Therapeutic Compositions Containing Dipyridamole and Treatment Packs Including Such Compositions and Methods for Producing Same

Abstract

A treatment pack comprising: (a) multiple doses of a composition containing dipyridamole as an active ingredient; (b) packaging material; and (c) instructions for topical administration of said composition to the anterior segment of the eye to treat an anterior segment eye disorder.

1 . A treatment pack comprising:
 (a) multiple doses of a composition containing dipyridamole as an active ingredient;   (b) packaging material; and   (c) instructions for topical administration of said composition to the anterior segment of the eye to treat an anterior segment eye disorder.   
     
     
         2 . A treatment pack according to  claim 1 , wherein said composition is formulated in a form selected from the group consisting of solution, cream and ointment. 
     
     
         3 . A treatment pack according to  claim 1 , wherein said composition does not comprise a physiologically effective amount of any member of the group consisting of caffeine, a corticosteroid, a benzisoselenazole (e.g. ebselen), amoxapine, sertraline, dipivefrin, prostaglandin E, rolipram, an additional anti-VEGF compound, and an HMG-CoA reductase inhibitor (e.g. a statin) and/or nitric oxide (NO) inhibitors if said instructions are followed. 
     
     
         4 . A treatment pack according to  claim 1 , wherein said composition contains dipyridamole at a concentration of at least about 10 −6  molar (moles/liter). 
     
     
         5 . A treatment pack according to  claim 1 , wherein said instructions specify administration of said composition to the eye(s) of a subject at least once every other day. 
     
     
         6 . A treatment pack according to  claim 1 , wherein said instructions specify a dosing regimen which leads to an aggregate daily dosage of dipyridamole of 0.5 mg per day or less. 
     
     
         7 . A treatment pack according to  claim 1 , comprising a single container for said multiple doses. 
     
     
         8 . A treatment pack according to  claim 1 , comprising multiple containers, each of said multiple containers containing a single dose of said multiple doses. 
     
     
         9 . A composition comprising:
 (a) a physiologically effective amount of dipyridamole formulated for treatment of the anterior segment of the eye of a subject suffering from an anterior segment eye disorder; and   (b) a physiologically acceptable carrier.   
     
     
         10 . A composition according to  claim 9 , formulated as a solution. 
     
     
         11 . A composition according to  claim 9 , formulated as a cream or ointment. 
     
     
         12 . A composition according to  claim 9 , wherein said physiologically effective amount of dipyridamole comprises a concentration of at least about 10 −6  molar (moles/liter). 
     
     
         13 . A composition according to  claim 9  comprising 200 μg/ml or less of dipyridamole. 
     
     
         14 . A composition according to  claim 13 , comprising 100 μg/ml or less of dipyridamole. 
     
     
         15 . A composition according to  claim 9 , not comprising a physiologically active concentration of any member of the group consisting of caffeine, a corticosteroid, a benzisoselenazole (e.g. ebselen), amoxapine, sertraline, dipivefrin, prostaglandin E, rolipram, an HDAC inhibitor, an additional anti-VEGF compound, and an HMG-CoA reductase inhibitor (e.g. a statin) and/or nitric oxide (NO) inhibitor. 
     
     
         16 . A method comprising:
 (a) adjusting the pH of a physiologically acceptable ophthalmologic solution to between about 5.5 and about 6.8;   (b) dissolving dipyridamole in said solution at a concentration of 5 μg/ml to 200 μμg/ml; and   (c) sterilizing the resultant dipyridamole composition.   
     
     
         17 . A method according to  claim 16 , comprising titrating said solution to achieve said pH of about 6.7. 
     
     
         18 . A method according to  claim 16 , wherein said dissolving comprises dissolving at a concentration of at least 85 μg/ml. 
     
     
         19 . A method according to  claim 16 , comprising packaging the sterilized dipyridamole composition in container configured to deliver drops to the eye. 
     
     
         20 . A method according to  claim 19 , comprising assembling a treatment pack comprising said container, packaging material and instructions for topical administration of said composition to the eye to treat an anterior segment eye disorder in a subject in need thereof.