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(12) Patent Application Publication (10) Pub. No.: US 2011/005250.6 A1 Abel Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/005250.6 A1 Abel Et Al US 2011 0052506A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/005250.6 A1 Abel et al. (43) Pub. Date: Mar. 3, 2011 (54) STABLE AEROSOL TOPICAL FOAMS Publication Classification COMPRISINGA HYPOCHLORITE SALT (51) Int. Cl. (75) Inventors: Douglas Abel, Sudbury, MA (US); st 94;O CR Ronald M. Gurge, Franklin, MA ( .01) (US); Mark W. Trumbore, A6IP3L/00 (2006.01) Westford, MA (US) (52) U.S. Cl. .......................................................... 424/45 (73) Assignee: Collegium Pharmaceutical, Inc., (57) ABSTRACT Cumberland, RI (US) Described herein are compositions useful in the treatment of atopic dermatitis and other skin conditions, which composi (21) Appl. No.: 12/872,566 tions exhibit enhanced stability. The compositions contain a 1-1. hypochlorite salt, useful for its antimicrobial properties, and (22) Filed: Aug. 31, 2010 are non-irritating when applied to the skin. The compositions O O also provide enhanced moisturizing properties. The compo Related U.S. Application Data sitions can be formulated into a topical aerosol foam with (60) Provisional application No. 61/238,439, filed on Aug. inert, non-flammable propellants, such as hydrofluoroal 31, 2009. kanes, and may be used in cosmetics or pharmaceuticals. US 2011/005250.6 A1 Mar. 3, 2011 STABLE AEROSOL TOPCAL FOAMS itch associated with atopic dermatitis; however, they can COMPRISINGA HYPOCHLORITE SALT cause sleepiness and may not help in all cases of atopic dermatitis. RELATED APPLICATION 0007 For mild cases of atopic dermatitis, an over-the counterformulation of coal taris often used. Coaltar has long 0001. This application claims benefit under 35 U.S.C. 119 been a treatment for a variety of skin conditions. Shampoos (e) of U.S. Provisional Application No. 61/238,439, filed on and Soaps containing coal tar can help with mild cases of Aug. 31, 2009, the entire content of which is incorporated atopic dermatitis. Coal tar tends to work better on thickened herein by reference. skin that is not scaly and the early symptoms of itching. However, coal tar can be irritating to already inflamed skin. BACKGROUND Coal tar is used for mild cases of atopic dermatitis only. 0008 For more severe flares of atopic dermatitis—for 0002 Atopic dermatitis (AD) is a disease characterized by example if the rash covers a large part of the body or face— dry, cracked, itchy, and inflamed skin, often presenting on oral corticosteroids, Such as prednisone, prednisolone, and greater than 10% of the body surface area. In accounts for medrol, may be used. Long-term use of oral steroids has 10-20% of all visits to a dermatologist and affects approxi numerous side effects, including weight gain, thinning of the mately 3% of the US population, most of whom are children. bones, and Suppression of the immune system; consequently, The condition is characterized by intense pruritus (itch) and a though they may clear atopic dermatitis well, the side effects course marked by exacerbations and remissions. Higher tran are too risky to warrant using them as a first-line treatment. To sepidermal water loss (TEWL) has also been noted in dry skin avoid these side effects, but still benefit from the medication, atopic patients; TEWL is indicative of a disturbed barrier oral steroids are often prescribed for a short course (e.g., five function, and it has been correlated to pruritus intensity in days) to calm the rash. Topical steroids can then be used on the patients. Furthermore, the compromised skin barrier allows remaining rash. excessive water loss through the epidermal layer of the skin 0009. As discussed above, atopic dermatitis reduces the and the potential penetration of allergens. skin's natural defenses, making it easier for skin to become 0003 Environmental factors, such as psychological stress, infected. If the skin becomes infected, antibiotics are often climate (e.g., low humidity caused by cold winters and central prescribed. Antibiotics, such as cefadroxil or cephalexin, are heating), and exposure to irritants and allergens determine the often prescribed at the first sign of infection. course of the disease. The defective barrier function associ 0010 Transient immersion of affected skin in a low con ated with AD can also make atopic patients more prone to centration chlorine bleach bath (i.e., aqueous Sodium irritant contact dermatitis, since ordinary Soaps and deter hypochlorite) has been shown to decrease the microbial bur gents often irritate the skin. Exposure to hard water, espe den associated with atopic dermatitis, resulting in an cially to calcium salts in domestic water, has been found to be improvement in Symptoms. Skin and wound cleansers con associated with a higher prevalence