Methods of providing therapeutic effects using cyclosporin components
View Patent ↗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.
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.