Stable Formulation of Modified GLP-1

Abstract

Pharmaceutical formulations of GLP-1 compounds and methods for preparation thereof.

1 . A pharmaceutical formulation comprising an aqueous solution of: a) 0.1 mg/ml to 100 mg/ml of a Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37) peptide; b) a buffer; c) 8-16 mg/ml of an isotonicity agent; and d) a preservative; wherein the formulation has a pH between 7.4 and 8.4, a turbidity below 8.3 NTU and does not contain a surfactant. 
     
     
         2 . The formulation of  claim 1 , wherein the pH of said formulation is from 7.4 to 8.0. 
     
     
         3 . The formulation of  claim 2 , wherein the pH of said formulation is from 7.4 to 7.7. 
     
     
         4 . The formulation of  claim 2 , wherein the pH of said formulation is from 7.7 to 8.0. 
     
     
         5 . The formulation of  claim 1 , wherein the pH of said formulation is from 8.0 to 8.4 
     
     
         6 . The formulation of  claim 1 , wherein the concentration of the Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37) is present in the formulation in a concentration of 1-10 mg/ml. 
     
     
         7 . The formulation of  claim 6 , wherein the preservative is present in the formulation in a concentration of 5-10 mg/ml. 
     
     
         8 . The formulation of  claim 5 , wherein non-crystallized Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37) is the concentration of the present in the formulation in a concentration of 1-10 mg/ml. 
     
     
         9 . The formulation of  claim 8 , wherein the preservative is present in the formulation in a concentration of 5-10 mg/ml. 
     
     
         10 . A pharmaceutical formulation comprising an aqueous solution of: a) 0.1 mg/ml to 100 mg/ml of Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37); b) a buffer; c) an isotonicity agent; and d) a preservative; wherein the formulation has a pH between 7.7 and 8.4, a turbidity below 8.3 NTU and does not contain a surfactant. 
     
     
         11 . The formulation of  claim 10 , wherein the pH of said formulation is from 7.7 to 8.0. 
     
     
         12 . The formulation of  claim 10 , wherein the pH of said formulation is from 8.0 to 8.4 
     
     
         13 . The formulation of  claim 10 , wherein the concentration of the Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37) is present in the formulation in a concentration of 1-10 mg/ml. 
     
     
         14 . The formulation of  claim 13 , wherein the preservative is present in the formulation in a concentration of 5-10 mg/ml. 
     
     
         15 . The formulation of  claim 12 , wherein the concentration of the Arg 34 ,Lys 26 (N-ε-(γ-Glu(N-α-hexadecanoyl)))-GLP-1(7-37) is present in the formulation in a concentration of 1-10 mg/ml. 
     
     
         16 . The formulation of  claim 15 , wherein the preservative is present in the formulation in a concentration of 5-10 mg/ml.