OPTIMIZATION PROCESSES IN PHARMACEUTICAL

INDUSTRY

HAFSA SHAHID

PHARM D COURSE

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 INTRODUCTION

It is defined as follows:
• The term optimize is defined as to make perfect, effective or as
functional as possible.
• It is the process of finding the best way of using the existing resources
while taking into account of all the factors that influences decisions in
any experiment.
• Optimization in pharmaceuticals refers to changing one variable at a
time, so to obtain solution of a problematic formulation.

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 OBJECTIVES

Safety and
Reducing
reducing
cost
error

Save time Reproducibili

ty

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 OPTIMIZATION PARAMETERS

Unconstrained
Problem types
Constrained
OPTIMIZATION
PARAMETERS
Independent
variables
VARIABLES
Dependent
variables

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 PROBLEM TYPES

• In unconstrained optimization problems there are no restrictions. For

a given pharmaceutical system one might wish to make the hardest
tablet possible. This making of the hardest tablet is the unconstrained
optimization problem.
• The constrained problem involved in it is to make the hardest tablet
possible, but it must disintegrate in less than 15 minutes

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 VARIABLES
Independent variables Dependent variables

X1 Diluent ratio Y1 Disintegration time

X2 Compressional force Y2 Hardness

X3 Disintegrant level Y3 Dissolution

X4 Binder level Y4 Friability

X5 Lubricant level Y5 Weight uniformity

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 APPLIED OPTIMIZATION METHODS

Evolutionary
Lagrangian Simplex lattice
operation Search method
method method
method

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 APPLIED OPTIMIZATION METHODS
1. Evolutionary Operation Method
Make very small changes in formulation repeatedly. The result of
changes are statistically analyzed. If there is improvement, the same
step is repeated until further change doesn’t improve the product.
Where we have to select this technique?
This technique is especially well suited to a production situation. The
process is run in a way that is both produce a product that meets all
specifications and (at the same time) generates information on product
improvement.

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 APPLIED OPTIMIZATION METHODS
2. Simplex method
• A simplex is a geometric figure, defined by no. of
points or vertices equal to one more than
number of factors examined.
• Once the shape of a simplex has been
determined, the method can employ a simplex of
fixed size or of variable sizes that are determined
by comparing the magnitudes of the responses
after each successive calculation.
• It is of two types:
A. Basic Simplex Method
B. Modified Simplex Method
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 APPLIED OPTIMIZATION METHODS
3. LAGRANGIAN Method
• It represents mathematical techniques.
• It is an extension of classic method applied to a pharmaceutical
formulation and processing.
• This technique require that the experimentation be completed before
optimization so that the mathematical models can be generated.

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 APPLIED OPTIMIZATION METHODS
4. Search Method
• It is defined by appropriate equations.
• Used for more than two independent variables.
• It take five independent variables into account and is computer
assisted.
• Persons unfamiliar with mathematics of optimization and with no
previous computer experience could carry out an optimization study.

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 NEW NETWORK FOR OPTIMIZATION
Artificial Neural Network & optimization of pharmaceutical
formulation
• ANN has been entered in pharmaceutical studies to forecast the
relationship b/w the response variables and casual factors.
• This relationship is nonlinear. ANN is most successfully used in multi
objective simultaneous optimization problem.
• Radial basis functional network (RBFN) is proposed simultaneous
optimization problems.
• RBF is a function whose value depends on the distance from the
Centre or origin.
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 APPLICATIONS

Formulation and Processing.

Clinical Chemistry.

Medicinal Chemistry.

High Performance Liquid Chromatographic Analysis.

Formulation of Culture Medium in Virological Studies.

Study of Pharmacokinetic Parameters.

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 USES
Provide solution to large
scale manufacturing
problems.
Provides string assurances
to regulatory agencies
superior drug product
quality.
In microencapsulation
process.

Improvement of physical &

biological properties by
modification.
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