Sophisticated Formulation Approaches For Insoluble Drug Candidates

By Jim Huang, PhD, Founder & CEO, Ascendia Pharmaceuticals

On many occasions, people have approached me with questions, such as “Are solution formulations a good, simple approach, whereas are nano-formulations too complex?” Or “What is a sophisticated formulation, and what role do nano-formulations play to accelerate the drug discovery/development process to the clinic?”

Undoubtably, there is no straight answer to those questions. As an example, for poorly water-soluble compounds with chemical instability, the development of a stable solution formulation with reasonable drug loading is a daunting task. By utilizing a nanoformulation approach, this formulation strategy may resolve the drug-loading and bioavailability issues for such compounds, while adding minimum complexity to the manufacturing process.