Software Used In Formulation Design Process (Pharmaceutics).Pdf

SOFTWARE USED IN FORMULATION DESIGN PROCESS 1
DESIGN OF EXPERIMENTS
“Is a structure organized method used to determine the factor affecting to process
and output of that process.”
Parsimony Principle:
➢ Some of factor are important, while another factor is not important.
➢ Few variables are effective or other are not effective.
➢ Experiment design is an integral part of optimization technique.
➢ Those technique used in the formulation optimization.
Design of Experiment for Formulation and
Development: All pharmaceutical products are formulated to specific
dosage from drugs to be effectively delivered to patient typical pharmaceutical
dosage from include tablets, capsules, solution & suspension etc. [07]
i. Different dosage form required different technology usually present
different technological challenges for formulation & development.
ii. Due to complex challenges, formulation scientist used effective
methodology like as experiment and statistical analysis for formulation
and development.
Formulation scientist used this method for process optimization and process
validation.
Formulation and Development are a process of selection of components and
processing.
Now days computer tools used in the formulation and development of
pharmaceutical products.
Pharmaceutical product is formulated to specific dosage forms for drugs to be
effectively delivered to patient.

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 often used in a way that includes dosage form.
Today, computers are so ubiquitous in pharmaceutical research and development
that it may be hard to imagine a time when there were no computers to assist the
medicinal chemist or biologist.[08]
Computers began to be utilized at pharmaceutical companies as early as the 1940s.
DRUG
Any substance is important to impart or give the therapeutic activity is known as
Drug.
Drug is important to give pharmacological response and it act has target site of
infection and prevent injury or disease and disorder; drug was administered in
various route of administration depending on their types.
Definition: - “A drug defined as any substance or group of substance which
affect living tissue.
OR
“It is defined as any substance used to prevent, diagnosis or treat disease or to
prevent pregnancy”.
Examples of Drugs-
Anti-hemorrhoid drugs, topical antibiotics, cough suppressants, anti-acne drugs,
non-steroidal anti-inflammatory drugs, antiseptics, analgesics, anesthetic,
anthelmintics, antipyretic, antidotes, anti-infective, anticonvulsants, antibiotics,
antidiarrheics, antitussive, androgens, salicylates, vasodilator, antacids,
expectorants, anti-fungal drugs, anti-histamines, antigas agents and smoking
cessation drugs and also many more including these.

Methods
A). Preformulation Study: Important step for determination of
physiochemical properties of all the material before incorporating it in formulation
development.
Preformulation studies are indispensable protocol for development of safe, effective
and stable dosage form.
B). Process Feasibility: Study to determine whether the manufacturing
process selected is capable to process the formulation.
C). Design of Experiment: DOE allows to evaluate multiple factors and their
interactions while fully controlling the number of experiments.
Design of Experiment (Design Expert Software 10.0)
“Design-Expert provides powerful tools to lay out an ideal experiment on your
process, mixture or combination of factors and components. Design-Expert’s design
wizards and intuitive layouts such as the stoplight configuration for two-level
factorials make it all far easier than you’d even imagine.”
Preformulation
Process Feasibility
Design of
Experiment/
Evaluation

Such techniques are usually referred to as ‘Computer-Aided Dosage from
Design’ (CADD).
D). Evaluation of Formulation This parameter include:
• % Yield.
• Drug entrapment efficiency and Drug Loading.
• Drug Excipients Compatibility study.
 FT-IR study.
 DSC Study.
 XRD Analysis.
• Morphological Characterization.
 Particle size and zeta potential Analysis.
 SEM & TEM Analysis.
• Drug Release Study.
• Drug Release Kinetics & Pharmacokinetics Study.
• Stability Study.
Tools for Drug Release & Pharmacokinetic Study
USP Dissolution Test Apparatus
High Performance Liquid Chromatography (HPLC).
High Performance Thin Layer Chromatography (HPTLC).

