Ophthalmic composition including a cationic glycoside and an anionic therapeutic agent

• US 6,277,365 B1
• Filed: 09/18/1997
• Issued: 08/21/2001
• Est. Priority Date: 09/18/1997
• Status: Expired due to Term

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Ellis, Edward James, Ellis, Jeanne Yang
• Primary Examiner(s): FAY, ZOHREH A
• Application Number:
  US08/932,676
• Time in Patent Office: 1,433 Days
• Field of Search: 424/78.04, 514/912
• US Class Current: 424/78.04
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

There are disclosed compositions and methods for treating the surface of the eye, or contact tenses to be placed on the eye, with an aqueous composition comprising a quaternary nitrogen-containing ethoxylated glycoside and a therapeutic agent. The subject invention is particularly suited for use with silicone-containing contact lenses. Examples of specific compositions include aqueous solutions of lauryl methyl gluceth-10 hydroxypropyl-dimonium chloride in combination with anionic polysaccharides such as hyaluronic acid.

Claims

1. A method for delivering an anionic therapeutic agent to an eye which method comprises applying topically to the eye a therapeutically effective amount of a sterile, aqueous composition, said composition comprising:

(a) an effective amount of the anionic therapeutic agent,

(b) an amount of a quaternary nitrogen-containing ethoxylated glycoside in the range of from 0.001 to 10 percent by weight of the composition to hold said anionic therapeutic agent in association with the surface of the eye or a contact lens worn in the eye.

2. The method of claim 1, wherein the composition is a solution that is applied directly to the eye in the form of eye drops, either in the presence or the absence of a contact lens in the eye.

3. The method of claim 1, wherein a contact lens is contacted with said composition and the contact lens is then placed in the eye.

4. The method of claim 1, wherein a contact lens is contacted with said contact lens by sequentially contacting the lens with a solution of the glycoside and a solution of the therapeutic agent, thereafter placing the contact lens in the eye.

5. The method of claim 1 wherein the anionic therapeutic agent is an anionic polysaccharide or a carboxy-containing polymer.

6. The method of claim 1 wherein the anionic therapeutic agent is hyaluronic acid or a derivative thereof and/or salts thereof.

7. A method for the treatment of dry eye or, with an ophthalmic drug, treating, preventing, or diagnosing disorders or diseases of the eye, which method comprises the delivery of an anionic therapeutic agent to an eye by applying an aqueous composition topically to the eye, said aqueous composition comprising:

(a) an effective amount of therapeutic agent,

(b) an effective amount of a delivery vehicle comprising an anionic polymer; and

(c) 0.001 to 10 percent by weight of the composition of a quaternary nitrogen-containing ethoxylated glycoside to hold said therapeutic agent in association with the surface of the eye or a contact lens worn in the eye.

8. The method of claim 7, wherein the composition, in the form of a solution or gel, is applied directly to the eyes.

9. The method of claim 7, wherein a contact lens is contacted with the composition and the contact lens is then placed in the eye.

10. The method of claim 7, wherein the anionic polymer delivery vehicle is a carboxy-containing polymer.

11. A method for treating dry eye comprising topically administering to an eye of a patient suffering from dry eye a composition comprising a therapeutically effective amount of a sterile, aqueous composition, said composition comprising:

(a) 0.001 to 10 percent by weight of the composition of a quaternary nitrogen-containing ethoxylated glycoside,

(b) an effective amount of an anionic polymer effective in treating dry eye.

12. The method of claim 11, wherein the solution is applied directly to the eye either in the presence or the absence of a contact lens in the eye.

13. The method of claim 11, wherein a contact lens is contacted with said composition and the contact lens is then placed in the eye.

14. The method of claim 11, wherein the anionic polymer is a polysaccharide.

15. The method of claim 14, wherein the anionic polymer is a glycosaminoglycan.

16. The method of claim 15, wherein the anionic polymer is a biopolymer selected from the group consisting of hyaluronic acid, xanthan gum, and derivatives and salts thereof.

17. The method of claim 11, wherein the anionic polymer is a synthetic polymer selected from the group consisting of carbomers and polyacrylic acids.

18. A method for increasing the beneficial effect of an anionic therapeutic agent in an eye comprising prolonging the association of the therapeutic agent with the surface of the eye by administering an effective amount of a sterile, aqueous composition, said composition comprising the anionic therapeutic agent in combination with an amount of a quaternary nitrogen-containing ethoxylated glycoside in the range of from 0.001 to 10 percent by weight of the composition to hold said anionic therapeutic agent in association with the surface of the eye or a contact lens worn in the eye.

19. The method of claim 18, wherein the composition is a solution that is applied directly to the eye in the form of eye drops, either in the presence or the absence of a contact lens in the eye.

20. The method of claim 19, wherein a contact lens is contacted with said composition and the contact lens is then placed in the eye.

21. The method of claim 20, wherein a contact lens is contacted with said contact lens by sequentially contacting the lens with a solution of the glycoside and a solution of the therapeutic agent, thereafter placing the contact lens in the eye.

22. The method of claim 21 wherein the anionic therapeutic agent is an anionic polysaccharide or a carboxy-containing polymer.

23. The method of claim 22 wherein the anionic therapeutic agent is hyaluronic acid or a derivative thereof and/or salts thereof.

24. The method of claim 22 wherein the anionic therapeutic agent is at one ophthalmic drug selected from the group consisting of anti-inflammatory agents, anti-infection agents, glaucoma agents, imaging agents, and wound-healing agents.

25. The method of claim 24 wherein the ophthalmic drug is at least one selected from the group consisting of prostaglandins, prostaglandin derivatives, salicylic acid, proprionic acid, fenemates including anthranilic acid derivatives and cromolyn, beta lactam antibiotics, carbonic anhydrase inhibitors, fluorescein, fluorescein derivatives, and peptide growth factors.

26. The method of claim 25 wherein the ophthalmic drug is at least one selected from the group consisting of antibiotics, antivirals, steroids, aminosubstituted steroids, polypeptides, cardiotonics, anti-hypertensives, anti-allergics, alpha- and beta-adrenergic blocking agents, anti-cataract agents, anti-glaucoma agents, anti-inflammatory agents, and anesthetic agents.