Why conduct polymorphism screening studies?
Understanding any polymorphism associated with your development compound is key to eliminating batch-to-batch inconsistency and ensuring consistent in vivo performance. With polymorphs differing in properties such as stability, hygroscopicity, and dissolution rate, some compounds can prove challenging to develop.
By performing comprehensive drug polymorphism screening studies, Charles River scientists can help you select the optimum solid form of your drug substance, identifying any issues before they cause delays to your program.
Understanding the polymorphism of a compound is a prerequisite for designing a suitable formulation strategy, giving increased confidence that pre-clinical performance will translate well into humans. It can also open lifecycle management opportunities by strengthening your intellectual property position.
With a suite of state-of-the-art characterization techniques and extensive experience in polymorphism screening, our solid-form experts can guide you through the process of identifying hydrates, solvates, and meta-stable forms of your compound. Our expertise in crystallization allows us to design scalable methods to reliably produce the optimum solid form and provide batches of up to 1 kg of non-GMP material for pre-clinical studies.
Frequently Asked Questions (FAQs) About Polymorphism Screening
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What is polymorphism screening?
Polymorphism screening is a process that aims to identify and characterize all the crystalline forms of a given compound and select the optimum form for development.
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When is the right time to conduct polymorph screening studies?
We recommend performing drug polymorphism screening as part of the process of selecting a pre-clinical candidate. This allows any challenges to be identified and overcome before causing any delays to your pre-clinical program.
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How much material is needed to conduct polymorphism screening?
Typically, around 5 g of material is needed for a full drug polymorphism screen.
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How long does polymorphism screening take?
A typical polymorph screen takes around eight weeks to perform.
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Does it matter if my compound has multiple polymorphs?
Provided they can be understood, and a form with suitable properties for development identified, having multiple polymorphs of your compound is not necessarily a problem, and may in fact open up additional intellectual property (IP) opportunities.