OPHTHALMIC COMPOSITION WITH HYALURONIC ACID AND POLYMERIC BIGUANIDE

• US 20080312182A1
• Filed: 04/25/2008
• Published: 12/18/2008
• Est. Priority Date: 06/13/2007
• Status: Active Grant

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Burke, Susan E., Venkastesh, Srini
• Granted Patent: US 8,759,321 B2
• Time in Patent Office: Days
• US Class Current: 514/54
• CPC Class Codes: A61L 12/142 Polymeric biguanides
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: C11D 1/90 Betaines
• CPC Class Codes: C11D 1/92 Sulfobetaines ; Sulfitobetaines
• CPC Class Codes: C11D 3/0078 Compositions for cleaning contact lenses, spectacles or lenses
• CPC Class Codes: C11D 3/222 Natural or synthetic polysaccharides, e.g. cellulose, starch, gum, alginic acid or cyclodextrin
• CPC Class Codes: C11D 3/227 with nitrogen-containing groups
• CPC Class Codes: C11D 3/3723 Polyamines or polyalkyleneimines
• CPC Class Codes: C11D 3/48 Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions

Abstract

An ophthalmic composition comprising 0.5 ppm to 3 ppm of poly(hexamethylene biguanide), and 0.002 wt. % to 0.03 wt. % of hyaluronic acid. The weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 45:1 to 120:1. The invention is also directed to a method of cleaning, disinfecting or packaging contact lenses with the composition, or to a method of rewetting contact lenses with the composition.

Claims

1. An ophthalmic composition comprising:

0.5 ppm to 3 ppm of poly(hexamethylene biguanide); and

0.002 wt. % to 0.015 wt. % of hyaluronic acid, wherein the weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 45;

1 to 120;

1.

2. The composition of claim 1 wherein the hyaluronic acid has a glucuronic acid content that is greater than 42% by weight.

3. The composition of claim 1 wherein the weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 55:

1 to 90;

1.

4. The composition of claim 1 further comprising 0.01 wt. % to 2 wt. % of an amphoteric surfactant of general formula I

wherein R¹ is R or —

(CH₂)_n—

NHC(O)R, wherein R is a C₈-C₃₀alkyl optionally substituted with hydroxyl and n is 2, 3 or 4;

R² and R³ are each independently selected from the group consisting of hydrogen and C₁-C₄alkyl;

R⁴ is a C₂-C₈alkylene optionally substituted with hydroxyl; and

Y is CO₂⁻

or SO₃⁻

.

5. The composition of claim 4 wherein R¹ is R;

R² and R³ are each independently selected from a C₁-C₂alkyl;

R⁴ is a C₂-C₄alkylene and Y is SO₃⁻

.

6. The composition of claim 4 wherein R¹ is —

(CH₂)_n—

NHC(O)R and n is 3 or 4;

R² and R³ are each independently selected from a C₁-C₂alkyl;

R⁴ is a C₂-C₄alkylene and Y is CO₂<sup>−

1</sup>.

7. The composition of claim 1 comprising α

-[4-tris(2-hydroxyethyl)-ammonium chloride-2-butenyl]poly[1-dimethyl ammonium chloride-2-butenyl]-ω

-tris(2-hydroxyethyl)ammonium chloride, which is present from 0.5 ppm to 2 ppm.

8. The composition of claim 1 further comprising 0.01 wt. % to 0.05 wt. % ethylenediaminetetraacetic acid or a corresponding salt thereof.

9. The composition of claim 1 wherein the hyaluronic acid or a salt thereof is obtained via a fermentation mixture comprising Streptococcus equi.

10. The composition of claim 1 further comprising a boric acid/borate buffer.

18. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in the ophthalmic composition of claim 3 for at least two hours.

11. An ophthalmic composition comprising:

0.8 ppm to 2 ppm of poly(hexamethylene biguanide);

0.002 wt. % to 0.015 wt. % of hyaluronic acid, wherein the weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 45;

1 to 120;

1;

a boric acid/borate buffer; and

a nonionic surfactant selected from poloxamer, poloxamine or any combination thereof.

12. The composition of claim 11 wherein the hyaluronic acid has a glucuronic acid content that is greater than 42% by weight.

13. The composition of claim 11 wherein the weight ratio of hyaluronic acid to poly(hexamethylene biguanide) in the composition is from 55:

1 to 90;

1.

14. The composition of claim 11 further comprising 0.01 wt. % to 0.05 wt. % ethylenediaminetetraacetic acid or a corresponding salt thereof.

15. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in the ophthalmic composition of claim 11 for at least two hours.

16. The method of claim 15 further comprising inserting the cleaned and disinfected contact lens into the eye without rinsing the lens after soaking.

17. The method of claim 15 further comprising rinsing the cleaned and disinfected contact lens with the ophthalmic composition prior to inserting the lens into the eye.