Implantable device for the delivery of risperidone and methods of use thereof

Abstract

This invention is related to the use of polyurethane-based polymer as a drug delivery device to deliver biologically active risperidone at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of risperidone to tissues or organs.

1 .- 25 . (canceled) 
     
     
         26 . A drug delivery device for the controlled release of risperidone over an extended period of time to produce systemic pharmacological effects, comprising:
 a) a polyurethane-based polymer formed to define a hollow space; and   b) a solid drug formulation consisting essentially of a formulation consisting essentially of risperidone and optionally one or more pharmaceutically acceptable carriers,   wherein the solid drug formulation is contained in the hollow space, and   wherein the device provides a pre-determined release rate of risperidone from the device after implantation, and   wherein the polyurethane-based polymer is a reaction product of 4,4′-diisocyanato dicyclohexylmethane (H12MDI), polytetramethylene ether glycol (PTMEG) and 1,4-butanediol.   
     
     
         27 . The drug delivery device of  claim 26 , wherein the drug delivery device is conditioned and primed under conditions chosen to be consistent with the water solubility characteristics of the risperidone. 
     
     
         28 . The drug delivery device of  claim 26  including one or more pharmaceutically acceptable carriers, and wherein the pharmaceutically acceptable carrier is stearic acid. 
     
     
         29 . The drug delivery device of  claim 28 , wherein the stearic acid comprises about 2 wt % of the solid drug formulation. 
     
     
         30 . The drug delivery device of  claim 26 , wherein the polyurethane-based polymer has a flex modulus of between about 1000 and about 92,000 psi. 
     
     
         31 . The drug delivery device of  claim 26 , which has an internal diameter of about 3.6 mm. 
     
     
         32 . The drug delivery device of  claim 26 , which has a length of about 7.5 mm to about 50 mm. 
     
     
         33 . The drug delivery device of  claim 26 , which has a length of about 45 mm. 
     
     
         34 . The drug delivery device of  claim 26 , wherein the polyurethane-based polymer has a wall thickness of 0.2 mm. 
     
     
         35 . The drug delivery device of  claim 26 , wherein the device provides a pre-determined release rate of risperidone of between about 0.001 mg/day to about 15 mg/day from the device after implantation. 
     
     
         36 . A method for delivering an effective amount of risperidone to a subject, comprising implanting the drug delivery device of  claim 26  into the subject.