US2013281364A1PendingUtilityA1

Preparation Comprising Insulin, Nicotinamide and an Amino Acid

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Assignee: NOVO NORDISK ASPriority: Jun 26, 2009Filed: Nov 7, 2012Published: Oct 24, 2013
Est. expiryJun 26, 2029(~3 yrs left)· nominal 20-yr term from priority
Inventors:Helle Birk OlsenSvend HavelundUlla Ribel-MadsenJeppe SturisHelle NaverMorten SchleinSvend Ludvigsen
A61P 3/10A61P 9/10A61P 3/08A61P 9/00A61K 47/22A61K 2121/00A61K 31/198A61K 9/0019A61K 31/455A61K 45/06A61K 47/02A61K 31/465A61K 47/183A61K 38/28A61K 47/18
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Claims

Abstract

Insulin preparations comprising an insulin compound or a mixture of two or more insulin compounds, a nicotinic compound and an amino acid.

Claims

exact text as granted — not AI-modified
1 . An insulin preparation comprising:
 an insulin compound;   a nicotinic compound;   arginine; and   a buffer.   
     
     
         2 . The insulin preparation of  claim 1 , wherein the buffer is a phosphate buffer. 
     
     
         3 . The insulin preparation of  claim 2 , wherein the insulin compound comprises B28Asp human insulin. 
     
     
         4 . The insulin preparation of  claim 1 , wherein the insulin compound is selected from the group consisting of B28Asp human insulin, B28LysB29Pro human insulin, and B3LysB29Glu human insulin. 
     
     
         5 . The insulin preparation of  claim 4 , wherein the buffer is a phosphate buffer. 
     
     
         6 . An insulin preparation comprising:
 B28Asp human insulin;   nicotinamide;   zinc;   arginine; and   a phosphate buffer.   
     
     
         7 . The insulin preparation of  claim 6 , wherein the nicotinamide is present at a concentration ranging from about 1 mM to about 300 mM. 
     
     
         8 . The insulin preparation of  claim 7 , wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 
     
     
         9 . The insulin preparation of  claim 8 , wherein the arginine is present in a concentration from about 10 mM to about 60 mM. 
     
     
         10 . The insulin preparation of  claim 9 , wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 
     
     
         11 . The insulin preparation of  claim 10 , wherein the preparation has a pH of about 7.4 or less. 
     
     
         12 . The insulin preparation of  claim 11 , wherein the preparation has a pH of about 7.1. 
     
     
         13 . The insulin preparation of  claim 6  wherein the nicotinamide is present at a concentration ranging from about 80 mM to about 260 mM. 
     
     
         14 . The insulin preparation of  claim 13 , wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 
     
     
         15 . The insulin preparation of  claim 14 , wherein the preparation has a pH of about 7.4 or less. 
     
     
         16 . The insulin preparation of  claim 15 , wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 
     
     
         17 . The insulin preparation of  claim 14 , wherein the preparation has a pH of about 7.1. 
     
     
         18 . The insulin preparation of  claim 17 , wherein less than about 4 zinc ions are present per six B28Asp human insulin molecules. 
     
     
         19 . An aqueous insulin preparation consisting essentially of:
 an insulin analog;   a nicotinic compound;   arginine;   a buffer;   zinc;   a preservative; and   an isotonicity agent.   
     
     
         20 . The aqueous insulin preparation of  claim 19 , wherein the buffer is a phosphate buffer. 
     
     
         21 . The aqueous insulin preparation of  claim 20 , wherein the insulin analog is selected from the group consisting of B28Asp human insulin, B28LysB29Pro human insulin, and B3LysB29Glu human insulin. 
     
     
         22 . The aqueous insulin preparation of  claim 20 , wherein the insulin analog is B28Asp human insulin. 
     
     
         23 . The insulin preparation of  claim 22 , wherein the nicotinic compound is nicotinamide. 
     
     
         24 . The insulin preparation of  claim 23  wherein the nicotinamide is present at a concentration ranging from about 80 mM to about 260 mM. 
     
     
         25 . The insulin preparation of  claim 24 , wherein the arginine is present in a concentration ranging from about 10 mM to about 40 mM. 
     
     
         26 . The insulin preparation of  claim 25 , wherein the preservative is selected from the group consisting of phenol, cresol, and combinations thereof, and wherein the preparation has a pH of about 7.4 or less. 
     
     
         27 . The insulin preparation of  claim 26 , wherein less than about 4 zinc ions are present per six insulin analog molecules. 
     
     
         28 . The insulin preparation of  claim 26 , wherein the preparation has a pH of about 7.1.

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