MeltDose® Technology Platform
The company’s proprietary MeltDose technology enables the formulation and drug delivery attributes of the Envarsus® product candidate. MeltDose enhances the bioavailability of compounds with low water solubility, supporting the creation of improved versions of marketed drugs. MeltDose has been validated in clinical studies and received regulatory acceptance through the FDA approval of Fenoglide for sale in the United States.
The fundamental limiting factor for oral absorption of drugs with low water solubility is the transfer of drug substance particles to dissolved molecules that can penetrate the epithelium of the gastrointestinal tract and enter into the bloodstream.
The majority of conventional drug delivery technologies aimed at increasing bioavailability of compounds with low water-solubility rely on reduction of the particle size of the drug substance – thereby increasing the surface area available for the dissolution process.
Veloxis believes that the company’s proprietary MeltDose technology provides a novel drug formulation technology that produces improved bioavailability of compounds with low water-solubility by solubilising them and incorporating the drug substance into a melted vehicle which is then sprayed onto a carrier. The result of this process is a granulate.
The drug substances are solubilised in low-melting vehicles such as PEG, poloxamers or lipids; all of which are so-called GRAS (generally recognised as safe). This process can be conducted under controlled atmosphere (nitrogen) in order to avoid degradation processes such as oxidation. The solubilised drug in this melted vehicle is transformed into solid particles by being sprayed under controlled conditions onto an inert carrier in a fluid bed. From the resulting granulate, known as a solid solution or solid dispersion, tablets can be manufactured by way of direct compression.
Potential clinical benefits of the company's proprietary MeltDose technology
Veloxis believes that the MeltDose technology, which forms the basis of the Envarsus® product candidate, may offer several meaningful clinical benefits, including but not limited to:
Through the development of Envarsus®, the company’s proprietary MeltDose technology has shown the ability to create a product candidate with a once-daily administration schedule compared with the twice-daily administration schedule of the currently marketed drug, Prograf.
BUSINESS DEVELOPMENT CONTACT:
John Weinberg, EVP, CCO
Telephone: +1 732-321-3208