US2020016176A1PendingUtilityA1

Compositions for the treatment of cataracts

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Assignee: CATACORE INCPriority: Jul 27, 2015Filed: Jul 24, 2019Published: Jan 16, 2020
Est. expiryJul 27, 2035(~9 yrs left)· nominal 20-yr term from priority
Inventors:Sam L. Nguyen
A61P 43/00A61P 27/02A61P 27/12A61K 9/0048A61K 9/5153A61K 9/0051A61K 9/08A61K 47/38A61K 31/575A61K 47/10
42
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Claims

Abstract

In one embodiment, the present application discloses an aqueous ophthalmic composition for the treatment of eye diseases, lesions and injuries, comprising: a) one steroid, or a combination of at least two steroids selected from the group consisting of lanosterol, dihydrolanosterol, 4,4-dimethylcholesta-8(9),14,24-trien-3β-ol, 4,4-dimethylcholesta-8,24-dien-3β-ol, 4,4-dimethylcholesta-8-en-3β-ol, 4,4-dimethylcholesta-8(9),14-dien-3β-ol, 14-desmethyl lanosterol, lathosterol, Δ7.24-cholestadienol, cholesterol, cholesta-7-enol, cholesteryl ester, 7-dehydrocholesterol, desmosterol, 7-dehydrodesmosterol, zymosterol, 27-hydroxycholesterol, cholesta-7,24-dien-3-β-ol, cholesta-8(9)-en-3-β-ol, 5α-cholestan-3β-6-one, 5-cholesten-3β,25-diol, 5-cholesten-3β,25-OSO3H (5-cholesten-3β,25-sulfate), 5-cholesten-3β-OSO3H,25-ol (5-cholesten-3β-sulfate,25-ol), 5-cholesten-3β,25-diol, disulfate, and their esters thereof, or a pharmaceutically acceptable salt thereof, in a concentration effective for the treatment and/or prophylaxis of the eye diseases, lesions and injuries; and b) a pharmaceutical excipient; and methods of treatment using such compositions.

Claims

exact text as granted — not AI-modified
What is claimed: 
     
         1 - 25 . (canceled) 
     
     
         26 . An aqueous, isotonic ophthalmic composition comprising:
 a) a steroid selected from the group consisting of 5-cholesten-3β-OSO 3 H,25-ol (5-cholesten-3β-sulfate,25-ol), 5-cholesten-3β,25-diol, lanosterol and 5-cholesten-3β-ol sulfate sodium salt, or a pharmaceutically acceptable salt thereof, or a combination thereof; and   b) a pharmaceutical excipient comprising 2-hydroxypropyl-β-cyclodextrin (CD) and hydroxypropyl methylcellulose (HPMC);   wherein the composition comprises water and ethanol; and   wherein the amount of the steroid or a mixture of steroid in the composition is in the range of 0.01% to 0.5% wt/wt.   
     
     
         27 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the pharmaceutically acceptable salt is a sodium salt. 
     
     
         28 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is 5-cholesten-3β-OSO 3 H,25-ol. 
     
     
         29 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is 5-cholesten-3β-ol sulfate sodium salt. 
     
     
         30 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is 5-cholesten-3β,25-diol or a pharmaceutically acceptable salt thereof. 
     
     
         31 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is a mixture consisting of 5-cholesten-3β-OSO 3 H,25-ol (5-cholesten-3β-sulfate,25-ol), 5-cholesten-3β,25-diol, lanosterol and 5-cholesten-3β-ol sulfate sodium salt, or a pharmaceutically acceptable salt thereof. 
     
     
         31 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is 5-cholesten-3β,25-diol. 
     
     
         32 . The aqueous, isotonic ophthalmic composition of  claim 26 , wherein the compound is lanosterol. 
     
     
         33 . A method for the treatment of cataracts, the method comprising an administration of an aqueous, isotonic ophthalmic composition comprising:
 a) a steroid selected from the group consisting of 5-cholesten-3β-OSO 3 H,25-ol (5-cholesten-3β-sulfate,25-ol), 5-cholesten-3β,25-diol, lanosterol and 5-cholesten-3β-ol sulfate sodium salt, or a pharmaceutically acceptable salt thereof, or a combination thereof; and   b) a pharmaceutical excipient comprising 2-hydroxypropyl-β-cyclodextrin (CD) and hydroxypropyl methylcellulose (HPMC);   wherein the composition comprises water and ethanol; and   wherein the amount of the steroid or a mixture of steroid in the composition is in the range of 0.01% to 0.5% wt/wt;   to a patient in need thereof, wherein the administration of the composition reverses protein aggregation in cataracts or significantly reduces the severity of the cataract and increases the lens clarity, or inhibits aggresome formation of both wild-type and mutated crystalline proteins.   
     
     
         34 . The method of  claim 33 , wherein the administration is by topical administration. 
     
     
         35 . The method of  claim 33 , wherein the administration is by intracameral administration. 
     
     
         36 . The method of  claim 33 , wherein the steroid is 5-cholesten-3β-OSO 3 H,25-ol (5-cholesten-3β-sulfate,25-ol), or a pharmaceutically acceptable salt thereof. 
     
     
         37 . Them method of  claim 35 , wherein the steroid is lanosterol, or a pharmaceutically acceptable salt thereof. 
     
     
         38 . The method of  claim 31 , wherein the steroid is 5-cholesten-3β-ol sulfate sodium salt, or a pharmaceutically acceptable salt thereof. 
     
     
         39 . The method of  claim 31 , wherein the steroid is 5-cholesten-3β,25-diol, or a pharmaceutically acceptable salt thereof.

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