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)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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 (12)

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)
IL (1) IL182144A (pt)
MX (1) MX2007003919A (pt)
NZ (1) NZ554213A (pt)
PL (1) PL1793809T3 (pt)
WO (1) WO2006039692A2 (pt)

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US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
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
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
US20070077297A1 (en) 2004-09-30 2007-04-05 Scolr Pharma, Inc. Modified release ibuprofen dosage form
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
KR101616246B1 (ko) 2008-01-25 2016-05-02 그뤼넨탈 게엠베하 약제학적 투여형
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
US20130115250A1 (en) * 2009-05-13 2013-05-09 Wyeth Llc Burst Drug Release Compositions
TWI478733B (zh) * 2009-05-13 2015-04-01 惠氏有限責任公司 突釋藥物釋放組合物
WO2011009602A1 (en) 2009-07-22 2011-01-27 Grünenthal GmbH Hot-melt extruded controlled release dosage form
TWI473628B (zh) 2009-07-22 2015-02-21 用於對氧化敏感之類鴉片藥劑之抗破壞劑型
CA2808219C (en) 2010-09-02 2019-05-14 Gruenenthal Gmbh Tamper resistant dosage form comprising inorganic salt
WO2012028318A1 (en) 2010-09-02 2012-03-08 Grünenthal GmbH Tamper resistant dosage form comprising an anionic polymer
ES2648129T3 (es) 2011-07-29 2017-12-28 Grünenthal GmbH Pastilla a prueba de manipulación que proporciona una liberación inmediata de un medicamento
AU2012289764B2 (en) 2011-07-29 2017-03-02 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US20130225697A1 (en) 2012-02-28 2013-08-29 Grunenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
PL2838512T3 (pl) 2012-04-18 2018-12-31 Grünenthal GmbH Farmaceutyczna postać dawkowania odporna na niewłaściwe użycie i odporna na uderzeniowe uwalnianie dawki
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
JP6466417B2 (ja) 2013-05-29 2019-02-06 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 二峰性放出プロファイルを有する改変防止(tamper−resistant)剤形
AU2014273227B2 (en) 2013-05-29 2019-08-15 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
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
KR101890649B1 (ko) * 2013-07-30 2018-09-28 라이온 가부시키가이샤 정제
EP3073994A1 (en) 2013-11-26 2016-10-05 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
JP6443891B2 (ja) * 2014-01-31 2018-12-26 塩野義製薬株式会社 徐放性製剤
EP3142646A1 (en) 2014-05-12 2017-03-22 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
EA201692388A1 (ru) 2014-05-26 2017-05-31 Грюненталь Гмбх Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы
BR112017021475A2 (pt) 2015-04-24 2018-07-10 Gruenenthal Gmbh forma de dosagem resistente à adulteração (tamper) com liberação imediata e resistência contra extração de solvente
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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
JP2008515802A (ja) 2008-05-15
CA2582150A1 (en) 2006-04-13
PL1793809T3 (pl) 2012-12-31
HK1107002A1 (en) 2008-03-28
BRPI0516718A (pt) 2008-09-16
AU2005292185B2 (en) 2010-06-17
BRPI0516718B1 (pt) 2019-05-14
MX2007003919A (es) 2007-09-07
EP1793809B1 (en) 2012-07-11
EP1793809A4 (en) 2010-05-12
WO2006039692A3 (en) 2006-06-15
KR20070064352A (ko) 2007-06-20
IL182144A0 (en) 2007-07-24
IL182144A (en) 2014-01-30
CA2582150C (en) 2014-01-14
US20060068009A1 (en) 2006-03-30
WO2006039692A2 (en) 2006-04-13
AU2005292185A1 (en) 2006-04-13
EP1793809A2 (en) 2007-06-13
NZ554213A (en) 2010-01-29

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Legal Events

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

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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