US008557285B2
`
`a2) United States Patent
`US 8,557,285 B2
`(10) Patent No.:
`
` Plachetka (45) Date of Patent: *Oct. 15, 2013
`
`
`(54) PHARMACEUTICAL COMPOSITIONS FOR
`THE COORDINATED DELIVERY OF NSAIDS
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`(75)
`
`Inventor:
`
`John R. Plachetka, Chapel Hill, NC
`US)
`(
`(73) Assignee: Pozen Inc., Chapel Hill, NC (US)
`
`4,198,390 A
`4,255,431 A
`
`.
`/
`4/1980 Rider vcccccsseseeeeenn 424/471
`3/1981 Junggren et al. ow... 514/338
`(Continued)
`
`(*) Notice:
`
`FOREIGN PATENT DOCUMENT'S
`Subject to any disclaimer, the term ofthis
`2006235929
`ty
`se isextended da adjusted under 35
`11/2006
`
`
`S.C. 154(b) by0days. CA 2139653 7/2001
`
`
`This patent is subject to a terminal dis-
`(Continued)
`claimer.
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 13/215,855
`
`(22)
`
`Filed:
`
`Aug. 23, 2011
`
`(65)
`
`upper
`improves
`significantly
`“PN400_
`al,
`et
`Goldstein
`gastrointestinal tolerability compared with enteric-coated naproxen
`alone in patients requiring chronic NSAID therapy: Results from
`Two Prospective, Randomized, Controlled Trials,’ POZEN Inc.
`sponsored study, 2009, (Document D15 from Letter to European
`Patent Office for counterpart EuropeanApplication No. 02 734 602.2,
`regarding Oral Proceedings dated Dec. 18, 2009).
`(Continued)
`
`Primary Examiner — Nissa Westerberg,
`(74) Attorney, Agent, or Firm — Parker Highlander PLLC
`
`Prior Publication Data
`US2012/0064156 Al
`Mar. 15, 2012
`Related U.S. Application Data
`(60) Division of application No. 12/553,804,filed on Sep.
`3, 2009, now abandoned, which is a division of
`application No. 11/129,320, filed on May 16, 2005,
`now
`Pat.
`No.
`8,206,741,
`which
`is
`a
`continuation-in-part of application No. 10/158,216,
`ABSTRACT
`(57)
`filed on May 31, 2002, now Pat. No. 6,926,907.
`
`
`60) application No. 60/294,588, filedonJun.Provisional . Lg
`
`(60) 001. appucasonse
`econ
`The present invention is directed to drug dosage formsthat
`;
`release an agentthat raises the pH ofa patient’s gastrointes-
`(51)
`Int. Cl.
`tinal tract, followed by a non-steroidal anti-inflammatory
`AGIK 9/22
`drug. The dosage form is designed so that the NSAID is not
`AGIK 9/32
`released until the intragastric pH has been raised to a safe
`AOLK 9/24
`level. The invention also encompasses methodsoftreating
`AOLK 9/52
`patients by administering this coordinated release, gastropro-
`(52) U.S.C.
`tective, antiarthritic/analgesic combination unit dosage form
`424/472: 424/457: 424/463: 424/468:
`USPC
`to achieve pain and symptomrelief with a reduced risk of
`— ;
`developing gastrointestinal damage such as ulcers, erosions
`; 424/474: 424/482
`(58) Field of Classification Search
`and hemorrhages.
`None
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`See application file for complete search history.
`
`4 Claims, 2 Drawing Sheets
`
`BARRIER FILM
`COAT
`
`NAPROXEN SODIUM CORE TABLET
`
`
` ENTERIC FILM COAT
`
`ACID INHIBITOR COAT
`
`DRL EXHIBIT 1005 PAGE 1
`
`DRL EXHIBIT 1005 PAGE 1
`
`

`

`US 8,557,285 B2
`
`Page 2
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`DRL EXHIBIT 1005 PAGE 2
`
`DRL EXHIBIT 1005 PAGE 2
`
`

`

`US 8,557,285 B2
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