US008557285B2 (12) United States Patent (10) Patent No.: US 8,557,285 B2 Plachetka (45) Date of Patent: *Oct. 15, 2013 (54) PHARMACEUTICAL COMPOSITIONS FOR (56) References Cited THE COORONATED DELVERY OF NSAIDS U.S. PATENT DOCUMENTS (75) Inventor: John R. Plachetka, Chapel Hill, NC 4,198.390 A 4, 1980 Rider ............................ 424/471 (US) 4.255.431 A 3/1981 Junggren et al. .............. 514,338 (73) Assignee: Pozen Inc., Chapel Hill, NC (US) (Continued) (*) Notice: Subject to any disclaimer, the term of this FOREIGN PATENT DOCUMENTS patent is extended or adjusted under 35 AU 2006235929 11, 2006 U.S.C. 154(b) by 0 days. CA 2139653 T 2001 This patent is Subject to a terminal dis (Continued) claimer. OTHER PUBLICATIONS (21) Appl. No.: 13/215,855 Goldstein et al., “PN400 significantly improves upper (22) Filed: Aug. 23, 2011 gastrointestinal tolerability compared with enteric-coated naproxen alone in patients requiring chronic NSAID therapy: Results from (65) Prior Publication Data Two Prospective, Randomized, Controlled Trials.” POZEN Inc. sponsored study, 2009. (Document D15 from Letter to European US 2012/OO64156A1 Mar. 15, 2012 Patent Office for counterpart European Application No. 02734602.2, Related U.S. Application Data regarding Oral Proceedings dated Dec. 18, 2009). (60) Division of application No. 12/553,804, filed on Sep. (Continued) 3, 2009, now abandoned, which is a division of application No. 11/129,320, filed on May 16, 2005, Primary Examiner — Nissa Westerberg now Pat. No. 8,206,741, which is a (74) Attorney, Agent, or Firm — Parker Highlander PLLC continuation-in-part of application No. 10/158,216, filed on May 31, 2002, now Pat. No. 6,926,907. (57) ABSTRACT (60) Provisional application No. 60/294,588, filed on Jun. The present invention is directed to drug dosage forms that 1, 2001. release an agent that raises the pH of a patient's gastrointes (51) Int. C. tinal tract, followed by a non-steroidal anti-inflammatory A6 IK 9/22 (2006.01) drug. The dosage form is designed so that the NSAID is not A6 IK9/32 (2006.01) released until the intragastric pH has been raised to a safe A61 K9/24 (2006.01) level. The invention also encompasses methods of treating A61 K9/52 (2006.01) patients by administering this coordinated release, gastropro U.S. C. tective, antiarthritic/analgesic combination unit dosage form (52) to achieve pain and symptom relief with a reduced risk of USPC ........... 424/472: 424/457; 424/463; 424/468; developing gastrointestinal damage such as ulcers, erosions 424/474; 424/482 and hemorrhages. (58) Field of Classification Search None See application file for complete search history. 4 Claims, 2 Drawing Sheets BARRERF COAT NAPROXENSODIUM CORE TABLET ENERC FM COAT ACED INHIBITOR COAT US 8,557,285 B2 Page 2 (56) References Cited 6,632,451 B2 10/2003 Penhasi et al. ................ 424/464 6,641,838 B2 11/2003 Pather et al. ... 424/466 U.S. PATENT DOCUMENTS 6,645,988 B2 11/2003 Phillips ........ ... 514,338 6,673,819 B2 1/2004 Bergman et al. .............. 514,338 4,344,929 A 8, 1982 Bonsen et al. ................ 424/466 6,685,964 B1 2/2004 Bartholomaeus et al. ... 424/489 4,508,905 A 4, 1985 Junggren et al. 546,273.7 6,699,885 B2 3/2004 Phillips .................. ... 514,338 4.554.276 A 1 1/1985 LaMattina .................... 514,272 6,713,089 B1 3/2004 Bertelsen et al. ... 424/489 4562.26. A 12/1985 Hirata et al... 548.184 6,749,867 B2 6/2004 Robinson et al. ... 424/489 4,619,934. 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