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

shivaniper@gmail.com

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 shivaniper@gmail.com

https://in.linkedin.com/in/shivangchaudhary

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