US2010173965A1PendingUtilityA1

Antifungal composition

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Assignee: POLA PHARMA INCPriority: Sep 5, 2007Filed: Sep 5, 2008Published: Jul 8, 2010
Est. expirySep 5, 2027(~1.1 yrs left)· nominal 20-yr term from priority
Inventors:Takaaki MasudaNaoto NishidaNaoko KobayashiHideaki Sasagawa
A61P 31/10A61K 47/10A61K 47/12A61K 47/14A61K 47/26A61P 17/08A61K 47/34A61K 31/4178A61K 47/22A61K 47/32A61K 9/0014
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Claims

Abstract

Disclosed is a pharmaceutical composition for antifungal use, comprising: 1) one or more compounds selected from compounds represented by the general formula (1) below and physiologically acceptable salts thereof; 2) one or more compounds selected from polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol; and 3) one or more compounds selected from glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. General formula (1) (In the formula, X represents a halogen or hydrogen). wherein X represents a halogen or hydrogen.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition for antifungal use, comprising: 1) a compound selected from the group consisting of compounds represented by the general formula (1) below and physiologically acceptable salts thereof; 2) a compound selected from the group consisting of polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol; and 3) a compound selected from the group consisting of glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. 
     
       
         
         
             
             
         
       
     
     wherein X represents a halogen or hydrogen. 
   
   
       2 . The pharmaceutical composition according to  claim 1 , wherein the compound selected from the group consisting of compounds represented by the general formula (1) and physiologically acceptable salts thereof is luliconazole and/or a physiologically acceptable salt thereof. 
     
       
         
         
             
             
         
       
     
   
   
       3 . The pharmaceutical composition according to  claim 1  or  2 , comprising triacetin as the compound selected from the group consisting of polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol. 
   
   
       4 . The pharmaceutical composition according to  claim 1 , comprising glucono-δ-lactone as the compound selected from the group consisting of glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. 
   
   
       5 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutical composition for antifungal use is in the form of a single-phase solution. 
   
   
       6 . The pharmaceutical composition according to  claim 1 , further comprising ethanol and/or water. 
   
   
       7 . (canceled) 
   
   
       8 . A method for adjusting the storability in the horny cell layer of compounds represented by the general formula (1) and/or salts thereof in the pharmaceutical composition according to  claim 1 , which comprises increasing the storability in the horny cell layer by decreasing the total content of one or more compounds selected from polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol with respect to the total amount of the pharmaceutical composition, and/or by increasing the total content of one or more compounds selected from glucono-δ-lactone, propylene glycol, glycerin, and lactic acid with respect to the total amount of the pharmaceutical composition; or decreasing the storability in the horny cell layer by increasing the total content of one or more compounds selected from polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol with respect to the total amount of the pharmaceutical composition, and/or by decreasing the total content of one or more compounds selected from glucono-δ-lactone, propylene glycol, glycerin, and lactic acid with respect to the total amount of the pharmaceutical composition, in the case. 
   
   
       9 . A method for treating mycosis comprising administering transdermally to a subject in need thereof a composition comprising: 1) a compound selected from the group consisting of compounds represented by the general formula (1) below and physiologically acceptable salts thereof; 2) a compound selected from the group consisting of polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol; and 3) a compound selected from the group consisting of glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. 
     
       
         
         
             
             
         
       
     
     wherein X represents a halogen or hydrogen. 
   
   
       10 . The method according to  claim 9 , wherein the compound selected from the group consisting of compounds represented by the general formula (1) and physiologically acceptable salts thereof is luliconazole and/or a physiologically acceptable salt thereof. 
     
       
         
         
             
             
         
       
     
   
   
       11 . The method according to  claim 9 , wherein the composition comprises triacetin as the compound selected from the group consisting of polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol. 
   
   
       12 . The method according to  claim 9 , wherein the composition comprises glucono-δ-lactone as the compound selected from the group consisting of glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. 
   
   
       13 . The method according to  claim 9 , wherein the composition is in the form of a single-phase solution. 
   
   
       14 . The method according to  claim 9 , wherein the composition further comprises ethanol and/or water. 
   
   
       15 . The method according to  claim 9 , wherein the mycosis is seborrheic dermatitis. 
   
   
       16 . A method for stabilizing a compound represented by the general formula (1) in a medicine, the method comprising a step of adding, to the compound, 1) a compound selected from the group consisting of polypropylene glycol, diesters of dibasic acids, triacetin, 2-ethyl-1,3-hexanediol, lauromacrogol, and polyoxyethylene-polyoxypropylene glycol; and 2) a compound selected from the group consisting of glucono-δ-lactone, propylene glycol, glycerin, and lactic acid. 
   
   
       17 . The method according to  claim 16 , wherein the compound represented by the general formula (1) is luliconazole. 
   
   
       18 . The method according to  claim 16 , wherein the stabilizing effects are depletion of production of their isomers. 
   
   
       19 . The method according to  claim 18 , wherein the isomer(s) are E form and/or Z form of luliconazole.

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