Zinc-free and low-zinc insulin preparations having improved stability

• US 20070093411A1
• Filed: 01/23/2006
• Published: 04/26/2007
• Est. Priority Date: 03/20/1997
• Status: Abandoned Application

• Current Assignee: Svend Havelund
• Original Assignee: Svend Havelund
• Inventors: Havelund, Svend
• Application Number:
  US11/337,855
• Publication Number:
  US 20070093411A1
• Time in Patent Office: Days
• US Class Current: 514/6.4
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• 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
• CPC Class Codes: C07K 14/62 Insulins

Abstract

The invention relates to a formulation comprising a polypeptide selected from at least one of insulin, an insulin analog, and an insulin derivative; at least one surfactant; optionally at least one preservative; and optionally at least one of an isotonicizing agent, a buffer or an excipient, wherein the formulation is free from or low in zinc.

Claims

1. A formulation, comprising:

at least one polypeptide selected from at least one of insulin, an insulin analog, and an insulin derivative;

at least one surfactant;

optionally at least one preservative; and

optionally at least one of an isotonicizing agent, a buffer, and an excipient,

wherein the formulation is free from or low in zinc.

2. The formulation according to claim 1, wherein the polypeptide is insulin.

3. The formulation according to claim 1, wherein the polypeptide is an insulin analog.

4. The formulation according to claim 1, wherein the polypeptide is an insulin derivative.

5. The formulation according to claim 1, wherein the preservative is a phenolic compound.

6. The formulation according to claim 1, wherein the surfactant is selected from a salt of a fatty acid, a bile salt, and a phospholipid.

7. The formulation according to claim 1, wherein the isotonicizing agent is selected from sorbitol, mannitol, and sucrose.

8. The formulation according to claim 1 wherein the formulation is aqueous.

9. A method of treating diabetes mellitus comprising administering the formulation according to claim 1 to a patient in need thereof.