Performance & validation
Formulite® has been evaluated through in vitro, preclinical and clinical studies across a broad range of drug compounds and development stages.
Evaluated across a broad range of drug compounds
Formulite® has been evaluated with more than 100 drug compounds across multiple therapeutic areas and compound classes, with particular focus on poorly soluble compounds where dissolution and oral bioavailability present significant development challenges.
The work has included assessment of drug loading, amorphous stabilization, dissolution, stability and in vivo performance, providing a broad technical foundation for application of the platform to new development programs.
Dissolution and bioavailability performance
Formulite® is designed to increase apparent solubility and accelerate dissolution by stabilizing poorly soluble drug compounds in an amorphous state.
Across multiple compounds, in vitro studies have demonstrated enhanced dissolution compared with corresponding crystalline forms and, in selected development programs, marketed reference products. Preclinical pharmacokinetic studies have also demonstrated increased systemic exposure for multiple Formulite®-based formulations.
Long-term amorphous stability
Maintaining the amorphous state during storage is a key challenge in amorphous drug development. By restricting molecular mobility within its nanoporous structure, Formulite® helps suppress recrystallization over time.
Stability studies across multiple drug compounds, loading levels and storage conditions have demonstrated preservation of the amorphous state over extended periods, with available data extending up to 60 months.
Clinically validated in a first-in-human study
A first-in-human Phase I study was completed in 2025 to evaluate Formulite® in an oral drug formulation.
The study demonstrated that the Formulite®-based formulation was safe and well tolerated, with no adverse events attributed to the Formulite® platform. Completion of the study represents an important milestone in the translation of Formulite® from preclinical development into human use.
A platform ready for partnering discussions
Together, the technical, preclinical and clinical data support the application of Formulite® to new drug development and lifecycle management opportunities.
Disruptive Pharma works with pharmaceutical and biotechnology partners to identify compounds where improved dissolution, bioavailability, drug loading or product characteristics may create development or commercial value.