WO2005041968A3 - Once-a-day, oral, controlled-release, oxycodone dosage forms - Google Patents

Once-a-day, oral, controlled-release, oxycodone dosage forms Download PDF

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Publication number
WO2005041968A3
WO2005041968A3 PCT/US2004/036132 US2004036132W WO2005041968A3 WO 2005041968 A3 WO2005041968 A3 WO 2005041968A3 US 2004036132 W US2004036132 W US 2004036132W WO 2005041968 A3 WO2005041968 A3 WO 2005041968A3
Authority
WO
WIPO (PCT)
Prior art keywords
profiles
dosage forms
release
oral
day
Prior art date
Application number
PCT/US2004/036132
Other languages
French (fr)
Other versions
WO2005041968A2 (en
Inventor
Stephen Hwang
Nishit B Modi
Padmaja Shivanand
Original Assignee
Alza Corp
Stephen Hwang
Nishit B Modi
Padmaja Shivanand
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Alza Corp, Stephen Hwang, Nishit B Modi, Padmaja Shivanand filed Critical Alza Corp
Priority to JP2006538357A priority Critical patent/JP2007509979A/en
Priority to EP04817492A priority patent/EP1677798A2/en
Priority to CA002546691A priority patent/CA2546691A1/en
Priority to AU2004285547A priority patent/AU2004285547A1/en
Priority to BRPI0415639-0A priority patent/BRPI0415639A/en
Publication of WO2005041968A2 publication Critical patent/WO2005041968A2/en
Priority to IL175193A priority patent/IL175193A0/en
Priority to NO20062398A priority patent/NO20062398L/en
Publication of WO2005041968A3 publication Critical patent/WO2005041968A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Abstract

Oxycodone formulations are provided which produce substantially flat in vivo steady state plasma profiles. Tolerance levels associated with such profiles and tolerance levels associated with biphasic profiles are shown not to be statistically different. The substantially flat in vivo steady state plasma profiles are produced by dosage forms having substantially zero order in vitro release profiles. Such release profiles produce low single dose in vivo Cmax levels which can reduce the probability of adverse side effects.
PCT/US2004/036132 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms WO2005041968A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP2006538357A JP2007509979A (en) 2003-10-29 2004-10-28 Once a day, oral, controlled release, oxycodone dosage form
EP04817492A EP1677798A2 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms
CA002546691A CA2546691A1 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms
AU2004285547A AU2004285547A1 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms
BRPI0415639-0A BRPI0415639A (en) 2003-10-29 2004-10-28 once daily controlled release oxycodone oral dosage forms
IL175193A IL175193A0 (en) 2003-10-29 2006-04-25 Once-a-day, oral, controlled-release, oxycodone dosage forms
NO20062398A NO20062398L (en) 2003-10-29 2006-05-26 Daily oral controlled release oxycodone dosage form

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US51588003P 2003-10-29 2003-10-29
US60/515,880 2003-10-29

Publications (2)

Publication Number Publication Date
WO2005041968A2 WO2005041968A2 (en) 2005-05-12
WO2005041968A3 true WO2005041968A3 (en) 2006-06-22

Family

ID=34549453

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/036132 WO2005041968A2 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms

Country Status (14)

Country Link
EP (1) EP1677798A2 (en)
JP (1) JP2007509979A (en)
KR (1) KR20060108690A (en)
CN (1) CN1933837A (en)
AU (1) AU2004285547A1 (en)
BR (1) BRPI0415639A (en)
CA (1) CA2546691A1 (en)
EC (1) ECSP066534A (en)
IL (1) IL175193A0 (en)
MA (1) MA28215A1 (en)
NO (1) NO20062398L (en)
RU (1) RU2006118323A (en)
WO (1) WO2005041968A2 (en)
ZA (1) ZA200604310B (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
US8114384B2 (en) 2004-07-01 2012-02-14 Gruenenthal Gmbh Process for the production of an abuse-proofed solid dosage form
US8114383B2 (en) 2003-08-06 2012-02-14 Gruenenthal Gmbh Abuse-proofed dosage form
US8192722B2 (en) 2003-08-06 2012-06-05 Grunenthal Gmbh Abuse-proof dosage form
US8383152B2 (en) 2008-01-25 2013-02-26 Gruenenthal Gmbh Pharmaceutical dosage form
US8722086B2 (en) 2007-03-07 2014-05-13 Gruenenthal Gmbh Dosage form with impeded abuse
US8951555B1 (en) 2000-10-30 2015-02-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8975273B2 (en) 1999-10-29 2015-03-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9161917B2 (en) 2008-05-09 2015-10-20 Grünenthal GmbH Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
US20110104214A1 (en) 2004-04-15 2011-05-05 Purdue Pharma L.P. Once-a-day oxycodone formulations
UA81224C2 (en) * 2001-05-02 2007-12-25 Euro Celtic S A Dosage form of oxycodone and use thereof
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
DE10361596A1 (en) 2003-12-24 2005-09-29 Grünenthal GmbH Process for producing an anti-abuse dosage form
DE102005005446A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Break-resistant dosage forms with sustained release
DE102004032049A1 (en) 2004-07-01 2006-01-19 Grünenthal GmbH Anti-abuse, oral dosage form
DE102005005449A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Process for producing an anti-abuse dosage form
SA07280459B1 (en) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. Tamper Resistant Oral Pharmaceutical Dosage Forms Comprising an Opioid Analgesic
US9226907B2 (en) 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
PE20120572A1 (en) 2009-07-22 2012-06-06 Gruenenthal Chemie HANDLING RESISTANT STABILIZED OXIDATION DOSAGE FORM
EP2456427B1 (en) 2009-07-22 2015-03-04 Grünenthal GmbH Hot-melt extruded controlled release dosage form
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
CA2832436C (en) * 2010-04-07 2018-08-14 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
PE20131126A1 (en) 2010-09-02 2013-10-21 Gruenenthal Chemie ALTERATION RESISTANT DOSAGE FORM INCLUDING AN ANIONIC POLYMER
NZ607392A (en) 2010-09-02 2015-03-27 Gruenenthal Chemie Tamper resistant dosage form comprising inorganic salt
EP2736495B1 (en) 2011-07-29 2017-08-23 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
DK2736497T3 (en) 2011-07-29 2017-11-13 Gruenenthal Gmbh Shock-resistant tablet that provides an immediate release of a drug.
MX356421B (en) 2012-02-28 2018-05-29 Gruenenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer.
LT2838512T (en) 2012-04-18 2018-11-12 GrĆ¼nenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
MX2015016254A (en) 2013-05-29 2016-04-20 Gruenenthal Gmbh Tamper resistant dosage form with bimodal release profile.
KR20160031526A (en) 2013-07-12 2016-03-22 그뤼넨탈 게엠베하 Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
CA2931553C (en) 2013-11-26 2022-01-18 Grunenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling
EP3142646A1 (en) 2014-05-12 2017-03-22 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
WO2017042325A1 (en) 2015-09-10 2017-03-16 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
CN109789141B (en) 2016-08-10 2022-08-26 豪夫迈·罗氏有限公司 Pharmaceutical compositions comprising Akt protein kinase inhibitors

