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United States Patent 19 11 Patent Number: 5,770,220 Meconi Et Al

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United States Patent 19 11 Patent Number: 5,770,220 Meconi Et Al USOO5770220A United States Patent 19 11 Patent Number: 5,770,220 Meconi et al. (45) Date of Patent: Jun. 23, 1998 54 ACTIVE SUBSTANCE-CONTAINING PATCH 4,911,707 3/1990 Heiber ..................................... 424/449 4,983,395 1/1991 Chang ..................................... 424/448 75 Inventors: Reinhold Meconi, Neuwied; Frank 5,008,110 4/1991 Benecke .................................. 424/448 Seibertz, Bad Hónningen/Ariendorf, 5,314,694 5/1994 Gale ........................................ 424/448 both of Germany FOREIGN PATENT DOCUMENTS 73 Assignee: LTS Lohmann Therapie Systeme 0208395 1/1987 European Pat. Off. ....... A61M 35/OO GmbH, Neuwied, Germany 3 315 272 3/1986 Germany. 3 503 111 8/1986 Germany. 21 Appl. No.: 640,791 3 522 060 1/1987 Germany. 22 PCT Filed: Nov. 23, 1994 3 843 239 2/1990 Germany. 86 PCT No.: PCT/EP94/03866 Primary Examiner-D. Gabrielle Phelan Attorney, Agent, or Firm Wenderoth, Lind & Ponack S371 Date: Aug. 5, 1996 57 ABSTRACT S 102(e) Date: Aug. 5, 1996 An active Substance-containing patch for the controlled 87 PCT Pub. No.: WO95/15158 release of active Substances, comprising a backing layer, an adjoining active Substance-containing reservoir layer soft PCT Pub. Date:Jun. 8, 1995 ening at body temperature, a membrane controlling the 30 Foreign Application Priority Data active Substance release, a pressure-sensitive adhesive device permitting fixation of the patch to the skin, and a Dec. 4, 1993 DEI Germany .......................... 43 41 444.3 removable protective layer, is characterized by the fact that 51) Int. Cl." ...................................................... A61F 13/02 the reservoir layer which Softens at body temperature is 52 U.S. Cl. ............................................. 424/448; 424/449 Spaced away from the controlling membrane by means of a device made of a material impermeable to the active sub 58 Field of Search ...................................... 424/448, 449 stance which extends all over the mutually facing surfaces of 56) References Cited the reservoir and the membrane and which has at least one passage for the reservoir layer which Softens at body tem U.S. PATENT DOCUMENTS perature. 3,598,122 8/1971 Zaffaroni................................. 424/449 4,877,618 10/1989 Reed, Jr. ................................. 424/448 11 Claims, 1 Drawing Sheet Y. Y: w . S....Mr ; W. Av o 1 -. - v W v w w ---. 15 . W. N 14 13 N E 12 11 U.S. Patent Jun. 23, 1998 5,770.220 A/G 7 16 14 III 13 E 12 11 S. KYZ3.2 Sfa, Mw: .- : i 5N 25 as N 24 NIH2 E 22 21 23 5,770.220 1 2 ACTIVE SUBSTANCE-CONTAINING PATCH application and thereby makes it possible for the active Substance to pass through the device for adjusting the This application is a 371 of PCT/EP94/03866, filled Nov. distance to the membrane. 23, 1994. The device for adjusting the distance provides a Space between reservoir layer and membrane and thereby prevents SPECIFICATION their premature contact. This prevents the active Substance The present invention relates to an active Substance from reaching the membrane undesirably rapidly or containing patch for the controlled release of active Spontaneously, which would cause the onset of active Sub Substances, comprising an active Substance-containing res stance release. ervoir mass which Softens at body temperature. The present The membrane has the function of controlling the active invention further relates to a proceSS for its production. Substance release and of ensuring Zero-order release. The device for regulating the distance extends over the BACKGROUND OF THE INVENTION whole, mutually facing Surfaces of the reservoir and the Active Substance-containing patches of the mentioned membrane. It is provided with at least one opening for the kind have been known for Some time. 15 reservoir content Softening at body temperature and may consist of both a coherent body or component parts not DE 35 03 111 describes a patch comprising drugs in a contacting one another. Solid reservoir mass which Softens at body temperature and In this connection, care must be taken that at least one is formed as a disk. The active Substance release Starts Sufficiently large passage is present So that the required immediately after application. active Substance amount reaches the membrane. It is also Another patch of this kind is described in DE 35 22 060, possible, however, to distribute Several openings Symmetri here a reservoir mass disk is fixed to an elastic plastic disk cally or unsymmetrically over the device. These openings having the same diameter. The two connected parts are may also have the form of Slots, for example. In any of these present in a housing that can be fixed to the Skin and