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(12) United States Patent (10) Patent No.: US 8,722,102 B2 Melman (45) Date of Patent: May 13, 2014

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(12) United States Patent (10) Patent No.: US 8,722,102 B2 Melman (45) Date of Patent: May 13, 2014 USOO8722102B2 (12) United States Patent (10) Patent No.: US 8,722,102 B2 Melman (45) Date of Patent: May 13, 2014 (54) COMPOSITIONS FOR TREATMENT OFSKN (56) References Cited AND EAR INFECTIONS U.S. PATENT DOCUMENTS (75) Inventor: Steven A. Melman, Boca Raton, FL 5,110,809 A * 5/1992 Wang et al. ................... 514,171 (US) 5,461,068 A * 10/1995 Thaler et al. .................. 514,399 5,480,658 A 1/1996 Melman (73) Assignee: Dechra Veterinary Products LLC, 5,536,742 A 7/1996 Mason Overland Park, KS (US) 5,643,937 A 7, 1997 Mason 5,853,767 A 12/1998 Melman 2004/0033208 A1* 2/2004 Cagle et al. ................ 424/78.02 (*) Notice: Subject to any disclaimer, the term of this 2004/O120954 A1* 6, 2004 Seiki et al. ..... ... 424,146.1 patent is extended or adjusted under 35 2006/0046970 A1 3/2006 Bowman et al. ................ 514, 28 U.S.C. 154(b) by 0 days. 2007/00781 16 A1* 4/2007 Lane ............................. 514,171 2008/0317737 A1 12/2008 Patel et al. (21) Appl. No.: 13/018,388 OTHER PUBLICATIONS (22) Filed: Jan. 31, 2011 Malacetic Ultra Flush for Dogs, Cats, and Horses (2 oz.), Nov. 6, 2009. http://www.entirelypets.com/malaceticultraflush20z.html.* (65) Prior Publication Data US 2012/OO27875A1 Feb. 2, 2012 * cited by examiner Primary Examiner — Scott Long Related U.S. Application Data Assistant Examiner — Sarah Alawadi (74) Attorney, Agent, or Firm — Berenato & White, LLC (60) Provisional application No. 61/299,889, filed on Jan. 29, 2010. (57) ABSTRACT Int. C. The present invention relates to a composition for the treat (51) ment of skin and ear infections in humans and animals such as A6 IK33/22 (2006.01) dogs, cats and horses. In particular, the present invention A6 IK3I/4164 (2006.01) relates to a topical composition comprising acetic acid, an A6IP3I/00 (2006.01) antibacterial and/or an anti-fungal, and preferably also an A6IP 29/00 (2006.01) anti-inflammatory. More specifically, the composition of the A6IP 7/04 (2006.01) present invention is a bandage, bedding, clothing, condi A6IP3 L/10 (2006.01) tioner, cream, drape, dressing, film, foam, gauze, gel, lotion, A 6LX3/573 (2006.01) mousse, otic Solution, pad, patch, serum, shampoo, solution, A6IP3/04 (2006.01) spray, or wipe for treatment or prevention of skin infections, (52) U.S. C. wherein the composition comprises about 0.1-10% acetic USPC ............................ 424/659; 514/171; 514/399 acid, about 0.1-10% boric acid, about 0.01-20% azole, and (58) Field of Classification Search optionally about 0.01-20% corticosteroid. None See application file for complete search history. 3 Claims, No Drawings US 8,722,102 B2 1. 2 COMPOSITIONS FORTREATMENT OFSKN bination of at least one antifungal agent and at least one AND EAR INFECTIONS hydroxy acid agent formulated into shampoos, creams, lotions, gels, sprays, foams, pads, films, patches, and solu CROSS-REFERENCE TO RELATED tions for treatment of skin disorders and diseases in both APPLICATIONS humans and animals. However, there remains a need for a composition with This application claims priority to U.S. Provisional Appli enhanced efficacy against the treatment of infections, cation No. 61/299,889 filed Jan. 29, 2010. whether bacterial, fungal, or parasitic, which preferably also has anti-inflammatory properties. FIELD OF INVENTION 10 SUMMARY OF INVENTION The present invention relates to a composition for the treat ment of skin and ear infections inhumans and animals such as It is an object of the invention to provide a composition for dogs, cats and horses. In particular, the present invention the treatment of infections, especially skin and ear infections, relates to a topical composition comprising acetic acid, an 15 including bacterial, fungal and parasitic infections, in humans antibacterial and/or an anti-fungal, and preferably also an and animals such as dogs, cats and horses. anti-inflammatory. More specifically, the present invention It is another object of the invention to provide a topical relates to a composition that combines the antimicrobial composition comprising acetic acid, an antibacterial and/or effects of acetic and boric acid with the antifungal effects of an anti-fungal, and preferably also an anti-inflammatory. an azole, preferably with the antipruritic effects of a topical It is another object of the invention to provide a composi steroid. The present invention also relates to a method of tion for the treatment and prevention of bacterial, fungal and treating a skin or ear infection in a human or an animal parasitic infections of the skin and ears with a composition comprising administering an effective amount of a composi comprising an antimicrobial, an antibacterial and/or an anti tion comprising acetic acid, an antibacterial and/or an anti