US2006078580A1PendingUtilityA1

Organo-gel formulations for therapeutic applications

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Assignee: MEDIQUEST THERAPEUTICS INCPriority: Oct 8, 2004Filed: Jun 13, 2005Published: Apr 13, 2006
Est. expiryOct 8, 2024(expired)· nominal 20-yr term from priority
Inventors:Frederick J. Dechow
A61P 43/00A61P 31/10A61P 9/08A61P 31/04A61P 9/10A61K 8/345A61K 31/74A61K 9/0012A61K 8/042A61Q 19/00A61K 9/0014A61K 9/7015A61P 17/06A61K 8/42A61K 8/37A61K 8/466A61P 11/06A61K 8/553A61K 9/06A61K 8/34
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Claims

Abstract

A composition suitable for the local delivery of cosmetic and/or pharmaceutical agents into the skin containing at least two biocompatible organic solvents, a polar lipid, a surfactant, water, urea and a thickener wherein the organic solvents include an ester and a dihydric and/or polyhydric alcohol is provided. Also disclosed are compositions that further contain a cosmetic and/or pharmaceutical agent, along with the preparation and use thereof.

Claims

exact text as granted — not AI-modified
1 . A composition suitable for the delivery of at least one cosmetic agent or pharmaceutical agent or both through the skin or nails of a mammal, which comprises two biocompatible organic solvents, a polar lipid, at least one or more surfactant, water, urea and thickener; wherein the organic solvents comprise an ester and a dihydric alcohol and/or polyhydric alcohol; and wherein the composition comprises about 2 to about 30% of the ester and about 0.5 to about 20% of the dihydric alcohol and/or polyhydric alcohol.  
   
   
       2 . The composition of  claim 1 , wherein the ester is a fatty monoester.  
   
   
       3 . The composition of  claim 2 , wherein the ester is obtainable by replacing the active hydrogen of a fatty acid having 4 to 22 carbon atoms by the alkyl group of a monohydric alcohol having 2 to about 8 carbon atoms.  
   
   
       4 . The compositions of  claim 2 , wherein the ester is an isopropyl ester.  
   
   
       5 . The composition of  claim 1 , wherein the ester is at least one of isopropyl myristate or isopropyl palmitate.  
   
   
       6 . The composition of  claim 1 , wherein the ester is isopropyl myristate.  
   
   
       7 . The composition of  claim 1 , wherein the dihydric or polyhydric alcohol is an alkane alcohol and contains 3 to 8 carbon atoms.  
   
   
       8 . The composition of anyone of claims  1 - 6 , wherein the alcohol is at least one of propylene glycol or glycerol.  
   
   
       9 . The composition of anyone of claims  1 -6, wherein the alcohol is propylene glycol.  
   
   
       10 . The composition of  claim 1 , wherein the polar lipid is at least one of lecithin or phosphalidylcholine.  
   
   
       11 . The composition of  claim 1 , wherein at least one surfactant is selected from the group consisting of docusate sodium, docusate sodium benzoate, docusate calcium, tetradecyltrimethylammonium bromide, pentaoxyethylene glycol monododecyl ether, and triethanolamine laureth sulfate.  
   
   
       12 . The composition according to  claim 2 , wherein the thickener is selected from the group of polyethylene glycol, methyl cellulose, and carbomer.  
   
   
       13 . The composition of  claim 1 , wherein the amount of the polar lipid is about 10 to about 30% by weight; the amount of the surfactant is about 0.5 to about 15% by weight, the amount of water is about 40 to about 65% by weight, the amount of which is about 1 to about 15% by weight and amount of the thickener is about 0.05 to about 5% of weight.  
   
   
       14 . The composition of  claim 1 , wherein further contains at least one of a cosmetic agent or pharmaceutical agent or both.  
   
   
       15 . The composition of  claim 14 , wherein the amount of the cosmetic agent or pharmaceutical agent or both is about 0.001 to about 30% by weight.  
   
   
       16 . The composition of  claim 14 , having a pH of about 5.5 to about 7.5.  
   
   
       17 . The composition of  claim 16 , wherein the pH is about 6 to about 7.  
   
   
       18 . The composition of  claim 1 , further comprising at least 0.2-1.8% of a vasodilating agent.  
   
   
       19 . The composition of  claim 18 , wherein the vasodilating agent is glyceryl trinitrate.  
   
   
       20 . The composition, according to  claim 1 , further comprising about 1 to about 12% of an antimicrobial agent.  
   
   
       21 . The composition of  claim 20 , wherein the antimicrobial agent is selected from the group consisting of ciclopirox, miconazole, itraconazole, metronidazole, an allylamine and mixtures thereof and pharmaceutically acceptable salts thereof.  
   
   
       22 . The composition of  claim 20 , wherein the antimicrobial agent is selected from the group consisting of ciclopirox, miconazole, terbinafine and naftifine and mixtures thereof and salts thereof.  
   
   
       23 . The composition of  claim 1 , further comprising about 0.001-10.0% of an inhibitor of cell growth or proliferation.  
   
   
       24 . The composition of  claim 23 , wherein said inhibitor is 2-deoxy-D-glucose.  
   
   
       25 . The composition, according to  claim 1 , further comprising about 0.001-5.0% of an inhibitor of polyamine transport or 0.005-5.0% of an inhibitor of polyamine synthesis.  
   
   
       26 . The composition, according to  claim 1 , further comprising about 0.001-5.0% of an antizyme inducer.  
   
   
       27 . The composition, according to  claim 1 , further comprising about 0.5-10% of a decalcifying skin agent.  
   
   
       28 . The composition of  claim 27 , wherein the decalcifying skin agent is lactic acid.  
   
   
       29 . The composition, according to  claim 1 , further comprising at least two active ingredients.  
   
   
       30 . A method of delivering an active agent into and through the epidermis tissue of a human or animal which comprises topically applying to the skin of the human or animal a composition according to  claim 14 .  
   
   
       31 . A method for treating a patient suffering from onychomycosis which comprises topically applying to the patient's nail(s) infected with fungus a composition according to  claim 21 .  
   
   
       32 . A method of treating a patient suffering from onychomycosis which comprises topically applying to the patient's nail(s) infected with fungus a composition according to  claim 22 .  
   
   
       33 . A method of making a composition suitable for cutaneous delivery of a pharmaceutically active substance which comprises: 
 a. Dissolving a polar lipid, at least in two biocompatible organic solvents comprising at least one ester and at least one dihydric or polyhydric alcohol;    b. Adding one or more surfactants to the composition of step (a);    c. Dissolving a pharmaceutically active compound in the solvent-polar lipid, surfactant mixture of step (b);    d. Adding urea and thickener(s) to water; and    e. Combining the composition from c and d and adjusting the pH to about 5.5 to about 7.5, if necessary.    
   
   
       34 . A composition prepared according to the method of  claim 33 .  
   
   
       35 . A method of making a composition suitable for cutaneous delivery of a pharmaceutically active substance which comprises: 
 a. Dissolving a polar lipid, at least in two biocompatible organic solvents comprising at least one ester and at least one dihydric or polyhydric alcohol;    b. Adding one or more surfactants to the composition of step (a);    c. Adding urea and thickener(s) to water;    d. Dissolving a pharmaceutically active compound in the thickened aqueous urea; and    e. Combining the composition from (b) and (d) and adjust the pH to about 5.5 to about 7.5, if necessary.    
   
   
       36 . A composition prepared according to the method of  claim 35.

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