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United States Patent (19) 11 Patent Number: 5,789.399 Strube 45 Date of Patent: Aug

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United States Patent (19) 11 Patent Number: 5,789.399 Strube 45 Date of Patent: Aug USOO5789.399A United States Patent (19) 11 Patent Number: 5,789.399 Strube 45 Date of Patent: Aug. 4, 1998 54 TREATMENT OF PRURTUS WITH 5,362,719 11/1994 Godtfredsen ............................ 54767 WTAMN ID AND ANALOGS THEREOF 5,374,629 12/1994 Calverley et al. ...................... 514,167 76 Inventor: Marilyn E. Strube, 1017 Olive St. OTHER PUBLICATIONS Belleville, i. 62220 Blachley et al., Uremic Pruritus: Skin Divalant Ion Content and Response to Ultraviolet Phototherapy, Am. J. Kidney 21 Appl. No.: 720,698 Dis. 5:237-241, 1985. Martindale. The Extra Pharmacopoeia 30th Ed., Martindale, 22 Filed: Oct. 2, 1996 1993, pp. 1058–1059. Related U.S. Application Data The Merck Index (11th Ed.) Budavari et al. Merck & Co., Inc., Rahway, N.J. (1989) p. 1206. 60 Provisional application No. 60/005,030 Oct. 10, 1995. Primary Examiner-Marianne M. Cintins (51 Int. Cl. ............................... A61K3159 Assistant Examiner M. Moezie 52 U.S. Cl. ........................................................... 514/167 Attorney, Agent, or Firn-Howell & Haferkamp, L.C. 5858l Field of Search .............................................. 514/1614f1(57 57 ABSTRACT (56 References Cited A method for treating pruritus comprising topical adminis U.S. PATENT DOCUMENTS tration of formulation of vitamin D or an analog of vitamin D is disclosed. The formulation comprises a therapeutically 3,711,602 1/1973 Herschler .................................. effective, water-based emulsion, water-based suspension or : t E". t oil-based formulation of vitamin D or analog of vitamin D. 5,190,935 3/1993 Binderup et al. ... 51467 5,342,833 8/1994 Doran et al. ..... ... 514/67 7 Claims, 1 Drawing Sheet U.S. Patent Aug. 4, 1998 5,789.399 se 9. O L?) E O N b) (N i. to 3 (N 9 t ?t A. t C) OC) H O r O O O A c. 3 Pr D &: O 5,789.399 1 2 TREATMENT OF PRURTUS WITH wide variety of causes or that are able to alleviate pruritus WTAMIND AND ANALOGS THEREOF produced by different causes than those that can be treated by currently available agents. This application claims priority under 35 U.S.C. S 119(e) The ability of vitamin D to effectively treat pruritus when to provisional application No. 60/005.030 filed Oct. 10. 5 administered in a topical treatment formulation has not been 1995. heretofore known. The effectiveness of UVB light therapy in the treatment of pruritus has been noted to be incidentally BACKGROUND OF THE INVENTON related to the production of vitamin D in the skin (Blachley et al., Am J Kidney Dis 5:237-241, 1985). The same (1) Field of the Invention wavelengths of between 290 and 310 nm used in UVB This invention relates generally to the field of treating treatment is also able to photolyze provitamin D(7- pruritus and, more particularly, to the topical treatment of dehydrocholesterol) which then internally isomerizes to pruritus using vitamin D and analogs thereof. form vitamin D. Nevertheless no direct link between vita (2) Description of the Related Art min D production in the skin and the antipruritic effective Pruritus is a condition involving localized or general 15 ness of UVB light treatment has been reported and, in itching which can be mediated by stimulation of sensory addition, the mechanism of the therapeutic benefit of UVB nerve endings. Although usually occurring in the skin. light remains unknown. pruritus can also occur in non-cutaneous sites such as Vitamin D is also incidentally present in some formula mucous membranes or cornea. A variety of causes for the tions that are indicated to be useful in certain conditions condition of pruritus are known including external and 20 involving itching. One such nonspecific topical preparation exogenous causes, localized skin disorders and systemic was reported in U.S. Pat. No. 3,711.602 issued to Herschler. diseases. This patent discloses a formulation containing lanolin, The first line of treatment involves diagnosis of the DMSO, isopropyl myristate, vitamin A and vitamin D that underlying condition that causes the pruritus and intervening is applied topically for the treatment of burns, skin imitation, therapeutically to alleviate that underlying condition. Such 25 diaper rash and pruritus. This preparation is nonaqueous and therapeutic treatment is appropriate for example in the provides occlusion and physical soothing actions. It is treatment of psoriasis with UV light or with topical vitamin believed, however, that the vitamin D present in the formu D analogs. These treatments are not considered to be direct lation at a concentration of 7.5 g/ml does not directly treatments of the pruritus and only indirectly relieve the contribute any anti-pruritic effect. This is because the lowest itching. Indeed, some treatment modalities for psoriasis can 30 concentration found to have an anti-pruritic effect in a cause itching (for example, see product insert for the vitamin non-aqueous vehicle in the studies reported herein was 521 D analog