Poor aqueous solubility remains one of the most significant challenges in modern pharmaceutical development. Formulite® is a proprietary bioavailability platform designed to address this challenge.
A substantial proportion of new chemical entities (NCEs) have limited oral bioavailability because they do not dissolve sufficiently in the gastrointestinal tract. Conventional formulation approaches can improve drug exposure but may introduce challenges related to physical stability, drug loading, manufacturing complexity and scale-up.
Formulite® is based on a specifically developed grade of nanoporous magnesium carbonate. Through nanoporous confinement, the platform stabilizes drug compounds in an amorphous state, supporting improved dissolution and oral bioavailability.
The platform is designed to support scalable development of oral drug products, from early feasibility and formulation development to manufacturing scale-up.
Based on Disruptive Pharma’s preclinical studies, formulation development work and clinical experience, Formulite® offers several relevant benefits in oral pharmaceutical product development: