WHITEPAPER – Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion & Polyvinyl Alcohol

Solubility of the active pharmaceutical ingredient (API) in an oral formulation is critical for absorption from the gastrointestinal (GI) tract and the intended therapeutic effect. Ensuring that an API has the necessary solubility can be challenging for drug developers and formulators. If limitations in solubility cannot be successfully addressed, a new chemical entity (NCE) is unlikely to advance in the development pipeline. Addressing this potential roadblock to clinical success is becoming increasingly important as NCEs continue to become larger and more lipophilic and, as a result, less soluble. This white paper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol can be used to increase the solubility of DCS IIb molecules.