DRUG DISCOVERY SOFTWARE
INTORDUCTION: Drug discovery software is used to develop new
pharmaceutical drugs and test whether a newly created drug will be effective in
treating a particular disease. Drug discovery software automates and leverages
innovative technology that significantly cuts down on the arduous process of drug
development, testing, and going to market.[10]
Most drug discovery solutions offer screening, predictive analytics, modeling,
simulation, and computational capabilities.
Researchers and scientists use drug discovery software to gain market intelligence,
take advantage of advancements in drug design and synthesis, tackle evolving and
adapting diseases, and maintain and manage the integrity of data as drugs
transition from the discovery phase to the clinical trial phase.
Computer aided drug design uses computational chemistry to discover enhance or
study drugs and related biologically active molecules. Software based drug
discovery and development methods have major role in the development of bioactive
compounds for over last three decades.
Computer- assist drug design (CADD), also called Computer assist
molecular design (CAMD), and represent more recent applications of computer as
tools in the drug design process and many new software used in modern days, and
in the fields of biochemistry, molecular biology, and cell biology, facilitated by
development in genomics and proteomics, are producing a large number of novel
biological targets that may be exploited för therapeutic intervention. [04]
The latest technological advances (QSAR, QSPR, Structure-based design,
Ligand Based Design, Combinatorial library design, Cheminformatics &
Bioinformatics).

DRUG DESIGN PROCESS
It is the inventive process of finding new medications based on the knowledge of a
biological target.
It involves the design of molecules that are complementary in shape and charge to
the biomolecular target with which they interact and therefore will bind to it.[02]
Selected/Designed molecule should be-
❑ Organic small molecules/ Complementary in shape to the target.
❑ Oppositely charge to the biomolecules target.
This molecule will-
❑ Interact with target/Bind to the target.
❑ Activates or inhibits the function of a biomolecules such as a protein.
This type of modeling is sometimes referred to as Computer-aided drug design.

LIGAND-BASED DRUG DESIGN: - Target site is
known. These ligands can be used to developed a pharmacophore model or molecule
which
In LBDD, 3D structure of the target protein is not known possesses
all necessary structural features for bind to a but the knowledge of ligands which
binds to the desired target active site. [01]
Figure for Outline of process involved in LBDD
Ligand based drug design is an approach used in the absence of the receptor 2D
information and it relies on knowledge of molecules that bind to the biological
target of interest. 3D quantitative structure activity relationship (3D QSAR) and
pharmacophore modeling are the most important and widely used tools in ligand-
based drug design.
They can provide predictive models suitable for lead identification and optimization.
Further information on these methods and their applications to 5-LOX inhibitor
design and development are presented elsewhere in the reviews.

STRUCTURE-BASED DRUG DESIGN
Structure based drug design (or direct drug design) relies on knowledge of the three-
dimensional structure of the biological target obtained through methods such as x-
ray crystallography or NMR spectroscopy.
If experimental structure is not available. Within many of the rational drug design
projects in the group, computer-aided methods, such as virtual screening and de
novo design techniques, play an important role in follows 3-D structure three-
dimensional structure of compound can generated and studies using molecular
modeling software package such as Chem3D. [01-02]]
The 2-D structure is converted into a 3-D structure is converted into 3-D structure,
which is quite clever, but is not error free, since the structure created is usually
distorted (the bond lengths and the bond angles are not ideal).

COMPUTER AIDED DRUG FORMULATION
Formulation and development are a process of selection of components and
processing. Now days computer tools used in the formulation and development of
pharmaceutical products.
- Various techniques, such as design of experiment are implemented for
optimization of formulation and processing parameter.[02]
- Traditionally optimization in pharmaceuticals refer changing one variable at
a one time, so to obtain solution of a problematic formulation.
Many times, finding the correct answer is not simple and straight forward in such
cases use of computer tools (Optimization procedure) for best compromise is the
smarter way to solve problem.
Optimization means- Optimization means choosing the best element from some
set of available alternatives.
Optimization
Reducing
cost
Saving
time
Saving
money
Safety &
Reducin
g Error

COMPUTER SOFTWARE- There are several software which
are used in the formulation process, mainly given below and some of their feature
also include in: - [09]
Software Silent Feature
Design Expert Powerful & compressive package used for
optimizing pharmaceutical formulation and
process.
Minitab Powerful DOE software for automated data
analysis data analysis MS-Excel compatibility.
Include almost all design of RSM.
DOE PRO XL MS-Excel compatible DOE software for automated
data analysis.
CARD Powerful DOE software for data analysis includes
graphics and help feature.