which cases, the device forms a coherent unit. is closed on the Side away from the skin but open towards 25 Adjusting the distance may also be achieved by three the skin Surface. The elastic plastic disk exerts constant dimensional formed pieces, for example, Spheres, preSSure on the reservoir layer. In this case again, the active hemispheres, Spherical caps, cuboids, cylinders, and cubes. Substance release Starts immediately after application. Suitable materials of which the device to adjust the However, it is not always desirable that the active Sub distance may consist include metals, natural and/or Synthetic stance release Sets in immediately after application of the and/or organic polymers, or glass. These Substances must be patch. For instance, there may be the medical demand to impermeable to the active Substance. These include, for manufacture a patch wherein the onset of active Substance example, proteins, Such as collagen, elastin, albumin, and release begins after a defined period from application. This casein, polysaccharides, Such as cellulose and cellulose ensures that only part of the wearing period of the patch is derivatives, Starch and Starch derivatives, as well as available for active Substance release. If the patch is changed 35 galacto mannan, chitin and pectin; polyethylene, daily, there are phases without any active Substance release polypropylene, polyester, polyamide, polyurethane, alternating with those wherein active Substance is delivered polyisobutylene, polyethylene-acrylic acid-copolymers, to the body. A patch of this kind has not yet been known in polyacrylonitrile, polyvinyl chloride, polyvinylidene the art. chloride, polytetrafluoroethylene, Styrene-butadiene-Styrene 40 block copolymers, Styrene-isoprene-styrene block DESCRIPTION OF THE INVENTION copolymers, Styrene-ethylene-butylene-styrene block It is accordingly the object of the present invention to copolymers, Silicones, acrylonitrile-butadiene-styrene provide an active Substance-containing patch with an active rubber, polycarbonate, poly methyl methacrylate, Substance-containing reservoir mass Softening at body polyoxyethylene, polyoxymethylene, polystyrene, polyvinyl temperature, which releases the active Substance only after 45 alcohol, polyvinyl acetate; polysilicic acid, Silicates, a predetermined period from application. magnesium-aluminium-silicates, bentonite. Most Surprisingly, it has been found that this object is Further materials for the device to adjust the Space may be achieved by the fact that the reservoir layer, which softens Selected from groups consisting of textile fabrics, paper, at body temperature, is spaced away from a controlling films, and foamed material. These include, for example, membrane by means of a device made of a material which 50 nonwovens, wovens, Scrims as well as paper of different is impermeable to the active Substance and which extends qualities and films of different mentioned polymers and over the complete, mutually facing Surfaces of the reservoir metals, as well as foams manufactured from known raw and the membrane and has at least one passage for the materials. reservoir layer which Softens at body temperature. The reservoir layer Softening at body temperature com Accordingly, the active Substance-containing patch for the 55 prises active Substances. These include, for example: controlled release of active Substances consists of a backing atenolol, acinetone, acetylsalicylic acid, aceclidine, layer, an adjoining reservoir layer Softening at body tem amfetaminil, amphetamine, amyl nitrate, apophedrine, perature and comprising active Substances, a membrane atebrin, alprostadil, aZulene, arecoline, anethole, amylene controlling the active Substance release, a pressure Sensitive hydrate, acetylcholine, acridine, adenosine triphosphoric adhesive device permitting fixation of the patch to the skin, 60 acid, L-malic acid, alimemazine, allithiamine, allyl and a removable protective layer, wherein the reservoir layer isothiocyanate, aminoethanol, apyZine, apiole, azatadine, Softening at body temperature is spaced away from the alprenolol, ethinaZone, batrafen, betahistine, biperidine, controlling membrane by means of a device formed accord beta-acetyldigoxine, bopindolol, benzatropine, bupranolol, ing to the present invention and made of a material which is benclonidine, bupre norphine, bisnore phe drine, impermeable to the active Substance. 65 butacetoluide, benactyzine, clonidine, clemastine, carazolol, The active Substance-containing reservoir has the function clenbuterol, camphor, collecalciferol, chloral hydrate, of accommodating the active Substance. It Softens after clemastine, chlorobutanol, capsaicin, cyclopentamine, 5,770.220 3 4 clobutinol, chamaZulene, codeine, chlorpromazine, quinine, The controlling membrane may be formed of a pressure chlorothy mol, cyclophosphamide,
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