MA28215A1 - Galenic forms of oxycodone controlled release for once-daily oral administration - Google Patents

Galenic forms of oxycodone controlled release for once-daily oral administration

Info

Publication number
MA28215A1
MA28215A1 MA28979A MA28979A MA28215A1 MA 28215 A1 MA28215 A1 MA 28215A1 MA 28979 A MA28979 A MA 28979A MA 28979 A MA28979 A MA 28979A MA 28215 A1 MA28215 A1 MA 28215A1
Authority
MA
Morocco
Prior art keywords
profiles
once
galenic forms
oral administration
controlled release
Prior art date
Application number
MA28979A
Other languages
French (fr)
Inventor
Stephen Hwang
Nishit B Modi
Padmaja Shivanand
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 MA28215A1 publication Critical patent/MA28215A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Abstract

FORMES GALÉNIQUES DE L'OXYCODONE À LIBÉRATION CONTRÔLÉE POUR ADMINISTRATION ORALE UNE FOIS PAR JOUR La présente invention concerne des formulations d'oxycodone qui produisent des profils plasma tiques en équilibre dynamique in vivo pratiquement plats. Les niveaux de tolérance associés à de tels profils et les niveaux de tolérance associés aux profils biphasiques se sont révélés ne pas être statistiquement différents. Les profils p.iasmatiques en équilibre dynamique in vivo pratiquement plats sont produits par des formes galéniques ayant des profils de libération in vit.ro pratiquement de l'ordre de zéro. De tels prot ils de libération produisent des niveaux faibles de Cmaz in vivo avec une dose unique qui peuvent diminuer la probabilité des effets secondaires néfastes.The present invention relates to oxycodone formulations that produce substantially in vivo dynamic equilibrium plasma profiles in practically flat equilibrium. The tolerance levels associated with such profiles and the tolerance levels associated with biphasic profiles have been shown not to be statistically different. The substantially in vivo dynamic equilibrium p.iasmatic profiles are produced by galenic forms having in vitro release profiles of substantially zero order. Such release proteins produce low levels of Cmaz in vivo with a single dose that may decrease the likelihood of adverse side effects.

MA28979A 2003-10-29 2006-04-28 Galenic forms of oxycodone controlled release for once-daily oral administration MA28215A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US51588003P 2003-10-29 2003-10-29

Publications (1)

Publication Number Publication Date
MA28215A1 true MA28215A1 (en) 2006-10-02

Family

ID=34549453

Family Applications (1)

Application Number Title Priority Date Filing Date
MA28979A MA28215A1 (en) 2003-10-29 2006-04-28 Galenic forms of oxycodone controlled release for once-daily oral administration

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)

Families Citing this family (39)

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ATE526950T1 (en) 1999-10-29 2011-10-15 Euro Celtique Sa CONTROLLED RELEASE HYDROCODONE FORMULATIONS
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
WO2002036099A1 (en) 2000-10-30 2002-05-10 Euro-Celtique S.A. Controlled release hydrocodone formulations
UA81224C2 (en) * 2001-05-02 2007-12-25 Euro Celtic S A Dosage form of oxycodone and use thereof
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
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE10336400A1 (en) 2003-08-06 2005-03-24 Grünenthal GmbH Anti-abuse dosage form
DE10361596A1 (en) 2003-12-24 2005-09-29 Grünenthal GmbH Process for producing an anti-abuse dosage form
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102005005446A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Break-resistant dosage forms with sustained release
DE102004032051A1 (en) 2004-07-01 2006-01-19 Grünenthal GmbH Process for the preparation of a secured against misuse, solid dosage form
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
DE102007011485A1 (en) 2007-03-07 2008-09-11 Grünenthal GmbH Dosage form with more difficult abuse
JP5774853B2 (en) 2008-01-25 2015-09-09 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 Pharmaceutical dosage form
US9226907B2 (en) 2008-02-01 2016-01-05 Abbvie Inc. Extended release hydrocodone acetaminophen and related methods and uses thereof
CA2723438C (en) 2008-05-09 2016-10-11 Gruenenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
MX2012000317A (en) 2009-07-22 2012-02-08 Gruenenthal Gmbh Hot-melt extruded controlled release dosage form.
MX2012000369A (en) 2009-07-22 2012-02-01 Gruenenthal Gmbh Tamper-resistant dosage form for oxidation-sensitive oploids.
US20110150989A1 (en) * 2009-12-22 2011-06-23 Mallinkckrodt Inc. Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans
EP2555756B1 (en) * 2010-04-07 2018-08-22 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
RU2604676C2 (en) 2010-09-02 2016-12-10 Грюненталь Гмбх Destruction-resistant dosage form containing an inorganic salt
ES2487244T3 (en) 2010-09-02 2014-08-20 Grünenthal GmbH Handling resistant dosage form comprising an anionic polymer
PT2736495T (en) 2011-07-29 2017-11-30 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
BR112014019988A8 (en) 2012-02-28 2017-07-11 Gruenenthal Gmbh BREAK-RESISTANT DOSAGE FORM COMPRISING A PHARMACOLOGICALLY ACTIVE COMPOUND AND AN ANIONIC POLYMER
JP6282261B2 (en) 2012-04-18 2018-02-21 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 Unauthorized use and overdose prevention pharmaceutical dosage forms
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
BR112015029616A2 (en) 2013-05-29 2017-07-25 Gruenenthal Gmbh tamper-resistant dosage form with bimodal release profile
CA2907950A1 (en) 2013-05-29 2014-12-04 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
KR20160031526A (en) 2013-07-12 2016-03-22 그뤼넨탈 게엠베하 Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
MX371372B (en) 2013-11-26 2020-01-28 Gruenenthal Gmbh Preparation of a powdery pharmaceutical composition by means of cryo-milling.
CA2947786A1 (en) 2014-05-12 2015-11-19 Grunenthal Gmbh Tamper resistant immediate release capsule formulation comprising tapentadol
WO2015181059A1 (en) 2014-05-26 2015-12-03 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
CN107889459A (en) 2015-04-24 2018-04-06 格吕伦塔尔有限公司 Tamper resistant dosage form with release immediately and to solvent-extracted resistance
AU2016319203A1 (en) 2015-09-10 2018-02-22 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
TW202329972A (en) 2016-08-10 2023-08-01 瑞士商赫孚孟拉羅股份公司 Pharmaceutical compositions comprising akt protein kinase inhibitors

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5914131A (en) * 1994-07-07 1999-06-22 Alza Corporation Hydromorphone therapy
UA81224C2 (en) * 2001-05-02 2007-12-25 Euro Celtic S A Dosage form of oxycodone and use thereof
US20040010000A1 (en) * 2002-04-29 2004-01-15 Ayer Atul D. Methods and dosage forms for controlled delivery of oxycodone
MXPA04012021A (en) * 2002-05-31 2005-08-16 Johnson & Johnson Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone.

Also Published As

Publication number Publication date
ECSP066534A (en) 2006-11-24
CA2546691A1 (en) 2005-05-12
WO2005041968A2 (en) 2005-05-12
RU2006118323A (en) 2007-12-10
AU2004285547A1 (en) 2005-05-12
CN1933837A (en) 2007-03-21
KR20060108690A (en) 2006-10-18
ZA200604310B (en) 2007-11-28
JP2007509979A (en) 2007-04-19
EP1677798A2 (en) 2006-07-12
NO20062398L (en) 2006-07-27
IL175193A0 (en) 2008-04-13
WO2005041968A3 (en) 2006-06-22
BRPI0415639A (en) 2006-12-12

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