Compositions for treatment of fungal nail infections
The present invention relates to a composition for use in the treatment of a fungal infection comprising a polymer capable of forming nanoparticles and terbinafine, or derivative or salt thereof, wherein the nanoparticles are formed with and/or in the presence of terbinafine, or derivative or salt thereof, and where the composition comprises: a) a ratio of terbinafine, or derivative or salt thereof, to polymer in the range of about 1:2 to 1:4; and b) up to about 30% (v/v) alcohol. The composition is particularly suited as a topical treatment for fungal nail or skin infections. The invention also relates to methods of producing such compositions and combinations which can be used to produce said same.
1 . A topical composition for use in the treatment of a fungal nail infection, the composition comprising nanoparticles, water, and ethanol, the nanoparticles formed of polyhexamethylene biguanide (PHMB) and terbinafine, or a derivative or salt thereof, wherein the composition comprises:
a) a ratio of terbinafine, or a derivative or salt thereof, to PHMB in the range of 1:2 to 1:4; and
b) from 10% (v/v) to 30% (v/v) ethanol.
2 . The composition as claimed in claim 1 , wherein the terbinafine, or a derivative or salt thereof, is present at from about 5 to about 600 μg/ml.
3 . The composition as claimed in claim 2 , wherein the terbinafine, or a derivative or salt thereof, is present at from about 25 to about 200 μg/ml.
4 . The composition as claimed in claim 2 , wherein the terbinafine, or a derivative or salt thereof, is present at from about 50 to about 150 μg/ml.
5 . The composition as claimed in claim 1 , wherein the ethanol is present at from about 10% (v/v) to about 20% (v/v).
6 . The composition as claimed in claim 1 , wherein the PHMB is present at from about 150 to about 450 μg/ml.
7 . The composition as claimed in claim 6 , wherein the PHMB is present at up to about 300 μg/ml.
8 . The composition as claimed in claim 1 , wherein the water is present at about 70% to about 90% (v/v).
9 . The composition as claimed in claim 8 , wherein the water is present at up to about 80% (v/v).
10 . A topical composition for use in the treatment of a fungal nail infection, the composition comprising nanoparticles and ethanol, the nanoparticles formed of PHMB and terbinafine, or a derivative or salt thereof, wherein:
(a) the terbinafine, or a derivative or salt thereof, is present in an amount in the range of 0.005% w/w to 1% w/w;
(b) the PHMB is present in an amount in the range of 0.015% w/w to 3% w/w;
(c) the ethanol is present at from about 10% (v/v) to 30% w/w; and
(d) water is present at up to 90% w/w.
11 . The composition as claimed in claim 10 , wherein:
(a) the terbinafine, or a derivative or salt thereof, at 0.1% w/w;
(b) PHMB at 0.3% w/w;
(c) ethanol at 20% w/w; and
(d) water.