL FACTORS
Factors (Variables) Levels of Factors studied -1 +1
A API Particle Size (microns) 10 25 B Polymer Content (%w/w) 20 30
NO. OF FACTORS
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
2
2
22 FULL FACTORIAL DESIGN
22
= 4
OBJECTIVE To Evaluate Effects of Critical Formulation Variables of Sustained Release Composition for Encapsulation into Hard Gelatin Capsule
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
IDENTIFICATION OF FACTORS
ANALYSIS OF RESPONSE
DESIGNING OF EXPERIMMENTS
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF SUSTAINED RELEASE HARD GELATIN CAPSULE
MIXTURE RESPONSE SURFACE FACTORIAL
A API PARTICLE SIZE
B
PO
LYM
ER
CO
NTE
NT
CA
SE
STU
DY
5
© Created & Copyrighted by Shivang Chaudhary
EVALUATION OF CRITICAL FACTORS
CQAs CMAs
PREDICTION EFFECT EQUATION OF EACH FACTOR & THEIR INTERACTIONS ON INDIVIDUAL RESPONSE BY LINEAR MODEL
%Drug Release Within 12 Hours = Y = β0 + β1X1 + β2X2 + β12X1X2
Run Order code Factor X1: API Particle Size D90 (in microns)
[coded level]
Factor X2: Polymer Content (in %w/w)
[coded level]
x1*x2 [coded level]
Response Y1: %Drug Released within 12 hours
1 1 10 [-1] 20 [-1] [+1] 96
2 a 25 [+1] 20 [-1] [-1] 75
3 b 10 [-1] 30 [+1] [-1] 84
4 ab 25 [+1] 30 [+1] [+1] 67
β1 =ab + a
2n−
b + 1
2n
β1 = 67+76
4 −
84+96
4
β1 = 35.50 − 45.00
β1 = −9.50
β2 =ab + b
2n−
a + 1
2n
β2 = 67+84
4 −
75+96
4
β2 = 37.75 − 42.75
β2 = −5.00
β12 =ab + 1
2n−
a + b
2n
β12 = 40.75 − 39.75
β12 = +1.00
β0 =1 + a + b + ab
2n
β1𝟐 = 67+96
4 −
75+84
4 β0 =
96 + 75 + 84 + 67
4
β0 = +𝟖𝟎. 𝟓𝟎
=+80.50 -9.50A -5.00B +1.00AB
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSE
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF SUSTAINED RELEASE HARD GELATIN CAPSULE
MIXTURE RESPONSE SURFACE FACTORIAL C
ASE
ST
UD
Y 5
© Created & Copyrighted by Shivang Chaudhary
SIGNIFICANT EFFECTS: MODEL TERMS
Responses (Effects) Goals for Individual Responses Y1 %Drug Release within 12 hours To achieve NLT 85% drug release within 12 hours
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF SUSTAINED RELEASE HARD GELATIN CAPSULE
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSE
EVALUATION OF CRITICAL FACTORS
MIXTURE RESPONSE SURFACE FACTORIAL C
ASE
ST
UD
Y 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
facebook.com/QbD.PAT.Pharmaceutical.Development
