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Details for Patent: 8,618,064

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Details for Patent: 8,618,064

Title:Methods of providing therapeutic effects using cyclosporin components
Abstract: Methods of treating an eye of a human or animal include administering to an eye of a human or animal a composition in the form of an emulsion including water, a hydrophobic component and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight of the composition. The weight ratio of the cyclosporin component to the hydrophobic component is less than 0.8.
Inventor(s): Acheampong; Andrew (Irvine, CA), Tang-Liu; Diane (Newport Beach, CA), Chang; James N. (Newport Beach, CA), Power; David F. (Trabuco Canyon, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Filing Date:Aug 28, 2007
Application Number:11/897,177
Claims:1. A method of treating or preventing corneal graft rejection, the method comprising administering to an eye of a human or animal in need thereof, at a frequency of once per day, a composition in the form of an emulsion comprising water, polysorbate 80, a hydrophobic component, and a cyclosporin component in a therapeutically effective amount equal to or less than 0.05% by weight of the composition, wherein the weight ratio of the cyclosporin component to the hydrophobic component is less than 0.08.

2. The method of claim 1 wherein the blood of the human or animal has no detectable concentration of the cyclosporin component.

3. The method of claim 1 wherein the blood of the human or animal has substantially no detectable concentration of the cyclosporin component as measured using a validated liquid chromatographylmass spectrometry analytical method.

4. The method of claim 1 wherein the blood of the human or animal has a concentration of the cyclosporin component of 0.1 ng/ml or less.

5. The method of claim 1 wherein the cyclosporin component comprises a material selected from cyclosporin A, derivatives of cyclosporin A and mixtures thereof.

6. The method of claim 1 wherein the cyclosporin component comprises cyclosporin A.

7. The method of claim 1 wherein the cyclosporin component is solubilized in the hydrophobic component present in the composition.

8. The method of claim 1 wherein the hydrophobic component is present in the composition in an amount greater than 0.625% by weight of the composition.

9. The method of claim 1 wherein the hydrophobic component comprises an oily material.

10. The method of claim 1 wherein the hydrophobic component comprises an ingredient selected from the group consisting of vegetable oils, animal oils, mineral oils, synthetic oils and mixtures thereof.

11. The method of claim 1 wherein the hydrophobic component comprises castor oil.

12. The method of claim 1 wherein the administering step comprises topically administering the composition to the eye of the human.

13. The method of claim 1 wherein the composition comprises an effective amount of a tonicity component.

14. The method of claim 1 wherein the composition comprises an effective amount of an organic tonicity component.

15. The method of claim 1 wherein the composition comprises a polyelectrolyte component in an amount effective in stabilizing the composition.

16. The method of claim 1 wherein the composition has a pH in the range of about 7.0 to about 8.0.

17. The method of claim 1 wherein the composition has a pH in the range of about 7.2 to about 7.6.

18. The method of claim 1, where the cyclosporin component is in a therapeutically effective amount of less than 0.05% by weight of the composition.

19. The method of claim 1, wherein the cyclosporin component is in a therapeutically effective amount of 0.05% by weight of the composition.
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