Composition and Method for Promoting Wound Healing

• US 20120070401A1
• Filed: 08/25/2011
• Published: 03/22/2012
• Est. Priority Date: 09/21/2010
• Status: Abandoned Application

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Zhang, Jinzhong, Ward, Keith W., Lopez, Francisco J., Jonasse, Matthew
• Application Number:
  US13/217,336
• Publication Number:
  US 20120070401A1
• Time in Patent Office: Days
• US Class Current: 424/78.04
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 2430/16 for reconstruction of eye parts, e.g. intraocular lens, cornea
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 33/02 Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection

Abstract

A composition for promoting wound healing comprises a bioadhesive polymer and a pharmaceutically acceptable liquid medium. Such a composition is applied to a wound to promote healing of the wound. The bioadhesive polymer can be selected from the group consisting of natural or synthetic hydrophilic polymers and hydrogels.

Claims

1. A composition comprising a bioadhesive polymer and a pharmaceutically acceptable vehicle, wherein the bioadhesive polymer comprises a mucoadhesive adhesive, and the pharmaceutically acceptable vehicle comprises a liquid medium, wherein the composition promotes healing of a wound.

2. The composition of any one of previous claims, wherein the liquid medium comprises an aqueous medium.

3. The composition of any one of previous claims, wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium, and wherein the bioadhesive polymer is selected from the group consisting of hydrophilic polymers, hydrogels, and mixtures thereof.

4. The composition of any one of previous claims, wherein the bioadhesive polymer is selected from the group consisting of polyvinylpyrrolidone, methyl cellulose, carboxymethyl cellulose and its salts, hydroxypropylmethyl cellulose, other hydrophilic cellulose derivatives, alginate and its salts, hyaluronic acid and its salts, and chitosan and derivatives thereof.

5. The composition of any one of previous claims, wherein the amount of the bioadhesive polymer is in the range from about 0.001 to about 10 percent by weight of the total composition.

6. The composition of any one of previous claims, wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium;

and the bioadhesive polymer comprises a lightly crosslinked poly(acrylic acid) in an amount in the range from about 0.1 to about 7 percent by weight of the total composition.

7. The composition of any one of previous claims, wherein the crosslinked poly(acrylic acid) is selected from the group consisting of polycarbophil (poly(acrylic acid) crosslinked with divinyl glycol), Carpobol®

polymers (poly(acrylic acid) crosslinked with allyl ethers of pentaerythritol or allyl ethers of sucrose), and poly(C_10-30 alkyl acrylate/acrylic acid) crosspolymers.

8. The composition of any one of previous claims, wherein the composition as disclosed herein has a viscosity in the range from about 2 to about 2,000 centipoises (or mPa·

s), as measured by a Brookfield viscometer (Model RVDV Ill) at 25°

C. and a shear rate of 1-7 sec<sup>−

1</sup>, with a CPE-40 spindle.

9. The composition of any one of previous claims;

wherein the bioadhesive polymer comprises a polycarbophil in an amount in the range from about 0.1 to about 7 percent by weight of the total composition;

the composition has a viscosity in the range from about 3 to about 1500 mPa·

s.

10. The composition of any one of previous claims, wherein the composition comprises:

(a) a bioadhesive polymer;

(b) a non-ionic or ionic tonicity agent;

(c) a pharmaceutically acceptable preservative; and

(d) a pharmaceutically acceptable aqueous medium;

wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium; and

the bioadhesive polymer comprises a polycarbophil in an amount in the range from about 0.1 to about 7 percent by weight of the total composition;

wherein the composition has a viscosity in the range from about 3 to about 1500 mPa·

s.

11. The composition of any one of previous claims, wherein the composition comprises:

(a) a bioadhesive polymer;

(b) a tonicity agent (non ionic or inonic);

(c) a pharmaceutically acceptable preservative;

(d) a preservative-enhancing material; and

(e) a pharmaceutically acceptable aqueous medium;

wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium; and

the bioadhesive polymer comprises a polycarbophil in an amount in the range from about 0.1 to about 7 percent by weight of the total composition;

wherein the composition has a viscosity in the range from about 3 to about 1500 mPa·

s;

wherein the preservative-enhancing material is selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof.

12. The composition of any one of previous claims, wherein the composition comprises:

(a) a bioadhesive polymer;

(b) a non ionic or inonic tonicity agent;

(c) a pharmaceutically acceptable preservative;

(d) a preservative-enhancing material;

(e) a chelating agent; and

(f) a pharmaceutically acceptable aqueous medium;

wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium; and

the bioadhesive polymer comprises a polycarbophil in an amount in the range from about 0.1 to about 7 percent by weight of the total composition;

wherein the composition has a viscosity in the range from about 3 to about 1500 mPa·

s, as measured at the condition disclosed herein;

wherein the preservative-enhancing material is selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof.

13. The composition of any one of previous claims, wherein the composition comprises:

(a) a bioadhesive polymer;

(b) a non ionic or inonic tonicity agent;

(c) a pharmaceutically acceptable preservative;

(d) a preservative-enhancing material;

(e) a chelating agent; and

(f) a pharmaceutically acceptable aqueous medium;

wherein the bioadhesive polymer is suspended or dissolved in the aqueous medium; and

the bioadhesive polymer comprises chitosan or a derivative thereof, in an amount in the range from about 0.1 to about 7 percent by weight of the total composition;

wherein the composition has a viscosity in the range from about 3 to about 1500 mPa·

s, as measured at the condition disclosed herein;

wherein the preservative-enhancing material is selected from the group consisting of D-glucose, sucrose, maltose, D-mannose, trehalose, glutamic acid, mixtures thereof, and combinations thereof.

14. The composition of any one of the previous claims, further comprising an active pharmaceutical ingredient (or therapeutic agent) selected from the group consisting of anti-inflammatory agents, antibiotics, immunosuppressive agents, antiviral agents, antifungal agents, antiprotozoal agents, combinations thereof, or mixtures thereof.

15. A method of for promoting wound healing, the method comprising applying to a wound a composition of any one of the previous claims.

16. The method of claim 15, wherein said wound is an ocular wound, and wherein the method comprises applying to said ocular wound any one composition of claims 1-14.

17. The method of any one of claims 15-16, wherein said composition is in a form of an eye drop, suspension, emulsion, dispersion, or gel.

18. The method of any one of claims 15-17, wherein said composition is in a form of an eye drop, emulsion, or gel.

19. The method of any one of claims 15-18, wherein said wound is an ocular wound resulting from an ocular surgery.

20. The method of any one of claims 15-19, wherein said wound is an ocular wound resulting from cataract surgery.