Method for administering insulin

• US 6,432,383 B1
• Filed: 03/30/2000
• Issued: 08/13/2002
• Est. Priority Date: 03/30/2000
• Status: Expired due to Term

• Current Assignee: Generex Pharmaceuticals Inc. (Generex Biotechnology Corp.)
• Original Assignee: Generex Pharmaceuticals Inc. (Generex Biotechnology Corp.)
• Inventors: Modi, Pankaj
• Primary Examiner(s): Low, Christopher S. F.
• Assistant Examiner(s): Mohamed, Abdel A.
• Application Number:
  US09/538,830
• Time in Patent Office: 866 Days
• Field of Search: 424/43, 424/45, 424/46, 424/434, 424/435, 424/455, 514/4, 514/3, 514/866, 514/946, 514/947, 530/303, 530/304
• US Class Current: 424/43
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/1075 Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers A61K9/0026 takes precedence

Abstract

A mixed micellar pharmaceutical formulation includes a micellar proteinic pharmaceutical agent, an alkali metal lauryl sulphate, alkali metal salicylate, a pharmaceutically acceptable edetate and at least one absorption enhancing compounds. The absorption enhancing compounds are selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening of primrose oil, trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof. The amount of each absorption enhancing compound is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and the total concentration of absorption enhancing compounds are less than 50 wt./wt. % of the formulation. A method for administering insulin to the buccal mucosa using a metered dose inhaler is also disclosed.

Claims

1. A method for administering insulin to the buccal mucosa comprising spraying an effective amount of said insulin to the buccal mucosa, using a metered dose inhaler.

2. The method of claim 1, wherein said insulin is administered in solution.

3. The method of claim 1, wherein said insulin is in a mixed micelle formulation.

4. The method of claim 3, wherein said micelles are 1 to 10 nm in size.

5. The method of claim 3, wherein said formulation comprises:

insulin, an alkali metal lauryl sulfate, a pharmaceutically acceptable edetate, at least one alkali metal salicylate, and at least one micelle forming compound selected from the group consisting of lecithin, hyaluronic acid, pharmaceutically acceptable salts of hyaluronic acid, octylphenoxypolyethoxyethanol, glycolic acid, lactic acid, chamomile extract, cucumber extract, oleic acid, linolenic acid, borage oil, evening of primrose oil, trihydroxy oxo cholanylglycine, glycerin, polyglycerin, lysine, polylysine, triolein and mixtures thereof;

wherein each of said sulfate, edetate and salicylate is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and wherein each micelle forming compound is present in a concentration of from 1 to 10 wt./wt. % of the total formulation, and the total concentration of sulfate, edetate, salicylate and micelle forming compounds is less than 50 wt./wt. % of the formulation.

6. The method of claim 5, wherein said alkali metal lauryl sulfate is sodium lauryl sulfate.

7. The method of claim 5, wherein said edetate is an alkali metal edetate.

8. The method of claim 5, wherein said alkali metal salicylate is sodium salicylate.

9. The method of claim 5, wherein said micelle forming compound is lecithin, lecithin in combination with hyaluronic acid, evening of primrose oil or borage oil.

10. The method of claim 5, wherein said formulation comprises a combination selected from the group consisting of:

i) sodium lauryl sulphate, sodium salicylate, disodium edetate, saturated phospholipid, and sodium hyaluronate;

ii) sodium lauryl sulphate, sodium salicylate, disodium edetate, lecithin, and sodium hyaluronate;

iii) sodium lauryl sulphate, sodium salicylate, disodium edetate, sodium hyaluronate, and evening of primrose oil;

iv) sodium lauryl sulphate, sodium salicylate, disodium edetate, saturated phospholipid, and bacitracin, v) sodium lauryl sulphate, sodium salicylate, disodium edetate, saturated phospholipid, sodium hyaluronate and bacitracin; and

vi) sodium lauryl sulphate, sodium salicylate, disodium edetate, sodium hyaluronate, oleic acid and gamma linoleic acid.

11. The method of claim 5, wherein said mixed micelle formulation further comprises water.