Implantable polymeric device for sustained release of dopamine agonist

摘要

The present invention provides compositions, methods, and kits for treatment of Parkinson's disease and other conditions for which treatment with a dopamine agonist is therapeutically beneficial. The invention provides a biocompatible nonerodible polymeric device which releases dopamine agonist continuously with generally linear release kinetics for extended periods of time. Dopamine agonist is released through pores that open to the surface of the polymeric matrix in which it is encapsulated. The device may be administered subcutaneously to an individual in need of continuous treatment with dopamine agonist.

主权项

1. An implantable device for subcutaneous administration of a dopamine agonist to a mammal in need thereof, comprising a dopamine agonist and a biocompatible, nonerodible polymeric matrix,
wherein said dopamine agonist is encapsulated within said matrix, wherein the polymeric matrix comprises ethylene vinyl acetate copolymer (EVA), wherein the implantable device is produced by an extrusion process, wherein said dopamine agonist and the polymer are blended, melted, and extruded into a structure, wherein the implantable device further comprises a coating of EVA having a lower dopamine agonist loading than the remainder of the implantable device; wherein the implantable device is washed, wherein the dopamine agonist is selected from the group consisting of lisuride, pergolide, bromocriptine, pramipexole, ropinirole, and rotigotine, and wherein when said implantable device is implanted subcutaneously in said mammal, said dopamine agonist is continuously released in vivo over a sustained period of time through pores that open to the surface of said matrix at a rate that results in a steady state plasma level of at least about 0.01 ng/ml for the sustained period of time, wherein the sustained period of time is at least about 3 months.