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(12) United States Patent (10) Patent No.: US 6,790,847 B2 Wach (45) Date of Patent: Sep

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(12) United States Patent (10) Patent No.: US 6,790,847 B2 Wach (45) Date of Patent: Sep USOO6790847B2 (12) United States Patent (10) Patent No.: US 6,790,847 B2 Wach (45) Date of Patent: Sep. 14, 2004 (54) TOPICAL APPLICATION OF CETIRIZINE JP O2835985 B 12/1998 AND LORATADNE WO WO9219276 A 11/1992 WO WO O1/39774 A1 6/2001 (75) Inventor: Hatto Walch, Baden (DE) WO WO 01/87236 A2 11/2001 OTHER PUBLICATIONS (73) Assignee: Oramon Arzneimittel GmbH, Laupheim (DE) International Search Report, Applin. No. 02000131.9-2123, dated Jun. 28, 2002. (*) Notice: Subject to any disclaimer, the term of this Origoni et al., “Topical oXatomide: an alternative approach patent is extended or adjusted under 35 for the treatment of vulvar lichen Sclerosus’, International U.S.C. 154(b) by 0 days. Journal of Gynecology and Obstetrics, 1996, pps. 259-264. Origoni et al., “Efficacy of Topical Oxatomide in Women (21) Appl. No.: 10/334,331 with Pruritus Vulvae”, Drugs. Exptl. Clin. Res., XVI (11), 1990, pps. 591-596. (22) Filed: Dec. 30, 2002 Sacerdoti et al., “Evalution of the inhibition of allergen-spe (65) Prior Publication Data cific and nonspecific skin responses by topical oXatomide,” G Ital Dermatol Venereol, vol. 125, No. 7-8, 1990, pps. US 2003/0129209 A1 Jul. 10, 2003 XXIX-XXXII. (30) Foreign Application Priority Data Lodi et al., “OXatomide in the treatment of pruriginous skin diseases of various nature', G Ital Dermatol Venereol, vol. Jan. 4, 2002 (EP) ............................................ O2OOO131 125, No. 10, 1990, pps. LV-LIX. Leggieri et al., “Topical oXatomide in the treatement of (51) Int. Cl." ........................ A61K 31/50; A61K 31/44; urticaria”, Reparto di Immunologia e Allergologia Clinica, A61K 31/445; A61K 31/74 1992, pps. 137–144. (52) U.S. Cl. ....................... 514/252; 514/315; 514/279; Garcia-Campayo et al., “Independent Activities of FSH and 424/78.05 LH Structurally Confined in a Single Polypeptide: Selective (58) Field of Search ................................. 514/252, 315, Modification of the Relative Potencies of the Hormones', 514/279 Endocrinology, vol. 142(12), 2001, pps. 5203-5211. (56) References Cited * cited by examiner U.S. PATENT DOCUMENTS Primary Examiner Sreeni Padmanabhan ASSistant Examiner Jennifer Kim 5,567,420 A * 10/1996 McEleney et al. ............ 424/60 (74) Attorney, Agent, or Firm-Ratner Prestia 5,993,833 A 11/1999 De Lacharriere et al. (57) ABSTRACT FOREIGN PATENT DOCUMENTS EP O 484529 A1 5/1992 The present invention relates to a drug composition con EP 1005 865 A1 6/2000 taining the non-sedating H antihistamines cetirizine, JP 62164624 A 7/1987 loratadine, mixtures or pharmaceutically acceptable Salts JP O1 102O24 A 4/1989 thereof for topical application in the form of a gel. JP 01 121218 A 5/1989 JP O9 O3O972 A 2/1997 9 Claims, No Drawings US 6,790,847 B2 1 2 TOPCAL APPLICATION OF CETRIZINE use as an anti-allergic, anti-histaminic, bronchio-dilatory AND LORATADINE and anti-Spasmodic agent. In a general form, the document also describes a possible oral, parenteral or topical use of the hydroxy Zine derivatives disclosed. However, no examples BACKGROUND OF THE INVENTION for a topical formulation are given. In case of the above mentioned indications, cetirizine has, on the whole, been The present invention relates to a pharmaceutical com administered only orally or, for experimental purposes, position comprising the non-Sedating H antihistamines nasally. cetirizine, loratadine, mixtures, or pharmaceutically accept Likewise, other Second generation H antihistamines Such able Salts thereof for topical application in the form of a gel. as loratadine are exclusively formulated and administered Histamine is a biogenic amine formed by decarboxylation orally in practical applications. According to the American of the amino acid histidine and is present as a tissue hormone DrugdeX Drug Evaluations, loratadine is also a non-Sedating in human and animal organisms, especially in the skin and anti-histamine. The active ingredient is administered to in the lung. However, it is also contained in bee poison, in adults in one oral dose of 10 mg per day and to children in the Salivary Secretion of biting insects, in Stinging nettles, one dose of 5 mg per day. Oral combination products, for and Such like. In the human body, histamine is Stored in the 15 example with pseudoephedrine, are also known. Similar to basophilic granulocytes and the mastocytes. When allergic cetirizine, areas of indication for the use of loratadine are skin reactions occur, exceSS histamine is released and is then allergic rhinitis, asthma and chronic idiopathic urticaria. one of the factors responsible for itching and the formation The preparation of the substance is described in U.S. Pat. of skin weals and flares. This release takes place whenever No. 4,282,233, which also describes pharmaceutical prepa human and animal cells are damaged and causes reactions of rations for enteral or parenteral administration, but not the Surrounding tissue. Even though histamine is rapidly topical administration of the active ingredient. metabolised in the human body, the effects caused by the European patent application 0903 151 describes the use release may last for a considerable period of time which of combinations of non-Sedating antihistamines and Severely affects the well-being of the person concerned. At C.