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Wo 2009/063493 A2 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date (10) International Publication Number 22 May 2009 (22.05.2009) PCT WO 2009/063493 A2 (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/58 (2006.01) A61K 31/575 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, (21) International Application Number: CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, PCT/IN2008/000577 EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (22) International Filing Date: LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, 8 September 2008 (08.09.2008) MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, (25) Filing Language: English RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 1725/MUM/2007 kind of regional protection available): ARIPO (BW, GH, 10 September 2007 (10.09.2007) IN GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (71) Applicant (for all designated States except US): GLEN- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), MARK PHARMACEUTICALS LIMITED [IN/IN]; European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, Glenmark house, HDO-Corporate Bldg, Wing-A, B.D FR, GB, GR, HR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, Sawant Marg, Chakala, Andheri (East), Maharashtra (IN). NO, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (72) Inventors; and (75) Inventors/Applicants (for US only): SEN, Nilendu Declarations under Rule 4.17: [IN/IN]; Flat # 302, Nishant Arcade, Plot # 86, Sector - — as to applicant's entitlement to applyfor and be granted a 17, Koper Khairne, Maharashtra, Navi Mumbai 400709 patent (Rule 4.17(U)) (IN). GOLE, Kusum Dinkar [IN/IN]; 402, A wing, Chi- — of inventorship (Rule 4.17(iv)) trakut, Bhatwadi Market, Ghatkopar (West), Maharashtra, Mumbai 400084 (IN). SHARMA, Akhilesh Dayanand Published: [IN/IN]; D/206, Soni Sarovar, Opp: Sai Towers, Old MHB — without international search report and to be republished Colony, Off Gorai Road, Borivali ( West), (IN). upon receipt of that report (54) Title: TOPICAL PHARMACEUTICAL COMPOSITION FOR THE COMBINATION OF FUSIDIC ACID AND A CORTI COSTEROID (57) Abstract: The present invention relates to topical compositions comprising combination of mometasone furoate and fusidic acid. The present invention also relates to use of topical combinations of mometasone furoate and fusidic acid for prevention and treatment of dermal infections. The present invention also relates to topical compositions comprising Halobetasol propionate and fusidic acid and their use for prevention and treatment of dermal conditions. TOPICAL PHARMACEUTICAL COMPOSITION FOR THE COMBINATION OF FUSIDIC ACID AND A CORTICOSTEROID PRIORITY DETAILS This patent application claims priority to Indian Patent .Application No.1725/MUM/2007, filed on September 10, 2007, the contents of which are hereby incorporated as reference. TECHNICAL FIELD OF THE INVENTION The present invention relates to a combination therapy of a topical antibiotic and a topical steroid for the treatment of inflammatory dermatoses associated with secondary bacterial infections. In particular the present invention relates to topical pharmaceutical compositions comprising a combination of fusidic acid and corticosteroid such as Mometasone furoate useful in treatment of infected eczema's such as secondarily infected dermatitis, including secondarily infected contact dermatitis, psoriasis, allergic contact dermatitis and atopic dermatitis with secondary bacterial infections of skin. In particular the present invention also relates to topical pharmaceutical compositions comprising a combination of fusidic acid and corticosteroid such as Mometasone furoate useful in prevention of infection in cases of dermatitis, especially atopic dermatitis who are at risk of getting secondary bacterial infection In particular the present invention also relates to topical pharmaceutical compositions comprising a combination of fusidic acid and corticosteroid such as Halobetasol propionate useful in treatment of infected steroid responsive dermatoses such as secondarily infected dermatoses including secondarily infected contact dermatitis, allergic contact dermatitis, atopic dermatitis, psoriasis and other corticosteroid responsive dermatoses (CRD) with secondary bacterial infections of skin. In particular the present invention also relates to topical pharmaceutical compositions comprising a combination of fusidic acid and corticosteroid such as Halobetasol propionate useful in prevention of secondary bacterial infections in patients with non-infected dermatoses BACKGROUND OF THE INVENTION Bacteria such as Staphylococcus can live harmlessly on many skin surfaces, but when the skin is punctured or broken for any reason, staphylococcus bacteria can enter the, wound and cause the infections. There are more than 30 species in the staphylococcus family of bacteria, and they can cause different kinds of illnesses. But most staphylococcus infections are caused by the species Staphylococcus aureus (S. aureus) and Streptococcus pyogenes. Skin and soft-tissue infections are among the most common infections, and may lead to serious local and systemic complications. Bacterial infections occur frequently in lesions of eczema and atopic dermatitis. One of the common causes of skin and soft-tissue infections is the occurrence of secondary bacterial infection that complicates skin lesions. Secondary bacterial skin infections are common complications of primary dermatoses, primary nonbacterial skin infections, traumatic lesions, ulcers, cutaneous infestations, and other miscellaneous skin diseases. Despite the differences in the underlying cause and clinical presentation, overt secondary bacterial infection with Staphylococcus aureus and Streptococcus pyogenes, or both ,is a common problem in patients with inflammatory skin diseases such as allergic contact dermatitis, atopic dermatitis, or psoriasis. Various host factors have been suggested to be the cause of secondarily infected dermatitis (SID), including the lack of expression of antimicrobial peptides on the skin, and the demonstration of increased adherence of Staphylococcus aureus to the skin of patients with atopic dermatitis, A serious consequence of atopic dermatitis, psoriasis, and allergic contact dermatitis is that the integrity of the skin barrier is compromised. Recent studies of patients with atopic dermatitis have shown that levels of both epidermal hydration and skin surface lipids are reduced, making the skin more susceptible to colonization with pathogens. A correlation between the severity of the eczema and colonization with S. aureus has been demonstrated, and it has been determined that bacterial colonization is an important factor aggravating skin lesions. Staphylococcus aureus has also been found on the skin of more than half of the patients with chronic plaque psoriasis, and colonization with staphylococci and streptococci has been reported to exacerbate psoriasis. Staphylococcal superantigens contribute to the pathogenesis of cutaneous inflammation in atopic dermatitis through various potential mechanisms, viz. direct stimulation of antigen presenting cells and keratinocytes, stimulation of T cell proliferation (by binding to T cell receptors), expansion of skin-homing cutaneous lymphocyte antigen positive T cells. Topical corticosteroid is commonly used in the treatment of eczema and atopic dermatitis and several studies have shown the impact of such treatment on bacterial skin flora. Antibacterials, whether topical or systemic, in combination with topical corticosteroids, may produce a more rapid decrease in S. aureus colonization than topical corticosteroids monotherapy. Corticosteroids are commonly used in treatment of eczema and Atopic dermatitis. However, when steroid application or administration is stopped, the diseases easily relapse, and when it is used for a long time it may lead to a number of adverse effects such as skin atrophy and secondary infection. Bacterial superantigens were recently shown to induce corticosteroid insensitivity. Hence the eradication of Staphylococcus aureus may lead to a steroid-saving effect. Leyden et al. (Br J Dermatol 1974; 90:525-30.) first showed that the therapeutic effect of antibiotics combined with steroid was better than that of steroid monotherapy. In several open or double-blind placebo-controlled trials, topical and systemic antimicrobials were able to reduce the colonization density and led to a partial improvement of skin lesions. Larsen FS and et al (Acta Derm Venereol. 2007;87 (1):62-8.) provides a formulation of fusidic acid and betamethasone 17-valerate as an alternative for the short-term treatment of clinically infected atopic dermatitis. M. A . Cobb (The Veterinary Journal Volume 169, Issue 2, March 2005, Pages 276-280) and et al provides a comparative study of topical preparation containing 0.5% fusidic acid and 0.1% betamethasone-17-valerate with the systemic therapy. The study demonstrates no difference and that both treatment regimes represent effective treatment options for the condition such as canine acute moist
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