Software for Drug Designing, Formulation and
Development
The software is further categorized on the basis of task performing by the software
and their working principle like software assessing pharmacokinetics
parameters, ligand interaction and molecular dynamic, molecular
modelling and structural activity relationship, image analysis, visualizers,
data analyzer and behavior analysis software etc. [03-04]
Sr.
No.
Pharmacological
Activity
Software Name Major Uses
01. Pharmacokinetics
Parameters
DDDPlus
MapCheck
-Dissolution and disintegration study.
-Compare dose or fluency measurement.
02. Ligand Interactions &
Molecular Dynamic
Autodock
Schrodinger
GOLD
BioSuite
-Evaluate the ligand-protein interaction
-ligand receptor docking
-Protein-ligand docking
-Genome analyzing & sequence analysis
03. Molecular modeling &
Structural Activity
Relationship
Maestro
ArgusLab
Sanjeevini
PASS
-Molecular modeling analysis
-Molecular docking calculation and molecular
modeling package.
-Predict protein-ligand binding affinity
-Create and analysis of SAR Model.
04. Image analysis and
Visualizers
AMIDE (A Medical
Image Data Examiner)
Discovery Studio®
Visualizer
Imaging Software Scge-
Pro
-Medical image analysis in molecular
imaging.
-Viewing and analyzing protein data.
-Cytogenetic & DNA damage analysis.
05. Data analysis QSARPro
REST 2009 Software
-Protein-Protein interaction study.
-analysis of gene expression data.
06. Behavior study Ethowatcher
MARS (Multimodal
Animal Rational System)
-Behavior analysis.
-Animal activity tracking, enzyme activity,
nanoparticle tracking and delivery study.
These all the highlights software commonly used software used for new drug
development along their potential uses.

CADD (Computer Aided Drug Design)
Drug design is a lengthy process that takes around 10-15 years and costs up to
2.558 billion USD för a drug to reach the market. Computer aided drug design
(CADD) method is widely CADD consist use of any software program based used as
a new drug design approach. It has been seen process for establishing a standard to
relate activity to that by the use of CADD approaches we can reduce the structure.
It is a multistep process that begins with the identification of suitable drug target,
validation of drug target, hit to lead discovery, optimization of lead molecules, and
preclinical and clinical studies.
Figure 2:General Principle for Drug design through CADD.
Major types of approaches in CADD
There are mainly two types of approaches for drug design through CADD is thefollowing:
1. Structure based Drug Design / Direct Approach
2. Ligandbased Drug Design / Indirect Approach
CADD
Structure Based
drug design
Binding site
identification
Docking
and scoring
ligand based
drug design
Pharmacophore
modelling
Quantitative structure
activity relationship
Drug
candidate
Virtual
Screening
New Drug
Lead Optimization
Compound Selection

The use of computer aided drug design (CADD) techniques in preliminary
studies by leading pharmaceutical companies and research groups has helped to
expedite the drug discovery and development process minimizing the cost and the
failures in the final stage.
This revies article provides useful insight into some of the common in silico methods
used in CADD and how these methods have been currently used and can be of help
in the drug discovery process of COVID-19 as well as other drug molecules.
Other Update Versions of DE-
History: - Stat-Ease Company released its version of DE in 1998.
In 1996 the fil released version 5 which was the first version of the
software-
 DE Version 6.0
 DE Version 7.0
 DE Version 8.0
 DE Version 9.0
 DE Version 10.0.7
 Latest Version of DE Software – 11
Computer Aided Software:
 Design-Expert ® 7.0.0. Software.
 Design-Expert® 10.0.0. Software.
MapCheck: The MapCheck compare absolute dose measurements of both
systems with ion chamber results. It compares IMRT QA process of Sunnuclear’s
MapCheck and Varian’s Portal Dosimetry. The MapCheck system create
verification plan for each field, export calculated dose map (Frontal) to MapCheck
for each field, calibrated diode array prior to collecting data. Standard deviation
increases with plan complexity. [05-06]
The average measured dose is independent of plan complexity.
Use. - MapCheck used for IMRT verification. - Small detectors identify MLC. -
Dose based EPID IMRT QA done by using MapCheck.

