EP1835885A1 — Polymeric implants, preferably containing a mixture of peg and plg, for controlled release of a gnrh

USPTO Abstract

Controlled release compositions for controlling release of a GnRH molecule or a GnRH analog are provided. The compositions include a GnRH molecule or GnRH analog as an active agent, and a controlled release component for controlling release of the GnRH molecule or GnRH analog from the composition. The compositions provide a sustained mean steady state plasma concentration (Css) of the active agent of at least about 1.5 ng/mL for a period of at least about 48 hours when the composition is administered to a subject. In addition, the use of a controlled release component in the manufacture of a composition for the controlled release of a GnRH molecule or GnRH analog is provided. The controlled release component'is capable of providing a sustained mean steady state plasma concentration (C38) of the active agent of at. least about 1.5 ng/mL for a period of at least about 48 hours when the manufactured composition is administered to a subject. The controlled release component can include a polymeric material and/or a non-polymeric material. When the compositions are administered to a subject, for example when implanted, the compositions release the active agent in a controlled fashion. Methods for producing the compositions are also provided, as are methods of using the compositions to provide for controlled release of the GnRH molecule or GnRH analog in a subject. Preferred polymeric material is PLG or a copolymer of PLG and a PEG derivative such as methoxy PEG. Preferred non-polymeric material can be SAIB.