Parenteral Formulations for Synthetic Retinoids

DESCRIPTION (provided by applicant): SciTech LLC develops novel intravenous (IV) formulations for investigational drugs with poor physical properties. Fenretinide and other poorly soluble retinoids are currently under investigational as chemopreventive and anti-tumor agents, including orphan indications like neuroblastoma chemotherapy. Poor solubility in physiologically compatible vehicles has limited patient access to oral dosage forms that show poor bioavailability. Consequently patients must take unreasonable numbers of capsules (upto 90/day). Parenteral dosage forms may be more acceptable to patients. The Pharmacology Core at Wayne State University found that novel co-polymer mixtures or lipid emulsions may be suitable IV carriers for fenretinide that may be useful to exceed the apparent saturable absorption identified during the WSU Phase I trial of oral fenretinide. This SBIR aims to understand how physicochemical properties and composition affect solubility, dissolution, and stability and to confirm the feasibility of achieving the required formulation concentration. In Phase II, a clinical formulation from each strategy will complete IND-directed studies. Understanding fenretinide solubility may lead to improved oral dosage forms as well. This SBIR concerns a dosage form of programmatic interest to the NCI (CTEP), and responds to focus areas listed by Division of Cancer Treatment and Diagnosis (NCI), and the Office of Orphan Products Development (FDA). PROPOSED COMMERCIAL APPLICATION: Not available