BRPI0516718B8 - formulação de liberação modificada de ibuprofeno fornecendo liberação imediata e prolongada do fármaco - Google Patents

formulação de liberação modificada de ibuprofeno fornecendo liberação imediata e prolongada do fármaco

Info

Publication number
BRPI0516718B8
BRPI0516718B8 BRPI0516718A BRPI0516718A BRPI0516718B8 BR PI0516718 B8 BRPI0516718 B8 BR PI0516718B8 BR PI0516718 A BRPI0516718 A BR PI0516718A BR PI0516718 A BRPI0516718 A BR PI0516718A BR PI0516718 B8 BRPI0516718 B8 BR PI0516718B8
Authority
BR
Brazil
Prior art keywords
ibuprofen
dosage form
release
modified
drug
Prior art date
Application number
BRPI0516718A
Other languages
English (en)
Inventor
Brunelle Alan
Federici Cathy
Hite Michael
Turner Stephen
Original Assignee
Scolr Pharma Inc
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 Scolr Pharma Inc filed Critical Scolr Pharma Inc
Publication of BRPI0516718A publication Critical patent/BRPI0516718A/pt
Publication of BRPI0516718B1 publication Critical patent/BRPI0516718B1/pt
Publication of BRPI0516718B8 publication Critical patent/BRPI0516718B8/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

forma de dosagem de ibuprofeno de liberação modificada. a presente invenção refere-se a uma forma de dosagem sólida para administração oral de ibuprofeno compreendendo uma formulação de liberação modificada de ibuprofeno que provê um efeito de explosão imediato e em seguida uma liberação sustentada de ibuprofeno suficiente para manter níveis sanguíneos de pelo menos 6,4 (mi)g/ml durante um período prolongado de pelo menos 8 horas seguindo administração em uma dose única. a forma de dosagem libera ibuprofeno em uma taxa suficiente para inicialmente aplicar uma quantidade eficaz de ibuprofeno dentro de cerca de 2,0 horas seguindo administração. a forma de dosagem então subseqüentemente aplica a quantidade restante de ibuprofeno em uma taxa relativamente constante suficiente para manter um nível de ibuprofeno durante um período de aplicação predeterminado por pelo menos 8 horas.
BRPI0516718A 2004-09-30 2005-09-30 formulação de liberação modificada de ibuprofeno fornecendo liberação imediata e prolongada do fármaco BRPI0516718B8 (pt)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US61493204P 2004-09-30 2004-09-30
US60/614,932 2004-09-30
US68963105P 2005-06-10 2005-06-10
US60/689,631 2005-06-10
US11/238,802 US20060068009A1 (en) 2004-09-30 2005-09-29 Modified release ibuprofen dosage form
US11/238,802 2005-09-29
PCT/US2005/035630 WO2006039692A2 (en) 2004-09-30 2005-09-30 Modified release ibuprofen dosage form

Publications (3)

Publication Number Publication Date
BRPI0516718A BRPI0516718A (pt) 2008-09-16
BRPI0516718B1 BRPI0516718B1 (pt) 2019-05-14
BRPI0516718B8 true BRPI0516718B8 (pt) 2021-05-25

Family

ID=36099442

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0516718A BRPI0516718B8 (pt) 2004-09-30 2005-09-30 formulação de liberação modificada de ibuprofeno fornecendo liberação imediata e prolongada do fármaco

Country Status (13)

Country Link
US (1) US20060068009A1 (pt)
EP (1) EP1793809B1 (pt)
JP (1) JP2008515802A (pt)
KR (1) KR20070064352A (pt)
AU (1) AU2005292185B2 (pt)
BR (1) BRPI0516718B8 (pt)
CA (1) CA2582150C (pt)
HK (1) HK1107002A1 (pt)
IL (1) IL182144A (pt)
MX (1) MX2007003919A (pt)
NZ (1) NZ554213A (pt)
PL (1) PL1793809T3 (pt)
WO (1) WO2006039692A2 (pt)

