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

    • 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

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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US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
CN1407884B (en) 1999-10-29 2012-06-20 欧罗赛铁克股份有限公司 Controlled release hydrocodone formulations
CN100518827C (en) 2000-10-30 2009-07-29 欧罗赛铁克股份有限公司 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
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
DE10361596A1 (en) 2003-12-24 2005-09-29 Grünenthal GmbH Process for producing an anti-abuse dosage form
DE102004032051A1 (en) 2004-07-01 2006-01-19 Grünenthal GmbH Process for the preparation of a secured against misuse, solid dosage form
DE102005005446A1 (en) 2005-02-04 2006-08-10 Grünenthal GmbH Break-resistant dosage forms with sustained release
DE10336400A1 (en) 2003-08-06 2005-03-24 Grünenthal GmbH Anti-abuse dosage form
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed 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
WO2009092601A1 (en) 2008-01-25 2009-07-30 Grünenthal GmbH Pharmaceutical dosage form
JP2011511782A (en) 2008-02-12 2011-04-14 アボット・ラボラトリーズ Extended release hydrocodone acetaminophen and related methods and uses
CN102123701B (en) 2008-05-09 2013-03-27 格吕伦塔尔有限公司 Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
PL2456424T3 (en) 2009-07-22 2013-12-31 Gruenenthal Gmbh Oxidation-stabilized tamper-resistant dosage form
PE20121067A1 (en) 2009-07-22 2012-09-05 Gruenenthal Chemie CONTROLLED RELEASE DOSAGE FORM EXTRUDED BY HOT MELTING
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
NZ608865A (en) 2010-09-02 2015-03-27 Gruenenthal Chemie Tamper resistant dosage form comprising an anionic polymer
BR112013005194A2 (en) 2010-09-02 2016-05-03 Gruenenthal Gmbh tamper-resistant dosage form comprising inorganic salt
DK2736497T3 (en) 2011-07-29 2017-11-13 Gruenenthal Gmbh Shock-resistant tablet that provides an immediate release of a drug.
EA201400172A1 (en) 2011-07-29 2014-06-30 Грюненталь Гмбх SUSTAINABLE TO DESTRUCTION TABLET THAT PROVIDES IMMEDIATE RELEASE OF MEDICINES
JP6117249B2 (en) 2012-02-28 2017-04-19 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 Tamper resistant dosage forms comprising a pharmacologically active compound and an anionic polymer
TR201815502T4 (en) 2012-04-18 2018-11-21 Gruenenthal Gmbh Tamper or pharmaceutical dosage form that is resistant and resistant to dose discharge.
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
WO2014191397A1 (en) 2013-05-29 2014-12-04 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
CA2913209A1 (en) 2013-05-29 2014-12-04 Grunenthal Gmbh Tamper resistant dosage form with bimodal release profile
WO2015004245A1 (en) 2013-07-12 2015-01-15 Grünenthal GmbH 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
CA2949422A1 (en) 2014-05-26 2015-12-03 Grunenthal 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
WO2017042325A1 (en) 2015-09-10 2017-03-16 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
CN115350192A (en) 2016-08-10 2022-11-18 豪夫迈·罗氏有限公司 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
RU2004134594A (en) * 2002-04-29 2005-06-27 Алза Корпорейшн (Us) METHODS AND DRUG FORMS FOR CONTROLLED DELIVERY OF OXYCODONE
PL372797A1 (en) * 2002-05-31 2005-08-08 Alza Corporation Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone

Also Published As

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

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