Unlocking bioavailability with Formulite®

HOW IT WORKS

A biodegradable amorphous drug delivery platform

Poor aqueous solubility is a major challenge in drug development and a key barrier to the clinical and commercial success of oral drug candidates. Our proprietary technology, Formulite® is designed to address this challenge.

Enabling drugs to reach full therapeutic potential

Formulite is built on biodegradable mesoporous magnesium carbonate (MMC). Its pore structure, with its high internal surface area, allows drug molecules to be loaded and retained in an amorphous state. As a result, solubility is enhanced and complete drug dissolution in the gastrointestinal tract enabled.

Formulite is approved for human use and was recently validated in a clinical study, underscoring its safety and applicability in real-world drug development.

Material characteristics

Formulite is a dry powder with a well-defined nanoporous structure, typically exhibiting pore sizes in the 4-8 nm range, and a high internal surface area. The confined pore environment suppresses crystallization and stabilizes drugs in an amorphous state. Upon administration, the Formulite matrix dissolves, ensuring complete drug release.

The particle size is approximately 200 ± 50 µm, optimized to ensure rapid dissolution while maintaining a free-flowing powder suitable for large-scale drug manufacturing.

Excellent intrinsic flowability is retained even at high drug loadings, and the material is compatible with standard pharmaceutical processing.

Scientific validation

The Formulite platform has demonstrated feasibility across more than 100 APIs, with over 20 compounds evaluated in pharmacokinetic (PK) studies, supporting the platform’s broad applicability and performance. The technology is underpinned by published research describing the physicochemical properties of mesoporous magnesium carbonate, its ability to stabilize amorphous drugs, and its impact on dissolution and bioavailability.

Selected publications
Frykstrand et al 2014 – Pore forming mechanism of MMC
Zhang et al 2014 – Stabilization of amorphous ibuprofen in MMC
Zhang et al 2016 – Controlled Drug Release from MMC
Zhang Thesis 2016 – MMC as a drug delivery vehicle for stabilizing amorphous drugs and regulating their release rate
Gomez de la Torre et al 2022 – Bioavailability of Celecoxib in MMC, An In Vivo Evaluation
Katsiotis et al 2024 – Development of a simple paste for 3D printing

Unlocking the full potential of oral drug products

The Formulite technology transforms drugs with poor bioavailability into effective, patient-friendly oral solid dosage forms.

Smaller pill size and reduced pill burden

Designed for robust manufacturing

Formulite addresses key formulation and manufacturing challenges that commonly limit the performance, scalability, and sustainability of oral drug products.

Eco-friendly process

Clinical validation

In 2025, Disruptive Pharma completed a Phase 1 clinical study evaluating the Formulite platform using sorafenib as a model compound. The study confirmed that Formulite can be used as a safe and functional drug carrier in humans, supporting the clinical feasibility of the platform.