(19) United States
`(12) Reissued Patent
`Burnside et al.
`
`111111111111111111111 u 11111USR44E 1111111111111111111111111
`
`US RE41,148 E
`(10) Patent Number:
`(45) Date of Reissued Patent:
`Feb. 23, 2010
`
`(54) ORAL PULSED DOSE DRUG DELIVERY
`SYSTEM
`
`(75)
`
`Inventors: Beth A. Burnside, Bethesda, MD (US);
`Xiaodi Gue, Apex, NC (US); Kimberly
`Fiske, Downingtown, PA (US); Richard
`A. Couch, Bryn Mawr, PA (US); Donald
`J. Treacy, Woodbine, MD (US);
`Rong -Kun Chang, Rockville, MD (US);
`Edward M. Rudnic, North Potomac,
`MD (US); Charlotte M. McGuinness,
`Bethesda, MD (US)
`
`(73) Assignee: Shire Laboratories, Inc., Rockville,
`MD (US)
`
`(21) Appl. No.:
`
`11/091,010
`
`(22) PCT Filed:
`
`Oct. 20,1999
`
`(86) PCT No.:
`
`PCT/0899 /24554
`
`§ 371 (c)(1),
`(2), (4) Date:
`
`Jul. 19, 2001
`
`(87) PCT Pub. No.: W000/23055
`
`PCT Pub. Date: Apr. 27, 2000
`
`Related U.S. Patent Documents
`
`Reissue of:
`(64) Patent No.:
`Issued:
`Appt. No.:
`Filed:
`
`6,605,300
`Aug. 12, 2003
`09/807,462
`Jul. 19, 2001
`
`(51)
`
`U.S. Applications:
`(63) Cont inuation -in -pan of application No. 09/176,542, filed on
`Oct. 21, 1998, now Pat. No. 6,322,819.
`Int.Cl.
`A6IK 9/48
`A61 %9/24
`A61IC 9/26
`A6IK 31/135
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl.
`424/452; 424/458; 424/468;
`424/469; 424/470; 424/471; 424/472; 514/649
`(58) Field of Classification Search
`424/452,
`424/458, 468-472, 514, 649
`See application file for complete search history.
`
`(56)
`
`References Cited
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`11/1937 Keller
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`(Continued)
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`
`(Continued)
`
`Primary Examiner- Shengjun Wang
`
`(74) Attorney, Agent, or Finn - McDermott Will & Emery
`
`LLP
`
`(57)
`
`ABSTRACT
`
`A multiple pulsed dose drug delivery system for pharmaceu-
`tically active amphetamine salts, comprising an immediate -
`release component and an enteric delayed -release compo-
`nent wherein (1) the enteric release coating has a defined
`minimum thickness and/or (2) there is a protective layer
`between the pharmaceutically active amphetamine salt and
`the enteric release coating and/or (3) there is a protective
`layer over the enteric release coating. The product can be
`composed of either one or a number of beads in a dosage
`form, including either capsule, tablet, or sachet method for
`administering the beads.
`
`20 Claims, 7 Drawing Sheets
`
`50
`45-
`40-
`35-
`30-
`25-
`20-
`15-
`10-
`5-
`Oa
`
`0
`
`4
`
`6
`
`12
`TIME (HOURS)
`
`16
`
`20
`
`24
`
`KVK-TECH EXHIBIT 1048
`
`

`

`US RE41,148 E
`Page 2
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