WO2010003078A3 - Processus de granulation par fusion - Google Patents

Processus de granulation par fusion Download PDF

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Publication number
WO2010003078A3
WO2010003078A3 PCT/US2009/049548 US2009049548W WO2010003078A3 WO 2010003078 A3 WO2010003078 A3 WO 2010003078A3 US 2009049548 W US2009049548 W US 2009049548W WO 2010003078 A3 WO2010003078 A3 WO 2010003078A3
Authority
WO
WIPO (PCT)
Prior art keywords
granulation process
melt granulation
quinoline compound
extruder
contain
Prior art date
Application number
PCT/US2009/049548
Other languages
English (en)
Other versions
WO2010003078A2 (fr
Inventor
Zhihui Qiu
Shoufeng Li
Daniel Eliot Benjamin
Original Assignee
Novartis Ag
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 Novartis Ag filed Critical Novartis Ag
Priority to MX2010014566A priority Critical patent/MX2010014566A/es
Priority to RU2011103651/15A priority patent/RU2491918C2/ru
Priority to BRPI0913843A priority patent/BRPI0913843A2/pt
Priority to EP09774527A priority patent/EP2309987B1/fr
Priority to PL09774527T priority patent/PL2309987T3/pl
Priority to CA2729596A priority patent/CA2729596A1/fr
Priority to ES09774527T priority patent/ES2393949T3/es
Priority to US13/000,044 priority patent/US20110092515A1/en
Priority to AU2009266833A priority patent/AU2009266833B2/en
Priority to JP2011516879A priority patent/JP2011526928A/ja
Priority to CN200980125276XA priority patent/CN102076329B/zh
Publication of WO2010003078A2 publication Critical patent/WO2010003078A2/fr
Publication of WO2010003078A3 publication Critical patent/WO2010003078A3/fr

Links

Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L’invention concerne un processus de préparation de formes pharmaceutiques solides contenant un composé de quinoléine. Le processus, par exemple, fournit l’utilisation inventive d’une extrudeuse, en particulier d’une extrudeuse à double vis, pour granuler par fusion le composé de quinoléine avec un excipient de granulation.
PCT/US2009/049548 2008-07-03 2009-07-02 Processus de granulation par fusion WO2010003078A2 (fr)

Priority Applications (11)

Application Number Priority Date Filing Date Title
MX2010014566A MX2010014566A (es) 2008-07-03 2009-07-02 Proceso de granulacion de fundido.
RU2011103651/15A RU2491918C2 (ru) 2008-07-03 2009-07-02 Способ грануляции из расплава
BRPI0913843A BRPI0913843A2 (pt) 2008-07-03 2009-07-02 processo de granulação por fusão
EP09774527A EP2309987B1 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion
PL09774527T PL2309987T3 (pl) 2008-07-03 2009-07-02 Granulacja metodą stapiania
CA2729596A CA2729596A1 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion
ES09774527T ES2393949T3 (es) 2008-07-03 2009-07-02 Proceso de granulación en estado fundido
US13/000,044 US20110092515A1 (en) 2008-07-03 2009-07-02 Melt granulation process
AU2009266833A AU2009266833B2 (en) 2008-07-03 2009-07-02 Melt granulation process
JP2011516879A JP2011526928A (ja) 2008-07-03 2009-07-02 溶融造粒方法
CN200980125276XA CN102076329B (zh) 2008-07-03 2009-07-02 熔融制粒法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13385108P 2008-07-03 2008-07-03
US61/133,851 2008-07-03

Publications (2)

Publication Number Publication Date
WO2010003078A2 WO2010003078A2 (fr) 2010-01-07
WO2010003078A3 true WO2010003078A3 (fr) 2010-05-27

Family

ID=41328880

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/049548 WO2010003078A2 (fr) 2008-07-03 2009-07-02 Processus de granulation par fusion

Country Status (14)

Country Link
US (1) US20110092515A1 (fr)
EP (1) EP2309987B1 (fr)
JP (1) JP2011526928A (fr)
KR (1) KR20110031485A (fr)
CN (1) CN102076329B (fr)
AU (1) AU2009266833B2 (fr)
BR (1) BRPI0913843A2 (fr)
CA (1) CA2729596A1 (fr)
ES (1) ES2393949T3 (fr)
MX (1) MX2010014566A (fr)
PL (1) PL2309987T3 (fr)
PT (1) PT2309987E (fr)
RU (1) RU2491918C2 (fr)
WO (1) WO2010003078A2 (fr)

