FORMULITE

FORMULITE – An amorphization technology with excellent intrinsic flowability

Our proprietary Formulite™ technology, based on mesoporous magnesium carbonate (MMC),  provides amorphous formulations that significantly enhance solubility, absorption, and oral bioavailability across multiple drug classes and therapeutic areas. Formulite™ enables development of small molecules, peptides and selected other drugs, enabling medicines to reach their full therapeutic potential.

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

Formulite™ intrinsic excellent flowability provides straightforward mixing, tableting and encapsulation.  Its product characteristics ensure accelerated development from lab to market.

Pore and particle size

Formulite^™ is a white nanoporous powder material. These pores can be loaded with numerous pharmaceutical active ingredients and the confined space suppress crystallization and stabilizes the amorphous form of the drugs. Formulite^™ has an exceptional intrinsic flowability which is retained also when loaded with a drug substance (up to 45% w/w). The pore properties of Formulite^™ make it ideal as a drug carrier.

Formulite™ dissolves completely upon delivery of drug, thus ensuring complete absorption in the gastrointestinal tract. and as it is based on magnesium carbonate it is safe to use in humans.

Medical need

Drugs that are poorly soluble represent approximately 70% of all pharmaceutical drugs in development. The Formulite^™ technology enables amorphous solid dispersions of numerous drugs, hence increasing the dissolution and the body’s ability to absorb the drug. Formulite^™ may be used to obtain improved versions of approved products, to enable drug compounds in development or for drug repurposing.

Manufacturing

Formulite^™ is manufactured under GMP conditions on a pilot scale, suitable for kilogram batches. Investments to upscale the plant to commercial scale tonnage quantities have been initiated.

The API loading process onto the Formulite^™ carrier is cost efficient, relies completely on standard process equipment, and is scalable from small technical trials through clinical quantities all the way to commercial quantities. The loading dose can be varied freely, making Formulite^™ an ideal carrier for small-animal model testing. After API loading the Formulite^™ powder is free-flowing and ready for filling into capsules, tablet compression, or further processing. Long-term stability of the loaded drug compound has been shown to exceed 24 months (ongoing study).