Polymorphism is an aspect of solid-state drugs that can throw up problems if ignored but can offer benefits if tackled early. Dr Tony Flinn, ceo, and Dr Jules Northen, research manager, Onyx Scientific, review the integration of solid-state development within traditional process development of new drugs
The US Food and Drug Administration (FDA) requires that all companies register the polymorphic structure of any new drug. Moreover, manufacturers need to demonstrate that each polymorph is stable and can be reliably reproduced. To show equivalence with existing drug substances, it is a requirement to show that the polymorph (and hence other properties) is equivalent to that already on the market. Guidance documents have been developed that have been co-ordinated through the International Conference on Harmonisation (ICH) to improve international consistency.
Regulatory authorities begin to take an interest in the solid-state form of a drug when the Investigational New Drug Application (INDA in the US) is submitted. Clearly polymorphism studies should have been initiated before then.
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