Ophthalmic composition with hyaluronic acid and polymeric biguanide

• US 8,759,321 B2
• Filed: 04/25/2008
• Issued: 06/24/2014
• 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
• Primary Examiner(s): Bland, Layla
• Assistant Examiner(s): CRAIGO, BAHAR ALAWI
• Application Number:
  US12/109,599
• Publication Number:
  US 20080312182A1
• Time in Patent Office: 2,251 Days
• Field of Search: 514/54
• 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. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in a multi-purpose lens care solution for at least two hours, the lens care solution 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(nexamethylene biguanide) in the composition is from 45;

1 to 120;

1; and

0.5 ppm to 2 ppm of α

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

-tris(2-hydroxyethyl)ammonium Chloride,

wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani, for a storage time period of up to and including four months at 30°

C., in accordance with FDA-Premarket Notification 510(k) Guidance Document for contact lens care products.

2. The method of claim 1 further comprising inserting the cleaned and disinfected contact lens into the eye without rinsing the lens after soaking.

3. The method of claim 1 further comprising rinsing the cleaned and disinfected contact lens with the lens care solution prior to inserting the lens into the eye.

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

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

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

7. The method of claim 1 further comprising a disuccinate of formula IV below or a corresponding salt thereof;

8. The method of claim 1 wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani for a storage time period of up to and including four months at 40°

C.

9. The method of claim 1 wherein the poly(hexamethylene biguanide) is present from 1 ppm to 2 ppm, and the α

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

-tris(2-hydroxyethyl)ammonium chloride is present from 1 ppm to 2 ppm.

10. The method of claim 1 wherein the lens care solution comprises diglycine, which is present at a concentration of 0.01 wt. % to 2.0 wt. %.

13. The method of claim 1 wherein the contact lens comprises a silicone hydrogel.

11. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in a multi-purpose lens care solution for at least two hours, the lens care solution comprising:

1 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;

1 ppm to 2 ppm of α

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

-tris(2-hydroxyethyl)ammonium chloride, and

a boron buffer component selected from the group consisting of boric acid, sodium or potassium borate, tetraborate and metaborate;

wherein the lens care solution maintains disinfecting ability against each of S. aureus, P. aeruginosa, S. marcescens, C. albicans and F. solani, for a storage time period of up to and including four months at 30°

C., in accordance with FDA Premarket Notification 510(k) Guidance Document for contact lens care products.

12. The method of claim 11 wherein the lens care solution comprises diglycine, which is present at a concentration of 0.01 wt. % to 2.0 wt. %.

14. The method of claim 11 wherein the contact lens comprises a silicone hydrogel.