RU2405539C2 - Экструзионный способ приготовления композиций, содержащих плохо прессующиеся лекарственные соединения - Google Patents

Экструзионный способ приготовления композиций, содержащих плохо прессующиеся лекарственные соединения Download PDF

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Publication number
RU2405539C2
RU2405539C2 RU2007145522/15A RU2007145522A RU2405539C2 RU 2405539 C2 RU2405539 C2 RU 2405539C2 RU 2007145522/15 A RU2007145522/15 A RU 2007145522/15A RU 2007145522 A RU2007145522 A RU 2007145522A RU 2405539 C2 RU2405539 C2 RU 2405539C2
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RU
Russia
Prior art keywords
therapeutic compound
mixture
extruder
granules
pharmaceutical composition
Prior art date
Application number
RU2007145522/15A
Other languages
English (en)
Russian (ru)
Other versions
RU2007145522A (ru
Inventor
ВАСАНТАВАДА Мадхав (US)
ВАСАНТАВАДА Мадхав
ЛАКШМАН Джей (US)
ЛАКШМАН Джей
ТОН Вэйцинь (US)
ТОН Вэйцинь
Т. М. СЕРАДЖУДДИН Абу (US)
Т. М. СЕРАДЖУДДИН Абу
ЙОШИ Ятиндра (US)
ЙОШИ Ятиндра
КОВАЛСКИ Джеймс (US)
КОВАЛСКИ Джеймс
Original Assignee
Новартис Аг
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 Новартис Аг filed Critical Новартис Аг
Publication of RU2007145522A publication Critical patent/RU2007145522A/ru
Application granted granted Critical
Publication of RU2405539C2 publication Critical patent/RU2405539C2/ru

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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

Landscapes

  • 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)
RU2007145522/15A 2005-05-10 2006-05-08 Экструзионный способ приготовления композиций, содержащих плохо прессующиеся лекарственные соединения RU2405539C2 (ru)

Applications Claiming Priority (4)

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

Publications (2)

Publication Number Publication Date
RU2007145522A RU2007145522A (ru) 2009-06-20
RU2405539C2 true RU2405539C2 (ru) 2010-12-10

Family

ID=37022916

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2007145522/15A RU2405539C2 (ru) 2005-05-10 2006-05-08 Экструзионный способ приготовления композиций, содержащих плохо прессующиеся лекарственные соединения

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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US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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
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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
WO2022216977A1 (en) 2021-04-07 2022-10-13 Batelle Memorial Institute Rapid design, build, test, and learn technologies for identifying and using non-viral carriers
EP4432861B1 (en) * 2021-11-16 2026-01-28 DSM IP Assets B.V. Granule comprising encapsulated active ingredients
EP4432860A1 (en) * 2021-11-16 2024-09-25 DSM IP Assets B.V. High potency granules obtainable by continuous melt granulation
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
TW202412735A (zh) * 2022-08-31 2024-04-01 義大利商沙克米機械合作伊莫拉公司 製造固體藥劑的方法及裝置
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US5945127A (en) * 1995-03-21 1999-08-31 Basf Aktiengesellschaft Storage-stable drug form
US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
US6318650B1 (en) * 1997-05-22 2001-11-20 Basf Aktiengesellschaft Method for producing small-particle preparations of biologically active substances
WO2002028181A1 (en) * 2000-10-02 2002-04-11 Usv Limited Sustained release pharmaceutical compositions containing metformin and method of its production

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US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
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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
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
JP5400377B2 (ja) 2014-01-29
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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Effective date: 20140509