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US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
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DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US7749537B2 (en) 2006-12-04 2010-07-06 Scolr Pharma, Inc. Method of forming a tablet
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
EP2249811A1 (en) 2008-01-25 2010-11-17 Grünenthal GmbH Pharmaceutical dosage form
EP2273983B1 (en) 2008-05-09 2016-07-20 Grünenthal GmbH Process for the preparation of an intermediate powder formulation and a final solid dosage form under usage of a spray congealing step
US20130115250A1 (en) * 2009-05-13 2013-05-09 Wyeth Llc Burst Drug Release Compositions
TWI478733B (zh) * 2009-05-13 2015-04-01 Wyeth Llc 突釋藥物釋放組合物
PL2456427T3 (pl) 2009-07-22 2015-07-31 Gruenenthal Gmbh Wytłaczana na gorąco postać dawki o kontrolowanym uwalnianiu
PL2456424T3 (pl) 2009-07-22 2013-12-31 Gruenenthal Gmbh Stabilizowana przed utlenianiem odporna na naruszenie postać dawkowania
AU2011297901B2 (en) 2010-09-02 2014-07-31 Grunenthal Gmbh Tamper resistant dosage form comprising inorganic salt
MX2013002293A (es) 2010-09-02 2013-05-09 Gruenenthal Gmbh Forma de dosificacion resistente a alteracion que comprende un polimero anionico.
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
PE20141638A1 (es) 2011-07-29 2014-11-22 Gruenenthal Chemie Tableta a prueba de manipulacion que proporciona liberacion de farmaco inmediato
US20130225697A1 (en) 2012-02-28 2013-08-29 Grunenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
EA201401139A1 (ru) 2012-04-18 2015-03-31 Грюненталь Гмбх Устойчивая к разрушению и к сбросу дозы фармацевтическая лекарственная форма
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
MX2015016254A (es) 2013-05-29 2016-04-20 Gruenenthal Gmbh Forma de dosificacion resistente al uso indebido con perfil de liberacion bimodal.
JP6445537B2 (ja) 2013-05-29 2018-12-26 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 1個または複数の粒子を含有する改変防止(tamper−resistant)剤形
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
JP6304896B2 (ja) * 2013-07-30 2018-04-04 ライオン株式会社 錠剤
JP6480936B2 (ja) 2013-11-26 2019-03-13 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 クライオミリングによる粉末状医薬組成物の調製
WO2015115586A1 (ja) * 2014-01-31 2015-08-06 塩野義製薬株式会社 徐放性製剤
WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EP3148512A1 (en) 2014-05-26 2017-04-05 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
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CN112168796B (zh) * 2020-09-28 2022-10-25 北京诺康达医药科技股份有限公司 双相缓释系统控制释放的药物缓释制剂及其制备方法

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Also Published As

Publication number Publication date
MX2007003919A (es) 2007-09-07
JP2008515802A (ja) 2008-05-15
HK1107002A1 (en) 2008-03-28
NZ554213A (en) 2010-01-29
AU2005292185A1 (en) 2006-04-13
BRPI0516718B1 (pt) 2019-05-14
WO2006039692A3 (en) 2006-06-15
PL1793809T3 (pl) 2012-12-31
EP1793809B1 (en) 2012-07-11
IL182144A (en) 2014-01-30
AU2005292185B2 (en) 2010-06-17
US20060068009A1 (en) 2006-03-30
BRPI0516718A (pt) 2008-09-16
KR20070064352A (ko) 2007-06-20
CA2582150A1 (en) 2006-04-13
EP1793809A2 (en) 2007-06-13
WO2006039692A2 (en) 2006-04-13
IL182144A0 (en) 2007-07-24
CA2582150C (en) 2014-01-14
EP1793809A4 (en) 2010-05-12

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Legal Events

Date Code Title Description
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 9A ANUIDADE.

B08G Application fees: restoration [chapter 8.7 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07C Technical examination (opinion): republication [chapter 7.3 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B09X Republication of the decision to grant [chapter 9.1.3 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 14/05/2019, OBSERVADAS AS CONDICOES LEGAIS. (CO) 10 (DEZ) ANOS CONTADOS A PARTIR DE 14/05/2019, OBSERVADAS AS CONDICOES LEGAIS

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/09/2005 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF