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(12) Patent Application Publication (10) Pub. No.: US 2004/0101538A1 Larnier Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2004/0101538A1 Larnier Et Al US 2004O1 O1538A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2004/0101538A1 Larnier et al. (43) Pub. Date: May 27, 2004 (54) TOPICAL COMPOSITION (30) Foreign Application Priority Data (76) Inventors: Catherine Larnier, Founex (CH); Mar. 30, 2001 (GB)......................................... O1080829 Michel Steiger, La Tour-de-Peilz (CH) Publication Classification Correspondence Address: THOMAS HOXE (51) Int. Cl." ...................... A61K 31/405; A61K 31/195 NOVARTIS, CORPORATE INTELLECTUAL (52) U.S. Cl. ......................... 424/400; 514/649; 514/420; PROPERTY 514/567 ONE HEALTH PLAZA 430/2 EAST HANOVER, NJ 07936-1080 (US) (57) ABSTRACT (21) Appl. No.: 10/472,697 The invention relates to topical pharmaceutical composi tions comprising an antifungal, e.g. terbinafine, and a Second (22) PCT Filed: Mar. 28, 2002 drug, e.g. diclofenac or indomethacin. Said compositions exhibit beneficial antimycotic properties, especially against (86) PCT No.: PCT/EP02/03547 dermatophytes. US 2004/0101538A1 May 27, 2004 TOPCAL COMPOSITION antifungal Selected from the group consisting of terbinafine, naftifine, butenafine, bifonazole, clotrimazole, econazole, 0001. The invention relates to topical pharmaceutical isoconazole, ketoconazole, miconazole, oxiconazole, Serta compositions with antimycotic activity, more specifically conazole, Sulconazole, tioconazole, tolnaftate, terconazole, anti-dermatophyte activity. amorolfine, ciclopiroX and undecylenic acid-in particular 0002 Dermatophytes are fungi that can cause infections terbinafine-, and topically acceptable Salts of any of Said of the skin, hair and nails due to their ability to utilize compounds, and a Second drug Selected from the group keratin. The organisms colonize the keratin tissues and cause consisting of diclofenac, indomethacin, flufenamic acid, fungal infections, e.g. known as tinea or ringworm, in niflumic acid, flurbiprofen, ibuprofen, SulfaSalazine and asSociation with the infected body part. The organisms are piroXicam-in particular diclofenac or indomethacin-, and transmitted by either direct contact with infected host topically acceptable Salts of any of Said compounds, together (human or animal) or by direct or indirect contact with with at least one topically acceptable carrier. infected exfoliated skin or hair in combs, hair brushes, clothing, furniture, theatre Seats, caps, bed linens, towels, 0008 All the antifungals and drugs concerned are known hotel rugs and locker room floors. Depending on the Species and e.g. described in The Merck Index, Twelfth Edition, the organism may be viable In the environment for up to 15 1996, for example: months. There is an increased Susceptibility to infection 0009 Terbinafine can be found under No. 9299; it is when there is a pre-existing injury to the skin Such as Scares, commercially available under the trademark LAMISIL. burns, marching, excessive temperature and humidity. Topically acceptable Salts thereof are e.g. terbinafine hydro 0003. The topical application of antifungal drugs, like chloride, terbinafine lactate or terbinafine ascorbat. Pre terbinafine, in the treatment of fungal Infections, Such as ferred are terbinafine and terbinafine hydrochloride, in par mycoses, especially dermatomycoses caused by dermato ticular terbinafine (=free base). phytes, e.g. athlete's foot (=tinea pedis), jock itch (=tinea 0010 Diclofenac (free acid) can be found under No. cruris), ringworm, (e.g. facial) Seborrheic dermatitis, or 3132; it is commercially available under the trademark onychomycosis, is known in the art. VOLTAREN. Topically acceptable salts thereof are e.g. 0004. It has now Surprisingly been found that by topical diclofenac Sodium, diclofenac potassium, diclofenac diethy application of certain Selected antifungals-in particular lammonium and diclofenac epolamine. Preferred is terbinafine-together with certain Selected Second drugs diclofenac Sodium. in particular diclofenac and Indomethacin-the antimycotic 0011 Indomethacin (free acid) can be found under properties are improved in an unexpected manner. Surpris No.4998. Topically acceptable salts thereof are e.g. ingly, the combinations of the present invention are particu indomethacin Sodium (e.g. the trihydrate) or the meglumine larly beneficial in fighting dermatophytes. AS already out Salt of indomethacin (meglumine =N-methyl-D-glucamine). lined above, the latter are the main cause for Superficial Preferred is indomethacin Sodium. mycoses frequently occurring in humans, Such athlete's foot, 0012 Preferably, the invention relates to topical compo jockitch or ringworm. Treatment of Said Superficial mycoses Sitions, wherein the antifungal is Selected from the