JP5400377B2 - 圧縮性に乏しい治療用化合物を有する組成物の製造法 - Google Patents

圧縮性に乏しい治療用化合物を有する組成物の製造法 Download PDF

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Publication number
JP5400377B2
JP5400377B2 JP2008511233A JP2008511233A JP5400377B2 JP 5400377 B2 JP5400377 B2 JP 5400377B2 JP 2008511233 A JP2008511233 A JP 2008511233A JP 2008511233 A JP2008511233 A JP 2008511233A JP 5400377 B2 JP5400377 B2 JP 5400377B2
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Prior art keywords
polymer
mixture
metformin hydrochloride
extruder
granules
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Legal status (The legal status 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 status listed.)
Expired - Fee Related
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JP2008511233A
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English (en)
Japanese (ja)
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JP2008540540A5 (enExample
JP2008540540A (ja
Inventor
マダヴ・ヴァサンタヴァダ
ジェイ・ラクシュマン
ウェイ−キン・トン
アブ・ティ・エム・セラジュディン
ヤティンドラ・ジョシ
ジェイムズ・コワルスキー
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ノバルティス アーゲー
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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
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K9/14—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2008511233A 2005-05-10 2006-05-08 圧縮性に乏しい治療用化合物を有する組成物の製造法 Expired - Fee Related JP5400377B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US67958705P 2005-05-10 2005-05-10
US60/679,587 2005-05-10
US69315505P 2005-06-23 2005-06-23
US60/693,155 2005-06-23
PCT/US2006/017708 WO2006122021A1 (en) 2005-05-10 2006-05-08 Extrusion process for making compositions with poorly compressible therapeutic compounds

Publications (3)

Publication Number Publication Date
JP2008540540A JP2008540540A (ja) 2008-11-20
JP2008540540A5 JP2008540540A5 (enExample) 2009-07-02
JP5400377B2 true JP5400377B2 (ja) 2014-01-29

Family

ID=37022916

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2008511233A Expired - Fee Related JP5400377B2 (ja) 2005-05-10 2006-05-08 圧縮性に乏しい治療用化合物を有する組成物の製造法

Country Status (16)

Country Link
US (2) US20100152299A1 (enExample)
EP (1) EP1881819A1 (enExample)
JP (1) JP5400377B2 (enExample)
KR (2) KR20130135403A (enExample)
CN (1) CN102552162A (enExample)
AU (2) AU2006244213B2 (enExample)
BR (1) BRPI0608609A2 (enExample)
CA (1) CA2607624A1 (enExample)
IL (1) IL186456A0 (enExample)
MA (1) MA29465B1 (enExample)
MX (1) MX2007014041A (enExample)
NO (1) NO20076298L (enExample)
NZ (2) NZ585116A (enExample)
RU (1) RU2405539C2 (enExample)
TN (1) TNSN07415A1 (enExample)
WO (1) WO2006122021A1 (enExample)

