IP Library Patent Application 16174216
Patent Application
App. No. 16/174,216

EBASTINE TOPICAL COMPOSITION

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Patent No.
US None
App. No.
16/174,216
Abstract

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.

Claims (34)

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.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 11, 2024
From: TIMBER PHARMACEUTICALS, INC.; TIMBER PHARMACEUTICALS, LLC; BIOPHARMX, INC.
To: LEO PHARMA A/S
Reel/Frame 066782/0409 →
SECURITY INTEREST Recorded Feb 11, 2020
From: BIOPHARMX, INC.
To: TIMBER PHARMACEUTICALS LLC
Reel/Frame 051789/0070 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 3, 2019
From: CHEN, XIN; JUMAA, MOUHANNAD; NAGAVARAPU, USHA; HERMSMEIER, MAIKO C.
To: BIOPHARMX, INC.
Reel/Frame 047890/0760 →