IP Library Granted Patent US 10,653,721
Granted Patent B2
US 10,653,721 · App. 15/850,128 · Granted May 19, 2020

Peroxide formulations and methods and applicators for using the same

Inventors: Stuart D. Shanler (Malvern, PA); Christopher Powala (Radnor, PA); Christopher Phillips (Doylestown, PA); Brian Beger (Newtown, PA); Charles Rodney Greenaway Evans (Surrey, GB); Sian Tiong Lim (Surrey, GB); Marc Barry Brown (Watford, GB); Michael A. Botta (Ridge, NY); Thomas Nagler (Greenlawn, NY)
Assignee: ACLARIS THERAPEUTICS, INC.
A61K33/40A61K8/22A61K8/34A61K9/0014A61K9/08A61K47/10A61M35/003A61Q19/00A61Q19/08A61K2800/872A61M2205/7545
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Quick Facts
Patent No.
US 10,653,721
App. No.
15/850,128
Granted
May 19, 2020
Kind
B2
Abstract

Embodiments are directed to a stable composition comprising stabilized hydrogen peroxide and 2-propanol and applicators configured to store, dispense, and apply such stable compositions. Such compositions may be used to treat skin conditions such as warts, condyloma accuminatum, molluscum contagiosum, acrochordons, seborrheic keratosis, or a combination thereof. Some embodiments also describe take home compositions, in office compositions, over-the-counter compositions, and kits for the use of such compositions.

Claims (32)

1. A method of treating a wart in a human in need thereof comprising: topically administering to the wart of said human, a composition comprising about 45% w/w hydrogen peroxide and about 1% w/w to about 10% w/w 2-propanol.

2. The method of claim 1 , wherein the wart is selected from the group consisting of common warts, palmoplantar warts, flat warts, crecurrent warts, recalcitrant warts, treatment nave warts, epidermodysplasia veruciformis related warts, anogenital warts, condyloma acuminata, palmar warts, plantar warts, mosaic warts, butcher's warts and combinations thereof.

3. The method of claim 1 , wherein the composition is administered once to the human.

4. The method of claim 1 , wherein the composition is administered twice to the human.

5. The method of claim 1 , wherein the composition is administered once a week to the human.

6. The method of claim 1 , wherein the composition is administered twice a week to the human.

7. The method of claim 4 , wherein the second administration of the composition to the human occurs about 3 weeks after the first administration of the composition to the human.

8. The method of claim 1 , wherein the hydrogen peroxide is a stabilized hydrogen peroxide.

9. The method of of claim 1 , wherein the composition has a surface tension of about 42 mN·m-1 to about 55 mN·m-1 at 37° C.

10. The method of claim 1 , wherein the composition is stable for at least two years at 5° C., at least one year at 30° C., at least 6 months at 40° C., or a combination thereof.

11. The method of claim 1 , wherein the composition has a mean steady state release of hydrogen peroxide between 0.5 hours and 4 hours of between about 1000 μg/cm2/hour and about 1750 μg/cm2/hour.

12. The method of claim 1 , wherein the composition has a mean redox potential of about 415 mV to about 430 mV.

13. The method of claim 1 , wherein the composition has a pH of about 3.5 to about 4.

14. The method of claim 1 , wherein the composition is a solution.

15. The method of claim 1 , wherein the composition is a gel.

16. The method of claim 1 , wherein administering the composition comprises contacting the wart with an applicator selected from the group consisting of a sponge, a swab, a foam tipped stick, a cotton ball, a brush, a woven or non-woven fabric, roller, gauze, a glove, a pen-type applicator, a flocked, doe-foot applicator or a combination thereof.

17. The method of claim 1 , wherein administering the composition comprises contacting the wart with a tip of an applicator, wherein the applicator comprises:

a frangible ampoule having the composition disposed therein,

an applicator body having the frangible ampoule arranged therein;

an applicator hub in fluid communication with the applicator body;

the tip arranged at a proximal end of the applicator hub; and

a filter arranged between the frangible ampoule and the tip.

18. The method of claim 17 , wherein administering the composition comprises controlling a flow rate of the composition out of the tip by varying a squeezing force applied to the exterior surface of the applicator body.

19. The method of claim 17 , wherein administering the composition comprises contacting the tip with the wart whereby the composition dispenses through the tip onto the wart.

20. The method of claim 17 , wherein administering the composition further comprises applying pressure to a pressure area arranged on an outer surface of the applicator body causing the frangible ampoule to rupture.

21. The method of claim 17 , wherein administering the composition comprises causing the frangible ampoule to rupture and release the composition through the tip; and contacting the tip to the wart.

22. The method of claim 1 , wherein the composition further comprises a surface tension modifying agent.

23. The method of claim 1 , wherein the composition further comprises a stabilizer.

24. The method of claim 1 , wherein the composition further comprises a gelling agent.

25. The method of claim 1 , wherein no additional active agent is needed to treat the wart.

26. The method of claim 1 , wherein no additional therapeutic intervention is needed to treat the wart.

27. The method of claim 1 , wherein the composition comprises 2-propanol in an amount of about 1% w/w to about 5% w/w.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2018
From: LIM, SIAN TIONG; BROWN, MARC BARRY; GREENAWAY EVANS, CHARLES RODNEY; MEDPHARM LIMITED
To: ACLARIS THERAPEUTICS, INC.
Reel/Frame 045411/0895 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2018
From: NAGLER, THOMAS; BOTTA, MICHAEL A.; NATECH PLASTICS, INC.
To: ACLARIS THERAPEUTICS, INC.
Reel/Frame 045412/0443 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2018
From: SHANLER, STUART D.; POWALA, CHRISTOPHER; PHILLIPS, CHRISTOPHER; BEGER, BRIAN
To: ACLARIS THERAPEUTICS, INC.
Reel/Frame 045412/0546 →
Continuity (5)
Continuation 15591894 · May 10, 2017
Continuation 14692665 · Apr 21, 2015
Provisional Application 62085466 · Nov 28, 2014
Provisional Application 61982217 · Apr 21, 2014
Related Publication 20180185413A1 · Jul 5, 2018