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A higher proportion of new drug candidates
are exhibiting very low solubility in water leading to poor dissolution
rates and correspondingly low oral bioavailability. Additionally, some new
API materials have undesirable properties including hygroscopicity or
instability, either chemical or physical. Solid state chemistry
may be used to counter these problems and plays an important role in
ensuring your drug has the desired properties when delivered to market. At
Aptuit, our detailed analysis techniques can often result in manufacturing
efficiencies, reduced waste, less cost and improved timelines.
SSCI, part of Aptuit's integrated services,
provides the solid state chemistry services for which we
have
an outstanding reputation. We provide specialized services in the areas of
polymorphism, crystallization, problem
solving and stability. Our focus is to understand, improve
and protect your
active pharmaceutical ingredient
(API, drug substance), formulated product and intellectual property.
Solid state chemistry plays an important role throughout the
development of drug candidates and we can assist every step of the way.
At the early stages of development,
API is often in short supply, so to counter this challenge our
experienced scientists have been optimizing screening techniques for the
past decade. These internal research and development efforts have enabled us
to become more proficient in our screening efforts, potentially using less
API material in the process. Additionally, an extensive research program has
been conducted on cocrystals, amorphous materials and amorphous dispersions
to support our clients’ growing needs for new forms to help overcome
physical property constraints and to obtain intellectual property. Our
analytical chemists have also been working extensively on developing solid
state analytical methods for the quantification of solid forms in
drug substance or drug product.
Our solid state chemistry
group brings widespread experience of polymorphism, crystallization and API
development and the ability to solve virtually any problems/issues presented
to them. This enables us to support our clients in developing API while
building sound intellectual property. Our areas of expertise include:
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Drug Substance Development and Screening Techniques
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Process and Crystallization Development
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Amorphous and Disordered Material Characterization
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Analytical Research Services
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Structural Characterization
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Solid State Methods for Drug Substance and Drug Products
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Biochemistry
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Problem Solving
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India