EBASTINE TOPICAL COMPOSITION
Provided herein is a topical composition for treatment of a hair-loss related condition or disease and related methods for making and using the topical composition. The topical composition generally comprises ebastine dissolved in a solvent. In some exemplary embodiments, the solvent comprises a monohydric aliphatic alcohol and an ester. In some exemplary embodiments, the solvent comprises a polyol.
1 . A topical pharmaceutical composition, comprising:
ebastine, and
a solvent,
wherein the ebastine is dissolved in the composition at room temperature.
2 . The topical pharmaceutical composition of claim 1 ,
wherein the solvent comprises a volatile solvent and a non-volatile solvent.
3 . The topical pharmaceutical composition of claim 2 , wherein the non-volatile solvent is evaporated to form a residual composition, and ebastine is dissolved in the residual composition.
4 . The topical pharmaceutical composition of claim 2 , wherein ebastine is more soluble at room temperature in the volatile solvent than in the non-volatile solvent.
5 . The topical pharmaceutical composition of claim 2 , wherein ebastine is more soluble at room temperature in the non-volatile solvent than in the volatile solvent.
6 . The topical pharmaceutical composition of claim 2 , wherein ebastine is more soluble at room temperature in the solvent than in either the volatile solvent or the non-volatile solvent.
7 . The topical pharmaceutical composition of claim 2 , wherein the volatile solvent is a monohydric aliphatic alcohol and the non-volatile solvent is an ester.
8 . The topical pharmaceutical composition of claim 7 , wherein the monohydric aliphatic alcohol is ethanol.
9 . The topical pharmaceutical composition of claim 7 , wherein the ester is selected from the group consisting of diethyl sebacate, dimethyl succinate, and ethyl acetate.
10 . The topical pharmaceutical composition of claim 7 , wherein the ratio of concentrations by weight of monohydric aliphatic alcohol to ester is in the range of 1:1 to 99:1.
11 . The topical pharmaceutical composition of claim 7 , wherein the monohydric aliphatic alcohol comprises 40 percent to 99 percent of the composition by weight.
12 . The topical pharmaceutical composition of claim 1 , wherein the solvent comprises a polyol.
13 . The topical pharmaceutical composition of claim 12 , wherein the polyol is propylene glycol.
14 . The topical pharmaceutical composition of claim 1 , wherein the ebastine is stable when stored in a sealed glass container for at least 2 months or longer at 40° C. in a dark environment.
15 . The topical pharmaceutical composition of claim 1 ,
wherein the solvent comprises
a concentration of water and
a concentration of a non-aqueous solvent,
wherein the concentration of the non-aqueous solvent exceeds the concentration of water, and
wherein the pH of the composition is in the range of 3 to 7.
16 . The topical pharmaceutical composition of claim 1 , wherein the composition is non-aqueous.
17 . The topical pharmaceutical composition of claim 1 , wherein the composition does not comprise an active pharmaceutical ingredient other than ebastine.
18 . A method for the treatment of a hair-loss related condition or disease, comprising: topically applying a composition comprising ebastine dissolved in a solvent to the scalp of a human patient at least once daily for a period of at least one month.
19 . The method of claim 18 , wherein the hair-loss related condition or disease is selected from the group consisting of scarring alopecia, non-scarring alopecia, androgenetic alopecia, and alopecia areata .
20 . The method of claim 18 , wherein the daily dosage of ebastine is in the range of 1.0 mg/cm 2 to 10 mg/cm 2 .
21 . The method of claim 18 , wherein the composition does not comprise an active pharmaceutical ingredient other than ebastine.
22 . A kit for the delivery of a topical pharmaceutical composition, comprising:
a container closure,
a topical pharmaceutical composition comprising ebastine dissolved in a solvent, and instructions for use,
wherein the instructions for use comprises instructions to apply the composition to the scalp of a patient.