Schrodinger: Schrodinger software has wide range of applications that can
solve most of the challenges these bio-molecules will bring. It highlights particular
advances in molecular modeling, molecular dynamics, ligand-receptor docking, and
biologics that were designed to handle these challenges. [ 05-06]
Structure based properties of molecule such as understanding of conformational changes
and hydrophobicity of structures can be analyzed by this software.
This intern provides information atomic movements of macrocycles that further used to
understand shape, stability, and energetics. Schrodinger provides powerful and intuitive
graphical interfaces for system setup, running simulations, and analyzing trajectories.
The molecular dynamics simulations software is employed to study a series of stabilized
stapled α-helical peptides at different temperatures.
Use. - Molecular dynamics simulation studies - Quantum mechanics - Prediction of
binding affinity.

ArgusLab
ArgusLab is a molecular modeling, graphics, and drug design program for Windows
operating systems. [05-06] Conformational analysis such as P.G. Jamkhande et al.
Bulletin of Faculty of Pharmacy, Cairo University 55 (2017) 203–210 206 geometry
optimization study was performed on a window-based computer using ArgusLab.
This software works on the principle of quantum mechanics and helps to predict
potential energies, molecular structures, geometry optimization of structure,
vibration frequencies of coordinates of atoms, bond length, bond angle and reactions
pathway. ArgusLab calculate minimum potential energy using geometry
convergence function.
Use. - Molecular docking calculations. - It is used to build molecules. - Building of
molecules using template structure. - For molecular modeling Package.

Discovery Studio Visualizer Discovery Studio Visualizer
(DS Visualizer) is used for viewing, sharing and analyzing protein and small
molecule data. It is a free and employed for both small molecule and macromolecule
applications. It allows data to be transferred and analyze data in several formats
like graphics, 3D structures, SMILES and sequences.[05-06]
The required structures and sequence can be downloaded from PDB or NCBI.
Molecular properties can be explored by editing structures and performing
calculations.
Uses.
- Visualization: - Advanced molecular visualizations.
- Macromolecule design: - multi-domain protein sequences (e.g., Antibodies) editing.
- Prediction of secondary structures.
- Ligand-based design: - Sketching and fragment building tools.
- Generation of pharmacophores.
- Structure-based design: - Define, display and edit ligand binding sites.
- Create 2D ligand-receptor interaction diagrams.
- Visualize 3D molecules in Microsoft Office© and web pages (ActiveX Control).

QSARPro: - This software identifies of relationship of a molecular activity
or property with the structural parameters, analysis of such relationships and rapid
predictions using reliable statistical modeling.
It is employed to evaluate more than 1000 molecular descriptors including
physicochemical, topological and electro-topological, information theory based,
quantum mechanical, electrostatic and hydrophobic, alignment independent,
MMFF atom types and so on. [05-06]
QSAR modeling typically involve activities such as descriptor choice and
calculation, statistical evaluation of the calculated descriptors, training and test set
assignment, regression and results analysis.
It evaluates multiple options for classes of descriptors, test set, choice of linear or
nonlinear regression and choice of regression technique to determine the option that
is most suitable to a particular project.
Use. - Explore and exercise various combinations of variable selection methods and
regression methods. - Aligning given set of molecules in the protein active site with
respect to the co-crystal ligand to develop a basis for the placement of ligand. -
Protein-protein interaction studies

MARS (Multimodal Animal Rotation System)
MARS is a Multimodal Animal Rotation System which captures 360° movement of
an experimental animal. The software is designed in such a way that it
automatically rotates a mouse to the required positions or angels to track all the
relevant molecular and anatomical information of experimental animal. It also
captures optical signals generated due to orientation of experimental. Using this
software automatic co-registration and capturing of multimodal and multispectral
data sets from all acquired angles is possible. [05]
The software amplifies obtained signal sensitivity by quantifying the perfect image
or exporting complete rotation movements or video. This software includes animal
rotation device, controlling software, and multimodal visualization and co-
registration software.
Use. - Cell tracking. - Enzyme activity. - Bone disease. - Inflammatory disease. -
Nanoparticle tracking and delivery.

