Multipurpose Lens Care Solution with Benefits to Corneal Epithelial Barrier Function

• US 20110046033A1
• Filed: 11/04/2010
• Published: 02/24/2011
• Est. Priority Date: 01/31/2008
• Status: Abandoned Application

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Zhang, Jinzhong
• Application Number:
  US12/939,262
• Publication Number:
  US 20110046033A1
• Time in Patent Office: Days
• US Class Current: 510/112
• CPC Class Codes: A01N 25/02 containing liquids as carriers, diluents or solvents
• CPC Class Codes: A01N 33/12 Quaternary ammonium compounds
• CPC Class Codes: A01N 47/44 Guanidine; Derivatives thereof
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61L 12/141 Biguanides, e.g. chlorhexidine
• CPC Class Codes: A61L 12/145 Polymeric quaternary ammonium compounds
• CPC Class Codes: C11D 1/88 Ampholytes; Electroneutral compounds C11D1/002, C11D1/004, C11D1/008 take precedence
• 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 3/26 containing nitrogen C11D3/162, C11D3/164, C11D3/166, C11D3/168 take precedence
• CPC Class Codes: C11D 3/37 Polymers polymeric surface-active agents C11D1/008; polysaccharides C11D3/222
• CPC Class Codes: C11D 3/48 Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions

Abstract

A multipurpose lens care solution comprising 0.005 wt. % to 1 wt. % of an anionic biopolymer, and an antimicrobial agent selected from 0.5 ppm to 2 ppm of poly(hexamethylene biguanide), 0.5 ppm to 2 ppm polyquaternium-1, or 1 ppm to 4 ppm alexidine. The lens care solution exhibits a ZO-1 immunostaining of HCEpiC similar to phosphate buffered saline for after thirty minutes of contact time with the solution. The lens care solution will also have a transepithelial electrical resistance (TEER) of HCEpiC within a 25% difference or less than phosphate buffered saline in Ohm/cm² after one hour of contact time with a 3:1 dilution (solution:DMEM), or the ECIS electrode arrays exhibit a 25% difference or less than phosphate buffered saline in Ohm after one hour of contact time with a 1:1 dilution (solution:DMEM).

Claims

1. A multipurpose lens care solution comprising:

0.005 wt. % to 1 wt. % of an anionic biopolymer; and

an antimicrobial component selected from the group consisting of 0.5 ppm to 2 ppm of poly(hexamethylene biguanide), 0.5 ppm to 3 ppm of polyquaternium-1, 1 ppm to 4 ppm of alexidine and any one mixture thereof;

wherein the ZO-1 immunostaining of HCEpiC is similar to phosphate buffered saline after thirty minutes of contact time with the solution; and

the transepithelial electrical resistance (TEER) of HCEpiC exhibits a 25% difference or less than phosphate buffered saline in Ohm/cm² after one hour of contact time with a 3;

1 dilution (solution;

DMEM), or the ECIS electrode arrays exhibit a 25% difference or less than phosphate buffered saline in Ohm after one hour of contact time with a 1;

1 dilution (solution;

DMEM).

2. The solution of claim 1 wherein the antimicrobial component is 0.5 ppm to 2 ppm of poly(hexamethylene biguanide).

3. The solution of claim 2 wherein the anionic biopolymer is hyaluronic acid, which is present from 0.002 wt. % to 0.04 wt. %.

4. The solution of claim 2 comprising 0.01 wt. % to 1 wt. % of the amphoteric surfactant of general formula I.

5. The solution 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 solution of claim 2 further 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 1 ppm to 2 ppm.

7. The solution of claim 1 further comprising propylene glycol, hydroxypropylmethyl cellulose or hydroxypropyl guar.

8. The solution of claim 2 wherein the solution exhibits a biocidal profile against Candida albicans of at least 2 log reduction in the presence of 10% organic soil using the “

Stand-Alone Procedure for Disinfecting Products”

dated May 1, 1997 of the U.S. Food and Drug Administration.

9. The solution of claim 2 wherein the transepithelial electrical resistance (TEER) of HCEpiC exhibits a 10% difference or less than phosphate buffered saline in Ohm/cm² after one hour of contact time with a 3:

1 dilution (solution;

DMEM), or the ECIS electrode arrays exhibit a 10% difference or less than phosphate buffered saline in Ohm after one hour of contact time with a 1;

1 dilution (solution;

DMEM).

10. The solution of claim 1 wherein the antimicrobial component is 0.5 ppm to 3 ppm of polyquaternium-1.

11. The solution of claim 10 wherein the anionic biopolymer is hyaluronic acid, which is present from 0.002 wt. % to 0.04 wt. %.

12. The solution of claim 10 further comprising poly(hexamethylene biguanide), which is present from 0.5 ppm to 2 ppm.

13. The solution of claim 10 further comprising citrate, citric acid or a mixture thereof.

14. The solution of claim 10 further comprising propylene glycol, hydroxypropylmethyl cellulose or hydroxypropyl guar.

15. The solution of claim 12 wherein the solution exhibits a biocidal profile against Candida albicans of at least 2 log reduction in the presence of 10% organic soil using the “

Stand-Alone Procedure for Disinfecting Products”

dated May 1, 1997 of the U.S. Food and Drug Administration.

16. The solution of claim 10 wherein the transepithelial electrical resistance (TEER) of HCEpiC exhibits a 10% difference or less than phosphate buffered saline in Ohm/cm² after one hour of contact time with a 3:

1 dilution (solution;

DMEM), or the ECIS electrode arrays exhibit a 10% difference or less than phosphate buffered saline in Ohm after one hour of contact time with a 1;

1 dilution (solution;

DMEM).

17. The solution of claim 1 wherein the antimicrobial component is 1 ppm to 4 ppm of alexidine.

18. The solution of claim 17 wherein the anionic biopolymer is hyaluronic acid, which is present from 0.002 wt. % to 0.04 wt. %.

19. The solution of claim 17 further comprising poly(hexamethylene biguanide), which is present from 0.5 ppm to 2 ppm, or polyquaternium-1, which is present from 1 ppm to 3 ppm.

20. The solution of claim 19 wherein the solution exhibits a biocidal profile against Candida albicans of at least 2 log reduction in the presence of 10% organic soil using the “

Stand-Alone Procedure for Disinfecting Products”

dated May 1, 1997 of the U.S. Food and Drug Administration.

21. The solution of claim 19 wherein the transepithelial electrical resistance (TEER) of HCEpiC exhibits a 10% difference or less than phosphate buffered saline in Ohm/cm² after one hour of contact time with a 3:

1 dilution (solution;

DMEM), or the ECIS electrode arrays exhibit a 10% difference or less than phosphate buffered saline in Ohm after one hour of contact time with a 1;

1 dilution (solution;

DMEM).

22. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in the multipurpose lens care solution of claim 1 for at least two hours.

23. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in the multipurpose lens care solution of claim 10 for at least two hours.

24. A method of cleaning and disinfecting a contact lens, the method comprising soaking the contact lens in the multipurpose lens care solution of claim 17 for at least two hours.