ECSP066534A - DOSAGE FORMS OF CONTROLLED OXYCODONE, ORALS, ONCE A DAY - Google Patents

DOSAGE FORMS OF CONTROLLED OXYCODONE, ORALS, ONCE A DAY

Info

Publication number
ECSP066534A
ECSP066534A EC2006006534A ECSP066534A ECSP066534A EC SP066534 A ECSP066534 A EC SP066534A EC 2006006534 A EC2006006534 A EC 2006006534A EC SP066534 A ECSP066534 A EC SP066534A EC SP066534 A ECSP066534 A EC SP066534A
Authority
EC
Ecuador
Prior art keywords
profiles
dosage forms
orals
vivo
day
Prior art date
Application number
EC2006006534A
Other languages
Spanish (es)
Inventor
Stephen Hwang
Padmaja Shivanand
Nishit B Modi
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 ECSP066534A publication Critical patent/ECSP066534A/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

Se proveen formulaciones de oxicodona que producen perfiles de plasma en estado estable in vivo sustancialmente planos; los niveles de tolerancia relacionados con dichos perfiles y niveles de tolerancia relacionados con perfiles bifásicos no se muestran estadísticamente diferentes; los perfiles de plasma en estado estable in vivo sustancialmente planos se producen a través de formas de dosificación que tienen perfiles de liberación in vitro sustancialmente de orden cero; dichos perfiles de liberación producen bajos niveles de Cmax in vivo de dosis única los cuales pueden reducir la probabilidad de efectos secundarios adversos.Oxycodone formulations that produce substantially flat stable in vivo plasma profiles are provided; the tolerance levels related to said profiles and tolerance levels related to biphasic profiles are not statistically different; substantially flat in vivo stable plasma profiles are produced through dosage forms having substantially zero-order in vitro release profiles; such release profiles produce low levels of Cmax in vivo single dose which can reduce the likelihood of adverse side effects.

EC2006006534A 2003-10-29 2006-04-28 DOSAGE FORMS OF CONTROLLED OXYCODONE, ORALS, ONCE A DAY ECSP066534A (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
ECSP066534A true ECSP066534A (en) 2006-11-24

Family

ID=34549453

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2006006534A ECSP066534A (en) 2003-10-29 2006-04-28 DOSAGE FORMS OF CONTROLLED OXYCODONE, ORALS, ONCE A DAY

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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
MA28215A1 (en) 2006-10-02
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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