LIPOSOMAL NANOPARTICLES AND OTHER FORMULATIONS OF FENRETINIDE FOR USE IN THERAPY AND DRUG DELIVERY

摘要

Formulations of neutral retinoids, in particular fenretinide (HPR) in the form of lipid nanoparticles, solid dispersions and emulsions are disclosed. These compositions are used to treat diseases that are amenable to treatment by HPR, such as neoplastic diseases by achieving higher and more prolonged concentrations of HPR in the subject. The key steps for preparing lipid nanovesicles of HPR include mixing and sonication, sterile filtration, without or without lyophilization for long-term stable storage, and employ processes and materials that are scalable from the laboratory to the manufacturing level. The formulation are suitable for injection into human or animal patients without causing allergic or hypersensitivity responses by avoiding chemical surfactants and animal sources of phospholipids in their manufacture.