optimization techniques and factorial designs in pharmaceutical product development.its examples in pharmaceutics and formulation for both b.pharm, m.pharm and pharm.d students

1. Optimization techniques,
statistical Designs
in
pharmaceutical product
development
Dr. K. L.DEEPTHI, M.PHARM. PH.D
ASSOCIATE PROFESSOR
DEPARTMENT OF PHARMACEUTICS

5. To
reduce
the cost
Safety &
reduce
the error
Innovati
on &
efficacy
reprodu
cibility
Save
the
time

9. Independent variables Dependent variables

16. • Widely used method(mostly used for tablets).

18. development of an analytical
method i.e. A continuous flow analyser
Triangle
for 2
vriable
Line for 1variable

20. Basic simplex method and modified simplex method

23. Y- response, a- regression coefficient, X- dependent variable

34. Formulation Standard
symbols
Effect (%drug
release)
Low drug- low excipient 1 10 %
Low drug- high excipient a 10%
High drug- low excipients b 20%
High drug- high excipient ab 30%
Experiment f1 f2 f3 Interpretation
1 -1 -1 -1 Zero level interaction
2 -1 +1 -1 Main factor effect f2
3 +1 -1 -1 Main factor effect f1
4 -1 -1 +1 Main factor effect f3
5 +1 +1 +1 Interaction between f1,
f2,f3.

36. full:
. fractional:

37. Factor
ial
design
factor
s
levels No.of
runs
22 2 2 4
23 3 2 8
32 2 3 9
33 3 3 27
Types:
1. Two level:
2. Three level
Two level

38. advantage:
allows independent
estimation of main
effect an dinteractions
limitation:
incresesd no.of
experiments require
increse no of factors

44. Thank you