Whitepaper/App Note

Whitepaper: Accelerating development of enabled formulations for poorly soluble drugs

Posted: 20 February 2017 | | No comments yet

In this whitepaper, Quotient Clinical discuss poorly soluble drugs and how they have developed an innovative approach to identify and overcome these solubility challenges…

Efficacy issues due to inadequate gastrointestinal (GI) absorption caused by insufficient aqueous solubility are encountered in up to 70% of new drugs in development. Typically, in vitro analysis and preclinical studies are used to predict the behaviour of the drug in vivo.

These methods are notoriously poor at predicting drug behaviour in humans however, meaning that solubility issues are often only discovered when the drug is first administered in clinical trials. The drug substance and/or formulation must then be reworked and the process started again. The cost and time expended in this process can be considerable. Importantly, the selection of formulation prototypes to overcome a solubility issue using these tools also carries a significant risk of non-resolution in subsequent clinical testing.

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