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
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RU2007145522/15A
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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
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Application filed by Новартис Аг filed Critical Новартис Аг
Publication of RU2007145522A publication Critical patent/RU2007145522A/ru
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Publication of RU2405539C2 publication Critical patent/RU2405539C2/ru

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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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K9/14Particulate 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs 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 (https=)
EP (1) EP1881819A1 (https=)
JP (1) JP5400377B2 (https=)
KR (2) KR20080007357A (https=)
CN (1) CN102552162A (https=)
AU (2) AU2006244213B2 (https=)
BR (1) BRPI0608609A2 (https=)
CA (1) CA2607624A1 (https=)
IL (1) IL186456A0 (https=)
MA (1) MA29465B1 (https=)
MX (1) MX2007014041A (https=)
NO (1) NO20076298L (https=)
NZ (2) NZ562304A (https=)
RU (1) RU2405539C2 (https=)
TN (1) TNSN07415A1 (https=)
WO (1) WO2006122021A1 (https=)

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US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
DE102004032049A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
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US20130225697A1 (en) 2012-02-28 2013-08-29 Grunenthal Gmbh Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
PL2838512T3 (pl) 2012-04-18 2018-12-31 Grünenthal GmbH Farmaceutyczna postać dawkowania odporna na niewłaściwe użycie i odporna na uderzeniowe uwalnianie dawki
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
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AU2014273227B2 (en) 2013-05-29 2019-08-15 Grunenthal 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
JP6449871B2 (ja) 2013-07-12 2019-01-09 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 エチレン−酢酸ビニルポリマーを含有する改変防止剤形
CA3042642A1 (en) 2013-08-12 2015-02-19 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
EP3073994A1 (en) 2013-11-26 2016-10-05 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP3142646A1 (en) 2014-05-12 2017-03-22 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
CA2955229C (en) 2014-07-17 2020-03-10 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
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CA2983640A1 (en) 2015-04-24 2016-10-27 Grunenthal Gmbh Tamper-resistant fixed dose combination providing fast release of two drugs from different particles
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BR112017021475A2 (pt) 2015-04-24 2018-07-10 Gruenenthal Gmbh forma de dosagem resistente à adulteração (tamper) com liberação imediata e resistência contra extração de solvente
MX2017013643A (es) 2015-04-24 2018-03-08 Gruenenthal Gmbh Combinacion de dosis fija resistente a la manipulacion que proporciona una liberacion rapida de dos farmacos desde particulas y una matriz.
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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
CN116887866A (zh) 2020-12-03 2023-10-13 巴特尔纪念研究院 聚合物纳米颗粒和dna纳米结构组合物及用于非病毒递送的方法
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
WO2023088962A1 (en) * 2021-11-16 2023-05-25 Dsm Ip Assets B.V. Granule comprising encapsulated active ingredients
US20250009005A1 (en) * 2021-11-16 2025-01-09 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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US5160680A (en) * 1984-10-03 1992-11-03 Roquette Freres Method for the preparation of directly compressible granular manitol
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
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US5965161A (en) * 1994-11-04 1999-10-12 Euro-Celtique, S.A. Extruded multi-particulates
US5945127A (en) * 1995-03-21 1999-08-31 Basf Aktiengesellschaft Storage-stable drug form
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KELEB E I; VERMEIRE A; VERVAET C; REMON JEAN PAUL: "Extrusion granulation and high shear granulation of different grades of lactose and highly dosed drugs: a comparative study", DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, vol.30, no.6, 2004, pages 679-691, XP008069495, abstract. *

Also Published As

Publication number Publication date
EP1881819A1 (en) 2008-01-30
MA29465B1 (fr) 2008-05-02
AU2006244213A1 (en) 2006-11-16
JP2008540540A (ja) 2008-11-20
WO2006122021A1 (en) 2006-11-16
TNSN07415A1 (en) 2009-03-17
IL186456A0 (en) 2008-01-20
KR20080007357A (ko) 2008-01-18
CN102552162A (zh) 2012-07-11
KR20130135403A (ko) 2013-12-10
US20120077879A1 (en) 2012-03-29
US20100152299A1 (en) 2010-06-17
AU2010212296B2 (en) 2011-06-16
AU2006244213B2 (en) 2010-05-13
CA2607624A1 (en) 2006-11-16
MX2007014041A (es) 2008-02-11
NO20076298L (no) 2007-12-06
NZ585116A (en) 2011-12-22
BRPI0608609A2 (pt) 2010-01-19
NZ562304A (en) 2010-06-25
RU2007145522A (ru) 2009-06-20
JP5400377B2 (ja) 2014-01-29
AU2010212296A1 (en) 2010-09-02

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Effective date: 20140509