US2015164999A1PendingUtilityA1

Long-Acting Formulations of Insulin

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Assignee: SANOFI SAPriority: May 19, 2010Filed: Feb 17, 2015Published: Jun 18, 2015
Est. expiryMay 19, 2030(~3.8 yrs left)· nominal 20-yr term from priority
Inventors:Reinhard BeckerAnnke FrickPeter BoderkeChristiane FuerstWerner MuellerUlrich Werner
A61P 5/50A61P 3/08A61P 5/48A61P 3/10A61K 47/02A61K 47/26A61K 38/28A61K 47/30A61K 9/08A61K 38/2278A61K 9/0019A61K 47/10A61K 38/26
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Claims

Abstract

The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.

Claims

exact text as granted — not AI-modified
1 . An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin]. 
     
     
         2 . The aqueous pharmaceutical formulation of  claim 1  further comprising at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         3 . The aqueous pharmaceutical formulation of  claim 2  comprising
 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
 
     
     
         4 . The aqueous pharmaceutical formulation of  claim 1 , wherein the pH is between 3.4 and 4.6. 
     
     
         5 . The aqueous pharmaceutical formulation of  claim 4 , wherein the pH is 4. 
     
     
         6 . A method of treating Type I and Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to said patient an aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin]. 
     
     
         7 . The method of  claim 6 , wherein the aqueous pharmaceutical formulation further comprises at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         8 . The method of  claim 7 , wherein the aqueous pharmaceutical formulation further consists of 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
     
     
         9 . The method of  claim 7 , wherein the aqueous pharmaceutical formulation further comprises 90 μg/mL zinc, 2.7 mg/mL m-cresol, 20 μg/mL polysorbate 20, and 20 mg/mL glycerol 85%. 
     
     
         10 . The method of  claim 6 , wherein the aqueous pharmaceutical formulation has a pH between 3.4 and 4.6. 
     
     
         11 . The method of  claim 10 , wherein the aqueous pharmaceutical formulation has a pH of 4. 
     
     
         12 . The aqueous pharmaceutical formulation of  claim 1  further comprising an analogue of exendin-4. 
     
     
         13 . The aqueous pharmaceutical formulation of  claim 12 , wherein the analogue of exendin-4 is selected from the group consisting of lixisentatide, exenatide, and liraglutide. 
     
     
         14 . The aqueous pharmaceutical formulation of  claim 13  comprising 0.1 μg to 10 μg lixisenatide per U insulin glargine. 
     
     
         15 . The aqueous pharmaceutical formulation of  claim 14  comprising 0.2 μg to 1 μg lixisenatide per U insulin glargine. 
     
     
         16 . The aqueous pharmaceutical formulation of  claim 15  comprising 0.25 μg to 0.7 μg lixisenatide per U insulin glargine. 
     
     
         17 . The method of  claim 6 , wherein said aqueous pharmaceutical formulation further comprises an analogue of exendin-4. 
     
     
         18 . The method of  claim 17 , wherein the analogue of exendin-4 is selected from the group consisting of lixisentatide, exenatide, and liraglutide. 
     
     
         19 . The method of  claim 18 , wherein said aqueous formulation further comprises 0.1 μg to 10 μg lixisenatide per U insulin glargine. 
     
     
         20 . The method of  claim 19  wherein said aqueous formulation further consists of 0.2 to 1 μg lixisenatide per U insulin glargine. 
     
     
         21 . The method of  claim 20 , wherein said aqueous formulation further comprises 0.25 μg to 0.7 μg lixisenatide per U insulin glargine. 
     
     
         22 . A method of reducing the incidence of hypoglycaemia in the treatment of Type I and Type II Diabetes Mellitus in a patient in need thereof comprising subcutaneously administering to said patient an aqueous pharmaceutical composition formulation comprising insulin glargine in a concentration of 300 U/mL [equimolar to 300 IU human insulin]. 
     
     
         23 . An aqueous pharmaceutical formulation comprising 300 U/mL of insulin glargine [equimolar to 300 IU human insulin], wherein the pharmacokinetic profile and the pharmacodynamic profile are flatter than in an aqueous pharmaceutical formulation comprising 100 U/mL of insulin glargine wherein the pH of said U300 U/mL aqueous formulation is between 3.4 and 4.6. 
     
     
         24 . The aqueous pharmaceutical formulation of  claim 23  further comprising at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         25 . The aqueous pharmaceutical formulation of  claim 24  comprising
 90 μL/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
 
     
     
         26 . The aqueous pharmaceutical formulation of  claim 23 , wherein the pH is between 3.4 and 4.6. 
     
     
         27 . The aqueous pharmaceutical formulation of  claim 26 , wherein the pH is 4.

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