The Crystal Maze
Unexpected hydrates of an API can cause a frustrating detour in the drug development pathway – the right analysis (and expertise) can help manufacturers find their way
David Pearson | | Longer Read
Despite having modern modeling software, cloud-based computing, and an arsenal of analytical protocols at their disposal, predicting the crystalline nature of an API in its solid state remains a trying task for pharmaceutical manufacturers. This is particularly true of hydrates – APIs whose crystal structure contains water molecules. Up to 75 percent of all pharmaceutical compounds form hydrates during the manufacturing process, affecting many of the physicochemical properties of an active ingredient (1).
This is a sticking point for companies wanting to move their API through the clinical pipeline as quickly as possible as it challenges their ability to discern the overall bioavailability, physicochemical properties and intellectual property position of their material early in the development process. To help overcome these hurdles, larger pharmaceutical companies are increasingly turning to CDMOs to perform solid-state analyses in expert laboratories. Valued in excess of $150 million, CDMOs represent over 50 percent of the total market share for solid-state services (2).
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