OPTIMIZATION OF RANGES
SCANNING & TESTING
SCREENING & OPTIMIZATION OF CPPs OF ROLLER COMPACTION DRY GRANULATION PROCESS
FOR SOLID ORAL DOSAGE FORMS DEVELOPMENT AS PER QbD
ROLLER PRESSURE 1
3 MILLING SPEED
ROLLER GAP 2
MILL ORIFICE SIZE 4
NO. OF LEVELS
EXPERIMENTAL DESIGN SELECTED
TOTAL NO OF EXPERIMENTAL RUNS (NO OF TRIALS)
3
FRACTIONAL FACTORIAL DESIGN WITH ADD. CENTER POINTS
24-1
+3 = 11
NO. OF FACTORS
ADD. CENTER POINTS
4
3
3 LEVEL FACTORIAL
PLACKETTE BURMAN
ANALYSIS OF RESPONSE
DESIGNING OF EXPERIMMENTS
IDENTIFICATION OF FACTORS
MIXTURE RESPONSE SURFACE FACTORIAL
2 LEVEL FRACTIONAL FACTORIAL WITH CP C
ASE
ST
UD
Y 4
© 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
IDENTIFICATION OF FACTORS
Factors (Variables) Levels of Factors studied -1 0 +1
A Roller Pressure (bar) 20 50 80 B Roller Gap (mm) 1.2 1.8 2.4 C Mill Speed (rpm) 20 60 100 D Mill Orifice Screen Size (mm) 0.6 1.0 1.4
FACTORS TO BE STUDIED
To Evaluate Effects of Critical Processing Parameters of Roller Compaction Dry Granulation .
SCREENING & OPTIMIZATION OF CPPs OF ROLLER COMPACTION DRY GRANULATION PROCESS
Responses (Effects) Goals for Individual Responses Y1 Ribbon Density (g/cc) To achieve granule density from 1 to 1.2 g/cc
Y2 Granule D50 (um) To achieve mean particle size in the range from 400 to 800 um Y3 Granule Flowability (ffc) To achieve the desired ffc more than 6
Y4 Tablet Hardness (Kp) To achieve tablet hardness more than 9.0 kP
Y5 Tablet CU (%RSD) To minimize % RSD in CU i.e. NMT 5%
RESPONSES TO BE MEASURED
OBJECTIVE
3 LEVEL FACTORIAL
PLACKETTE BURMAN
OPTIMIZATION OF RANGES
SCANNING & TESTING
ANALYSIS OF RESPONSE
DESIGNING OF EXPERIMMENTS
MIXTURE RESPONSE SURFACE FACTORIAL
2 LEVEL FRACTIONAL FACTORIAL WITH CP C
ASE
ST
UD
Y 4
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
CPPs CQAs
3 LEVEL FACTORIAL
PLACKETTE BURMAN
OPTIMIZATION OF RANGES
SCANNING & TESTING
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSE
SCREENING & OPTIMIZATION OF CPPs OF ROLLER COMPACTION DRY GRANULATION PROCESS
MIXTURE RESPONSE SURFACE FACTORIAL
2 LEVEL FRACTIONAL FACTORIAL WITH CP C
ASE
ST
UD
Y 4
© Created & Copyrighted by Shivang Chaudhary
SIGNIFICANT EFFECTS: MODEL TERMS
3 LEVEL FACTORIAL
PLACKETTE BURMAN
Ribbon Density =+1.11+0.14A-0.033B Granule d50 =+639.50+1.00B-7.50C+4.50AC + 114.50BC-3.00CD+338.00ABC+150.00BCD Granule Flow ability=
+7.42+1.62A-0.53B+1.09D
Hardness @10kN = +11.51 -2.29A +0.74B
Tablet CU =+3.14 -0.89A +0.29B -0.61D
OPTIMIZATION OF RANGES
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSE
SCANNING & TESTING
SCREENING & OPTIMIZATION OF CPPs OF ROLLER COMPACTION DRY GRANULATION PROCESS
MIXTURE RESPONSE SURFACE FACTORIAL
2 LEVEL FRACTIONAL FACTORIAL WITH CP C
ASE
ST
UD
Y 4
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF FACTORS
DESIGNING OF EXPERIMMENTS
ANALYSIS OF RESPONSE
SCANNING & TESTING
Responses (Effects) Goals for Individual Responses Y1 Ribbon Density (g/cc) To achieve granule density from 1 to 1.2 g/cc Y2 Granule d50 (um) To achieve mean particle size from 400 to 800 um
Y3 Granule Flowability (ffc) To achieve the desired ffc more than 6 Y4 Tablet Hardness (kp) To achieve tablet hardness more than 9.0 kP
Y5 Tablet CU (%RSD) To minimize % RSD in CU i.e. NMT 5%
3 LEVEL FACTORIAL
PLACKETTE BURMAN
OPTIMIZATION OF RANGES
SCREENING & OPTIMIZATION OF CPPs OF ROLLER COMPACTION DRY GRANULATION PROCESS
MIXTURE RESPONSE SURFACE FACTORIAL
2 LEVEL FRACTIONAL FACTORIAL WITH CP C
ASE
ST
UD
Y 4
© 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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