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Claims for Patent: 7,671,070

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Claims for Patent: 7,671,070

Title:Method of treating ophthalmic infections with moxifloxacin compositions
Abstract:Ophthalmic, otic and nasal compositions containing a new class of antibiotics (e.g., moxifloxacin) are disclosed. The compositions preferably also contain one or more anti-inflammatory agents. The compositions may be utilized to treat ophthalmic, otic and nasal conditions by topically applying the compositions to the affected tissues.
Inventor(s): Cagle; Gerald (Fort Worth, TX), Abshire; Robert L. (Fort Worth, TX), Stroman; David W. (Irving, TX), Yanni; John M. (Burleson, TX)
Assignee: Alcon, Inc. (Hunenberg, CH)
Application Number:10/715,055
Patent Claims: 1. A method of treating opthalmic infections, which comprises topically applying to the eye a therapeutically effective amount of a pharmaceutical composition comprising moxifloxacin or a pharmaceutically useful hydrate or salt thereof in a concentration of 0.1 to 1.0 wt. % of moxifloxacin and a pharmaceutically acceptable vehicle therefor.

2. A method according to claim 1, wherein the composition further comprises a steroidal or non-steroidal anti-inflammatory agent.

3. A method according to claim 2, wherein the anti-inflammatory agent comprises a steroidal agent.

4. A method according to claim 3, wherein the steroidal agent comprises a glucocorticoid.

5. A method according to claim 4, wherein the glucocorticoid is selected from the group consisting of dexamethasone, rimexolone, prednisolone, fluorometholone, hydrocortisone, mometasone, fluticasone, beclormethasone, flunisolide, triamcinolone, budesonide, and combinations thereof.

6. A method according to claim 4, wherein the glucocorticoid comprises dexamethasone.

7. A method according to claim 4, wherein the glucocorticoid comprises a 21-ether derivative of dexamethasone.

8. A method according to claim 4, wherein the glucocorticoid comprises a 21-benzyl ether derivative of dexamethasone.

9. A method according to claim 2, wherein the anti-inflammatory agent comprises a non-steroidal agent selected from the group consisting of prostaglandin H synthetase inhibitors, cyclooxygenase type II selective inhibitors, PAF antagonists, PDE IV inhibitors, and combinations thereof.

10. A method according to claim 9, wherein the non-steroidal agent comprises a prostaglandin H synthetase inhibitor.

11. A method according to claim 10, wherein the prostaglandin H synthetase inhibitor comprises nepafenac.

12. A method according to claim 10, wherein the prostaglandin H synthetase comprises ketorolac.

13. A method according to claim 10, wherein the prostaglandin H synthetase comprises diclofenac.

14. A method according to claim 9, wherein the non-steroidal agent comprises a cyclooxygenase type II selective inhibitor.

15. A method according to claim 1, wherein the composition is applied to the eye in connection with the treatment of a condition selected from the group consisting of conjunctivitis, keratitis, blepharitis, dacyrocystitis, hordeolum, corneal ulceration, and combinations thereof.

16. A method according to any one of claims 1-14, wherein the composition is applied to the eye in connection with an opthalmic surgical procedure.

17. A method according to any one of claims 1-15, wherein the composition contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof at a concentration of about 0.35 wt. % of moxifloxacin.

18. A method according to any one of claims 1-15, wherein the composition is applied to the eye in connection with the treatment of conjunctivitis.

19. A method according to claim 17, wherein the composition is applied to the eye in connection with the treatment of conjunctivitis.

20. A method according to claim 1, wherein the composition is a liquid that contains sodium chloride.

21. A method according to claim 20, wherein the composition further comprises at least one of a viscosity enhancing agent and a surfactant.

22. A method according to claim 1, wherein the composition has a pH in the range of from 4.5 to 8.0.

23. A method according to claim 22, wherein the composition has a pH in the range of from 5.5 to 8.0.

24. A method according to claim 1, wherein the composition has an osmotic value compatible with the aqueous humor of the eye and opthalmic tissue and in the range of from about 200 to about 400 milliosmoles per kilogram of water.

25. A method according to claim 1, wherein the composition has an osmotic value compatible with the aqueous humor of the eye and opthalmic tissue and in the range of from about 200 to about 300 milliosmoles per kilogram of water.

26. A method according to claim 25, wherein the osmotic value is about 300 milliosmoles per kilogram of water.

27. A method according to claim 1, wherein the composition contains a preservative at a concentration of from 0.001 to 1.0 wt. %.

28. A method according to claim 1, wherein the composition is a sterile solution provided in a multi-dose form.

29. A method according to claim 28, wherein the composition is applied to the eye in connection with the treatment of conjunctivitis.

30. A method according to claim 18, wherein the composition inhibits the growth of S. aureus and contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof in an amount sufficient to provide a moxifloxacin concentration in the lacrimal fluid and aqueous humor of the eye of at least about 0.13 micrograms per milliliter.

31. A method according to claim 18, wherein the composition inhibits the growth of S. epidermidis and contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof in an amount sufficient to provide a moxifloxacin concentration in the lacrimal fluid and aqueous humor of the eye of at least about 0.25 micrograms per milliliter.

32. A method according to claim 29, wherein the composition inhibits the growth of S. pneumoniae and contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof in an amount sufficient to provide a moxifloxacin concentration in the lacrimal fluid and aqueous humor of the eye of at least about 0.25 micrograms per milliliter.

33. A method according to claim 1, wherein the composition is applied to the eye in connection with the treatment of keratitis and wherein the composition inhibits the growth of P. aeruginosa and contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof in an amount sufficient to provide a moxifloxacin concentration in the lacrimal fluid and aqueous humor of the eye of at least about 0.25 micrograms per milliliter.

34. A method according to claim 18, wherein the composition wherein the composition inhibits the growth of H. influenzae and contains moxifloxacin or a pharmaceutically useful hydrate or salt thereof in an amount sufficient to provide a moxifloxacin concentration in the lacrimal fluid and aqueous humor of the eye of at least about 0.06 micrograms per milliliter.

35. A method according to claim 1, wherein the composition is a sterile solution having a pH in the range of from 4.5 to 8.0; wherein the composition has an osmotic value compatible with the aqueous humor of the eye and opthalmic tissues, including tissues that may have been compromised as the result of preexisting disease, trauma, surgery or other physical conditions, said osmotic value being in the range of from about 200 to about 400 milliosmoles per kilogram of water.

36. A method according to claim 35, wherein the pH is from 5.5 to 8.

37. A method according to claim 35, wherein the osmotic value is about 300.

38. A method according to claim 35, wherein the solution also contains sodium chloride.

39. A method according to claim 38, wherein the composition is applied to the eye in connection with the treatment of conjunctivitis.

40. A method according to claim 35, wherein the composition is applied to the eye in connection with the treatment of conjunctivitis.

41. A method according to claim 39, wherein the composition inhibits the growth of at least one pathogen selected from the group consisting of S. aureus, S. epidermidis, S. pneumoniae, P. aeruginosa, and H. influenzae.

42. A method according to claim 35, wherein the composition is applied to the eye in connection with an opthalmic surgical procedure.
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