The document discusses factorial design in the context of pharmaceutical formulation, emphasizing its role in optimizing drug delivery systems through design of experiments (DOE). It outlines different types of factorial designs, their advantages and disadvantages, and their application in research. Additionally, it underscores the importance of patient safety and product quality linked to quality by design principles.

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Presented By-:
Suryawanshi Nishinandan R.
(M Pharm 1 St
Year, Sem-I)
Dept. Of Pharmaceutics
Roll No:-5006
Channabasweshwar Pharmacy College (degree), Latur.
Guided by :-
Dr. S.N. NAGOBA SIR
Prof. and head
Department of Pharmaceutics
Seminar on

2.  Introduction
 Definition.
 Types of Factorial Design.
 Characteristics.
 Factorial Design Testing.
 Advantages.
 Disadvantages.
 Application.
 Reference.
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3.  Effective Drug Delivery System are formulated to the patient safety
and efficacy.
 Safety is one of the most important parameter in formulation and
product development.
 Patient safety is directly linked to product quality and quality by
design (QbD), Design of Experiment (DoE) is one of the element of
QbD.
 QbD is essential tool to ensure quality in the formulation, which
was discovered by “Ronald A. Fisher” in 1935.
 Experimental Design play an important role in new product design
and manufacturing process.
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4.  Factorial design involves more than one independent variable or factor in a
study.
 Various types of design such as 3² Factorial Design, 2² Factorial Design, 2³
Factorial Design, etc. Are commonly applied for optimization of
pharmaceutical formulation.
 To understand the factorial design exp. You must know the basic term,
1) Factor :- Broad term used to describe independent variable that is
manipulated by the researcher in the exp.
2) Main Effect :- It refers to the change produced in response to change in level
of factor.
3) Interaction :- An interaction between factors occurs when the difference in
response between the levels.
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5. DoE:-
Design of Experiment is defined as a branch of applied statistics that deals
with planning, conducting, analyzing and interpreting controlled tests to
evaluate the factor that control the value of parameter.
Factorial Design:-
Factorial Design is a type of research methodology that allow the
investigation of main and interaction effect between two or more
independent variable and one or more outcome variable.
Selected value of two or more independent variable are manipulated by the
researcher in all possible combination so that the independent as well as
interactive effect may be studied up on the dependent variable.
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6.  According to Merriam Webster dictionary Optimization means “an act,
process or methodology of making something as fully perfect,
functional or effective as possible”.
 In the mathematically procedure “It is the process of obtaining optimum
formulation. It means to optimize something or use something to find a
perfect, effective or functional answer.
 Aim of optimization is to understand formulation and target processing
parameters and formulation ingredients.
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7. There are mainly three types of factorial design,
1)Within Subject Factorial design.
All independent variables are manipulated within subject.
It is more efficient for the researcher and control existing participant
variables.
2) Between Subject Factorial Design.
All independent variable are manipulated between subject.
3)Mixed Factorial Design.
To manipulate one independent variable between subject and another
within subject.
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8.  Factorial Design involves more than one independent variable or factor in a
study.
 Factorial Design allow the researchers to look at how multiple factors affect a
dependent variable, both independently and together.
 In Factorial Design, the main effect is an important feature to be considered.
 It must be genuinely interested in learning about treatment combination
required for the factorial design.
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9.  In statistics, a full factorial experiment is an experiment whose
design consist of two or more factors, each with separate
possible value or “levels”.
 Factorial design can reduce the number of experiments one has to
perform by studying multiple factors simultaneously.
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2³

11.  It’s easy to study the combination effect of two or more factors
simultaneously.
 Easy to analyze interrelationship between two or more factors.
 Is save time.
 More efficient than OFAT exp. (One Factor At a Time ).
 They provide information at similar cost.
 Very efficient and less expensive.
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12.  Difficult of experimenting with more than two factors, or many
levels.
 Increase in factor size leads to increase the chances of error.
 It’s complex when several factors are involved simultaneously.
 Wastage of time and exp. material.
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13.  Formulation and Processing.
 Clinical Chemistry.
 Medicinal Chemistry
 HPLC Analysis.
 Formulation of culture media in virological studies.
 Study of pharmacokinetic parameters.
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14.  Minitab. Design Expert 7.1.3
 Matrex. CYTEL East 3.1
 Omega.
 Compact 21-Apr-15 O
 SYSTAT sigma Stat 3.11
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15.  Textbook of Industrial Pharmacy by Shobha Rani Hiremath .
 Introduction of Factorial Design – STAT ONLINE
 Biostatistics & Research Methodology by Prof. Chandrakant Kokare Nirali Prakashan
 A Textbook of Biostastics & Research Methodology Final Year B. Pharmacy
 Www.Google.Com
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