Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicles

Abstract

This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at an exit shear rate of between about 1 to 1×10 7 reciprocal second.

What is claimed is: 
     
         1 . A non-aqueous formulation comprising a beneficial agent, polymer, and sugar; suspended in a non-aqueous single-phase vehicle, wherein:
 the beneficial agent is glucagon-like peptide-1 (GLP-1) or a peptide analog thereof;   the polymer comprises at least one of polylactic acid or polylacticpolyglycolic acid; and   the non-aqueous single-phase vehicle comprises sesame oil, peanut oil or Miglyol® triglycerides.   
     
     
         2 . The non-aqueous formulation of  claim 1 , wherein the beneficial agent is GLP-1. 
     
     
         3 . The non-aqueous formulation of  claim 1 , wherein the beneficial agent is a peptide analog of GLP-1. 
     
     
         4 . The non-aqueous formulation of  claim 3 , wherein the polymer comprises polylactic acid. 
     
     
         5 . The non-aqueous formulation of  claim 3 , wherein the polymer comprises polylacticpolyglycolic acid. 
     
     
         6 . The non-aqueous formulation of  claim 5 , wherein the non-aqueous single-phase vehicle comprises sesame oil. 
     
     
         7 . The non-aqueous formulation of  claim 5 , wherein the non-aqueous single-phase vehicle comprises peanut oil. 
     
     
         8 . The non-aqueous formulation of  claim 5 , wherein the non-aqueous single-phase vehicle comprises Miglyol® triglycerides. 
     
     
         9 . The non-aqueous formulation of  claim 8 , wherein the sugar comprises sucrose. 
     
     
         10 . The non-aqueous formulation of  claim 1 , consisting of a beneficial agent, polymer, and sugar; suspended in a non-aqueous single-phase vehicle, wherein
 the beneficial agent is glucagon-like peptide-1 (GLP-1) or a peptide analog thereof;   the polymer is polylacticpolyglycolic acid; and   the non-aqueous single-phase vehicle is Miglyol® triglycerides; and   the sugar is sucrose.   
     
     
         11 . A non-aqueous formulation comprising a beneficial agent and polymer; suspended in a non-aqueous single-phase vehicle, wherein:
 the beneficial agent is glucagon-like peptide-1 (GLP-1) or a peptide analog thereof;   the polymer comprises at least one of polylactic acid or polylacticpolyglycolic acid; and   the non-aqueous single-phase vehicle comprises sesame oil, peanut oil or Miglyol® triglycerides.   
     
     
         12 . The non-aqueous formulation of  claim 11 , consisting of a beneficial agent and polymer; suspended in a non-aqueous single-phase vehicle, wherein
 the beneficial agent is glucagon-like peptide-1 (GLP-1) or a peptide analog thereof;   the polymer is polylacticpolyglycolic acid; and   the non-aqueous single-phase vehicle is Miglyol® triglycerides.   
     
     
         13 . An implantable drug delivery device, comprising a reservoir containing the non-aqueous formulation of  claim 1 ; said implantable drug delivery device further comprising an osmotic engine, a piston, and a rate controlling membrane.