Compositions and methods for the treatment of wounds and the reduction of scar formation

• US 20070059377A1
• Filed: 06/28/2006
• Published: 03/15/2007
• Est. Priority Date: 08/22/2005
• Status: Active Grant

• Current Assignee: Osiris Therapeutics Incorporated (Smith & Nephew PLC)
• Original Assignee: Healagenics, Inc.
• Inventors: Keum, Ki, Yoo, Won, Yoo, Naechoon, Freddo, Mary
• Granted Patent: US 7,323,184 B2
• Time in Patent Office: Days
• US Class Current: 424/601
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

The present invention relates to methods and compositions for inhibiting scar formation on wound region. In certain embodiments, the methods include administering an alkalinization agent in combination with hyaluronic acid to a wound site to reduce the formation of scars at the wound site. Suitable alkalization agents include sodium bicarbonate, sodium hydroxide and potassium hydroxide.

Claims

1. A method for reducing scar formation at a wound site comprising administering to the wound site an effective amount of an composition comprising an alkalinizing agent together or in alternation with hyaluronic acid, to raise the pH at the wound site, to allow the wound site to heal and thereby reduce scar formation at the site.

2. The method of claim 1, wherein the composition comprises the alkalinizing agent and hyaluronic acid in a pharmaceutically acceptable carrier and has an alkaline pH.

3. The method of claim 2, wherein the composition comprises an aqueous solution of the alkalinizing agent and hyaluronic acid, buffered to an alkaline pH.

4. The method of claim 1, wherein composition comprises an aqueous solution at alkaline pH.

5. The method of claim 1, wherein the raised pH at the wound site is about 8.5 to 10.

6. The method of claim 2, wherein the composition is administered to the wound site by topical administration to the wound.

7. The method of claim 1 or 2, wherein the alkalinizing agent is selected from a group consisting of sodium bicarbonate, sodium hydroxide, potassium hydroxide, tromethamine (THAM), acetazolamide (Diamox), sodium citrate, potassium citrate, potassium phosphate, dibasic sodium phosphate, tribasic sodium phosphate, and sodium lactate.

8. The method of claim 1 or 2, wherein the alkalinizing agent is sodium bicarbonate, sodium hydroxide, potassium hydroxide, or sodium bicarbonate.

9. The method of claim 3, wherein the pH of said composition is about 8.0 to 10.0.

10. The method of claim 2, wherein the pharmaceutically acceptable carrier is suitable for intradermal delivery, subcutaneous delivery, body cavity delivery or topical delivery.

11. The method of claim 1, wherein the composition is administered to a body cavity of the ear, nose or throat, optionally after surgery.

12. The method of claim 2, wherein the concentration of hyaluronic acid is between 0.5% to 5% (wt./wt.).

13. A pharmaceutical composition for inhibiting scar formation on wound region comprising an alkalinizing agent and hyaluronic acid, wherein said composition has an alkaline pH.

14. The composition of claim 13, wherein the alkalinizing agent is selected from a group consisting of sodium bicarbonate, sodium hydroxide, potassium hydroxide, tromethamine (THAM), acetazolamide (Diamox), sodium citrate, potassium citrate, potassium phosphate, dibasic sodium phosphate, tribasic sodium phosphate, and sodium lactate.

15. A kit for reducing scar formation at a wound site comprising:

(i) at least one container containing an effective amount of an alkalinizing agent to raise pH at the wound site and inactivate TGF-β

at the wound site in a pharmaceutically acceptable carrier wherein the raised pH at the wound site may be in the range of 8.5 to 10.0;

(ii) hyaluronic acid; and

(ii) written instructions on the use of the kit for reducing scar formation.

16. The kit of claim 15 for reducing scar formation after ear, nose or throat surgery, the kit comprising a formulation of hyaluronic acid at a pH of about 8.5-10.0 suitable for implant in a cavity of the ear nose, or throat optionally after surgery.