Solvent/polymer solutions as suspension vehicles

Abstract

A nonaqueous, single-phase vehicle that is capable of suspending an active agent. The nonaqueous, single-phase vehicle includes at least one solvent and at least one polymer and is formulated to exhibit phase separation upon contact with an aqueous environment. The at least one solvent may be selected from the group consisting of benzyl benzoate, decanol, ethyl hexyl lactate, and mixtures thereof and the at least one polymer may be selected from the group consisting of a polyester, pyrrolidone, ester of an unsaturated alcohol, ether of an unsaturated alcohol, polyoxyethylenepolyoxypropylene block copolymer, and mixtures thereof. In one embodiment, the at least one solvent is benzyl benzoate and the at least one polymer is polyvinylpyrrolidone. A stable, nonaqueous suspension formulation that includes the nonaqueous, single-phase vehicle and an active agent, and a method of forming the same, are also disclosed.

1 .- 25 . (canceled) 
     
     
         26 . A suspension formulation comprising: an active agent and at least one excipient, wherein: the active agent is present in the suspension formulation at approximately 3-12% (w/w), the active agent comprises a peptide, the peptide is a glucagon-like peptide analog, the at least one excipient comprises sucrose; the suspension formulation further comprising phosphate buffer and a polymer, wherein the polymer comprises one or more of polylactide, polyglycolide, polycaprolactone, and polylacticpolyglycolic acid. 
     
     
         27 . The suspension formulation of  claim 26 , wherein the polymer comprises polylactide. 
     
     
         28 . The suspension formulation of  claim 26 , wherein the polymer comprises polyglycolide. 
     
     
         29 . The suspension formulation of  claim 26 , wherein the polymer comprises polylacticpolyglycolic acid. 
     
     
         30 . The suspension formulation of  claim 30 , wherein the suspension formulation is an injectable formulation. 
     
     
         31 . An implantable delivery device comprising a suspension formulation, the suspension formulation comprising: an active agent and a polymer, wherein: the active agent comprises a peptide, the peptide is a glucagon-like peptide analog, and the polymer comprises one or more of polylactide, polyglycolide, polycaprolactone and polylacticpolyglycolic acid. 
     
     
         32 . The implantable delivery device of  claim 31 , wherein the polymer comprises polylactide. 
     
     
         33 . The implantable delivery device of  claim 31 , wherein the polymer comprises polyglycolide. 
     
     
         34 . The implantable delivery device of  claim 31 , wherein the polymer comprises polylacticpolyglycolic acid. 
     
     
         35 . The implantable delivery device of  claim 31 , wherein the suspension formulation further comprises sucrose. 
     
     
         36 . The implantable delivery device of  claim 31 , wherein the suspension formulation further comprises phosphate buffer. 
     
     
         37 . A method for the treatment of diabetes in a patient, comprising administering the suspension formulation of  claim 26  to the patient. 
     
     
         38 . The method of  claim 37 , wherein the polymer comprises polylactide. 
     
     
         39 . The method of  claim 37 , wherein the polymer comprises polyglycolide. 
     
     
         40 . The method of  claim 37 , wherein the polymer comprises polylacticpolyglycolic acid. 
     
     
         41 . A method for the treatment of diabetes in a patient, comprising administering the implantable delivery device of  claim 31  to the patient. 
     
     
         42 . The method of  claim 41 , wherein the polymer comprises polylactide. 
     
     
         43 . The method of  claim 41 , wherein the polymer comprises polyglycolide. 
     
     
         44 . The method of  claim 41 , wherein the polymer comprises polylacticpolyglycolic acid.