of atopic eczema in pri taining bleach have also been shown to reduce microbial skin mary-school children. contamination. To date, all bleach containing products for 0004 Another potential triggering factor for AD is the topical use are intended fortransient skin contact, no leave-on colonization of the skin with microorganisms, such as Sta products such as creams, lotions or topical foams intended for phylococcus aureus and Malassezia. S. aureus can release long term skin contact and containing bleach exist. Incorpo Superantigenic exotoxins, which produce a massive release of ration of bleach into leave-on products intended for long term cytokines Staphylococcus enterotoxin B also induces eczema skin contact allows for the potential to provide additional when applied to uninvolved atopic and normal skin, while the long-term treatment benefits such as improved moisturization severity of AD has been reported to correlate linearly with S. and control of transepidermal water loss not possible with a tirett.S COuntS. products intended for transient skin contact. 0011 Hypochlorite salts are inherently unstable in aque 0005. A doctor has three main goals in designing a treat ous solution. The decomposition rate of hypochlorite in water ment regime for the patient: healing the skin and keeping it is dependent on concentration, temperature, and pH. High healthy, preventing flare ups, and treating symptoms when temperatures and acidic pHs greatly accelerate the rate of they do occur. Proper skin care and moisturizing ointments decomposition, as does the presence of metal ions. The nor are the mainstays of topical treatment. Moisturizers which mal shelf-life of bleach solutions is approximately six months improve barrier function have been reported which reduce the at a pH of between 12 and 13.5. Additionally, due to the high prevalence of AD and can reduce the associated symptoms. pH and oxidative potential of bleach, bleach solutions are 0006. In addition to moisturizers, a variety of medications frequently irritating to the skin. may be prescribed to help manage the condition. Topical 0012. There exists a need for a stable, non-irritating topi steroids are the first-line treatment for atopic dermatitis flares cal formulation containing bleach Suitable for the long-term because they are effective at reducing the inflammation application in the treatment of atopic dermatitis. caused by this disease. Immunomodulators (calcineurin inhibitors, such as tacrolimus and pimecrolimus) may also be SUMMARY OF THE INVENTION prescribed. Immunomodulators change Some of the functions of the immune system that cause atopic dermatitis without 0013. In certain embodiments, the invention relates to a Suppressing the whole immune system. Other immune-Sup composition containing monovalent or divalent salts of pressing medications being investigated as a treatment for hypochlorite, wherein the concentration of hypochlorite does atopic dermatitis include: cyclosporine, interferon, methotr not appreciably change with time. In certain embodiments, exate, and azothiaprine. Another mechanism of treatment the composition is packaged into an aerosol can and pressur includes the use of oral antihistamines, such as diphenhy ized with a hydrofluorocarbon propellant. In certain embodi dramine or hydroxyZine. Oral antihistamines are used to treat ments, when the can is actuated, a foam is dispensed. In US 2011/005250.6 A1 Mar. 3, 2011 certain embodiments, the dispensed foam is time- and tem tion, thus overcoming the expected and well-known stability perature-stable, exhibits robust antimicrobial activity, mois issues associated with these chemicals. turizes the skin, and is non-irritating. 0020. In one embodiment, the compositions are formu lated such that the chemical instability is reduced. For DETAILED DESCRIPTION OF THE INVENTION example, compositions were formulated with the addition of antioxidants to the concentrate. In one embodiment, the air in 0014. In certain embodiments, the invention relates to a the container headspace may be replaced with an inert gas thickened aerosol foam composition containing a monova (argon). Compositions formulated in this way may exhibit lent or divalent hypochlorite salt that is stable. In certain improved stability in the presence of HFA propellants (e.g., embodiments, when applied to the skin a composition of the HFA-134a and HFA-227). invention reduces the number of skin-associated bacteria, yeasts, and fungi, improves skin moisture levels, and is non Moisturization and Irritation irritating and non-drying. In certain embodiments, the inven tion relates to a composition that is suitable for the treatment 0021 Topical formulations of hypochlorite salts are of atopic dermatitis. known to be generally irritating and lack the ability to hydrate 0015. In one embodiment, the
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