US2018078606A1PendingUtilityA1

Methods of providing therapeutic effects using cyclosporin components

66
Assignee: ALLERGAN INCPriority: Sep 15, 2003Filed: May 3, 2017Published: Mar 22, 2018
Est. expirySep 15, 2023(expired)· nominal 20-yr term from priority
Inventors:Andrew AcheampongDiane Tang-LiuJames N. ChangDavid F. Power
A61P 9/10A61P 27/02A61K 9/107A61K 47/10A61K 9/0048A61K 38/13A61K 47/22A61K 47/44A61K 47/32A61K 47/02
66
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Claims

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.

Claims

exact text as granted — not AI-modified
1 . A method of treating an eye of a human or animal comprising:
 administering to an eye of a human or animal a composition in the form of an emulsion comprising 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 ration of the cyclosporin component to the hydrophobic component is less than 0.08.   
     
     
         2 . The method of  claim 1  wherein the administering step is effective in treating a condition selected from the group consisting of dry eye syndrome, phaconaphylactic endophthalmitis, uveitis, vernal conjunctivitis, atopic keratoconjunctivitis and corneal graft rejection. 
     
     
         3 . The method of  claim 1  wherein the administering step is effective in treating dry eye syndrome. 
     
     
         4 . The method of  claim 1  wherein the blood of the human or animal has substantially no detectable concentration of the cyclosporin component. 
     
     
         5 . 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 chromatogaphy/mass spectrometry-mass spectrometry analytical method. 
     
     
         6 . 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. 
     
     
         7 . The method of  claim 1  wherein the cyclosporin component comprises a material selected from cyclosporin A, derivatives of cyclosporin A and mixtures thereof. 
     
     
         8 . The method of  claim 1  wherein the cyclosporin component comprises cyclosporin A. 
     
     
         9 . The method of  claim 1  wherein the cyclosporin component is solubilized in the hydrophobic component present in the composition. 
     
     
         10 . 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. 
     
     
         11 . The method of  claim 1  wherein the hydrophobic component comprises an oily material. 
     
     
         12 . 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. 
     
     
         13 . The method of  claim 1  wherein the hydrophoboic component comprises castor oil. 
     
     
         14 . The method of  claim 1  wherein the administering step comprises topically administering the composition to the eye of the human. 
     
     
         15 . The method of  claim 1  wherein the composition comprises an effective amount of an emulsifier component. 
     
     
         16 . The method of  claim 1  wherein the composition comprises an effective amount of a tonicity component. 
     
     
         17 . The method of  claim 1  wherein the composition comprises an effective amount of an organic tonicity component. 
     
     
         18 . The method of  claim 1  wherein the composition comprises a polyelectrolyte component in an amount effective in stabilizing the composition. 
     
     
         19 . The method of  claim 1  wherein the composition has a pH in the range of about 7.0 to about 8.0. 
     
     
         20 . The method of  claim 1  wherein the composition has a pH in the range of about 7.2 to about 7.6. 
     
     
         21 . A composition for treating an eye of a human or animal comprising an emulsion comprising water, a hydrophobic component, and a cyclosporin component in a therapeutically effective amount of less than 0.1% by weight, the weight ratio of the cyclosporin component to the hydrophobic component being less than 0.08. 
     
     
         22 . The composition of  claim 21  having a make-up so that when the composition is administered to an eye of a human in an effective amount in treating dry eye syndrome, the blood of the human has substantially no detectable concentration of the cyclosporin component. 
     
     
         23 . The composition of  claim 21  wherein the cyclosporin component comprises a material selected from cyclosporin A, derivatives of cyclosporin A and mixtures thereof. 
     
     
         24 . The composition of  claim 21  wherein the cyclosporin component comprises cyclosporin A. 
     
     
         25 . The composition of  claim 21  in the form of an emulsion. 
     
     
         26 . the composition of  claim 21  wherein the hydrophobic component is present in an amount greater than 0.625% by weight of the composition. 
     
     
         27 . The composition of  claim 21  wherein the hydrophobic component is an oily material. 
     
     
         28 . The composition of  claim 21  wherein the hydrophobic component comprises an ingredient selected from the group consisting of vegetable oils, animal oils, mineral oils, synthetic oils, and mixtures thereof. 
     
     
         29 . The composition of  claim 21  wherein the hydrophobic component comprises castor oil. 
     
     
         30 . The composition of  claim 21  wherein the administering step comprises topically administering the composition to the eye of the human. 
     
     
         31 . The composition of  claim 21  wherein the composition comprises an effective amount of an emulsifier component. 
     
     
         32 . The composition of  claim 21  wherein the composition comprises an effective amount of a tonicity component. 
     
     
         33 . The composition of  claim 21  wherein the composition comprises an effective amount of an organic tonicity component. 
     
     
         34 . The composition of  claim 21  wherein the composition comprises a polyelectrolytic component in an amount effective in stabilizing the composition. 
     
     
         35 . The composition of  claim 21  wherein the composition includes water and has a pH in the range of about 7.0 to about 8.0. 
     
     
         36 . The composition of  claim 21  wherein the composition includes water and has a pH in the range of about 7.2 to about 7.6.

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