optimization of cmas & cpps of “suspension homogenization process” using box behnken rsm for...
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FOR LIQUID ORAL DOSAGE FORM DEVELOPMENT AS PER QbD
OPTIMIZATION OF CMAs & CPPs OF SUSPENSION HOMOGENIZATION PROCESS
QUALITY COMPROMISED EFFICACY COMPROMISED SAFETY COMPROMISED
INADEQUATE ZETA POTENTIAL
RISKS
INADEQUATE VISCOSITY HIGH RATE OF SEDIMENTATION
CONTENT UNIFORMITY COMPROMISED
FACTORIAL MIXTURE
CENTRAL COMPOSITE
RESPONSE SURFACE
BOX BEHNKEN
A
B
C STIRRING TIME
HYDROCOLLOID
SURFACTANT
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
DESIGN OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
CA
SE
STU
DY
16
© 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
Factors (Variables) Levels of Factors Studied -1 0 +1
A HYDROCOLLOID (%) 20%w/w 30%w/w 40%w/w B SURFACTANT (%) 0.50%w/w 1.00%w/w 1.50%w/w C STIRRING TIME (min) 30min 45min 60min
NO. OF FACTORS
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
ADD. CENTER POINTS
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
3
BOX BEHNKEN DESIGN
2
12MP + 3CP
=15
To Optimize CMAs & CPPs of Liquid Suspension Dosage Form OBJECTIVE
DEVELOPMENT OF DESIGN SPACE
ANALYSIS OF RESPONSES
FACTORIAL MIXTURE
CENTRAL COMPOSITE
RESPONSE SURFACE
BOX BEHNKEN
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
OPTIMIZATION OF CMAs & CPPs OF SUSPENSION HOMOGEMIZATION
A HYDROCOLLOID
C
STIR
RIN
G T
IME
CA
SE
STU
DY
16
© Created & Copyrighted by Shivang Chaudhary
PREDICTION EFFECT EQUATION OF EACH FACTOR, THEIR INTERACTIONS & CURVATURES ON INDIVIDUAL RESPONSE BY QUADRATIC MODEL
Sedimentation Volume Ratio =+0.037-0.013A-0.068B-0.033C+0.010 AB+0.010AC+0.015BC+0.042A2+0.13B2+0.047C2
Zeta Potential =-42.00-1.75A-19.38B-6.63C+2.25AB-1.25AC+7.00BC-1.75A2+5.00B2-2.50C2
Viscosity=+45.00+1.88A+16.13B+6.00C+0.75AB+0.50AC +0.000BC+0.38A2+0.38B2-1.38C2
Content Uniformity=+1.73-0.075A-0.14B-0.24C-0.025AB+0.075AC+0.050BC+0.28A2+0.46B2+0.51C2
CQAs CMAs CPP
DEVELOPMENT OF DESIGN SPACE
FACTORIAL MIXTURE
CENTRAL COMPOSITE
RESPONSE SURFACE
BOX BEHNKEN
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSES
OPTIMIZATION OF CMAs & CPPs OF SUSPENSION HOMOGEMIZATION
CA
SE
STU
DY
16
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
Responses (Effects) Goal for Individual Responses Y1 Sedimentation Volume Ratio To achieve the minimum SVR i.e. NMT 0.1 Y2 Zeta Potential (mV) To achieve zeta potential of suspension in the range of -35 to -45 mv Y3 Viscosity (cps) To achieve viscosity in the range of 40 to 50 cps Y4 Content Uniformity (AV) To achieve minimum acceptance value in CU i.e. NMT 2.0
Factors (Variables) Knowledge Space Design Space Control Space A HYDROCOLLOID (%) 20.0-40.0 27.5-32.5 28.0-32.0 B SURFACTANT (%) 0.50-1.50 0.60-1.40 0.75-1.25 C STIRRING TIME (min) 30-60 37-53 40-50
ANALYSIS OF RESPONSES
FACTORIAL MIXTURE
CENTRAL COMPOSITE
RESPONSE SURFACE
BOX BEHNKEN
DEVELOPMENT OF DESIGN SPACE
OPTIMIZATION OF CMAs & CPPs OF SUSPENSION HOMOGEMIZATION
CA
SE
STU
DY
16
© 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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