COMPUTER AIDED FORMULATION

DEVELOPMENT : OPTIMISATION

NAME: KRISH PATEL

ENROLLMENT NO: 23024671007
M.PHARM(2ND SEMESETER)
DEPARTMENT OF PHARMACEUTICS
SHREE S.K.PATEL COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH

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CONTEN
TS
• CONCEPT OF OPTIMIZATION

• OPTIMISATION PARAMETERS

• VARIABLES IN OPTIMIZATION

• EXPERIMENTAL DESIGN

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CONCEPT OF OPTIMIZATION:
• Product formulation is often considered as an art, the formulator’s experience and
creativity of converting raw materials into product

•The pharmaceutical scientist has the responsibility to choose and combine ingredients
that will result in a formulation, whose result or responses are of expected value.

•Before the advances in the research technique and availability of computes, the
formulation research was based on experience and experimenting by trial and error.

• In a pharmaceutical formulation and development various formulation trials have to

be done to obtain a good process and a suitable formulation.

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• Optimization is defined as follows:

“Choosing the best element from some set of available alternatives”.

It is the process of finding the best way of using the existing resources while taking
in to the account of all the factors that influences decisions in any experiment.

• The objective of designing quality formulation is achieved by various

Optimization techniques like DoE (Design of Experiment).

• The term FbD (Formulation by Design) & QbD (Quality by Design) indicates that
quality in the product can be built by using various techniques of DOE (Design of
Experiment).

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Why optimization is necessary?

• Reduce the cost

• Save the time

• Safety and reduce the error

• Reproducibility

• Innovation and efficacy

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OPTIMISATION PARAMETERS

OPTIMISATION
PARAMETERS

PROBLEM VARIABLE
TYPE TYPE

CONSTRAINED UNCONSTRAINED DEPENDENT INDEPENDENT

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 Eg: preparation
NO
of hardest tablet
RESTRICTIONS
without any
UNCONSTRAINED ARE PLACED
disintegration or
ON THE
dissolution
SYSTEM
PROBLEM parameters.
TYPE IN
OPTIMIZATION Eg: preparation
RESTRICTIONS of hardest tablet
ARE PLACED which has the
CONSTRAINED
ON THE ability to
SYSTEM disintegrate in
less than 15min

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 EXPERIMENTAL DESIGN

• Experimental design is a statistical design that prescribes or advises a

set of combination of variables.

• The number and layout of these design points within the experimental
region, depends on the number of effects that must be estimated.

• Depending on the number of factors, their levels, possible interactions

and order of the model, various experimental designs are chosen.

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1. Factorial Designs
 Factorial designs (FDs) are very frequently used response surface designs.
 These are the designs of choice for simultaneous determination of the effects of
several factors & their interactions.
 Used in experiments where the effects of different factors or conditions on
experimental results are to be elucidated.
 Two types
 Full factorial- Used for small set of factors
 Fractional factorial- Used for optimizing more number of factors
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Full Factorial Designs

• Involves study of the effect of all factors(n) at various levels(x) including the interactions among them with
total number of experiments as Xn

• . If the number of levels is the same for each factor in the optimization study, the FDs are said to be
symmetric, whereas in cases of a different number of levels for different factors, FDs are termed
asymmetric.''

Fractional Factorial Design (FFD)

• Fractional factorial design is generally used for screening of factor.

• This design has low resolution due to less number of run.

• It is used to examine multiple factors efficiently with fewer runs than corresponding full factorial design.

DEPT OF PHARMACEUTICS. NGSMIPS 11

 Types of fractional factorial designs
 Homogenous fractional
 Mixed level fractional
 Box-Hunter
 Plackett - Burman
 Taguchi
 Latin square

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2. Screening Designs

It is used for identify the important factor and their level which affect the Quality of
Formulation. Screening Designs generally support only the linear responses.

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 3. Response Surface Designs
• These designs are used when we required exact image of
response, estimating interaction and even quadratic effects.
Response surface designs generally support non linear and
quadratic response and capable of detecting curvatures .
 Two most common designs generally used in this response
surface modelling are
 Central composite designs
Response surface representing the
 Box-Behnken designs relationship between the independent
variables X1 and X2 and the dependent
variable Y.

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 4.Mixture Design

• Here the fraction cannot be negative, and sum of the fractions of the
components should be equal to one.
• Hence, they have often been described as the experimental design for
formulation optimization

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THANK YOU

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