PL2309987T3 - Granulacja metodą stapiania - Google Patents

Granulacja metodą stapiania

Info

Publication number
PL2309987T3
PL2309987T3 PL09774527T PL09774527T PL2309987T3 PL 2309987 T3 PL2309987 T3 PL 2309987T3 PL 09774527 T PL09774527 T PL 09774527T PL 09774527 T PL09774527 T PL 09774527T PL 2309987 T3 PL2309987 T3 PL 2309987T3
Authority
PL
Poland
Prior art keywords
granulation process
melt granulation
melt
granulation
Prior art date
Application number
PL09774527T
Other languages
English (en)
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
Publication of PL2309987T3 publication Critical patent/PL2309987T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K31/4709Non-condensed quinolines and containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets 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)
PL09774527T 2008-07-03 2009-07-02 Granulacja metodą stapiania PL2309987T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13385108P 2008-07-03 2008-07-03
PCT/US2009/049548 WO2010003078A2 (en) 2008-07-03 2009-07-02 Melt granulation process
EP09774527A EP2309987B1 (en) 2008-07-03 2009-07-02 Melt granulation process

Publications (1)

Publication Number Publication Date
PL2309987T3 true PL2309987T3 (pl) 2013-01-31

Family

ID=41328880

Family Applications (1)

Application Number Title Priority Date Filing Date
PL09774527T PL2309987T3 (pl) 2008-07-03 2009-07-02 Granulacja metodą stapiania

Country Status (14)

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

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
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
CA2713128C (en) 2008-01-25 2016-04-05 Gruenenthal Gmbh Pharmaceutical dosage form
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 (zh) 2009-07-22 2015-07-29 格吕伦塔尔有限公司 氧化稳定的抗干扰剂型
KR101738369B1 (ko) 2009-07-22 2017-05-22 그뤼넨탈 게엠베하 핫 멜트 압출된 제어 방출 투여형
ES2606227T3 (es) * 2010-02-03 2017-03-23 Grünenthal GmbH Preparación de una composición farmacéutica en polvo mediante una extrusora
TWI516286B (zh) 2010-09-02 2016-01-11 歌林達股份有限公司 含陰離子聚合物之抗破碎劑型
BR112013005194A2 (pt) 2010-09-02 2016-05-03 Gruenenthal Gmbh forma de dosagem resistente à violação compreendendo sal inorgânico
EA201400172A1 (ru) 2011-07-29 2014-06-30 Грюненталь Гмбх Устойчивая к разрушению таблетка, которая обеспечивает немедленное высвобождение лекарственного средства
BR112014001091A2 (pt) 2011-07-29 2017-02-14 Gruenenthal Gmbh comprimido resistente à adulteração que fornece liberação imediata do fármaco
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.
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
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
WO2014192026A2 (en) * 2013-05-27 2014-12-04 Steer Engineering Private Limited A hot melt fragmentation extruder and process
EP3003279A1 (en) 2013-05-29 2016-04-13 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
BR112016000194A8 (pt) 2013-07-12 2019-12-31 Gruenenthal Gmbh forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila
AU2014348502B2 (en) 2013-11-15 2019-08-15 Tangible Science, Inc. Contact lens with a hydrophilic layer
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 (ru) 2014-05-26 2017-05-31 Грюненталь Гмбх Лекарственная форма в виде множества частиц, защищенная от вызываемого этанолом сброса дозы
CN107206119B (zh) 2014-12-09 2021-01-29 实体科学公司 具有生物相容性层的医疗设备涂层
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
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

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
DE19504832A1 (de) * 1995-02-14 1996-08-22 Basf Ag Feste Wirkstoff-Zubereitungen
HN1998000115A (es) * 1997-08-21 1999-06-02 Warner Lambert Co Formas de dosificación farmacéuticas sólidas
EP1718306A2 (en) * 2004-02-20 2006-11-08 Chiron Corporation Modulation of inflammatory and metastatic processes
NZ562304A (en) * 2005-05-10 2010-06-25 Novartis Ag Extrusion process for making compositions with poorly compressible therapeutic compounds e.g. metformin hydrochloride
CN101166517B (zh) * 2005-05-10 2012-01-04 诺瓦提斯公司 制备含有可压性差的治疗性化合物的组合物的挤压方法
BRPI0611375A2 (pt) * 2005-05-23 2010-08-31 Novartis Ag formas cristalinas e outras de sais de ácido láctico de 4-amino-5-flúor-3-[6-(4-metilpiperazin-1-il)-1h-benzimid azol-2-il]-1h-quinolin-2-ona
NZ567550A (en) * 2005-11-29 2011-08-26 Novartis Ag Formulations of lactic acid salts of 4-amino-5-fluoro-3-[6-(4-methyl-piperazin-1-yl)-1 H-benzimidazol-2-yl]1H-quinolin-2-one
CN101316593B (zh) * 2005-11-29 2012-05-02 诺瓦提斯公司 喹啉酮类的制剂

Also Published As

Publication number Publication date
JP2011526928A (ja) 2011-10-20
CA2729596A1 (en) 2010-01-07
CN102076329B (zh) 2013-03-06
US20110092515A1 (en) 2011-04-21
AU2009266833B2 (en) 2013-01-31
WO2010003078A3 (en) 2010-05-27
EP2309987B1 (en) 2012-08-29
PT2309987E (pt) 2012-12-13
RU2491918C2 (ru) 2013-09-10
EP2309987A2 (en) 2011-04-20
RU2011103651A (ru) 2012-08-10
MX2010014566A (es) 2011-02-15
ES2393949T3 (es) 2013-01-02
KR20110031485A (ko) 2011-03-28
BRPI0913843A2 (pt) 2015-10-20
CN102076329A (zh) 2011-05-25
AU2009266833A1 (en) 2010-01-07
WO2010003078A2 (en) 2010-01-07

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