Antifungal composition
There is provided a pharmaceutical composition for the treatment of fungal infection of the nail comprising a anti-fungal allylamine compound present in an amount of about 10%, an organic acid or an ester thereof, a diol and a sequestering agent where the pharmacological composition is essentially water-free.
1. A pharmaceutical composition for the treatment of onychomycosis of the nail comprising terbinafine present in an amount of more than 5%, an organic acid or an ester thereof present in an amount of 1 to 30%, a diol present in an amount of about 50 to 95% and EDTA present in an amount of 0.01 to 5%, said pharmaceutical composition being essentially water-free; wherein:
said diol is one or more selected from the group consisting of propanediol, butanediol, pentanediol, and hexanediol;
said organic acid is one or more selected from the group consisting of saturated or unsaturated, straight or branched, aliphatic mono-, di- or poly-carboxylic acids having 1-8 carbon atoms, araliphatic dicarboxylic acids having 1-8 carbon atoms, aromatic dicarboxylic acids having 1-8 carbon atoms, oxy-carboxylic acids having 1-8 carbon atoms, and hydroxyl-carboxylic acids having 1-8 carbon atoms; and
said ester of the organic acid is one or more C 14 alkyl esters of said organic acid.
2. The composition according to claim 1 , wherein the antifungal allylamine compound is dissolved in the composition.
3. The composition according to claim 1 , wherein the organic acid is lactic acid.
4. The composition according to claim 1 , wherein the organic acid or ester thereof is present in an amount of 5% to 25%.
5. The composition according to claim 1 , wherein the allylamine antifungal compound is present in an amount of from 5% to 12%.
6. The composition according to claim 5 , wherein the allylamine antifungal compound is present in an amount of from 8% to 11.5%.
7. The composition according to claim 1 , comprising lactic acid in an amount of 5% to 25%; a diol selected from the group consisting of propanediol, butanediol, pentanediol and hexanediol in an amount of about 50 to 95%; terbinafine in an amount of from 5% to 12%; and EDTA in an amount between 0.03% and 1%.
8. The composition according to claim 1 , comprising from about 67.5% to about 84% of propandiol, from 8% to 20% of lactic acid, from 0.03% to 0.1% EDTA and from 8% to 12% of terbinafine.
9. A method of treatment of onychomycosis of the nail wherein a composition according to claim 1 , is administered to the nail of a patient.
10. The pharmaceutical composition according to claim 1 , wherein said pharmaceutical composition increases delivery of the terbinafine into the nail as compared to said pharmaceutical composition not comprising EDTA.