Adhesive patch for treatment of tinea unguium
AssigneeHisamitsu Pharmaceutical Co., Inc.
InventorsArata Toshimitsu, Naoko Fujita, Toshihiro Kogure
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Abstract
The present invention provides an adhesive patch for the treatment of tinea unguium intended to be applied once a day, comprising terbinafine and/or a pharmacologically acceptable salt thereof in an amount of 3 mg/cm2, wherein the adhesive patch is used so that the terbinafine concentration in nails may be 295±127 ng/mg and the terbinafine concentration in plasma may be 23 pg/mL or less, 8 weeks after the start of application, per cm2 of the patch size.
Claims3
An adhesive patch for the treatment of tinea unguium intended to be applied once a day, comprising terbinafine and/or a pharmacologically acceptable salt thereof in an amount of 3 mg/cm2,
- wherein the adhesive patch is capable of dosing a terbinafine concentration in nails of 295±127 ng/mg and a terbinafine concentration in plasma of 23 pg/mL or less, 8 weeks after the start of application, per cm2 of the patch size.
A method for producing an adhesive patch for the treatment of tinea unguium in which side effects are reduced, the adhesive patch comprising a backing and a pressure sensitive adhesive layer arranged on at least one side of the backing, the method comprising:
- adding terbinafine and/or a pharmacologically acceptable salt thereof in an amount of 3 mg/cm2 to the pressure sensitive adhesive layer;
- and
- formulating the adhesive patch so that, when the adhesive patch having size of 1 cm2 is used so as to be applied to nails once a day, the patch is capable of dosing a terbinafine concentration in the nails of 295±127 ng/mg and a terbinafine concentration in plasma of 23 pg/mL or less, 8 weeks after the start of application.
A method of reducing side effects in a patient in the treatment of tinea unguium comprising administering to a patient in need thereof an adhesive patch comprising terbinafine and/or a pharmacologically acceptable salt thereof in an amount of 3 mg/cm2,
- wherein the adhesive patch is applied once per day, and
- wherein the adhesive patch is capable of dosing a terbinafine concentration in nails of 295±127 ng/mg and a terbinafine concentration in plasma of 23 pg/mL or less, 8 weeks after the start of application, per cm2 of the patch size.
Dependencies are inferred from the claim text.