DisExx™ and SolExx™, Complementary Solubility Enhancement Technologies
Approximately 90% of pipeline drugs fall into the two low solubility categories of the Biopharmaceutical Classification System (BCS), i.e. classes II & IV (volume of water to dissolve a single dose exceeds 250 mL). This is a significant increase when compared to the less than 36% of marketed drugs falling into these two classes. Low solubility of drug candidates can translate into poor (and varying) bioavailability, slow down the overall development process, and lead to the development of a suboptimal drug for the patient, or even to attrition from the pipeline, thus contributing to the increasing cost of the drug development process.
Enhancing the solubility of poorly soluble drug candidates does not only improve the viability of new chemical entities but also contribute significantly to the repurposing and life cycle management of existing drug products.
ExxPharma has developed are two innovative, complementary solubility enhancement technologies (DisExx™ and SolExx™) that are applicable to all poorly soluble drug substances. DisExx™ utilizes a hot melt extrusion process while SolExx™ relies on low temperature processing, both of which are easily scalable, solvent-free and continuous. The technologies can also integrate solubility enhancement with modified release properties or fixed dose combination products as needed.