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038856A1 (en) * 1994-07-07 2001-11-08 Sonya Merrill Hydromorphone therapy
WO2002087512A2 (en) * 2001-05-02 2002-11-07 Euro-Celtique, S.A. Once-a-day oxycodone formulations
WO2003092648A1 (en) * 2002-04-29 2003-11-13 Alza Corporation Methods and dosage forms for controlled delivery of oxycodone
WO2003101384A2 (en) * 2002-05-31 2003-12-11 Alza Corporation Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038856A1 (en) * 1994-07-07 2001-11-08 Sonya Merrill Hydromorphone therapy
WO2002087512A2 (en) * 2001-05-02 2002-11-07 Euro-Celtique, S.A. Once-a-day oxycodone formulations
WO2003092648A1 (en) * 2002-04-29 2003-11-13 Alza Corporation Methods and dosage forms for controlled delivery of oxycodone
WO2003101384A2 (en) * 2002-05-31 2003-12-11 Alza Corporation Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
HAGEN N A ET AL: "Comparative clinical efficacy and safety of a novel controlled-release oxycodone formulation and controlled-release hydromorphone in the treatment of cancer pain", CANCER, AMERICAN CANCER SOCIETY, PHILADELPHIA, PA, US, vol. 79, no. 7, 1997, pages 1428 - 1437, XP002249725, ISSN: 0008-543X *
SANTUS G ET AL: "Osmotic drug delivery: a review of the patent literature", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 35, no. 1, July 1995 (1995-07-01), pages 1 - 21, XP004037488, ISSN: 0168-3659 *

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9320717B2 (en) 1999-10-29 2016-04-26 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8975273B2 (en) 1999-10-29 2015-03-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8980291B2 (en) 1999-10-29 2015-03-17 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9278074B2 (en) 1999-10-29 2016-03-08 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9056107B1 (en) 1999-10-29 2015-06-16 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9526724B2 (en) 2000-10-30 2016-12-27 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9205055B2 (en) 2000-10-30 2015-12-08 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9572805B2 (en) 2000-10-30 2017-02-21 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8951555B1 (en) 2000-10-30 2015-02-10 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9023401B1 (en) 2000-10-30 2015-05-05 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9572804B2 (en) 2000-10-30 2017-02-21 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9517236B2 (en) 2000-10-30 2016-12-13 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9198863B2 (en) 2000-10-30 2015-12-01 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9504681B2 (en) 2000-10-30 2016-11-29 Purdue Pharma L.P. Controlled release hydrocodone formulations
US9289391B2 (en) 2000-10-30 2016-03-22 Purdue Pharma L.P. Controlled release hydrocodone formulations
US8309060B2 (en) 2003-08-06 2012-11-13 Grunenthal Gmbh Abuse-proofed dosage form
US8192722B2 (en) 2003-08-06 2012-06-05 Grunenthal Gmbh Abuse-proof dosage form
US8420056B2 (en) 2003-08-06 2013-04-16 Grunenthal Gmbh Abuse-proofed dosage form
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
US8114383B2 (en) 2003-08-06 2012-02-14 Gruenenthal Gmbh Abuse-proofed dosage form
US8114384B2 (en) 2004-07-01 2012-02-14 Gruenenthal Gmbh Process for the production of an abuse-proofed solid dosage form
US8722086B2 (en) 2007-03-07 2014-05-13 Gruenenthal Gmbh Dosage form with impeded abuse
US8383152B2 (en) 2008-01-25 2013-02-26 Gruenenthal Gmbh Pharmaceutical dosage form
US9161917B2 (en) 2008-05-09 2015-10-20 Grünenthal GmbH Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet

Also Published As

Publication number Publication date
WO2005041968A2 (en) 2005-05-12
BRPI0415639A (en) 2006-12-12
NO20062398L (en) 2006-07-27
EP1677798A2 (en) 2006-07-12
ECSP066534A (en) 2006-11-24
CN1933837A (en) 2007-03-21
IL175193A0 (en) 2008-04-13
AU2004285547A1 (en) 2005-05-12
ZA200604310B (en) 2007-11-28
MA28215A1 (en) 2006-10-02
CA2546691A1 (en) 2005-05-12
JP2007509979A (en) 2007-04-19
RU2006118323A (en) 2007-12-10
KR20060108690A (en) 2006-10-18

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