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United States Patent (19) 11) Patent Number: 5,457,128 Yanagawa 45 Date of Patent: Oct

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United States Patent (19) 11) Patent Number: 5,457,128 Yanagawa 45 Date of Patent: Oct USOO5457128A United States Patent (19) 11) Patent Number: 5,457,128 Yanagawa 45 Date of Patent: Oct. 10, 1995 54 TOPICAL PREPARATION FOR HEALING Derwent & C.A. 112:84201 Sucralfate-topical. WOUNDS OF THE SKN Baldoni et al. WO/PCT90/02133 (Mar. 8, 1990) Derwent 75 Inventor: Akira Yanagawa, Yokohama, Japan Sucralfate sounds topical/dermal. Caramella et al. EP402933 (Dec. 19, 1990) Derwinet Sucral 73) Assignee: Dott Limited Company, Japan fate Topical. Peterson et al. WO/PCT9104034 (Apr. 4, 1991) Derwent & (21) Appl. No.: 142,468 C.A. 115:42011 Sucralfate Topical Ulcers/Lesions. 22) PCT Filed: Mar. 26, 1993 Fabre FR 2646604 (Nov. 9, 1990) CA.114:129165. 86 PCT No.: PCT/P93/00379 Burch et al. Agents Actions 34(1/2)229-231 (1991) CA. S 371 Date: Nov. 29, 1993 115:174597. Hayashi et al. J. Pediatr. Sug. 26(11):1279–81 Nov. 1991 S 102(e) Date: Nov. 29, 1993 Medline Abstrot. 87). PCT Pub. No.: WO93/19744 Michaeli EP230023 (Jul. 29, 1987) Derwent & C.A. 08:11249. PCT Pub. Date: Oct. 14, 1993 30 Foreign Application Priority Data Primary Examiner–Shep K. Rose Mar. 28, 1992 JP Japan .................................... 4-10862 Attorney, Agent, or Firm-Lorusso & Loud (51 Int. Cl. .................... A61K 31/045; A61 K9/06 57 ABSTRACT 52 U.S. Cl. ............................................. 514/532, 514/546 58 Field of Search ...................................... 514/532, 546 Disclosed is a topical preparation for healing wounds of the skin, which can demonstrate remarkable effects of the treat (56) References Cited ment of wounds of the skin, such as an ulcer of the skin, traumatogenic wounds caused by the abrasion of the skin, U.S. PATENT DOCUMENTS traumatogenic wounds caused by the defect of the skin, an ulcer of the crus, Zoster, and so on. The topical preparation 4,912,093 3/1990 Michaeli ................................... 514/53 contains at least one pharmaceutically effective compound OTHER PUBLICATIONS selected from gefarnate, and Sofalcone. Daiichi Seiyaku JP 61033116 (Feb. 17, 1986) Derwent Cetraxete topical. Barsholom WO/PCT89/05646X, 89/05645 (Sep. 29, 1989) 5 Claims, No Drawings 5,457,128 1 2 TOPICAL PREPARATION FOR HEALNG In treating the ulcerated skin diseases such as decubitus WOUNDS OF THE SKN ulcers, burns at low temperature and crus ulcers as well as the traumatogenic wounds of the skin, the site of a lesion is sterilized and topical preparations containing a chemical This is a 371 of PCT/JP93/00379 Mar. 26, 1993. agent are applied for the purpose of a prevention of infec tion. This therapy is dependent mainly upon the natural TECHNICAL FIELD curing ability of the living body for curing the lesion and The present invention relates to a topical preparation for symptom of the skin disease. However, as things stand healing wounds of the skin, which can demonstrate remark today, few medicaments can positively and actively cure and heal the lesions and symptoms of the skin diseases. In this able effects of the treatment of wounds of the skin, such as 10 country, "Bendazac", or (1-benzyl-1-H-indazol-3-yl)oxyl an ulcer of the skin, traumatogenic wounds caused by the acetic acid, is the only one that can be adapted to the abrasion of the skin, traumatogenic wounds caused by the treatment of ulcers of the skin. Further, bovine blood extract defect of the skin, an ulcer of the crus, Zoster, and so on. preparations are employed as agents for accelerating the formation of granulation tissues. These medicaments, how BACKGROUND ART 15 ever, cannot always offer satisfactorily curing effects. As the era of an extraordinarily advanced age is coming A major therapy for the treatment of the zoster uses in this country, there is a drastically growing increase year topical preparations containing a non-steroid type anti by year in the number of the aged who cannot turn their inflammatory and analgesic agent, while preventing infec bodies over or a round in bed by themselves. This undoubt tion with a pathogen by application of an antibiotic oint edly increases the number of the aged who suffer from 20 ment. This therapy is conducted mainly in order to mitigate wounds of the skin caused by a stayed in bed without turning clinical symptoms of the Zoster. Over or around. Further, there is the increase in numbers of It should be noted herein that the term "skin ulcer' or traumatogenic wounds of the skin caused, for example, by related terms are intended to mean wounds of the skin, traffic accidents. From such background, growing attention caused by the defect of the skin tissues, such wounds having has recently been drawn in various fields to the significance 25 depression to some depth inside the body due to the necrosis of treating skin diseases. In