group is generally improved by use of the Specific combinations of consisting of terbinafine, naftifine, butenafine, bifonazole, the invention. This is quite Surprising in View of the fact that clotrimazole, isoconazole, ketoconazole, miconazole, oxi the antifungals concerned are known to be rather effective in conazole, Sertaconazole, Sulconazole, tioconazole, tolnaf the eradication and treatment of dermatophytes even when tate, terconazole, amorolfine, ciclopiroX, undecylenic acid, applied alone. and topically acceptable Salts of any of Said compounds, and 0005 There are great differences between Candida infec the Second drug is Selected from the group consisting of tions, e.g. with Candida albicans, and those caused by diclofenac, indomethacin, flufenamic acid, niflumic acid, dermatophytes: Candida infections are in general much flurbiprofen, SulfaSalazine, piroXicam, and topically accept more difficult to treat with antifungals and are often SyS able Salts of any of Said compounds-as well as to the use temic. Dermatophytes, in contrast to Candida, never become thereof. pathogenic Systemically. Candida Species, in contrast to dermatophytes, are yeasts, are normally present in humans 0013 Preferably, the antifungal is selected from the and usually become pathogenic only in case of overgrowth, group consisting of terbinafine, naftifine, butenafine, bifona often induced by local factors like immunodepression. The Zole, clotrimazole, Sertaconazole, Sulconazole, tioconazole, physiopathology of Candida and dermatophyte infections is amorolfine, ciclopiroX, and topically acceptable Salts of any completely different: Yeasts like Candida are opportunistic of Said compounds. agents and usually need co-factors to become pathogenic, 0014 Preferably, the second drug is selected from the predominantly Systemically. Dermatophytes, however, group consisting of diclofenac, indomethacin, flufenamic become immediately pathogenic when present, and on the acid, niflumic acid, piroXicam, and topically acceptable Salts skin exclusively. of any of Said compounds. 0006 With the combinations of the present invention, the 0015. In another embodiment of the invention, the second cure of Superficial mycoses caused by dermatophytes, e.g. drug is Selected from the group consisting of ibuprofen and athlete's foot, is In general achieved more quickly and a topically acceptable Salts thereof. quicker relief of typical Symptoms, Such as itching, 0016 Especially, the invention relates to topical compo erythema, Vesiculation, burning or fissures, is observed. Sitions, wherein the antifungal is Selected from the group 0007. Therefore, the invention relates to a pharmaceutical consisting of terbinafine and topically acceptable Salts composition adapted to topical administration comprising an thereof, and the Second drug is Selected from the group US 2004/0101538A1 May 27, 2004 consisting of diclofenac, indomethacin, and topically 0027 (4) Controlled double-blind comparative study, acceptable Salts of any of Said compounds. involving 570 patients with established tinea pedis who are randomized to three groups of 190 each undergoing either 0.017. In particular, the invention relates to topical com treatment with terbinafine/diclofenac sodium (1.0%/0.1%), positions, wherein the antifungal IS terbinafine, or a topically terbinafine/indomethacin sodium (1.0%/0.1%), terbinafine acceptable Salt thereof, and the Second drug is diclofenac, or alone (1.0%) or placebo (vehicle). Efficacy, i.e. clinical and a topically acceptable Salt thereof. mycological cure, is determined at 5 days, 7 days and week 0.018. In particular preferred is the combination of ter 6 after the beginning of treatment. binafine (free base) and diclofenac Sodium. 0028. The topical compositions of the invention are like 0.019 A further embodiment of the Invention is charac wise beneficial in the treatment of animals, especially pets terized by topical compositions, wherein the antifungal is and farm animals, in an analogous manner as described terbinafine, or a topically acceptable Salt thereof, and the herein for human treatment. Therefore the invention also Second drug is indomethacin, or a topically acceptable Salt relates to topical veterinary compositions which are com thereof. Another embodiment of the invention is character posed in the same way as the topical pharmaceutical com ized by topical compositions, wherein the antifungal is positions described herein. terbinafine, or a topically acceptable Salt thereof, and the 0029. In the topical compositions of the invention, the Second drug is ibuprofen, or a topically acceptable Salt antifungal component-in particular terbinafine-is typi thereof. cally present in an amount of from 0.1 up to 10%, especially 0020. The topically acceptable carriers used largely of from 0.2 up to 5%, and in particular of
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