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(12) United States Patent (10) Patent No.: US 8,383,152 B2 Jans Et Al

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(12) United States Patent (10) Patent No.: US 8,383,152 B2 Jans Et Al USOO8383152B2 (12) United States Patent (10) Patent No.: US 8,383,152 B2 Jans et al. (45) Date of Patent: Feb. 26, 2013 (54) PHARMACEUTICAL DOSAGE FORM (58) Field of Classification Search .................. 424/468, 424/464, 474: 514/654 (75) Inventors: Eugeen Marie Jozef Jans, Meerhout See application file for complete search history. (BE); Filip René Irena Kiekens, Geel (BE); Jody Firmin Marceline (56) References Cited Voorspoels, Reningelst (BE); Anne U.S. PATENT DOCUMENTS Faure, Vosselaar (BE); Elisabeth 3,806,603 A 4, 1974 Gaunt et al. Arkenau-Maric, Köln (DE); Lutz 3,865,108 A 2/1975 Hartop Barnscheid, Mönchengladbach (DE); 3,966,747 A 6, 1976 Monkovic et al. Johannes Bartholomäus, Aachen (DE); 3,980,766 A 9, 1976 Shaw et al. 4,002,173 A 1/1977 Manning et al. Marc Frevel, Monschau (DE); Eric 4,014,965 A 3, 1977 Stube et al. Galia, Inden (DE); Iris Ziegler, Neusaf 4,070,494 A 1/1978 Hoffmeister et al. (DE); Andrea Schissele, Berlin (DE) (Continued) (73) Assignee: Gruenenthal GmbH, Anchen (DE) FOREIGN PATENT DOCUMENTS (*) Notice: Subject to any disclaimer, the term of this AR 46994 12, 2004 patent is extended or adjusted under 35 AR O45.353 10/2005 U.S.C. 154(b) by 368 days. (Continued) (21) Appl. No.: 12/358,415 OTHER PUBLICATIONS El-Egakey, Adeletal, Pharmacerutica Acta Helvetiae, vol. 46, Mar. (22) Filed: Jan. 23, 2009 19, 1970. (65) Prior Publication Data (Continued) US 2009/0202634 A1 Aug. 13, 2009 Primary Examiner — Aradhana Sasan (74) Attorney, Agent, or Firm — Norris McLaughlin & (30) Foreign Application Priority Data Marcus, P.A. Jan. 25, 2008 (EP) ..................................... O8OO1415 (57) ABSTRACT Jan. 25, 2008 (EP). ... O8OO1416 The invention relates to a pharmaceutical dosage form, pref Oct. 17, 2008 (EP) ..................................... O8O18221 erably with controlled release of a pharmacologically active (51) Int. Cl. compound (A) contained therein, the pharmaceutical dosage A6 IK 9/22 (2006.01) form very preferably being tamper-resistant and most prefer A6 IK9/20 (2006.01) ably having a breaking strength B of at least 500 N in direc A6 IK 9/28 (2006.01) tion of extension E and having a breaking strength B of less A6 IK3I/35 (2006.01) than 500 N in direction of extension E. (52) U.S. Cl. ......... 424/468; 424/464; 424/474: 514/654 79 Claims, 21 Drawing Sheets AV6 8 26 A/6 US 8,383,152 B2 Page 2 U.S. PATENT DOCUMENTS 6,238,697 B1 5/2001 Kumar et al. 6,245,357 B1 6/2001 Edgren et al. 1991, A Es Sir et al. 6,248,737 B1 6/2001 Snet al. 4.200,704 A 4/1980 Stanley et al. 3864- W R 658 rabowskihis ki et al. 4,207,893 A 6/1980 Michaels 6,306.438 B1 10/2001 Oshlack et al. 4.262,017 A 4/1981 Kuipers 6,309.668 B1 10/2001 Bastin et al. 4,343,789 A 8/1982 Kawata et al. 6,318,650 B1 1 1/2001 Breitenbach et al. 4,353,887. A 10/1982 Hess et al. 6,340.475 B2 1/2002 Shell et al. is: A 3. 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