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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
GB2447898B (en) * 2007-03-24 2011-08-17 Reckitt Benckiser Healthcare A tablet having improved stability with at least two actives
TWI454288B (zh) 2008-01-25 2014-10-01 Gruenenthal Chemie 藥物劑型
BRPI0910545A2 (pt) * 2008-04-30 2015-09-29 Novartis Ag processo contínuo para fazer composições farmacêuticas
PT2309987E (pt) * 2008-07-03 2012-12-13 Novartis Ag Processo para granulação por fusão
ES2534908T3 (es) 2009-07-22 2015-04-30 Grünenthal GmbH Forma de dosificación de liberación controlada extruida por fusión en caliente
BR112012001466A2 (pt) 2009-07-22 2020-08-11 Grünenthal GmbH forma de dosagem resistente à falsificação para opioides sensíveis à oxidação, seu processo de fabricação, e embalagem
WO2012028318A1 (en) 2010-09-02 2012-03-08 Grünenthal GmbH Tamper resistant dosage form comprising an anionic polymer
CA2808219C (en) 2010-09-02 2019-05-14 Gruenenthal Gmbh Tamper resistant dosage form comprising inorganic salt
JP6063462B2 (ja) 2011-07-29 2017-01-18 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 即時薬剤放出を提供するタンパーレジスタント錠剤
BR112014002022A2 (pt) 2011-07-29 2017-02-21 Gruenenthal Gmbh comprimido resistente à violação proporcionando liberação de fármaco imediata
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
LT2838512T (lt) 2012-04-18 2018-11-12 Grünenthal GmbH Pažeidimui atspari ir dozės atpalaidavimo nuokrypiui atspari farmacinė vaisto forma
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
GB201218012D0 (en) * 2012-10-08 2012-11-21 Jagotec Ag Dosage forms
AU2014273227B2 (en) 2013-05-29 2019-08-15 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
MX2015016254A (es) 2013-05-29 2016-04-20 Gruenenthal Gmbh Forma de dosificacion resistente al uso indebido con perfil de liberacion bimodal.
AU2014289187B2 (en) 2013-07-12 2019-07-11 Grunenthal Gmbh Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
HK1224189A1 (zh) 2013-11-26 2017-08-18 Grünenthal GmbH 通过低温研磨制备粉状药物组合物
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015095391A1 (en) 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
WO2015173195A1 (en) 2014-05-12 2015-11-19 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
WO2016170093A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant fixed dose combination providing fast release of two drugs from particles and a matrix
WO2016170097A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US20160310428A1 (en) 2015-04-24 2016-10-27 Grunenthal Gmbh Tamper-resistant fixed dose combination providing fast release of two drugs from different particles
BR112017022856A2 (pt) 2015-04-24 2018-07-17 Gruenenthal Gmbh combinação de dose fixa inviolável que proporciona rápida liberação de duas drogas a partir de partículas
CA2998259A1 (en) 2015-09-10 2017-03-16 Grunenthal Gmbh Protecting oral overdose with abuse deterrent immediate release formulations
DE102018010063A1 (de) 2018-03-16 2019-09-19 Ludwig-Maximilians-Universität München Herstellung vesikulärer Phospholipid-Gele durch Schnecken-Extrusion
CN108888599B (zh) * 2018-07-26 2021-06-08 国药集团致君(深圳)制药有限公司 双氯芬酸钠缓释组合物及其制备方法
IL303390A (en) 2020-12-03 2023-08-01 Battelle Memorial Institute Compositions of polymer nanoparticles and DNA nanostructures and methods for non-viral transport
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WO2023145871A1 (ja) * 2022-01-31 2023-08-03 住友精化株式会社 製剤用組成物の製造方法及び製剤の製造方法
WO2023145869A1 (ja) * 2022-01-31 2023-08-03 住友精化株式会社 製剤用組成物の製造方法及び製剤の製造方法
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Also Published As

Publication number Publication date
WO2006122021A1 (en) 2006-11-16
NZ562304A (en) 2010-06-25
EP1881819A1 (en) 2008-01-30
MA29465B1 (fr) 2008-05-02
BRPI0608609A2 (pt) 2010-01-19
RU2405539C2 (ru) 2010-12-10
CN102552162A (zh) 2012-07-11
RU2007145522A (ru) 2009-06-20
AU2006244213B2 (en) 2010-05-13
IL186456A0 (en) 2008-01-20
AU2006244213A1 (en) 2006-11-16
AU2010212296A1 (en) 2010-09-02
US20100152299A1 (en) 2010-06-17
CA2607624A1 (en) 2006-11-16
TNSN07415A1 (en) 2009-03-17
KR20130135403A (ko) 2013-12-10
NZ585116A (en) 2011-12-22
KR20080007357A (ko) 2008-01-18
AU2010212296B2 (en) 2011-06-16
NO20076298L (no) 2007-12-06
US20120077879A1 (en) 2012-03-29
JP2008540540A (ja) 2008-11-20
MX2007014041A (es) 2008-02-11

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