Controlled Release of Medication

Period of Performance: 09/28/1998 - 03/31/1999

Unknown

Phase 1 SBIR

Recipient Firm

Proneura, Inc.
South San Francisco, CA 94080
Principal Investigator

Abstract

The primary objective of this proposal is to develop a controlled release implantable delivery system for haloperidol that can be easily administered and deliver the drug for periods of 6 months to a year. Haloperidol is indicated for use in the management of patients with mental disorders. Currently, long acting products to treat mental disorders available commercially have to be administered every two to four weeks. A product that can deliver drug from 6 months to a year will not only improve the management of patients with mental disorders, but it will also reduce the overall cost of this therapy. The goal of this project is to develop an ethylene-vinyl acetate implant formulation of haloperidol that would deliver haloperidol at 2 mg/day for a period of 6 months to a year. The formulation will consist of multiple implants to achieve the desired dose. Each implant will be approximately 2.4mm in diameter and 2.6 cm in length. The Phase I proposal involves formulation development, formulation optimization, manufacturing process optimization and development of a pharmacokinetic model which will serve as a critical tool in development of this product and other similar products. PROPOSED COMMERCIAL APPLICATION: The purpose of this project is to develop a commercially viable implantable delivery system for haloperidol that is easily implanted, stable and delivers the minimum concentration of the drug for periods of 6 months to a year.