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Adhesive Preparation (19) & (11) EP 2 062 584 A1 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 153(4) EPC (43) Date of publication: (51) Int Cl.: 27.05.2009 Bulletin 2009/22 A61K 31/663 (2006.01) A61K 9/70 (2006.01) A61K 47/06 (2006.01) A61K 47/08 (2006.01) (2006.01) (2006.01) (21) Application number: 07807007.5 A61K 47/10 A61K 47/14 A61K 47/32 (2006.01) A61P 1/02 (2006.01) (2006.01) (2006.01) (22) Date of filing: 10.09.2007 A61P 3/14 A61P 19/00 A61P 19/02 (2006.01) A61P 19/10 (2006.01) A61P 29/00 (2006.01) A61P 35/00 (2006.01) A61P 35/02 (2006.01) A61P 35/04 (2006.01) (86) International application number: PCT/JP2007/067597 (87) International publication number: WO 2008/032678 (20.03.2008 Gazette 2008/12) (84) Designated Contracting States: • HAYASHI, Noriyuki AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Imizu-shi HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE Toyama 939-0351 (JP) SI SK TR • SAKAI, Yoshiki Designated Extension States: Mishima-gun AL BA HR MK RS Osaka 618-8585 (JP) (30) Priority: 11.09.2006 JP 2006245965 (74) Representative: Keller, Günter et al Lederer & Keller (71) Applicant: Kyukyu Pharmaceutical Co., Ltd. Patentanwälte Tokyo 103-0023 (JP) Prinzregentenstrasse 16 80538 München (DE) (72) Inventors: • YAMAZAKI, Yuuhiro Imizu-shi Toyama 939-0351 (JP) (54) ADHESIVE PREPARATION (57) The present invention provides an adhesive of either of the bisphosphonic acid derivative or the salt, preparation having a plaster layer disposed on a support, a solubilizer for the active ingredient, propylene glycol, a the adhesive preparation comprising at least one active hydrogenated terpene resin, an adhesive base, and a ingredient selected from the group consisting of a bi- softening agent in the plaster layer. sphosphonic acid derivative, its salt thereof and a hydrate EP 2 062 584 A1 Printed by Jouve, 75001 PARIS (FR) EP 2 062 584 A1 Description TECHNICAL FIELD 5 [0001] The present invention relates to an adhesive preparation comprising a bisphosphonic acid derivative, a salt thereof or a hydrate of either of the bisphosphonic acid derivative or the salt (hereinafter sometimes collectively referred to as "bisphosphonic acid derivative or the like"). The present invention relates particularly to an adhesive preparation comprising 1-hydroxy-2-(imidazo[1,2-a]pyridin-3-yl)ethylidenebisphosph onic acid (hereinafter referred to as minodronic acid), 4-amino-1-hydroxybutane-1,1-bisphoshonic acid (referred to hereinafter as alendronic acid), 3-(N-methyl-N-n- 10 pentylamino)-1-hydroxypropane-1,1-bisphosph onic acid (referred to hereinafter as ibandronic acid), 1-hydroxy-2-(imi- dazol-1-yl)-ethane-1,1-bisphosphonic acid (referred to hereinafter as zoledronic acid), 1-hydroxy-2-pyridin-3-ylethylid- enediphosphonic acid (referred to hereinafter as risedronic acid), or a salt of any of the foregoing compounds or a hydrate of any of the foregoing compounds. 15 BACKGROUND ART [0002] Certain synthetic bisphosphonic acid derivatives, which are structural analogues of pyrophosphoric acid having a methanebisphosphonic acid structure and are stable also in vivo, have biological actions such as an excellent sup- pressive action on bone resorption and on ectopic calcification, etc. Such derivatives are useful as preparations for the 20 treatment of diseases associated with increased bone resorption, ectopic calcification, etc., for example, osteoporosis, Paget’s disease of bone, hypercalcemia accompanying malignant tumors, and bone metastasis accompanying cancer. Some of the derivatives have already been used clinically. [0003] Known bisphosphonic acid derivatives commercially available so far or currently under development include alendronic acid, ibandronic acid, incadronic acid, etidronic acid, olpadronic acid, clodronic acid, zoledronic acid, tiludronic 25 acid, neridronic acid, pamidronic acid, risedronic acid, minodronic acid, 1-hydroxy-3-(1-pyrrolidinyl)propylidenebisphos- phonic acid, salts of any of the foregoing compounds and hydrates of any of the foregoing compounds. In particular, nitrogen atom-containing bisphosphonic acid derivatives classified as third generation have a potent suppressive action on bone resorption, and exhibit drug effect persistently for a long period once adsorbed into the bone. For example, JP- B 06-99457 describes that minodronic acid, which has a potent suppressive action on bone resorption and an excellent 30 anti-inflammatory and analgesic antipyretic action, is useful for the treatment of increased bone resorption accompanying the following diseases: Paget’s disease, hypercalcemia, bone metastasis from cancer, osteoporosis or chronic rheuma- toid arthritis. [0004] Oral preparations comprising a bisphosphonic acid derivative, a salt thereof or a hydrate of either of the bi- sphosphonic