US2016339084A1PendingUtilityA1

Long-Acting Formulations of Insulin

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Assignee: SANOFI SAPriority: May 19, 2010Filed: May 23, 2016Published: Nov 24, 2016
Est. expiryMay 19, 2030(~3.8 yrs left)· nominal 20-yr term from priority
Inventors:Reinhard BeckerAnnke HahnPeter BoderkeChristiane FuerstWerner MuellerUlrich Werner
A61P 3/08A61P 5/50A61P 3/10A61P 5/48A61K 38/26A61K 47/02A61K 47/10A61K 9/08A61K 38/28A61K 47/26A61K 9/0019A61K 38/2278A61K 47/30
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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 200-1000 U/mL of insulin glargine [equimolar to 200-1000 IU human insulin]. 
     
     
         2 . The aqueous pharmaceutical formulation of  claim 1  comprising 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin]. 
     
     
         3 . The aqueous pharmaceutical formulation of  claim 2  further comprising at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         4 . The aqueous pharmaceutical formulation of  claim 3  further comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
     
     
         5 . The aqueous pharmaceutical formulation of  claim 4 , wherein the zinc is present in the form of zinc chloride. 
     
     
         6 . The aqueous pharmaceutical formulation of  claim 2 , wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6. 
     
     
         7 . The aqueous pharmaceutical formulation of  claim 6 , wherein the pH of the aqueous pharmaceutical formulation is 4.0. 
     
     
         8 . An aqueous pharmaceutical formulation comprising 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin] wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6. 
     
     
         9 . The aqueous pharmaceutical formulation of  claim 8 , wherein the pH of the aqueous pharmaceutical formulation is 4.0. 
     
     
         10 . The aqueous pharmaceutical formulation of  claim 8  further comprising at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         11 . The aqueous pharmaceutical formulation of  claim 10  further comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
     
     
         12 . The aqueous pharmaceutical formulation of  claim 11 , wherein the zinc is present in the form of zinc chloride. 
     
     
         13 . An aqueous pharmaceutical formulation comprising 270-330 U/mL of insulin glargine [equimolar to 270-330 IU human insulin], 90 μg/mL zinc chloride, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%, wherein the pH of the aqueous pharmaceutical formulation is 4.0. 
     
     
         14 . The aqueous pharmaceutical formulation of  claim 2 , wherein the pharmacokinetic profile and the pharmacodynamic profile of the aqueous pharmaceutical formulation are flatter than the pharmacokinetic profile and the pharmacodynamic profile of an aqueous pharmaceutical formulation comprising 100 U/mL of insulin glargine, and wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6. 
     
     
         15 . The aqueous pharmaceutical formulation of  claim 14 , wherein the pH of the aqueous pharmaceutical formulation is 4.0. 
     
     
         16 . The aqueous pharmaceutical formulation of  claim 14  further comprising at least one excipient selected from the group consisting of zinc, m-cresol, glycerol, and polysorbate 20. 
     
     
         17 . The aqueous pharmaceutical formulation of  claim 16  further comprising 90 μg/mL zinc, 2.7 mg/mL m-cresol, and 20 mg/mL glycerol 85%. 
     
     
         18 . The aqueous pharmaceutical formulation of  claim 17 , wherein the zinc is present in the form of zinc chloride. 
     
     
         19 . The aqueous pharmaceutical formulation of  claim 2 , wherein the aqueous pharmaceutical formulation provides a peakless long acting basal insulin, and wherein the pH of the aqueous pharmaceutical formulation is between 3.4 and 4.6. 
     
     
         20 . The aqueous pharmaceutical formulation of  claim 2 , wherein the aqueous pharmaceutical formulation exhibits an extended duration of exposure of insulin glargine than an aqueous pharmaceutical formulation comprising 100 U/mL insulin glargine, and wherein the pH of the aqueous formulation is between 3.4 and 4.6.

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