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`1111111111111111111111111111111111111111111111111111111111111
`US008772306Bl
`
`(12) United States Patent
`Eller
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,772,306 Bl
`*Jul. 8,2014
`
`(54) METHOD OF ADMINISTRATION OF
`GAMMA HYDROXYBUTYRATE WITH
`MONOCARBOXYLATE TRANSPORTERS
`
`(71) Applicant: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`(72)
`
`Inventor: Mark Eller, Redwood City, CA (US)
`
`(73) Assignee: Jazz Pharmaceuticals, Inc., Palo Alto,
`CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.c. 154(b) by 0 days.
`
`This patent is subject to a tenninal dis(cid:173)
`claimer.
`
`(21) Appl. No.: 13/872,997
`
`(22)
`
`Filed:
`
`Apr. 29, 2013
`
`Related U.S. Application Data
`
`(63)
`
`(60)
`
`Continuation of application No. 13/837,714, filed on
`Mar. 15,2013.
`
`Provisional application No. 611771,557, filed on Mar.
`1,2013, provisional application No. 611777,873, filed
`on Mar. 12,2013.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61K 31/505
`A61K 31/33
`A61K 31/55
`(52) U.S. Cl.
`USPC ....................... 5141275; 5141183; 514/214.03
`(58) Field of Classification Search
`USPC ..................................... 514/275,183,214.03
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`3,325,361 A
`3,385,886 A
`4,155,929 A
`4,393,236 A
`5,380,937 A
`5,758,095 A
`5,833,599 A
`5,845,255 A
`6,014,631 A
`6,067,524 A
`6,112,182 A
`6,204,245 Bl
`6,317,719 Bl
`6,356,873 Bl
`6,482,431 B2
`
`611967 Meunier
`511968 Nicholson et al.
`511979 Chignac et aI.
`711983 Klosa
`111995 Koehler et aI.
`511998 Albaum et al.
`1111998 Schrier et al.
`1211998 Mayaud
`112000 Teagarden et aI.
`5/2000 Byerly et al.
`8/2000 Akers et al.
`3/2001 Siegel et al.
`1112001 Schrier et al.
`3/2002 Teagarden et aI.
`1112002 Smith
`
`6,780,889 B2
`7,015,200 B2
`7,072,840 Bl
`7,262,219 B2
`7,572,605 B2
`7,668,730 B2
`7,765,106 B2
`7,765,107 B2
`7,797,171 B2
`7,851,506 B2
`7,895,059 B2
`8,263,650 B2
`8,324,275 B2
`2003/0171270 Al *
`2006/0018933 Al
`2008/0293698 Al *
`200910137565 Al
`201010112056 Al
`201010160299 Al
`201110237664 Al *
`201210076865 Al
`
`812004 Cook et aI.
`3/2006 Mamelak et al.
`7/2006 Mayaud
`8/2007 Cook et aI.
`8/2009 Mamelak et al.
`212010 Reardan et al.
`7/2010 Reardan et al.
`7/2010 Reardan et al.
`912010 Reardan et al.
`1212010 Cook et aI.
`212011 Reardan et al.
`912012 Cook et aI.
`1212012 Cook et aI.
`912003 Civelli et al.
`112006 Vaya et al.
`1112008 Johnson ........................ 514/220
`5/2009 Frucht
`512010 Rourke et al.
`6/2010 Baker, Jr. et aI.
`912011 Dalton et al.
`................. 514/522
`3/2012 Allphin et al.
`
`................... 514112
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`GB
`GB
`GB
`WO
`WO
`WO
`WO
`WO
`
`237309
`922029
`980279
`1 522450
`WO 2006/053186
`WO 20101053691
`WO 20111119839
`WO 20111139271
`WO 20121037457
`
`5/1985
`3/1963
`111965
`8/1978
`5/2006
`5/2010
`912011
`1112011
`3/2012
`
`OTHER PUBLICATIONS
`
`Arena et aI., "Absorption of Sodium y-Hydroxybutyrate and Its
`Prodrug y-Butyrolactone: Relationship between In Vitro Transport
`and In Vivo Absorption," J Pharmaceutical Sciences, 69(3): 356-
`358, 1980.
`Auler et aI., "Diclofenac Plasma Protein Binding: PK-PD Modelling
`in Cardiac Patients Submitted to Cardiopulmonary Bypass," Braz. J
`Med. Bio. Res., 30: 369-374, 1997.
`
`(Continued)
`
`Primary Examiner - Shirley V Gembeh
`Jones Day
`(74) Attorney, Agent, or Firm -
`
`(57)
`ABSTRACT
`One embodiment of the present invention is to improve the
`safety and efficacy of the administration of GHB or a salt
`thereof to a patient. It has been discovered that the concomi(cid:173)
`tant administration of an MCT inhibitor, such as diclofenac,
`valproate, or ibuprofen, will affect GHB administration. For
`example, it has been discovered that diclofenac lowers the
`effect of GHB in the body, thereby potentially causing an
`unsafe condition. Furthermore, it has been discovered that
`val pro ate increases the effect of GHB on the body, thereby
`potentially causing an unsafe condition.
`
`34 Claims, 10 Drawing Sheets
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