In-vitro dissolution testing methods for optimising molecule selection in early drug development stages

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November 17th 2022 at 11am EST

The development of new drugs relies on selecting the right molecule, understanding its in-vivo behaviour, and identifying any potential risks that might hinder the R&D process. The cost of APIs influences the amount of material used in early-stage development, and scientists are now being asked to provide greater amounts of useful data while having less material to work with.

It is usually in the later stages of development where the properties of Active Pharmaceutical Ingredients (APIs) are analysed. This is historically performed using dissolution rate measurements that act as a quality control protocol, and it is typically not used to select molecules or determine performance risks. This approach is not cost-effective as it uses a large amount of API material and it doesn’t provide insights into the fundamental and mechanistic understanding of the API in question, nor does it identify any potential failure modes.