fungal, an anti-inflammatory and/or antipruritic to provide fungal, and preferably also an anti-inflammatory to the 25 itch relief often associated with skin and ear infections. affected area. According to a preferred embodiment, the antibacterial com prises boric acid. According to another preferred embodi BACKGROUND OF INVENTION ment, the antifungal comprises at least one azole. According to yet another preferred embodiment, the anti-inflammatory There are many products on the market today to treat skin 30 comprises a corticosteroid. and ear infections. It is another object of the invention to provide a composi U.S. Pat. No. 5,480,658, which is incorporated herein by tion comprising acetic acid, preferably in quantities of about reference, discloses a preferably pH balanced multi-purpose 0.1% to about 10%, boric acid, preferably in quantities of cleaning solution containing acetic acid and boric acid in a about 0.1% to about 10%, and at least one azole, preferably water base, useful on pets for the routine cleaning of the ear, 35 present in quantities of about 0.01% to about 20%. the cleaning of the sensitive ear, particularly for cleaning It is another object of the invention to provide a composi moist, waxy or odiferous ears, the prevention and treatment of tion comprising acetic acid, preferably in quantities of about ear disease Such as Swimmer's Ear and other ear diseases, 0.1% to about 10%, boric acid, preferably in quantities of acidification of the ear, and wound cleaning. The claimed about 0.1% to about 10%, at least one azole, preferably in Solution may also contain a topical anesthetic, Such as 40 quantities of about 0.01% to about 20%, and a corticosteroid, lidocaine hydrochloride, to provide relief from pain during preferably in quantities of about 0.01 to about 20%. treatment, and may be used as a carrier material for topical It is another object of the invention to provide a composi applications of medications including antibiotics and corti tion comprising acetic acid, preferably in quantities of about costeroids. 0.1% to about 10%, boric acid, preferably in quantities of U.S. Pat. No. 5,536,742 discloses an anti-seborrhoeic com 45 about 0.1% to about 10%, and a corticosteroid, wherein the position containing both a broad spectrum antifungal drug corticosteroid is preferably present in quantities of about 0.01 and a topical antiseptic for the treatment of dogs. The com to about 20%. position can be formulated as a shampoo further containing a It is another object of the invention to provide a composi keratolytic or keratoplastic compound. The preferred antifun tion comprising acetic acid, preferably in quantities of about gal drug is miconazole and the preferred topical antiseptic is 50 0.1% to about 10%, and at least one azole, preferably in chlorhexidine, and the formulation optionally contains sele quantities of about 0.01% to about 20%. nium Sulphide as an added ingredient. It is another object of the invention to provide a composi U.S. Pat. No. 5,853,767, which is incorporated herein by tion comprising acetic acid, preferably in quantities of about reference, discloses a method for treating infections, bacte 0.1% to about 10%, at least one azole, preferably in quantities rial, fungal and parasitic in origin, especially infections of 55 of about 0.01% to about 20%, and a corticosteroid, preferably organs such as the vagina and skin, is provided and involves in quantities of about 0.01 to about 20%. administering to a patient in need thereof a composition com It is another object of the invention to provide a composi prising boric acid and acetic acid, in effective amounts. Such tion comprising acetic acid, preferably in quantities of about a composition is especially useful as a broad based treatment 0.1% to about 10%, at least one azole, preferably in quantities of vaginal infections of unknown bacterial or fungal origin 60 of about 0.01% to about 20%, and a topical antiseptic, pref and can be used without the need for medical diagnosis or erably in quantities of about 0.1% to about 5%. According to while Such a diagnosis is being determined. Such a compo a preferred embodiment, the topical antiseptic comprises sition is effective, safe, providing an alternative to existing chlorhexidine. forms of treatment which are toxic and is environmentally It is a further object of the invention to provide a compo friendly. 65 sition for the treatment and prevention of infections formu US Publication No. 2008/0317737 discloses a topical lated as a shampoo, a conditioner, a gel, a foam, a mousse, a treatment for skin disorders and diseases comprising a com spray, a dressing, a cream, a lotion, a serum, an otic, or a US 8,722,102 B2 3 4 Solution for topical or otic use as well as a material compris Zole, fenticonazole, fluconazole, isoconazole, itraconazole, ing the composition Such as a wipe, a bandage, gauze, cloth ketoconazole, miconazole, omoconazole, oxiconazole, posa ing, a drape, bedding, a dressing, a film, a pad or a patch.
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