Dovonex6, Westwood-Squibb). At the same time g/ml. the underlying disease is being treated, it might also be Other preparations that serve as nonspecific, physically desirable to directly treat the pruritus. Furthermore in some soothing formulations also sometimes contain vitamin D conditions involving pruritus, either the underlying cause for 35 such as for example A and D6 Ointment for soothing relief the pruritic condition cannot be determined or it cannot be of diaper rash or Desitin(s) also used to sooth diaper rash eliminated. In such cases the direct treatment of the pruritic including preventing the burning, pain and itch produced by condition is required. irritants. These preparations, however, provide only a pro Currently available treatment modalities for pruritus tective physical barrier to water and irritants and the vitamin include nonspecific topical agents such as emollients and D present in these preparations is incapable of producing counterirritants, topical drugs such as steroids, local anes any direct antipruritic action as a result of not being bio thetics and antihistamines, and physical modalities such as available from such formulations. ultraviolet phototherapy and thermal stimulation. Some of Thus, although vitamin D has been incidentally related to these treatments are effective in pruritic conditions of par some treatment modalities for pruritus, it has not heretofore ticular etiology, while others may show general but nonspe 45 been known that vitamin D can be effectively used in the cific benefit. treatment of pruritic conditions. Nonspecific topical preparations can act as moisturizing lotions or creams or as oil-based ointments that are occlusive SUMMARY OF THE INVENTION and serve to soften dry skin as well as providing a protective 50 In accordance with the present invention, it has been covering. These can sometimes contain chemical substances discovered that vitamin D can be applied topically in certain in the preparation which do not contribute to the nonspecific formulations that make the vitamin D bioavailable. antipruritic action of the preparation and provide no anti Surprisingly, when administered in such formulations at pruritic action themselves. pruritic sites, the vitamin D becomes therapeutically effec Topical formulations containing pharmacologically active 55 tive and the pruritus is rapidly and completely relieved. agents are often useful in particular pruritic conditions but Because vitamin D is a fat soluble substance, a water may not be generally useful in all pruritic conditions. For based emulsion formulation that is bioavailable and suitable example, topical corticosteroids are not indicated for symp for topical treatment can be used. Thus, one formulation for tomatic treatment unless a steroid responsive disorder is vitamin D that is effective in treating pruritus comprises a diagnosed. Physical modalities such as UV light have been mixture of water, a water-insoluble organic liquid, a surface particularly effective in a variety of conditions although active agent, and a vitamin D or an analog thereof. This undesirable side effects can be produced by UV light such as formulation is effective when the vitamin D is present at a an increased risk of developing skin cancer as well as concentration as low as 2.5 g/ml. undesirable phototoxic reactions (see for example, Marks, J A second formulation that is also effective in treating Dernatol Treat 1:233-234, 1989) 65 pruritus is based upon a nonaqueous carrier vehicle for Thus it would be desirable to develop new anti-pruritic vitamin D. This formulation comprises a water-insoluble agents that are effective in treating pruritus resulting from a organic liquid such as petroleum or corn oil and vitamin D. 5,789.399 3 4 The vitamin D concentration in this formulation can be as D. The surface active agentis biocompatible and suitable for low as 521 ug/ml. application by topical formulation. The formulation also contains a biocompatible water-insoluble organic liquid Another vitamin D formulation effective in treating pru such as an oil or lipid suitable for forming an oil-in-water or ritus comprises a suspension of water and a dispersed phase water-in-oil emulsion so that the formulation is a cream, containing vitamin D or analog thereof. This formulation is ointment, paste or the like. By biocompatible it is meant that effective at concentration of 12.5 g/ml. the substance produces no untoward biological effects such Among the several advantages achieved by the present as local or generalized toxic effects or local irritation at the invention, therefore, may be noted the provision of new site of topical application, Suitable water-insoluble organic treatment for pruritus that is broadly effective in a variety of liquids are well known in the art field of topically applied pruritic conditions; the provision of a treatment modality cosmetics and therapeutics and include but are not limited to that is safe being neither irritating nor toxic; the provision of mineral oil, corn oil or other vegetable oil, petroleum, a treatment that is inexpensive; and the provision of a lanolin, fish oil and the like.
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