Devices, formulations, and methods for delivery of multiple beneficial agents

Abstract

The present invention relates to osmotic delivery devices, formulations, and methods for delivery of two or more beneficial agents. In one aspect, the present invention provides osmotic delivery devices useful for substantially concurrent administration of two or more beneficial agents. In another aspect, the present invention provides beneficial agent formulations for use in the osmotic delivery devices. The formulations include formulations wherein beneficial agents are soluble in the vehicle, suspension formulations comprising particle formulations of one or more beneficial agent, and combinations thereof. Further, methods for treatment of a variety of diseases or conditions using two or more beneficial agents are disclosed, wherein the methods are preferably practiced using the osmotic delivery devices and/or formulations of the invention.

1 . An osmotic delivery device comprising:
 a beneficial agent formulation comprising:
 (i) a non-aqueous, viscous vehicle comprising a solvent and a polymer, the vehicle having a viscosity of between about 12,000 to about 18,000 poise at 33° C.; and 
 (ii) two or more polypeptides, wherein a first polypeptide is Glucagon-like peptide-1 (GLP-1) or exenatide and a second polypeptide is selected from the group consisting of amylin, an amylin analogue, a ghrelin antagonist, a G protein coupled receptor 119 (GRP 119) agonist, and leptin, 
 wherein the two or more polypeptides are suspended in the vehicle. 
   
     
     
         2 . The device of  claim 1 , wherein the two or more polypeptides are formulated into one particle formulation that is suspended in the vehicle. 
     
     
         3 . The device of  claim 1 , wherein the first polypeptide is formulated into a first particle formulation and the second polypeptide is formulated into a second particle formulation, and the first and second particle formulations are suspended in the vehicle. 
     
     
         4 . The device of  claim 1 , wherein the first polypeptide is exenatide and the second polypeptide is amylin. 
     
     
         5 . The device of  claim 1 , wherein the first polypeptide is exenatide and the second polypeptide is an amylin analogue. 
     
     
         6 . The device of  claim 5 , wherein the amylin analogue is pramlintide. 
     
     
         7 . The device of  claim 1 , wherein the first polypeptide is exenatide and the second polypeptide is a ghrelin antagonist. 
     
     
         8 . The device of  claim 1 , wherein the first polypeptide is exenatide and the second polypeptide is a GRP 119 agonist. 
     
     
         9 . The device of  claim 1 , wherein the first polypeptide is exenatide and the second polypeptide is leptin. 
     
     
         10 . The device of  claim 1 , wherein the first polypeptide is GLP-1 and the second polypeptide is amylin. 
     
     
         11 . The device of  claim 1 , wherein the first polypeptide is GLP-1 and the second polypeptide is an amylin analogue. 
     
     
         12 . The device of  claim 11 , wherein the amylin analogue is pramlintide. 
     
     
         13 . The device of  claim 1 , wherein the first polypeptide is GLP-1 and the second polypeptide is a ghrelin antagonist. 
     
     
         14 . The device of  claim 1 , wherein the first polypeptide is GLP-1 and the second polypeptide is a GRP 119 agonist. 
     
     
         15 . The device of  claim 1 , wherein the first polypeptide is GLP-1 and the second polypeptide is leptin. 
     
     
         16 . The device of  claim 1 , wherein the beneficial agent formulation comprises a third polypeptide selected from PYY and oxyntomodulin. 
     
     
         17 . The device of  claim 1 , wherein the solvent is selected from the group consisting of lauryl lactate, lauryl alcohol, and benzyl benzoate. 
     
     
         18 . The device of  claim 1 , wherein the polymer is polyvinylpyrrolidone. 
     
     
         19 . The device of  claim 17 , wherein the polymer is polyvinylpyrrolidone. 
     
     
         20 . The device of  claim 1 , wherein the solvent is benzyl benzoate and the polymer is polyvinylpyrrolidone. 
     
     
         21 - 63 . (canceled)