WO2010003078A3 - Processus de granulation par fusion - Google Patents

Processus de granulation par fusion Download PDF

Info

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

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
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
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
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
US8383152B2 (en) 2008-01-25 2013-02-26 Gruenenthal Gmbh Pharmaceutical dosage form
SI2273983T1 (sl) 2008-05-09 2016-11-30 Gruenenthal Gmbh Postopek za pripravo intermediatne praškaste formulacije in končne trdne odmerne oblike z uporabo stopnje strjevanja z razprševanjem
AU2010275755B2 (en) * 2009-07-22 2014-04-24 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
TW201105316A (en) 2009-07-22 2011-02-16 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
CN102821757B (zh) * 2010-02-03 2016-01-20 格吕伦塔尔有限公司 通过挤出机制备粉末状药物组合物
CN103179954A (zh) 2010-09-02 2013-06-26 格吕伦塔尔有限公司 包含阴离子聚合物的抗破碎剂型
MX2013002377A (es) 2010-09-02 2013-04-29 Gruenenthal Gmbh Forma de dosificacion resistente a manipulacion que comprende una sal inorganica.
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
RS56527B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
MX356421B (es) 2012-02-28 2018-05-29 Gruenenthal Gmbh Forma de dosificacion resistente a la manipulacion indebida que comprende un compuesto farmacologicamente activo y un polimero anionico.
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
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
JP6077713B2 (ja) 2013-05-27 2017-02-08 スティールライフ インディア プライベート リミテッド ホットメルト断片化押出機およびプロセス
BR112015026549A2 (pt) 2013-05-29 2017-07-25 Gruenenthal Gmbh forma de dosagem à prova de violação contendo uma ou mais partículas
CA2913209A1 (fr) 2013-05-29 2014-12-04 Grunenthal Gmbh Forme dosifiee inviolable a profil de liberation bimodale
CA2917136C (fr) 2013-07-12 2022-05-31 Grunenthal Gmbh Forme posologique inviolable contenant un polymere d'ethylene-acetate de vinyle
JP2017505922A (ja) 2013-11-15 2017-02-23 タンジブル サイエンス リミテッド ライアビリティ カンパニー 親水性層を有するコンタクトレンズ
WO2015078891A1 (fr) 2013-11-26 2015-06-04 Farmaceutici Formenti S.P.A. Préparation de composition pharmaceutique en poudre par cryo-broyage
WO2015173195A1 (fr) 2014-05-12 2015-11-19 Grünenthal GmbH Formulation pour capsule à libération immédiate résistant aux manipulations illicites comprenant du tapentadol
MX2016015417A (es) 2014-05-26 2017-02-22 Gruenenthal Gmbh Multiparticulas protegidas contra vertido de dosis etanolico.
EP3229851A4 (fr) 2014-12-09 2018-08-01 Tangible Science LLC Revêtement de dispositif médical avec une couche biocompatible
EP3285745A1 (fr) 2015-04-24 2018-02-28 Grünenthal GmbH Forme galénique inviolable avec libération immédiate et résistance à l'extraction par solvant.
JP2018526414A (ja) 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 乱用抑止性の即放性製剤を用いた経口過剰摂取に対する保護
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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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
US20110092515A1 (en) 2011-04-21
PL2309987T3 (pl) 2013-01-31
CN102076329B (zh) 2013-03-06
KR20110031485A (ko) 2011-03-28
EP2309987A2 (fr) 2011-04-20
BRPI0913843A2 (pt) 2015-10-20
AU2009266833A1 (en) 2010-01-07
MX2010014566A (es) 2011-02-15
WO2010003078A2 (fr) 2010-01-07
JP2011526928A (ja) 2011-10-20
RU2011103651A (ru) 2012-08-10
CA2729596A1 (fr) 2010-01-07
EP2309987B1 (fr) 2012-08-29
CN102076329A (zh) 2011-05-25
ES2393949T3 (es) 2013-01-02
PT2309987E (pt) 2012-12-13
RU2491918C2 (ru) 2013-09-10
AU2009266833B2 (en) 2013-01-31

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