particular, the skin of the aged of the skin tissues. The term 'skin ulcer' is employed as is in a state considerably different from that of the young in different from the term "erosion' that is intended to mean terms of its structure and functions, and there are many wounds of the skin which do not reach the dermis of the different kinds of skin diseases peculiar to the aged. Unfor skin. The ulcers of the skin may be attributed to various tunately however, currently drugs highly effective for curing 30 causes. Intractable skin ulcers may include, for example, (1) or healing such skin diseases has been developed. a decubitus ulcer and a crus ulcer, caused by disorders of Skin diseases occurring in many cases of the aged who local circulation; and (2) skin ulcers caused by burns, cannot turn over or a round in bed by themselves, include frostbite or congelation, disorders by radiation, and so on. intractable skin ulcers such as, for example, decubitus In addition, the zoster caused by infection with cytome ulcers, burns caused at low temperature, and so on. Further, 35 galo virus is such that bullas or blisters occurring in crowds the aged poor in a systemic state are likely to have their in an initial stage turn gradually into erosion and an ulcer whole bodies infected with opportunistic viruses including and they are usually cured or healed without particular herpes viruses such as, for example, simplex virus, cytome treatment or naturally in several weeks. In many cases, an galo virus, or the like. This systemic infection with such ache lasts during this period and such an ache may become viruses may in many cases accompany various symptoms on 40 less as the exanthema on the skin disappears. However, in the skin, like Zoster. order to alleviate pain of a patient, it is of significance to On the other hand, currently, as there are no topical treat and cure the exanthema on the skin. preparations suitable for the treatment of skin diseases with Furthermore, if a portion of the skin tissues has been lost a portion of the skin tissues depressed or for the treatment of 45 by an injury or burns or for other reasons, it is needless to skin ulcers caused by circulatory disorders such as buerger, say that the skin tissues be repaired immediately to avoid diabetes, phlebothrombosis, and so on, such treatment may infection. What is common in these disease conditions is the suffer from difficulty in many cases. necessity of promoting the propagation of granulation tis It can be said that a topical preparation capable of sues and the sloughing in order to rapidly repair or reflect the applying a medicament directly to the site of lesion is one of 50 skin tissues at the site of the lesion where they are lost due the most superior drug delivery systems for administering to erosion of the skin, an ulcer or by a physical impact. such a medicament; however, research and studies on such In order to improve such defects and disadvantages of a drug delivery system for administering topical prepara conventional medicaments, research has been made for tions are less advanced. As things stand today, for instance, developing new topical preparations for healing wounds of it can be said that few medicaments have been developed 55 the skin. As a result, there have been made reports on topical originally for topical application. As topical preparations, preparations containing as a pharmaceutically effective there have been extensively employed adrenocortical hor compound (teprenone) (as disclosed in Japanese Patent mones as if they are an all-round drug therefor. In fact, the Examined Publication No. 64-10,495) and (plaunotol) (as adrenocortical hormones are highly effective for many skin disclosed in Japanese Patent Examined Publication No. diseases; however, careful attention should be paid to the 60 2-33,008). However, these topical preparations have not yet fact that there are many cases in which the application of the entered into the market. adrenocortical hormones worsens a lesion or symptom of DISCLOSURE OF INVENTION Some skin disease, e.g. skin ulcers such as decubitus ulcers, burns, etc., Zoster and traumatogenic wounds caused by the The present invention has the object to provide a new abrasion of the skin and by the defect of the skin, and so on. 65 topical preparation having remarkable properties in enhanc Hence, the adrenocortical hormones should not be randomly ing the propagation of the granulation tissue and the forma applied. tion of a skin crust, or sloughing. 5,457,128 3 4 It has been found that at least one compound selected pylbutyrate, amylbutyrate, octyl butyrate, and so on; and a from gefarnate, and sofalcone can exhibit remarkably curing di-valent fatty acid ester such as di-ethyl succinate, di effects upon wounds of the skin. This invention has been isopropyl succinate, di-ethyl adipate, di-isopropyl adipate, completed on the basis of this finding.
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