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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (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
KR100889069B1 (en) 1999-10-29 2009-03-17 유로-셀티크 소시에떼 아노뉨 Controlled release hydrocodone formulations
US10179130B2 (en) 1999-10-29 2019-01-15 Purdue Pharma L.P. Controlled release hydrocodone formulations
AU2738302A (en) 2000-10-30 2002-05-15 Euro Celtique Sa 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
DE10361596A1 (en) 2003-12-24 2005-09-29 Grünenthal GmbH Process for producing an anti-abuse dosage form
DE10336400A1 (en) 2003-08-06 2005-03-24 Grünenthal GmbH Anti-abuse dosage form
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed 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
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
AU2009243681B2 (en) 2008-05-09 2013-12-19 Grunenthal Gmbh Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
CN102639118B (en) 2009-07-22 2015-07-29 格吕伦塔尔有限公司 Oxidation-stabilized tamper resistant dosage form
KR101738369B1 (en) 2009-07-22 2017-05-22 그뤼넨탈 게엠베하 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
WO2011124953A2 (en) * 2010-04-07 2011-10-13 Lupin Limited Controlled release pharmaceutical compositions of tapentadol
BR112013005194A2 (en) 2010-09-02 2016-05-03 Gruenenthal Gmbh tamper-resistant dosage form comprising inorganic salt
TWI516286B (en) 2010-09-02 2016-01-11 歌林達股份有限公司 Tamper resistant dosage form comprising an anionic polymer
EA201400172A1 (en) 2011-07-29 2014-06-30 Грюненталь Гмбх SUSTAINABLE TO DESTRUCTION TABLET THAT PROVIDES IMMEDIATE RELEASE OF MEDICINES
BR112014001091A2 (en) 2011-07-29 2017-02-14 Gruenenthal Gmbh tamper resistant tablet that provides immediate release of the drug
MX356421B (en) 2012-02-28 2018-05-29 Gruenenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer.
EP2838512B1 (en) 2012-04-18 2018-08-22 Grünenthal 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
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
EP3003279A1 (en) 2013-05-29 2016-04-13 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
BR112016000194A8 (en) 2013-07-12 2019-12-31 Gruenenthal Gmbh tamper-resistant dosage form containing ethylene vinyl acetate polymer
EP3073994A1 (en) 2013-11-26 2016-10-05 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EA201692388A1 (en) 2014-05-26 2017-05-31 Грюненталь Гмбх DOSAGE FORM AS PARTICLE MULTIPLE, PROTECTED AGAINST CALLED DOSE RESET BY ETHANOL
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
JP2018526414A (en) 2015-09-10 2018-09-13 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 Protection against oral overdose with abuse-inhibiting immediate release formulations
BR112019002007B1 (en) 2016-08-10 2024-01-16 F. Hoffmann-La Roche Ag PHARMACEUTICAL COMPOSITION AND USE OF A PHARMACEUTICAL COMPOSITION

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
WO2003092648A1 (en) * 2002-04-29 2003-11-13 Alza Corporation Methods and dosage forms for controlled delivery of oxycodone
CA2487786A1 (en) * 2002-05-31 2003-12-11 Alza Corporation Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone

Also Published As

Publication number Publication date
CN1933837A (en) 2007-03-21
AU2004285547A1 (en) 2005-05-12
EP1677798A2 (en) 2006-07-12
ZA200604310B (en) 2007-11-28
WO2005041968A3 (en) 2006-06-22
IL175193A0 (en) 2008-04-13
JP2007509979A (en) 2007-04-19
MA28215A1 (en) 2006-10-02
WO2005041968A2 (en) 2005-05-12
KR20060108690A (en) 2006-10-18
CA2546691A1 (en) 2005-05-12
RU2006118323A (en) 2007-12-10
BRPI0415639A (en) 2006-12-12
NO20062398L (en) 2006-07-27

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