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.

1 - 38 . (canceled) 
     
     
         39 . A non-aqueous formulation comprising at least one beneficial agent uniformly suspended in a non-aqueous single-phase biocompatible viscous vehicle, the non-aqueous single-phase biocompatible viscous vehicle comprising:
 a polymer component comprising at least one of polyvinylpyrrolidone, glycerol monolaurate, and polysorbate; and   a solvent component consisting of lauryl alcohol or a carboxylic acid ester,   wherein the at least one beneficial agent is present in an amount from about 0.1% (w/w) to about 50% (w/w) of the formulation.   
     
     
         40 . The formulation of  claim 39 , wherein the amount of the at least one beneficial agent is about 10% (w/w) to about 40% (w/w) of the formulation. 
     
     
         41 . The formulation of  claim 40 , wherein the amount of the at least one beneficial agent is at least about 20% (w/w) to about 30% (w/w) of the formulation. 
     
     
         42 . The formulation of  claim 39 , wherein the amount of the at least one beneficial agent is selected based at least one of a potency of the at least one beneficial agent, a duration of treatment with the at least one beneficial agent, and a rate of release of the at least one beneficial agent from a drug delivery device. 
     
     
         43 . A stable non-aqueous viscous protein formulation that is capable of being uniformly dispensed over an extended period of time at a low flow rate and is stable at body temperature for extended periods of time, the stable non-aqueous viscous protein formulation comprising:
 a) at least one protein; and   b) a non-aqueous single-phase biocompatible viscous vehicle comprising:
 a polymer component comprising at least one of polyvinylpyrrolidone, glycerol monolaurate, and polysorbate; and 
 a solvent component consisting of lauryl alcohol or a carboxylic acid ester, 
   wherein the at least one protein is present in an amount from about 0.1% (w/w) to about 50% (w/w) of the formulation.   
     
     
         44 . The formulation of  claim 43 , wherein the amount of the at least one protein is about 10% (w/w) to about 40% (w/w) of the formulation. 
     
     
         45 . The formulation of  claim 44 , wherein the amount of the at least one protein is at least about 20% (w/w) to about 30% (w/w) of the formulation. 
     
     
         46 . The formulation of  claim 43 , wherein the amount of the at least one protein is selected based on at least one of a potency of the at least one protein, a duration of treatment with the at least one protein, and a rate of release of the at least one protein from a drug delivery device. 
     
     
         47 . A drug delivery device, comprising an osmotic engine, a piston, a rate controlling membrane, and a reservoir, the reservoir containing a stable non-aqueous viscous protein formulation that is capable of being uniformly dispensed over an extended period of time at a low flow rate and is stable at body temperature for extended periods of time, the stable non-aqueous viscous protein formulation comprising:
 a) at least one protein; and   b) a non-aqueous single-phase biocompatible viscous vehicle comprising:
 a polymer component comprising at least one of polyvinylpyrrolidone, glycerol monolaurate, and polysorbate; and 
 a solvent component consisting of lauryl alcohol or a carboxylic acid ester, 
   wherein the at least one protein is present in an amount from about 0.1% (w/w) to about 50% (w/w) of the formulation.   
     
     
         48 . The drug delivery device of  claim 47 , wherein the amount of the at least one beneficial agent is about 10% (w/w) to about 40% (w/w) of the formulation. 
     
     
         49 . The drug delivery device of  claim 48 , wherein the amount of the at least one beneficial agent is at least about 20% (w/w) to about 30% (w/w) of the formulation. 
     
     
         50 . The drug delivery device of  claim 47 , wherein the amount of the at least one beneficial agent is selected based at least one of a potency of the at least one beneficial agent, a duration of treatment with the at least one beneficial agent, and a rate of release of the at least one beneficial agent from the drug delivery device. 
     
     
         51 . A drug delivery device, comprising an osmotic engine, a piston, a rate controlling membrane, and a reservoir, the reservoir containing a non-aqueous formulation comprising at least one beneficial agent uniformly suspended in a non-aqueous single-phase biocompatible viscous vehicle, the non-aqueous single-phase biocompatible viscous vehicle comprising:
 a polymer component comprising at least one of polyvinylpyrrolidone, glycerol monolaurate, and polysorbate; and   a solvent component consisting of lauryl alcohol or a carboxylic acid ester,   wherein the at least one beneficial agent is present in an amount from about 0.1% (w/w) to about 50% (w/w) of the formulation.   
     
     
         52 . The drug delivery device of  claim 51 , wherein the amount of the at least one protein is about 10% (w/w) to about 40% (w/w) of the formulation. 
     
     
         53 . The drug delivery device of  claim 52 , wherein the amount of the at least one protein is at least about 20% (w/w) to about 30% (w/w) of the formulation. 
     
     
         54 . The drug delivery device of  claim 51 , wherein the amount of the at least one protein is selected based on at least one of a potency of the at least one protein, a duration of treatment with the at least one protein, and a rate of release of the at least one protein from the drug delivery device.