IP Library Granted Patent US 8,927,006
Granted Patent B2
US 8,927,006 · App. 12/943,810 · Granted Jan 6, 2015

Methods and compositions for rapid treatment of otitis externa

Inventors: William R. Campbell (Jamestown, NC); Neil E. Paulsen (High Point, NC); Roland H. Johnson (Lexington, NC); Douglas I. Hepler (McLeansville, NC)
A61K45/06A61K47/14A61K9/107A61K9/0046A61K9/127A61K31/496A61K31/573A61K36/752
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 8,927,006
App. No.
12/943,810
Granted
Jan 6, 2015
Kind
B2
Abstract

Methods for treating and preventing otitis externa with a course of treatment consisting of as little as a single dose are provided. The methods are practiced by topical administration of compositions having a lipid carrier, such as liposomes and non-vesicular lipids, to the outer ear canal. Such compositions lack viscocity-enhancing celluloses or adhesives, and are preferably not in the form of a gel. Active agents useful for treating pain, inflammation, fungal or parasitic infestation and/or infections in the outer ear are co-administered in or with the composition.

Claims (19)

1. A method for treating an existing otitis externa infection and sequelae thereof in a mammal, comprising topically applying a single dose of a pharmaceutically acceptable composition to the outer ear canal of the mammal to resolve the infection within 14 days of dosing, wherein the composition:

(i) does not include viscosity-enhancing celluloses or adhesive components,

(ii) is not in the form of a gel; and

(iii) comprises a lipid carrier and at least two active agents selected from the group consisting of antibiotics, anti-fungals, anti-parasitics, anti-virals, non-steroidal anti-inflammatories, analgesics, anesthetics and steroids.

2. The method according to claim 1 , wherein the lipid carrier is a lipid vesicle.

3. The method according to claim 1 , wherein one active agent in said composition is an antibiotic.

4. The method according to claim 1 , wherein one active agent in said composition is an anti-fungal.

5. The method according to claim 1 , wherein one active agent in said composition is a non-steroidal anti-inflammatory drug (NSAID).

6. The method according to claim 3 , wherein the antibiotic is selected from the group consisting of quinolone antibiotics, penicillin antibiotics, macrolide antibiotics, cephalosporin antibiotics, sulfa antibiotics, and beta-lactamase inhibitors.

7. The method according to claim 6 , wherein said antibiotic comprises thiamphenicol.

8. The method according to claim 4 , wherein said anti-fungal is an allylamine anti-fungal agent.

9. The method according to claim 8 , wherein the allylamine is terbinafine.

10. The method according to claim 5 , wherein the NSAID is diclofenac.

11. The method according to claim 1 , wherein the active agents are an antibiotic, an anti-fungal and a NSAID.

12. The method according to claim 1 , wherein the antibiotic is thiamphenicol, the anti-fungal is terbinafine and the NSAID is diclofenac.

13. The method according to claim 12 , wherein the terbinafine is provided in a concentration of 1 to 1.5% w/w of the composition.

14. The method according to claim 12 , wherein the diclofenac is provided in a concentration of 0.5% w/w of the composition.

15. The method according to claim 12 , wherein the composition further includes an oil-insoluble preservative.

16. The method of claim 1 , wherein the infection and sequelae thereof are clinically resolved within 14 days of administration.

Assignments (5)
ASSIGNMENT OF SECURITY INTEREST IN PATENT RIGHTS, RECORDED ON OCTOBER 29, 2020, AT REEL/FRAME 054217/0148 Recorded Dec 3, 2025
From: GOLDMAN SACHS BANK USA, AS RETIRING COLLATERAL AGENT
To: JPMORGAN CHASE BANK, N.A., AS SUCCESSOR COLLATERAL AGENT
Reel/Frame 073816/0043 →
SECURITY INTEREST Recorded Oct 29, 2020
From: ELANCO US INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 054217/0148 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2020
From: BAYER HEALTHCARE LLC
To: ELANCO US INC.
Reel/Frame 054023/0286 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 18, 2014
From: BAYER BV
To: BAYER HEALTHCARE LLC
Reel/Frame 034283/0608 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2011
From: PIEDMONT PHARMACEUTICALS, LLC
To: BAYER B.V.
Reel/Frame 026163/0597 →
Continuity (2)
Provisional Application 61260309 · Nov 11, 2009
Related Publication 20110281809A1 · Nov 17, 2011