Formulations of insulin

• US 7,387,996 B2
• Filed: 07/29/2005
• Issued: 06/17/2008
• Est. Priority Date: 05/07/2002
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Langkjaer, Liselotte
• Primary Examiner(s): RUSSEL, JEFFREY E
• Application Number:
  US11/193,200
• Publication Number:
  US 20050261168A1
• Time in Patent Office: 1,054 Days
• Field of Search: None
• US Class Current: 514/6.4
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

Stable insulin formulations can be prepared by mixing a monomeric insulin and a soluble acylated insulin analog.

Claims

1. A pharmaceutical soluble formulation suitable for continuous infusion systems comprising:

(i) insulin aspart;

(ii) insulin detemir;

(iii) a phenolic preservative at a concentration of about 30 mM to about 40 mM;

(iv) glycerol in a concentration of about 0.17 M;

(v) a pH buffer at concentration of about 5 mM to about 7 mM; and

(vi) zinc ions in an amount corresponding to about 2.5 to about 3.5 Zn²⁺/hexamer insulin, wherein the lower limit of the molar ratio between the insulin detemir and the insulin aspart is 7;

93 and the upper limit of the molar ratio between the insulin detemir and the insulin aspart is 57;

43.