FORMULITE

FORMULITE – An amorphization technology with excellent intrinsic flowability

Formulite^™  made from Mesoporous Magnesium Carbonate (MMC), is a proprietary drug delivery technology for amorphous stabilization and bioavailability enhancement of drug substances and for unique drug formulations. 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 carrier of active pharmaceutical ingredients. Formulite^™ dissolves completely upon delivery of drug and as it is based on magnesium carbonate it is safe to use in humans.

Pore and particle size

Formulite^™ is a white powder material consisting of pores up to 10 nm in size. These pores can be loaded with numerous pharmaceutical active ingredients and the confined space suppress crystallization and stabilizes the amorphous form of the drugs. The Formulite^™ particle size is 200±50 µm, optimized for rapid dissolution and to achieve a free-flowing powder that allows for large scale manufacturing of drug products. With magnesium carbonate being the underlying chemical substrate, Formulite^™ is water soluble in acidic conditions and will dissolve without residues.

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).