-adrenergic active ingredients for the topical treatment of present, antihistamines are primarily administered orally to 25 rhinitis or conjunctivitis and of Symptoms of a cold. The treat these effects of histamine releases. topical preparations described contain the antihistamine in an amount of 0.001% to 0.5%, preferably 0.05% to 0.1%. Antihistamines are pharmaceutical agents which competi Apart from that, the application describes only topical tively displace histamine from its receptors and are therefore formulations for administration via the mucous membranes, able to counteract its effects. Depending on the histamine namely nose Sprays, nose drops or eye drops. Topical receptors they effect, they are classified as H antihistamines application to the Skin is not disclosed or intended. and H antihistamines. In addition to their antihistaminic WO 01/87 236 discloses a spray containing a pharmaco characteristics, almost all H antihistamines also have a logically active compound Such as an antihistamine to treat Spasmolytic and locally anaesthetising effect. In addition, insect bites, insect Stings, nettle rash, atopical dermatitis and most of these preparations have a Sedating effect on the 35 contact dermatitis, as well as Sunburn, neurodermatitis, central nervous System. urticaria and eczema. At the same time, the document In general, H antihistamines are indicated for all diseases discloses creams, gels, foams, ointments or lotions contain based on the release of histamine, Substances with a Stronger ing hydroxy Zine. No details concerning these compositions Sedating effect also being used as antiemetics or sleeping are provided. drugs. In any case, the most important Side effect is the 40 U.S. Pat. No. 5,993,833 discloses topical compositions influence on the central nervous System, i.e. the Sedating containing an antihistamine, an interleukin-1 antagonist effect. Because this Sedating effect prevented general and/or an TNFC. antagonist. These preparations may be application, for example in case of colds or hay fever, Second provided in any topical form possible including anhydrous generation H antihistamines with fewer Sedating side or lipophilic gels, creams, emulsions, foams and Such like. effects have been developed of late. In general and for the 45 However, this document primarily teaches the addition of an purposes of the present application, these are called “non antihistamine to a cosmetic, dermatological or pharmaceu Sedating H antihistamines”. Typical examples of non tical preparation instead of Such as composition per se, the Sedating H1-antihistamines are terfenadine, astemizole, antihistamine not being the actual active ingredient, but antazoline, cetirizine, loratadine, ketotifen, acrivastine, merely improving toleration of the latter. ebastine, efletirizine, epinastine, feXofenadine, 50 AS components of Said preparations all customary com levocabastine, mizolastine, Oxatomide, Sebastine, temelas ponents Such as oils, emulsifiers, Solvents (lower alcohols tine and azelastine. and propylene glycol), hydrophilic gelatinising agents For example, H antihistamines are typically administered (carbomer, acryl copolymers, polysaccharides Such as orally and Sometimes nasally in the form of a spray to treat hydroxy propyl cellulose as well as lipophilic gelatinising hay fever. Cetirizine or loratadine are preferably used as 55 agents Such as ethyl cellulose and polyethylene) are men active ingredients. tioned. The examples illustrate the use of the antihistamine According to the American DrugdeX Drug Evaluations, cetirizine or loratadine as a cream, gel or lotion. cetirizine, a metabolite of hydroxyzine, is a Hantagonist WO 01/39 774 discloses a preparation containing keto with non-Sedating characteristics. The recommended oral tifen which may be used for the treatment of allergic dose for cetirizine is 10 mg once per day for adults or 2.5 to 60 conditions including insect bites and Stings, nettle rash, 5 mg once per day for children. In general, cetirizine is used atopical and contact dermatitis as well as eczema, urticaria, to treat hay fever, allergic rhinitis, chronic urticaria and neurodermatitis, dry skin and Sunburn and may be present in asthma. Usually, it is administered orally. The intranasal
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