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FORMULATION CHEMISTRY:
INTRODUCTION

COURSE CONTENT
•

Formulation principles
...


Microbiology and preservation
Principles and practice of consumer testing and evaluation of products
Labeling and claims
Good manufacturing practices (GMP)
Quality control and assurance

•

Legislation, regulations and registration requirements of various consumer
products
...

• Problem-solving to develop solutions to improve performance of
customer’s formulations
...

• Generating prototypes for Sales and Marketing activities
...


• Defining key performance indicators for new products and identify
benchmarks against which to evaluate performance
...

• Researching in current government and industry regulations and
keep them in mind throughout the development process
...

• Conducting patent searches when necessary to both aid in
development and avoid property infringement
...


Formulation chemistry…
• Design multivariate studies of different formulations of a particular
product, minimizing the number of replicates while maximizing the
amount of information obtained
• Conduct studies on long-term stability of products
• Help manage clinical trials, pilot studies, and panel tests to compare
reactions of potential customers to proposed formulations
• Analyze results of experimental studies and write reports for both
corporate records and regulatory bodies
• Assist with scale-up from development to production quantities, in
collaboration with chemical engineers and plant production
personnel
• Modify excipients (inactive ingredients) to increase the
bioavailability of low-solubility active pharmaceutical ingredients

Range of services formulators offer
• R&D (foundation of all product innovation)

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QUALITY CONTROL AND ASSURANCE
PILOT / SMALL SCALE MANUFACTURING
PACKAGING & PRODUCT DEVELOPMENT
PRODUCT STABILITY / PACKAGING COMPATIBILITY
TESTING
MICROBIOLOGICAL & ANALYTICAL TESTING
CAPABILITIES
SAFETY TESTING & CLINICAL CLAIMS SUBSTANTIATION
GRAPHIC DESIGN & MARKETING SUPPORT
LEGAL AND REGULATORY ASSISTANCE

What is formulation science
• Only a few degree programs available
that adequately train students for a

formulation position •
Most
formulation scientists are: –Either
self-taught
–or
have
been
apprenticed under experienced
researchers

Formulation science
• is an interdisciplinary subject involving
knowledge of
–material science
–physical chemistry

–Mixture design: art of arriving at
optimum combination/ correct
proportion of components
• Formulation associated with “recipe”
...

• Formulation technology established in the areas
of coatings, cosmetics and food

Formulation chemistry: Definition
• Formulation chemistry deals with
– co-existence of several components in a mixture
– and the combined and simultaneous activity of
individual components
...
g colloid and surface chemistry), analysis
– Process technology

• Evolving from empirical to theoretical basis to
understand the relationship between
components and the properties of a formulation

Application areas
–
–
–
–
–

Cosmetics
Detergents
Pesticides
Fertilizers
Perfumes

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Paints
Pharmaceutical products
Adhesives
Lubricants
Solvents
Composite materials
Etc

formulations
• A formulation is a blend of substances prepared
by combining two or more constituents
...
e
...
blending music ingredients
to make a rich performance
...

• Ingredients are chosen for compatibility rather
than reactivity
...


– A sustained release formulationis an example for this
...

– SYNEGY: 1+1 > 2
– Two or more components in a formulation may act
simultaneously in a synergetic fashion
– i
...
higher degree of effectiveness than its individual
components for a particular action or application

– The mixture result in increased activity and performance to
meet a particular action or performance requirement
– For example: Certain drug formulations such as ‘pain killers’
have multiple active ingredients which work better when
administered together
...
Like any other developed product, a formulation must be
commercially viable i
...
a useful profitable material
...
Formulations have structural, functional, stability,
application and aesthetic properties
3
...


– two to several components
...
Although no chemical reactions happen in making the
mixture, there may be much chemistry going on to
actually make some of the ingredients e
...
chemically
synthesizing a drug before mixing it with water and other
ingredients to make a liquid medicine for oral
consumption
– Otherwise it is perfectly possible for a marketed
product to go on sale without a chemical equation
ever being written down
5
...
g
...
UV curable coatings are examples

– knowledge of chemistry of the reaction is extremely
essential
...
There are physical reactions (molecular interactions) mainly involving
thermodynamics, and surface chemistry, that take place during mixing

–
–
–

energy of mixing,
phase equilibria
Surface and colloid chemistry

7
...


the process of formulation, all ingredients lose their intrinsic
properties (e
...
solubility/miscibility, M
...
, S
...
, viscosity etc
...
, therefore each ingredient and its proportion
will have specific function in the formulation
...


–

There may be functionally inert medium namely “vehicle” or
“base”, which acts as carrier for active ingredients
...


9
...

10
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Formulation philosophy (Ref
...
Low inventory of ingredients
2
...
Low production of environmental waste
4
...
Low complication during scale-up
• The focus is creating a formula with the greatest value

for the consumer

Principles (Ref
...


Less is more: less ingredients, low levels keeping performance as a major
consideration
Know why you add any ingredient

2
...


Use ingredients that contribute to performance

Blind (blinded) test your product
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–

4
...


Find a similar product or use your best performing prototype
when you find a prototype that beats the standard, make this the new standard

Start with high levels then cut back as needed
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–

6
...


• Test batch production and evaluation to allow
proof of product and market testing
• Scaled-up production

Reverse engineering
• Deformulation or reverse engineering of a
chemical formulation for business and
corporations is the process of determining which
chemicals, substances or materials are
incorporated into a product
...

– Complex product formulations can contain dozens of
components of varying chemical nature and each of
these can be present at different concentration levels
...
: Quality
characteristics of the paint
• The qualities of a paint formulation that affect

its performance which may be tested or
specified in a std:
– Viscosity
– Substrate wetting
– Adhesion to the substrate
– Correct color, texture, feels etc
...
: Ingredients
selection
• Each ingredient classified as per following

functions:
– Film forming agent
– Viscosity (Rheology) control agent
– Wetting agent
– Leveling agent
– Anti-forming agent
– Antifungal agent

Ingredients stability
• Normally, the components with specific need to be stable and so
chemically inert during the course of its application
...


• Reactivity between components (molecular interactions) could
affect important characteristics of a formulation (in the stage of the
formulation) such as:
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–
–
–
–
–
–
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Miscibility
Stability of mix
Compatibility
Viscosity and related characteristics (Rheology)
Surface Tension
Wetting and Dispersing
Foaming
Easy bursting of air entrapments



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