A little bit information about formulation and development by using software like design expert,minitab and CARD etc

1. FORMULATION DATA
ANALYSIS BY
SOFTWARES
Presented by:-
Amit Ambadas Chaudhari
M.Pharmacy (Semester-II)
Department Of Pharmaceutics
KBHSS Trust’s Institute of Pharmacy,
Malegaon.
Date:-18/03/2019
Roll NO:-06
118-03-2019

2. CONTENTS
1. Introduction
2. Optimization and its term
3. Advantages
4. Various Experimental Design
5. Computer Software
6. SOP of Design Expert Software
7. Updated version of DE
8. References
218-03-2019

3. INTRODUCTION
Formulation and development is a process of selection of component
and processing.
 Now days computer tools used in the formulation and development
of pharmaceutical product.
 Various technique, such as design of experiment are implemented for
optimization of formulation and processing parameter.
 Traditionally optimization in pharmaceuticals refer changing one
variable at a one time so to obtain solution of a problematic
formulation.
Many times finding the correct answer is not simple and straight
forward in such cases use of computer tools (optimization procedure)
for best compromise is the smarter way to solve problem.
318-03-2019

4. Optimization And Its Term
Optimization means:- Optimization means choosing the best
element from some set of available alternatives.
Factor:- It is an assigned & independent variables ,Such as
temperature and concentration. Those are quantitative & qualitative.
Level:-Those are designation assigned to the factor. Level indicated
as high, low, medium , Eg :-polymer ratios.
Response:-It is an outcome of an experiment. Eg:- Disintegration
time
Response surface:-Response surface representing a relationship
between the independent variables X1&X2 and dependent variables
Y.
18-03-2019 4

5. ADVANTAGES
Optimization
Reducing
Cost
Saving
Time
Saving
Money
Safety
&Reducing
Error
18-03-2019 5

6. Design Of Experiment
Design of experiment :- Is a structure organized method
used to determine the factor affecting to process and output
of that process.
Parsimony Principle:-
some of factor are important ,while other factor are not
important.
Few variables are effective or other are not effective.
Experimental design is an integral part of optimization
technique.
Those technique used in the formulation optimization.
18-03-2019 6

7. Various Experimental Design
Experimental
Design
Complete
Randomize
Design
Randomized
Block Design
Adding Center
Point Design
Response
Surface Design
Statistical
Design
Factorial
Design
18-03-2019 7

8. Design of Experiment For Formulation
And Development
 All pharmaceutical products are formulated to specific
dosage form drugs to be effectively delivered to patient
typical pharmaceutical dosage form include tablets,
capsules, solution suspension, etc.
Different dosage form required different technology
usually present different technological challenge for
formulation & development .
 Due to complex challenges, formulations scientist used
effective methodology like as design of experiment and
statistical analysis for formulation and development .
Formulation scientist used this method for process
optimization and process validation .
18-03-2019 8

9. Computer Software
Software Silent Feature
Design Expert Powerful & Compressive package used for
optimizing pharmaceutical formulation and process
Minitab Powerful DOE software for automated data
analysis MS-Excel compatibility. Include almost all
design of RSM.
DOE PRO XL MS-Excel compatible DOE software for automated
data Analysis.
CARD Powerful DOE software for data analysis include
graphics and help feature.
18-03-2019 9

10. How to used design Expert software
version 7.0
 www.statease.com
How to install design expert software:-
1) Install the exe file.
2) Do not run design expert now.
3) Copy the crack from crack folder to C/ program file / DX
7trail run.
4) If you want help then press F1for help.
18-03-2019 10

11. SOP of Design Expert Software
1) File new design
2) Click response surface
3) Add numeric factor
4) Write name of independent variables
5) Add low limit and high limit
6) Continue
7) Add response
8) Run will be generated
18-03-2019 11

12. Applying DOE to Formulation And
Development
Factor Low Level (mg) High Level(mg) Effect On
Diluent Ratio 10 15 Disintegration
Time
Disintegration
Level
5 10 Dissolution
Binder Level 4 6 Friability
Lubricant Level 6 8 Weight Uniformity
18-03-2019 12

13. Major Technical Challenges In Tablet
Formulation Development & Role Of DOE
Major Challenges Potential Process Technologies
Uniformity Fluid Bed Granulation
Compatibility Highly Compressible excipient
Flow ability Free Flowing excipients
Dissolution Tablet Matrix containing polymers
18-03-2019 13

14. Common Formulation Factor For The Tablet
And Applicable Design of Experiment
Factor Response DOE approaches
% API Uniformity Factorial
% Binder Compactability Fractional Factorial
% Disintegration Flowability Central Composite
% Glidant Dissolution Central composite
mixture
% Lubricant Stability Box-Behnken
18-03-2019 14

15. 18-03-2019 15

16. 18-03-2019 16

17. 18-03-2019 17

18. Updated Versions Of DE
History:- Stat-Ease Company released its first version of
DE in 1998.
In 1996 the firm released version 5 which was the first
version of the software.
DE Version 6.0
DE Version 7.0
DE Version 8.0
DE Version 9.0
DE Version10.0.7
Latest Version Of DE Software - 11
18-03-2019 18

19. References
www.wikipedia.org
www.statease.com
www.slideshare.net
Bolton S, Bon C. Pharmaceutical Statistics Practical & Clinical
Application, 5TH ED. New York London ;INFORMA Healthcare
Publishing ; 2010.Pg No 239
Hussain AS,Shivanand P, Johnson Rd. Application Of Neural
Computing In Pharmaceutical Product Development: Computer Aided
Formulation Design. Drug Development And Industrial Pharmacy .
1994 Jan 1;20(10):1739-52.
18-03-2019 19

20. Thank you…….
18-03-2019 20