Patent ID: 7588753
Filing Date: 2009-09-15
Classification: A61K,A61P,A61Q

Abstract:
1. A method for synergistically improving the ungual or peri-ungual penetration of amorolfine or salt thereof comprising ungually or peri-ungually administering to a subject in need of such treatment a film-forming solution or nail varnish suited for ungual/peri-ungual administration, consisting essential: (a) amorolfine or salt thereof in an amount between 0.001 % and 20% by weight of the total composition; (b) a mixture of two pro-penetrating agents, said mixture consisting of (i) urea and lactic acid or (ii) urea and ethoxydiglycol, wherein urea is present in an amount ranging from 7% to 14% by weight based on the total composition minus the amount of (c) a mixture of organic solvents/cosolvents consisting of ethanol, ethyl acetate and butyl acetate, the acid is present in an amount ranging from 0.01 % to 15% by weight of the total composition, and the ethoxydiglycol is present in an amount ranging from 0.01 %-20% by weight of the total composition, and wherein the mixture of pro-penetrating agents being present in an effective amount to synergistically improve the ungual/peri-ungual penetration of said amorolfine or salt thereof; (c) a mixture or organic solvents/cosolvents consisting of ethanol, ethyl acetate and butyl acetate in an amount ranging from 30%-90% and from 0-30% by weight of the total composition; and (d) a film-forming agent in an amount ranging from 0.01 %-20% by weight of the total composition; wherein the amorolfine or salt thereof in (a) and the pro-penetrating agents and solvents/cosolvents in mixtures (b) and (c) being the only antifungal agents, pro-penetrating agents and solventssolvents/cosolvents in the solution or nail varnish.