ASSIGNMENT WRITING OF
“ EXPERIMENTAL DESIGN ”
SUBMITTED FOR
PHARMACETICAL PRODUCT DEVLOPMENT (BP814TT)
OF
BACHELOR OF PHARMACY
[SEMESTER-VIII (2022-23)]
PATEL KRUTARTH MUKESHKUMAR
Enrolment No:-192470290072
Guided By:- Ms. JAINI K. PATEL
SUBMITTED TO
SHARDA SCHOOL OF PHARMACY
PETHAPUR,GANDHINAGAR-382610
DESIGN OF EXPERIMENT
Design of experiment (DOE) is defined as a branch of applied stastics that deals
with planning,cunducting,analyzing and interpreting controlled test to evaluate the
factors that control the value of a parameter or group of parameter.
Design of experiment is a systematic method to determine the relationship between factors
affecting a process and the output of that process.
TERMINOLOGIES
FACTORS – Input to the process.
Quantitative : a numerical factor is assigned to it. Example : concentration 1%,2%,3% etc
Qualitative : there are non numerical Example : polymer grade , humidity condition etc.
LEVELS – these represent settings of each factor in the study
RESOPONSE – it is outcome of an experiment. It is the effect, which we are going to
evaluate i.e disintegration time, duration of buoyancy, thickness , etc. It is an outcome of
the experiment.
RESPONSE SURFACE – response surface representing the relationship between the
independent variables X1 and X2 and dependent variable Y.
RUN OR TRIALS – experiments conducted according to the selected experimental
designs.
KEY STEPS FOR EXPERIMENTAL DESIGN
TYPES OF DESIGN OF EXPERIMENT
SOFTWARE USED FOR DOE
Design Expert
DE PRO XL
MATREX
Mini Tab
OPTIMA
OMEGA
FACTOP
GRG2
FULL FACTORIAL DESIGN
A factorial design allow the effect of several factors and even interactions between them to
be determind with the same number of trials as are necessary to determine any one of the
effect by itself with same degree.
First, whenever we are interested in examining treatment variations , factorial design should
be strong candidates as design of choice.
Second, factorial design are efficient. Instead of conducting a series of independent studies
we are effectively able to combine these studies into one.
Finally, there are the only effective way to examine interaction effects.
The fitting of an empirical polynomial equation to the experimental result facilities the
optimization procedure. The general polynomial equation is as follows :
Where Y is the response,X1,X2,X3 are the levels (concentration) of the 1,2,3 factors and
B1,B2,B3,B12,B23,are the polynomial co-efficient,B0 is the intercept.
FULL FACTORIAL DESIGN
In a full factorial design (FFD) , the effect of all the factors and their interactions on the
outcomes in investigated.
In FFD, each setting of every factor appears with every setting of another factor.
If there are ‘k’ factors with each having ‘p’ levels, the design consist of (p) k runs/trails.
FRACTIONAL FACTORIAL DESIGN
Fractional factorial designs represent a part of the relevant full design, typically 1/2 or 1 /4
... of the full factorial.
They are typically used when the number of factors exceeds 4-5, for screening purposes.
Their main limitation is related to confounding or alias of main effects and interactions.
The term "resolution" refers to the ability of a design to estimate effects and interactions
without confounding
MIXTURE DESIGNS
In a mixture experiment, the independent factors are proportions of different components
of a blend In mixture experiments, the measured response is assumed to depend only on
the relative proportions of the ingredients or components in the mixture and not on the
amount of the mixture.
X 1 +X2+X3+X4 =1
In mixture problems, the purpose of the experiment is to model the blending surface with
some form of mathematical equation so that: Some measure of the influence on the
response of each component singly and in combination with other components can be
obtained
SIMPLEX LATTICE DESIGN
The simplex-lattice design selects points spread evenly over the factor space. They are
defined to support a polynomial model of degree m in q components over the lattice. This
is denoted as a 1 q, m} simplex-lattice. Thus, q=2 is a line, q=3 is an equilateral triangle,
and q=4 is a tetrahedron.
We will have m+1 equally spaced values from 0 to 1 on each axis such that x = 0, 1/m, 2/m,
1 where, x are the sampled points of each factor .
The possible designs for q=3 and m=2, the possible designs are
(xl, x2, x3) = (1,0,0) (0,1,0) (0,0,1) (1/2 , 1/2, 0) (1/2, 0, 1/2) (0, 1/2, 1/2)
SIMPLEX CENTROID DESIGN
A simplex centroid design of q components is composed of pure mixture runs, all
combinations of 2 to the k factors at equal levels, and a center point run with equal amounts
of all ingredients.
Therefore, the design will consist of 2q - 1 distinct design points. Figure 5 shows an
example for q=3 and q=4
RESPONSE SURFACE METHODOLOGY
A response surface design is a set of advanced design of experiments (DOE) techniques
that help you better understand and optimize your response.
The difference between a response surface equation and the equation for a factorial design
is the addition of the squared (or quadratic) terms that lets you model curvature in the
response, making them useful for: Y= BO + B1X1+ B2X2+ B3X34- B12X1X2+
B13X1X3+ B23 X2X3+ B11X3.2 +B22X22 + 333X32
Understanding or mapping a region of a response surface. Response surface equations
model how changes in variables affect a response of interest. Finding the levels of variables
that optimize a response. Selecting the operating conditions to meet specifications.
Two main types of RSM
1. Cental composite design
2. Box behnken design
CENTRAL COMPOSITE DESIGN
Central composite designs are a factorial or fractional factorial design with center points,
augmented with a group of axial points (also called star points) that let you estimate
curvature. You can use a central composite design to: • Efficiently estimate first- and
second-order terms.
Model a response variable with curvature by adding center and axial points to a previously-
done factorial design.
Central composite designs are especially useful in sequential experiments because you can
often build on previous factorial experiments by adding axial and center points.
TYPE OF CCD
Alpha (a) is the distance of each axial point (also called star point) from the center in a
central composite design
A value less than one puts the axial points in the cube; a value equal to one puts them on
the faces of the cube; and a value greater than one puts them outside the cube.
BOX BEHNKEN DESIGNS
A Box-Behnken design is a type of response surface design that does not contain an
embedded factorial or fractional factorial design.
Box-Behnken designs have treatment combinations that are at the midpoints of the edges
of the experimental space and require at least three continuous factors. The following figure
shows a three-factor Box-Behnken design. Points on the diagram represent the
experimental runs that are done:
Because Box-Behnken designs often have fewer design points, they can be less expensive
to do than central composite designs with the same number of factors.
APPLICATIONS OF EXPERIMENTAL DESIGN
Experimental design methods are also useful in engineering design activities, where new
products are developed and existing ones are improved. Some typical applications of
statistically designed experiments in engineering design include:
1. Evaluation and comparison of basic design configurations
2. Evaluation of different materials
3. Selection of design parameters so that the product will work well under a wide variety
of field conditions (or so that the design will be robust)
4. Determination of key product design parameters that affect product performance
The use of experimental design in the engineering design process can result in products that
are easier to manufacture, products that have better field performance and reliability than
their competitors, and products that can be designed. developed, and produced in less time.