effect evaluation of critical formulation variables of “metered dose inhaler” using 2^3 full...
TRANSCRIPT
FOR SUSPENSION AEROSOL DEVELOPMENT AS PER QbD
EFFECT EVALUATION OF CRITICAL FORMULATION VARIABLES OF METERED DOSE INHALER
INADEQUATE DRUG RELEASE PER SINGLE ACTUATION
EFFICACY COMPROMISED
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
B SUSPENDING AGENT
C PROPELLANT CONTENT
CA
SE
STU
DY
6
© 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
API PARTICLE SIZE A
RISKS
IDENTIFICATION OF FACTORS
Factors (Variables) Levels of Factors studied -1 +1
A API PARTICLE SIZE (microns) 1 10 B SUSPENDING AGENT (%w/w) 0.10 0.80 C PROPELLANT (%w/w) 70 90
NO. OF FACTORS
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
2
23 FULL FACTORIAL DESIGN
23
= 8
OBJECTIVE To Evaluate the Effects of Critical Formulation Variables of Metered Dose Inhaler (Suspension Aerosols))
EVALUATION OF CRITICAL FACTORS
ANALYSIS OF RESPONSE
DESIGNING OF EXPERIMMENTS
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF METERED DOSE INHALER (SUSPENSION AEROSOLS)
MIXTURE RESPONSE SURFACE FACTORIAL
A API PARTICLE SIZE
C
PR
OP
ELL
AN
T
CA
SE
STU
DY
6
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
CQA CMAs
PREDICTION EFFECT EQUATION OF EACH FACTOR & THEIR INTERACTIONS ON INDIVIDUAL RESPONSE BY LINEAR MODEL
NET CONTENT OF DRUG PER DISCHARGE FROM MDI= +89.20 -8.18A +3.13B +1.67C +1.45AB +0.55AC -0.45BC + 0.025ABC
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF METERED DOSE INHALER (SUSPENSION AEROSOLS)
EVALUATION OF CRITICAL FACTORS
DESIGNING OF EXPERIMMENTS
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
ANALYSIS OF RESPONSE
MIXTURE RESPONSE SURFACE FACTORIAL C
ASE
ST
UD
Y 6
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
Responses (Effects) Goals for Individual Responses Y1 %Net Content Per Discharge From MDI To achieve NLT 90% drug discharge per single actuation
SIGNIFICANT EFFECTS: MODEL TERMS
EFFECT EVALUATION OF CRITICALFORMULATION VARIABLES OF METERED DOSE INHALER (SUSPENSION AEROSOLS)
ANALYSIS OF RESPONSE
3 LEVEL FACTORIAL
PLACKETTE BURMAN
2 LEVEL FULL FACTORIAL
EVALUATION OF CRITICAL FACTORS
MIXTURE RESPONSE SURFACE FACTORIAL C
ASE
ST
UD
Y 6
NET CONTENT OF DRUG PER DISCHARGE FROM MDI= +89.20 -8.18A +3.13B +1.67C +1.45AB
© Created & Copyrighted by Shivang Chaudhary
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© 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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