IP Library Granted Patent US 10,857,159
Granted Patent B2
US 10,857,159 · App. 15/364,966 · Granted Dec 8, 2020

Halobetasol foam composition and method of use thereof

Inventors: Robert T. Gauthier (San Diego, CA); James D. Hammer (Uxbridge, MA)
Assignee: MAYNE PHARMA LLC
A61K31/573A61K9/0014A61K9/122A61K47/10A61K47/12A61K47/44
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Quick Facts
Patent No.
US 10,857,159
App. No.
15/364,966
Granted
Dec 8, 2020
Kind
B2
Abstract

The present invention provides a composition and method for treating various skin diseases. The composition is formulated as a foamable composition and includes the corticosteroid halobetasol.

Claims (14)

1. A storage stable, foamable composition consisting of, on a weight basis:

a) 0.02 to 0.10% halobetasol or its pharmaceutically acceptable salts, esters, and solvates;

b) 40 to 60% ethyl alcohol;

c) 0.1 to 5.0% Emulsifying Wax, NF;

d) 0.05 to 1.0% cetostearyl alcohol;

e) 0.05 to 1.0% polyoxyl 20 cetostearyl ether;

f) 1 to 10% propylene glycol;

g) 30 to 40% water;

h) greater than 0.0% and less than 0.0005% benzoic acid; and

i) a propellant,

wherein the composition has a pH of between about 4.0 to 6.3, and wherein an amount of degradation product of halobetasol is less than 2% after storage for 24 months at 25° C.

2. The composition of claim 1 , wherein the composition is present in a canister, and wherein the propellant is propane, n-butane, isobutane, or combinations thereof, at 3.25 to 5.75% w/w.

3. The composition of claim 2 , wherein the propellant is present in an amount ranging from 3.5 to 4% w/w.

4. The composition of claim 1 , wherein the composition has a pH of about 5.0-5.5.

Assignments (6)
RELEASE OF SECURITY INTEREST Recorded Jun 3, 2024
From: WESTPAC ADMINISTRATION PTY. LIMITED ACN 008 617 203
To: MAYNE PHARMA LLC
Reel/Frame 067598/0194 →
SECURITY INTEREST Recorded Jul 25, 2022
From: MAYNE PHARMA LLC
To: WESTPAC ADMINISTRATION PTY. LIMITED
Reel/Frame 060602/0385 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2019
From: THERAPEUTICS, INC.
To: MAYNE PHARMA LLC
Reel/Frame 047955/0874 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2018
From: HAMMER, JAMES
To: PHARMASOL CORPORATION
Reel/Frame 046092/0247 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2018
From: PHARMASOL CORPORATION
To: THERAPEUTICS INCORPORATED
Reel/Frame 046092/0547 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2018
From: GAUTHIER, ROBERT T.
To: THERAPEUTICS INCORPORATED
Reel/Frame 046092/0837 →
Continuity (2)
Provisional Application 62267749 · Dec 15, 2015
Related Publication 20170165275A1 · Jun 15, 2017