USOO8557285B2
`
`(12) United States Patent
`US 8,557,285 B2
`(10) Patent N0.:
`
` 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)
`(
`
`4,198,390 A
`4,255,431 A
`
`.
`,
`4/1980 Rider ............................ 424/471
`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
`31:13 Ilssixgeideg :1); adJuSted under 35
`~
`~
`~
`(
`) Y
`YS~
`
`AU
`CA
`
`1“UREIGN PATEN '1' DOCUMEN TS
`2006235929
`11/2006
`2139653
`7/2001
`
`This patent is subject to a terminal dis-
`claimer.
`
`(Continued)
`OTHER PUBLICATIONS
`
`(21) Appl.N0.: 13/215,855
`
`(22)
`
`Filed;
`
`Aug. 235 2011
`
`(65)
`
`Prior Publication Data
`
`Mar' 15’ 2012
`US 2012/0064156 A1
`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,
`HOW
`Pat.
`N0~
`8,206,741, WhiCh
`iS
`a
`continuation-in-part of application No. 10/158,216,
`filed on May 31, 2002, now Pat. No. 6,926,907.
`P
`'
`'
`l
`l'
`t' N .60/294,588, fil d
`J
`13351161111 app ica 1on
`0
`e on un
`5
`Int. Cl.
`A 61K 9/22
`A61K 9/32
`A 61K 9/24
`A6IK 9/52
`(52) US. Cl.
`USPC
`
`60
`
`)
`
`(
`
`(51)
`
`.
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Goldstein
`
`et
`
`al.,
`
`“PN400
`
`significantly
`
`improves
`
`upper
`
`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 European Application No. 02 734 602.2,
`regarding Oral Proceedings dated Dec. 18, 2009).
`(Continued)
`
`Primary Examiner iNissa Westerberg
`(74) Attorney, Agent, or Firm 7 Parker Highlander PLLC
`
`ABSTRACT
`(57)
`,
`,
`,
`,
`The present 1nvent10n 1s d1rected to drug dosage forms that
`release an agent that raises the pH of a patient’s gastrointes-
`tinal tract, followed by a non-steroidal anti-inflammatory
`drug. The dosage form is designed so that the NSAID is not
`released until the intragastric pH has been raised to a safe
`level. The invention also encompasses methods of treating
`patients by administering this coordinated release, gastropro-
`tective, antiarthritic/analgesic combination unit dosage form
`to achieve pain and symptom relief with a reduced risk of
`developing gastrointestinal damage such as ulcers, erosions
`and hemorrhages‘
`
`424/472. 424/457. 424/463‘ 424/468‘
`a
`a 424/47A; 424/482a
`iiiiiiiiiii
`(58) Field of Classification Search
`None
`
`See application file for complete search history.
`
`4 Claims, 2 Drawing Sheets
`
`BARRIER FILM
`C(MT
`
`NAPROXEN SODIUM CORE TABLE"
`
`
`
`
`ACID INHIBITOR COAT
`
`ENTRIC FIIM COAT
`
`MYLAN PHARMS. INC. EXHIBIT 1005 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1005 PAGE 1
`
`

`

`US 8,557,285 B2
`
`Page 2
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`
`MYLAN PHARMS. INC. EXHIBIT 1005 PAGE 2
`
`MYLAN PHARMS. INC. EXHIBIT 1005 PAGE 2
`
`

`

`US 8,557,285 132
`
`Page 3
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`(56)
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`)E
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`
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`GB
`GR
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