pediatric formulation development · desired drug solubility in solution. the lead formulation...
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Pediatric Formulation Development
For more information, email us at [email protected]
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Patheon’s Pediatric Services are dedicated to
developing palatable formulations, including
oral liquids, chewable tablets, dispersible tablets,
sachets, oral disintegrating tablets and softgels.
With in-depth knowledge of interactions between
API, flavors, sweeteners, colors, and preservatives,
we are the answer for your next project.
To help offer our customers the palatable pediatric
formulations the market demands, Patheon and Senopsys
have partnered to expand our service offerings. Together,
we deliver robust and manufacturable formulations that
are also optimized for taste and palatability:
• Our approach addresses both the formulation and sensory
challenges at early stages of the development program, allowing
you to make decisions faster.
• Both companies actively participate throughout the develop-
ment process, saving you valuable time in taking your drug
product to market.
• Formulation expertise
• Taste assessment via human taste panels under Good Clinical Practice
• Proprietary FlavorMetrics™ Taste
Assessment Tool
• Proven sensory-directed FlavorOpt™ Sensory Optimization System
Key Senopsys Benefits
Low-Solubil i ty SolutionThe Challenge
A pediatric solution of a low-solubility API was required. Develop-
ing the formulation involved selecting suitable excipients to
enhance the solubility of the drug, improving the taste of an
unpleasant base-formulation, and stabilizing a chemically-labile
compound in the solution.
The Solution
A detailed product profile was established to guide formulation develop-
ment, and the project was initiated with a scientific drug/compatibility
program that used statistical design of experiments. Potential excipients
were evaluated at safe and regulatory acceptable levels to achieve the
desired drug solubility in solution. The lead formulation composition was
defined following a well-designed taste-optimization program with a special
focus on the taste of the drug-solubility enhancer system.
Suspension FormulationThe Challenge
A pediatric suspension formulation was needed for a drug substance that
exhibited several polymorphic forms and significant drug particle aggregation
in suspension. Improvement in the suspension’s palatability was required due to
the API’s strong taste.
The Solution
A high quality polymorph screen, which would define potential polymorphs and their
thermodynamic stability and solubility, was recommended. Opportunistic crystal
growth due to solid-state transition and/or Ostwald ripening was reduced by judicious
choices of crystal form and excipients. A custom bitter masking system was developed
by flavor optimization specialists utilizing taste panels.
development services
pediatric formulation development CASE STUD IES
Published 4/12 PATH0041R1
European Headquarters
Patheon UK Ltd.Kingfisher DriveCovingham, SwindonWiltshire SN3 5BZUKP: +44 1793 524411F: +44 1793 487053www.patheon.com
For more information about Pediatric Formulation Development, contact your Patheon representative or email us at [email protected]
Two examples of how Patheon and Senopsys have solved
our customers’ pediatric development challenges...
Senopsys LLC
Jeff WorthingtonPresident & Founder
US Headquarters
Patheon Inc.4721 Emperor Blvd, Suite 200Durham, NC 27703-8580USAP: +1 919 226 3200F: +1 919 474 2269www.patheon.com