PRODUCT TEMPERATURE 4

2 SPRAY RATE

ATOMIZATION PRESSURE 3

AIR VOLUME 1

SCREENING & OPTIMIZATION OF CPPs OF WURSTER COATING DRUG LAYERING PROCESS

FOR MULTIUNIT PARTICULATES SYSTEM DEVELOPMENT FOR SOLID ORALS AS PER QbD

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

OPTIMIZATION OF RANGES

SCANNING & TESTING

ANALYSIS OF RESPONSE

DESIGNING OF EXPERIMMENTS

IDENTIFICATION OF FACTORS

MIXTURE RESPONSE SURFACE FACTORIAL

2 LEVEL FRACTIONAL FACTORIAL WITH CP C

ASE

ST

UD

Y 3

© 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

FACTORS TO BE STUDIED

OBJECTIVE To Screen Out & Optimize CPPs of Wurster Coating Drug Layering Process.

SCREENING & OPTIMIZATION OF CPPs OF WURSTER COATING DRUG LAYERING PROCESS

RESPONSES TO BE MEASURED

Factors (Variables) Levels of Factors studied -1 Center Point +1

A Air Volume (cfm) 80 cfm 100 cfm 120 cfm B Spraying Rate (gm/min) 25 gm/min 35 gm/min 45 gm/min C Atomization Pressure (bar) 1.2 bar 1.6 bar 2.0 bar D Product Temperature (°C) 42°C 46°C 50°C

Responses (Effects) Goal for Individual Responses Y1 Fines (%w/w) Fines should NMT 5%w/w Y2 Agglomerates (%w/w) Agglomerates should NMT 5%w/w Y3 Assay by HPLC (%) To achieve the assay of the product from 95% to 105%

3 LEVEL FACTORIAL

PLACKETTE BURMAN

OPTIMIZATION OF RANGES

SCANNING & TESTING

ANALYSIS OF RESPONSE

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

MIXTURE RESPONSE SURFACE FACTORIAL

2 LEVEL FRACTIONAL FACTORIAL WITH CP C

ASE

ST

UD

Y 3

© Created & Copyrighted by Shivang Chaudhary

CQAs CPPs

IDENTIFICATION OF FACTORS

3 LEVEL FACTORIAL

PLACKETTE BURMAN

OPTIMIZATION OF RANGES

SCANNING & TESTING

DESIGNING OF EXPERIMMENTS

ANALYSIS OF RESPONSE

SCREENING & OPTIMIZATION OF CPPs OF WURSTER COATING DRUG LAYERING PROCESS

MIXTURE RESPONSE SURFACE FACTORIAL

2 LEVEL FRACTIONAL FACTORIAL WITH CP C

ASE

ST

UD

Y 3

© Created & Copyrighted by Shivang Chaudhary

SIGNIFICANT EFFECTS: MODEL TERMS

%Agglomerates=+4.49-1.71A+1.04B-2.71D %Fines=+2.59+0.79A+1.94D+0.59AD

%Assay=+98.00-0.67A-1.52D-0.55AD

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

3 LEVEL FACTORIAL

PLACKETTE BURMAN

OPTIMIZATION OF RANGES

ANALYSIS OF RESPONSE

SCANNING & TESTING

SCREENING & OPTIMIZATION OF CPPs OF WURSTER COATING DRUG LAYERING PROCESS

MIXTURE RESPONSE SURFACE FACTORIAL

2 LEVEL FRACTIONAL FACTORIAL WITH CP C

ASE

ST

UD

Y 3

© Created & Copyrighted by Shivang Chaudhary

IDENTIFICATION OF FACTORS

DESIGNING OF EXPERIMMENTS

Responses (Effects) Goal for Individual Responses Y1 Fines (%w/w) Fines should NMT 5%w/w Y2 Agglomerates (%w/w) Agglomerates should NMT 5%w/w Y3 Assay by HPLC (%) To achieve the assay of the product within 95% to 105%

3 LEVEL FACTORIAL

PLACKETTE BURMAN

ANALYSIS OF RESPONSE

SCANNING & TESTING OPTIMIZATION

OF RANGES

SCREENING & OPTIMIZATION OF CPPs OF WURSTER COATING DRUG LAYERING PROCESS

MIXTURE RESPONSE SURFACE FACTORIAL

2 LEVEL FRACTIONAL FACTORIAL WITH CP C

ASE

ST

UD

Y 3

© 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

facebook.com/QbD.PAT.Pharmaceutical.Development