EP1677798A2 - Once-a-day, oral, controlled-release, oxycodone dosage forms - Google Patents

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

Info

Publication number
EP1677798A2
EP1677798A2 EP04817492A EP04817492A EP1677798A2 EP 1677798 A2 EP1677798 A2 EP 1677798A2 EP 04817492 A EP04817492 A EP 04817492A EP 04817492 A EP04817492 A EP 04817492A EP 1677798 A2 EP1677798 A2 EP 1677798A2
Authority
EP
European Patent Office
Prior art keywords
auc
oxycodone
formulation
hours
auco
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP04817492A
Other languages
German (de)
English (en)
French (fr)
Inventor
Stephen Hwang
Nishit B. Modi
Padmaja Shivanand
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alza Corp
Original Assignee
Alza Corp
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 filed Critical Alza Corp
Publication of EP1677798A2 publication Critical patent/EP1677798A2/en
Withdrawn legal-status Critical Current

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

Definitions

  • FIG 1 is a perspective view of one embodiment of a controlled release osmotic dosage form.
  • Dosage form 10 comprises wall 20 that surrounds and encloses an internal compartment (not seen in Figure 1).
  • the internal compartment contains a composition comprising oxycodone, and/or one or more of its pharmaceutically acceptable acid addition salts.
  • Wall 20 is provided with at least one drug delivery exit 60 for connecting the internal compartment with the exterior environment of use. Accordingly, following oral ingestion of dosage form 10, fluid is imbibed through wall 20 and oxycodone and/or one or more of its pharmaceutically acceptable acid addition salts is released through exit 60.
  • the preferred geometrical embodiment in Figure 1 illustrates a standard biconvex shaped tablet, the geometry may embrace a capsule shaped caplet and other oral dosage forms.
  • the final dosage form contained a color overcoat and a wax coat and had a mean release rate of 3.94 mg oxycodone hydrochloride, USP per hour (4.93 %/hr).
  • the formulation of this example is summarized in Table 5 and is referred to hereinafter as the "Example 3 SZO-24 dosage form.”
  • Example 4 Pharmacokinetics and Pharmacodynamics of Osmotic Oxycodone Hydrochloride (Fast and Slow) and Immediate Release Oxycodone Hydrochloride in Healthy Volunteers
  • This study investigated the pharmacokinetics and pharmacodynamics of the "fast” and “slow” osmotic oxycodone HCl systems of Example 1 and immediate release (IR) oxycodone HCl in healthy male volunteers.
EP04817492A 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms Withdrawn EP1677798A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US51588003P 2003-10-29 2003-10-29
PCT/US2004/036132 WO2005041968A2 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms

Publications (1)

Publication Number Publication Date
EP1677798A2 true EP1677798A2 (en) 2006-07-12

Family

ID=34549453

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04817492A Withdrawn EP1677798A2 (en) 2003-10-29 2004-10-28 Once-a-day, oral, controlled-release, oxycodone dosage forms

Country Status (14)

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

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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
KR20130010512A (ko) 1999-10-29 2013-01-28 유로-셀티크 소시에떼 아노뉨 서방성 하이드로코돈 제형
EP1337244A4 (en) 2000-10-30 2006-01-11 Euro Celtique Sa HYDROCODON FORMULATIONS WITH CONTROLLED RELEASE
UA81224C2 (uk) * 2001-05-02 2007-12-25 Euro Celtic S A Дозована форма оксикодону та її застосування
US20110104214A1 (en) 2004-04-15 2011-05-05 Purdue Pharma L.P. Once-a-day oxycodone formulations
US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
US9226907B2 (en) 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
WO2009135680A1 (en) 2008-05-09 2009-11-12 Grünenthal GmbH Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
CN102639118B (zh) 2009-07-22 2015-07-29 格吕伦塔尔有限公司 氧化稳定的抗干扰剂型
ES2534908T3 (es) 2009-07-22 2015-04-30 Grünenthal GmbH Forma de dosificación de liberación controlada extruida por fusión en caliente
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
US9884022B2 (en) * 2010-04-07 2018-02-06 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
PL2611426T3 (pl) 2010-09-02 2014-09-30 Gruenenthal Gmbh Postać dawkowania zawierająca nieorganiczne sole, odporna na zgniatanie
MX2013002293A (es) 2010-09-02 2013-05-09 Gruenenthal Gmbh Forma de dosificacion resistente a alteracion que comprende un polimero anionico.
DK2736495T3 (da) 2011-07-29 2017-11-13 Gruenenthal Gmbh Misbrugsbestandig tablet som tilvejebringer øjeblikkelig frigivelse af lægemiddel
RS56527B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
EP2819656A1 (en) 2012-02-28 2015-01-07 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
MX362357B (es) 2012-04-18 2019-01-14 Gruenenthal Gmbh Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis.
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
AU2014273226B2 (en) 2013-05-29 2019-06-27 Grunenthal Gmbh Tamper resistant dosage form with bimodal release profile
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
JP6449871B2 (ja) 2013-07-12 2019-01-09 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング エチレン−酢酸ビニルポリマーを含有する改変防止剤形
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
CN106456550A (zh) 2014-05-26 2017-02-22 格吕伦塔尔有限公司 避免乙醇剂量倾泻的多颗粒
CA2983642A1 (en) 2015-04-24 2016-10-27 Grunenthal Gmbh Tamper-resistant dosage form with immediate release and resistance against solvent extraction
CA2998259A1 (en) 2015-09-10 2017-03-16 Grunenthal Gmbh Protecting oral overdose with abuse deterrent immediate release formulations
WO2018029226A1 (en) 2016-08-10 2018-02-15 F. Hoffmann-La Roche Ag Pharmaceutical compositions comprising akt protein kinase inhibitors

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* Cited by examiner, † Cited by third party
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US5914131A (en) * 1994-07-07 1999-06-22 Alza Corporation Hydromorphone therapy
UA81224C2 (uk) * 2001-05-02 2007-12-25 Euro Celtic S A Дозована форма оксикодону та її застосування
WO2003092648A1 (en) * 2002-04-29 2003-11-13 Alza Corporation Methods and dosage forms for controlled delivery of oxycodone
EP1513497A2 (en) * 2002-05-31 2005-03-16 Alza Corporation Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005041968A2 *

Also Published As

Publication number Publication date
ZA200604310B (en) 2007-11-28
KR20060108690A (ko) 2006-10-18
CA2546691A1 (en) 2005-05-12
JP2007509979A (ja) 2007-04-19
WO2005041968A2 (en) 2005-05-12
MA28215A1 (fr) 2006-10-02
RU2006118323A (ru) 2007-12-10
IL175193A0 (en) 2008-04-13
CN1933837A (zh) 2007-03-21
AU2004285547A1 (en) 2005-05-12
BRPI0415639A (pt) 2006-12-12
NO20062398L (no) 2006-07-27
WO2005041968A3 (en) 2006-06-22
ECSP066534A (es) 2006-11-24

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