acid derivative or the salt, are clinically used at present, but their use is subject to the following indications: 35 "contraindication" in "patients who cannot sit up or stand for 30 minutes or more after taking the medication", "careful administration" to "patients with upper-gastrointestinal disorders such as dysphagia, esophagitis, gastritis, duodenitis, or ulcer", and "precaution", which is attributable to low absorbability and low bioavailability upon oral administration, of "daily oral administration together with about 180 mL of water on awakening, and avoidance of eating and drinking (except water) as well as taking other oral medications for at least 30 minutes after administration". The last indication 40 is attributed to the characteristics of the bisphosphonic acid derivative. That is, the absorption of the derivative is sup- pressed particularly in the presence of calcium or iron. For this reason, the influence of diet or the like must be avoided. The bisphosphonic acid derivative also has a potent gastrointestinal mucosa-damaging action. Retention or regurgitation of the drug in mucosa of the esophagus etc. must be avoided to prevent the subsequent mucosal irritation. Accordingly, the administration of the bisphosphonic acid derivative or the like is contraindicated in patients with esophageal food 45 obstruction or in patients who cannot maintain the standing position/sitting up position after taking the medication. Because of such restriction on oral administration, patients’ compliance with medication is extremely low. [0005] Elderly patients with osteoporosis, patients with steroid-induced osteoporosis, patients with fracture, and pa- tients with cancer often have difficulty in swallowing. It is often hard for such patients to be medicated by an oral preparation requiring multiple doses at regular time intervals under restricted condition for its administration. Further, oral adminis- 50 tration increases the amount of the drug exposed to the gastrointestinal tract and the liver, maximum drug concentration (Cmax) in blood and renal drug excretion, thereby increasing the incidence rate of adverse drug reactions such as renal damage in addition to gastrointestinal disorders particularly in the esophagus and gastric mucosa. [0006] Accordingly, from the viewpoint of improving the quality of life of patients having difficulty in oral administration, oral preparations to be intermittently administered once a week or once a month, in place of oral preparations to be 55 administered once a day, have been developed and examined to reduce and circumvent the problems described above. However, there are still many problems, one of which is an increased single dose. Injections to be administered once a month to once every 12 months have also been developed and examined. However, the administration of an injection causes pain, leads to a rapid increase in blood drug concentration possibly resulting in the incidence of adverse drug 2 EP 2 062 584 A1 reactions such as renal damage, and takes 15 minutes to 2 hours straight via intravenous route. Patients’ compliance with medication therefore remains low. Further, there is concern that oral preparations to be intermittently administered in a large single dose or injections increase the incidence rate of hypocalcemia and jawbone necrosis due to a rapid increase in blood drug concentration after administration. 5 [0007] Meanwhile, from the concept of drug delivery system intended for optimization of therapy, transdermally ab- sorbable preparations with sustained drug effects and reduced adverse drug effects attract attention and are under intense study. These effects make a clear distinction from those of the conventional external preparations. Specifically, parenteral administration routes, particularly a transdermal drug delivery system typically utilizing ointments and adhesive preparations, attract attention as effective routes of drug administration. In transdermal administration, a drug gradually 10 enters into subcutaneous capillaries directly without passing through the gastrointestinal tract. Thus, the drug can reach the target site with avoiding any hepatic first-pass effect, i.e. , hardly undergoing metabolism and decomposition, and without generating gastrointestinal disorders. Thereby, the transdermal administration increases the bioavailability of the drug. Based on this, it can be expected that stable blood pharmacokinetics can be achieved even in patients with gastrointestinal disorders or dysphasia, and that the onset of renal damage, hypocalcemia, and jawbone necrosis can 15 be also circumvented. [0008] The "transdermally absorbable preparations (transdermal systems)" are the preparations which are designed to deliver their active ingredient through
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