How to used Design Expert Software Version 7.0:
www.statease.com
How to install design expert software [11.]-
01. Install the exe file.
02. Do not run design expert now.
03. Copy the crack from crack folder to C/program file/DX 7 trail run.
04. If you want help then press F1 for help.
SOP of Design Expert Software
01). File new design.
02). Click response surface.
03). Add numeric factor.
04). Write name of independent variable.
05). Add lo limit and high limit.
06). Continue.
07). Add response/ Run will be generated.

ChemDraw
ChemDraw is a molecule editor first developed in 1985 by David A. Evans and
Stewart Rubenstein (later by the cheminformatics company Cambridge Soft).
The company was sold to PerkinElmer in the year 2011. ChemDraw, along with
Chem3D and ChemFinder, is the part of the ChemOffice suite of programs and is
available and is available for Macintosh and Microsoft Windows. A simplified,
touch optimized version for the iPad was released in late 2013. [13]
The drawing of chemical formulae and reaction schemes is a repetitive task for
chemical on all levels of their education. While hand sketching is most efficiency
used during discussions and learning, neat drawing is required for official reports,
publications & theses.
- Such drawing can be created with several computer programs and one
example is ChemDraw.[13]
ChemDraw is a simple-to-use program that allows to draw intuitively and
efficiently simple two-dimensional representation of organic molecules. It is
available for the PC as well as for the Mac platform.

Chem 3D- Modeling 3D compounds, import structure from large database,
interconvertible with ChemDraw.
ChemFinder- Transfer files into tables for search, import structure data.
Feature of ChemDraw: ChemDraw is a chemistry software
which helps us in many chemical structures. There main properties discussed
below: -[12]
01. Chemical structure to name conversion.
02. Chemical name to structure conversion.
03. NMR spectrum simulation.
04. Mass spectrum simulation.
05. Structure cleanup.
06. An extensive collection of templates, including style templates for most major
chemical journals.
07. Export to SVG (Window version only).
08. Export the structure into PDF (Mac version only).
09. It can give the properties of saturation and unsaturation.
10. It is very useful.

OTHER METHODS INVOLVING
SwissADME-
There website allows us to compute physiochemical descriptors as well as predict
ADME parameters. Pharmacokinetics properties. Drug like nature and medicinal
chemistry friendliness of one or multiple small molecules to support drug discovery
- The main article describing the web service and its underlying methodologies
is SwissADME: A free web tool to evaluate pharmacokinetics. Drug-likeness
and medicinal chemistry friendliness of small molecule. Scl Rep. (2017).
- Developed and maintained by the molecular modeling group of the SIB.
Swiss institute of Bioinformatics. [06]
This allows experts and as well as nonexpert to make use of the website for their
research. SwissADME was made for application in drug discovery and medicinal
chemistry contexts, which stresses for a balance between accuracy and speed in
order to deal with a large number of molecules.
Drug development involves assessment of absorption, distribution, metabolism and
excretion (ADME) increasingly earlier in the discovery process, at a stage when
considered compounds are numerous but access to the physical samples is limited.
Easy efficient input and interpretation are ensured thanks to a user-friendly
interface through the login-free website http://www.swissadme.ch. Specialists, but
also nonexpert in cheminformation or computational chemistry can predict rapidly
key parameters for a collection to molecules to support their drug discovery
endeavours.

01). SwissADME: SwissADME software (www.swissadme.ch. ) of Swiss
institute of bioinformatics (http://www.sib.swiss ) was accessed a web server that
displays the submission page of SwissADME in google was use to estimate
individual ADME behaviors of the compounds from the plant. The input zone itself
contains a molecular sketcher based on Chem Axons Marvin JS
(http://chemaxon.com ) that allows the user to draw and edit 2D chemical
structures.
- The structure transferred as a list to the right-hand side of the submission page, is
the actual input for computation. [06] The list is made to contain one input molecule
per line with several inputs, defined by Simplified Molecular Input Line Entry
System (SMILES) the results are presented for each molecule in tables, graphs
and also an excel spreadsheet.

