Nanoencapsulation of poorly water-soluble drugs with non-toxic, non-immunogenic, and biocompatible polymers has successfully enhanced drug delivery, safety, and effectiveness. Fulgent Pharma combines its patented nanoencapsulation technology with both established and newly discovered anti-cancer drugs to create new therapies with lower toxicity, targeted delivery, and enhanced tumor reduction. By surrounding the poorly water-soluble drug molecules within a capsule of polymeric molecules, nanoencapsulated drugs become much more water soluble. The encapsulating polymers are designed to protect the drug from degradation and in vivo precipitation. Biodistribution and bioavailability to the target tissues and cells can be improved, while toxicity may be reduced.
Our proprietary formulation and method for preparation enable us to produce polymer compositions with desired unique properties. This nanoencapsulation platform demonstrates our success in the development of its “Plug and Play” drug encapsulation and delivery that can be broadly applicable for many active pharmaceutical ingredients (APIs) - particularly those that are poorly soluble, need better pharmacokinetics, improved safety or tolerability, enhanced biodistribution or those requiring targeted delivery.
Unlike some drug delivery materials such as Human Serum Albumin, which is only soluble in water, our nano-drug delivery materials used for drug candidate development are soluble not only in water, but also in various organic solvents, as well as capable of hot melt mixing with active pharmaceutical ingredients (APIs). The technology is designed to provide a broader range of drug candidate formulations, particularly amorphous drug candidate formulations, which can be suitable for both IV and oral formulations with a goal to potentially improve PK profile, as well as safety and efficacy.
A drug master file (DMF) is a set of submissions to U.S. Food & Drug Administration (FDA) to provide detailed information about human drug products.
The DMF on a novel, nano-encapsulating polymer-based drug excipient was filed by our partner ANP Technologies Inc., accepted and published by the FDA as DMF#36513 in 2022. The DMF#36513 demonstrates our success in the development of its “Plug and Play” drug delivery platform that can be broadly applicable for many active pharmaceutical ingredients (APIs) - particularly those that are poorly soluble, need better pharmacokinetics, improved safety or tolerability, enhanced biodistribution, or those requiring targeted delivery.
The DMF#36513 has been successfully used in our first cancer drug candidate, FID-007. The excipient provided in the DMF#36513 is safe for intravenous (IV) injection in humans based on data from clinical trials in cancer patients. Our additional drug candidates have been developed using the same nano-drug delivery platform with the goal to provide next generation formulation solutions.