This document discusses the use of computers in pharmaceutical formulation. It begins with an introduction to pharmaceutical formulation and design of experiment techniques. It then provides examples of emulsion and microemulsion formulations. The document reviews several software programs used for design of experiment and optimization in formulation development. It also discusses using design of experiment techniques for screening critical factors and developing different dosage forms. Finally, it covers legal protection of innovative computer uses in research and development, including patents, copyright, database protection, and trade secrets.

1. COMPUTERS IN
PHARMACEUTICAL
FORMULATION
Prepared by : Sonal Suryawanshi
M. Pharmacy (sem-II)
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2. CONTENT
 Introduction
 Pharmaceutical formulation
 Design of Experiment
 Legal protection of innovative uses of computers in
R&D.
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3. WHAT INDUSTRY WANTS FROM PHARMA
PROFESSIONALS
 Updated knowledge
 New technologies
 Innovative ideas
 Research Attitude
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4. INTRODUCTION
 Formulation and development is a process of
selection of component and processing.
 Now days computer tools used in the formulation
and development of pharmaceutical product.
 Various technique, such as design of experiment
are implemented for optimization of formulation and
processing parameter.
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5.  Traditionally optimization in pharmaceuticals refer
changing one variable at a one time, so to obtain
solution of a problematic formulation.
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6.  Pharmaceutical formulation,
in pharmaceutics, is the process in
which different chemical
substances, including the
active drug, are combined to
produce a final medicinal product.
The word formulation is often used
in a way that includes dosage form
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7. EMULSION
 An emulsion is a biphasic liquid dosage form which
are immiscible in one another and get miscible by
the addition of emulsifying agent.
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8. MICRO EMULSION
 Microemulsion are clear ,thermodynamically stable,
isotropic liquid mixtures of oil, water and surfactant
frequently in combination with co surfactant.
 The aqueous phase may contain salt or other
ingredients and the “oil” may actually be a complex
mixture of different hydrocarbons.
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9. SOFTWARE SALIENT FEATURES
Design Expert Powerful and compressive
package used for optimizing
formulation and process.
Minitab Powerful DoE software for
automated data analysis
MS-Excel
compatibility.Include almost
all design of RSM
DOE PRO XL MS-Excel compatibility DOE
SOFTWARE for
automated data analysis.
CARD Powerful DOE software for
data analysis include
graphics and help features.
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10. DESIGN OF EXPERIMENT
 Design of experiment is a structure organised
method used to determine the factor affecting
to process and output of that process.
 Palsimony principle:
 Some of factor are important while other are
not important
 Few variable are effective while other are not
effective.
 Experimental design are integral part of
optimization technique.
 Those technique use in formulation
optimization
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11. DOE FOR FORMULATION DEVELOPMENT
 All pharmaceutical products are formulated to
specific
dosage form.
 Drugs to be effectively delivered to patient typical
pharmaceutical dosage form include tablets,
capsules, solution suspension, etc.
 Different dosage form required different technology
usually present different technological challenge for
formulation & development .
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12.  Due to complex challenges,
formulations scientist used effective
methodology
 Like as design of experiment and
statistical analysis for formulation and
development
 Formulation scientist used this
method for process optimization and
process seminar.
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14. EXPERIMENTAL DESIGN FOR R&D
PROJECTS
 Factorial Designs
 Fractional Factorial Designs
 Plackett-Berman Designs
 Central composite design (Star Designs)
 Box Benken Designs
 D-Optimal Designs
 Mixture Designs 14

15. SCREENING OF CRITICAL FACTORS
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Sr. No. Qualitative Factors Range of Screening
1. Type hydrophobic factor Different viscosity grades of Ethyl
cellulose(10cps, 20cps,45cps)
2. Type of Pore former Different Types of Pore former (HPC, HPMC)
3. Type of Plasticizer Different Types of Plasticizer (ATBC, TEC)

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17. LEGAL PROTECTION OF INNOVATIVE USES OF
COMPUTER IN R&D
 Intellectual Property Right:
 Patent
 Copyright
 Protection database
 Trade secret
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18. INTELLECTUAL PROPERTY RIGHT
 IPR are used to describe the legal instruments for
protecting innovation.
 These allow creator or owner of patent trademark
or copyright work to benefit from their work or
investment in a work.
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19. PATENT
 Patents are most important and strongest
intellectual property .
 Patent protects invention or technical innovation.
 Patent is an exclusive legal right granted for an
invention that is:
I. New (novelty)
II. Involves an innovative step (non obvious)
III. Capable of industrial application.
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20. COPYRIGHT
 Copyright is traditionally used to protect literally
works of art from copying .
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22. PROTECTION DATABASE
 In addition to patenting of database structure a
database can be protected either by copyright
protection or by database rights.
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23. TRADE SECRET
 Tradesecret as information including
formula, pattern, compilation, programe
device, method technique or processes.
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24. THANK YOU
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