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US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
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
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
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
KR101616246B1 (ko) 2008-01-25 2016-05-02 그뤼넨탈 게엠베하 약제학적 투여형
PL2273983T3 (pl) 2008-05-09 2017-01-31 Grünenthal GmbH Sposób wytwarzania pośredniego preparatu proszkowego i końcowej stałej postaci dawkowania z zastosowaniem etapu zestalania rozpyłowego
WO2011009604A1 (fr) 2009-07-22 2011-01-27 Grünenthal GmbH Forme galénique inviolable stabilisée à l’oxydation
JP5667183B2 (ja) 2009-07-22 2015-02-12 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 加熱溶融押出成型した制御放出性投与剤型
EP2531176B1 (fr) * 2010-02-03 2016-09-07 Grünenthal GmbH Préparation de composition pharmaceutique en poudre au moyen d'une extrudeuse
BR112013005194A2 (pt) 2010-09-02 2016-05-03 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo sal inorgânico
ES2487244T3 (es) 2010-09-02 2014-08-20 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende un polímero aniónico
MX348491B (es) 2011-07-29 2017-06-15 Gruenenthal Gmbh Tableta a prueba de manipulacion que proporciona liberacion inmediata de fármaco.
MX348054B (es) 2011-07-29 2017-05-25 Gruenenthal Gmbh Tableta a prueba de alteracion que proporciona liberacion inmediata del farmaco.
BR112014019988A8 (pt) 2012-02-28 2017-07-11 Gruenenthal Gmbh Forma de dosagem resistente a socamento compreendendo um composto farmacologicamente ativo e um polímero aniônico
TR201815502T4 (tr) 2012-04-18 2018-11-21 Gruenenthal Gmbh Kurcalama veya dirençli ve doz boşalımına dirençli farmasötik dozaj formu.
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
GB2502080A (en) * 2012-05-15 2013-11-20 Univ Bradford Preparation of metastable polymorphs of active pharmaceutical ingredients
US9395468B2 (en) 2012-08-27 2016-07-19 Ocular Dynamics, Llc Contact lens with a hydrophilic layer
HUE048041T2 (hu) 2013-05-27 2020-05-28 Steerlife India Private Ltd Forró olvadék-fragmentációs extruder és eljárás
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
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
EA032465B1 (ru) 2013-07-12 2019-05-31 Грюненталь Гмбх Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая этиленвинилацетатный полимер, и способ ее изготовления
EP3988992A1 (fr) 2013-11-15 2022-04-27 Tangible Science, Inc. Lentille de contact avec couche hydrophile
WO2015078891A1 (fr) 2013-11-26 2015-06-04 Farmaceutici Formenti S.P.A. Préparation de composition pharmaceutique en poudre par cryo-broyage
CA2947786A1 (fr) 2014-05-12 2015-11-19 Grunenthal Gmbh Formulation pour capsule a liberation immediate resistant aux manipulations illicites comprenant du tapentadol
CA2949422A1 (fr) 2014-05-26 2015-12-03 Grunenthal Gmbh Microparticules protegees contre une liberation massive dans l'ethanol
WO2016094533A1 (fr) 2014-12-09 2016-06-16 Ocular Dynamics, Llc Revêtement de dispositif médical avec une couche biocompatible
JP2018517676A (ja) 2015-04-24 2018-07-05 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 即時放出および溶媒抽出に対する耐性を有する改変防止製剤
EP3346991A1 (fr) 2015-09-10 2018-07-18 Grünenthal GmbH Protection contre un surdosage par voie orale à l'aide de formulations à libération immédiate dissuasives d'abus
US10342886B2 (en) 2016-01-26 2019-07-09 S.C. Johnson & Son, Inc. Extruded wax melt and method of producing same
US10010638B2 (en) 2016-06-14 2018-07-03 S. C. Johnson & Son, Inc. Wax melt with filler
KR102530612B1 (ko) * 2020-08-21 2023-05-09 한국휴텍스제약 주식회사 자가과립화 기법을 이용한 딜티아젬 서방정 조성물의 제조방법

Citations (2)

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US20010036476A1 (en) * 1994-11-04 2001-11-01 Euro-Celtique S.A. Melt-extruded orally administrable opioid formulations
WO2007064719A2 (fr) * 2005-11-29 2007-06-07 Novartis Ag Formulations de quinolinones

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Patent Citations (2)

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US20010036476A1 (en) * 1994-11-04 2001-11-01 Euro-Celtique S.A. Melt-extruded orally administrable opioid formulations
WO2007064719A2 (fr) * 2005-11-29 2007-06-07 Novartis Ag Formulations de quinolinones

Also Published As

Publication number Publication date
CN102076329B (zh) 2013-03-06
WO2010003078A2 (fr) 2010-01-07
ES2393949T3 (es) 2013-01-02
AU2009266833A1 (en) 2010-01-07
CA2729596A1 (fr) 2010-01-07
US20110092515A1 (en) 2011-04-21
BRPI0913843A2 (pt) 2015-10-20
RU2011103651A (ru) 2012-08-10
KR20110031485A (ko) 2011-03-28
JP2011526928A (ja) 2011-10-20
AU2009266833B2 (en) 2013-01-31
PT2309987E (pt) 2012-12-13
RU2491918C2 (ru) 2013-09-10
EP2309987B1 (fr) 2012-08-29
CN102076329A (zh) 2011-05-25
PL2309987T3 (pl) 2013-01-31
EP2309987A2 (fr) 2011-04-20
MX2010014566A (es) 2011-02-15

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