06). Pharmacokinetics:
Pharmacokinetics is the quantitative study of the drug movement in, through and
out of the body. Intensity of effect is related to concentration of the drug at the site
of action, which depends on its pharmacokinetics properties. Pharmacokinetics
properties of particular drug is important to determine the route of administration,
dose, onset of action, peak action time, duration of action and frequency of dosing.
Show in figure14
The role of pharmacokinetics (PK) in drug discovery is to support the optimization
of the absorption, distribution, metabolism and excretion (ADME) properties of lead
compounds with the ultimate goal.
A simple definition of pharmacokinetics is the study of the course of drugs
concentration in the body (what the body does to the drug).

07). Medicinal Chemistry: The role of the medicinal chemist in drug
discovery has undergone major changes in the past 24 years, mainly because of the
introduction of technologies such as combinatorial chemistry and structure-based
drug design.
Medicinal chemistry plays a crucial role in driving the drug discovery project by
relying on their knowledge and expertise in modern organic chemistry, biology of
the disease. Show in Image [13].
In vitro screens for pharmacokinetics properties, the focus on synthesizing drug-like
compounds, and in Vitro Toxicity screens are important new developments that aid
the medicinal chemist’s job today.
One of the fundamental aspects of CADD activity is to select the most promising
virtual molecules submitting to biological assay.
Main Content Include in Medicinal
Chemistry
QSAR, Molecular Docking & Pharmacophore Modelling.

CONCLUSIONS:
We have discussed different software based on different approaches that are
playing major role in the drug designing and drug discovery now days. Successful
implementation of software-based techniques provided an opportunity for the in
vitro identification of biologically active agents, without bias towards known hits or
leads.[13]
Using design of experiment formulation scientist evaluate the all-formulation
factors in systematically and timely manner to optimize the formulation and
manufacturing process.
When the pharmaceutical process and product are optimized by systematic
approach then process validation & scale up can be efficient because of the
robustness of the formulation and manufacturing process.
Design of experiment & statistical analysis have been used in the formulation
development.
Computer aided drug design is an efficient tool in the area of drug discovery and
development, through it we can find the most promising drug candidate in a very
cost-effective way. It always provides a hope for betterment in drug discovery area,
With the current achievement’s, there is a promising future of computer aided drug
design to aid drug discovery of many more curatives in future. [14]
The computer aided drug design has large number of success stories and continue
to play a vital role in the drug discovery process. In this regard, the approach has
been utilized in proposing drug candidate against coronavirus disease 2019
(COVID-19).

REFERENCES:
01). JAIN N K “Pharmaceutical Product Development”, CBS Publisher; New
Delhi 2010. Pp 295-340.
02). Ganesh R. GODAGE Advance Drug Delivery System, Tech Max Publication
Pune 2017. Pp 6.1-6.24.
03). Bolton S. Bon C, Pharmaceutical Statistic Practical & Clinical Application, 5th
ED, New York London; INFORMA Healthcare Publishing: 2010. Pg. No 239.
04). Aguilar JE (Eds). Formulation Tools for Pharmaceutical Development, PA:
Elsevier/Philadelphia, 2013.
05). https://www.slideshare.net/RonakkB17/computer-aided-formulation-and-
developmenthow-to-use-design-expert-software
06). https://www.slideshare.net/RonakkB17/computer-aided-formulation-design-
expert-software-case-study.
07)). https://www.slideshare.net/prkppt/pharmaceutical-emulsionemulsion
08). Bernard D, Coop A, MacKerell A D Jr. Computer-Aided Drug Design:
Structure-Activity Relationships of Delta Opioid Ligands. Drug Design Reviews.
2005;2: 277-291.
09). Lachman LH, Lieberman, Kanig JL. The Theory and Practice of Industrial
Pharmacy, Lea & Febiger, 3rd edition, 1986.
10). www.wikipedia.org
11). www.statase.com
12). Husaain AS, Shivanand P, Johnson Rd. Application of Neural Formulation
Design, Drug Development and Industrial Pharmacy- 1994 Jan 1;20(10): 1739-52.
13). Nature.com/article/nrd1523; “The role of the medicinal chemistry in drug
discovery- then and now.”
14). https://www.google.com/amp/s/slideplayer.com/amp/7724755/
15). Kapetanovic IM. Computer-aided drug discovery and development (CADD):
insilico-chemico-biological approach. Chemico-biological interactions. 2008;
171(2):165-76.

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