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Title: Introduction to Formulation Chemistry
Description: Well summarized notes on Introduction to Formulation Chemistry
Description: Well summarized notes on Introduction to Formulation Chemistry
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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)
•
•
•
•
•
•
•
•
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”
Title: Introduction to Formulation Chemistry
Description: Well summarized notes on Introduction to Formulation Chemistry
Description: Well summarized notes on Introduction to Formulation Chemistry