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

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

Info

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
Authority
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

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
    • 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 (enExample)
EP (1) EP1881819A1 (enExample)
JP (1) JP5400377B2 (enExample)
KR (2) KR20080007357A (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)

Families Citing this family (48)

* 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
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
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
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
EP2249811A1 (en) 2008-01-25 2010-11-17 Grünenthal GmbH Pharmaceutical dosage form
RU2010148536A (ru) * 2008-04-30 2012-06-10 Новартис АГ (CH) Способ непрерывного изготовления фармацевтических композиций
MX2010014566A (es) * 2008-07-03 2011-02-15 Novartis Ag Proceso de granulacion de fundido.
AR077493A1 (es) 2009-07-22 2011-08-31 Gruenenthal Gmbh Composicion farmaceutica extruida en caliente con liberacion controlada. procedimiento de preparacion
SI2456424T1 (sl) 2009-07-22 2013-10-30 Gruenenthal Gmbh Oksidacijsko stabilizirana odmerna oblika, varna pred zlorabo
PL2611425T3 (pl) 2010-09-02 2014-09-30 Gruenenthal Gmbh Odporna na ingerencję postać dawki zawierająca polimer anionowy
MX2013002377A (es) 2010-09-02 2013-04-29 Gruenenthal Gmbh Forma de dosificacion resistente a manipulacion que comprende una sal inorganica.
JP2014524925A (ja) 2011-07-29 2014-09-25 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
EP2736497B1 (en) 2011-07-29 2017-08-23 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
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.
AR090695A1 (es) 2012-04-18 2014-12-03 Gruenenthal Gmbh Forma de dosificacion farmaceutica resistente a la adulteracion y resistente a la liberacion inmediata de la dosis
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
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
MX371432B (es) 2013-05-29 2020-01-30 Gruenenthal Gmbh Forma de dosificacion resistente al uso indebido que contiene una o mas particulas.
EA032465B1 (ru) 2013-07-12 2019-05-31 Грюненталь Гмбх Защищенная от применения не по назначению пероральная фармацевтическая лекарственная форма, содержащая этиленвинилацетатный полимер, и способ ее изготовления
CA2919892C (en) 2013-08-12 2019-06-18 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
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
MX2016014738A (es) 2014-05-12 2017-03-06 Gruenenthal Gmbh Formulacion en capsula de liberacion inmediata resistente a alteraciones que comprende tapentadol.
MX2016015417A (es) 2014-05-26 2017-02-22 Gruenenthal Gmbh Multiparticulas protegidas contra vertido de dosis etanolico.
DK3169315T3 (da) 2014-07-17 2020-08-10 Pharmaceutical Manufacturing Res Services In Væskefyldt doseringsform til forhindring af misbrug med øjeblikkelig frigivelse
JP2017531026A (ja) 2014-10-20 2017-10-19 ファーマシューティカル マニュファクチュアリング リサーチ サービシズ,インコーポレーテッド 徐放性乱用抑止性液体充填剤形
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
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
EA035434B1 (ru) 2015-04-24 2020-06-15 Грюненталь Гмбх Защищенная от применения не по назначению лекарственная форма с немедленным высвобождением и устойчивостью к экстракции растворителями
BR112017022846A2 (pt) 2015-04-24 2018-07-17 Gruenenthal Gmbh combinação de dose fixa inviolável que proporciona rápida liberação de dois fármacos de partículas diferentes
WO2017042325A1 (en) 2015-09-10 2017-03-16 Grünenthal 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
AU2021391823A1 (en) 2020-12-03 2023-06-29 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
IL307454A (en) 2021-04-07 2023-12-01 Battelle Memorial Institute Technologies for rapid design, construction, testing, learning to identify and use non-viral vectors
CN118234388A (zh) * 2021-11-16 2024-06-21 帝斯曼知识产权资产管理有限公司 可通过连续熔融造粒获得的高效力颗粒
EP4432861A1 (en) * 2021-11-16 2024-09-25 DSM IP Assets B.V. Granule comprising encapsulated active ingredients
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
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
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
WO2025072751A1 (en) 2023-09-29 2025-04-03 Battelle Memorial Institute Polymer nanoparticle compositions for in vivo expression of polypeptides
WO2025122954A1 (en) 2023-12-08 2025-06-12 Battelle Memorial Institute Use of dna origami nanostructures for molecular information based data storage systems

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19504832A1 (de) * 1995-02-14 1996-08-22 Basf Ag Feste Wirkstoff-Zubereitungen
DE19504831A1 (de) * 1995-02-14 1996-09-05 Basf Ag Feste Wirkstoffzubereitungen enthaltend Hydroxypropylcellulose
HN1998000115A (es) * 1997-08-21 1999-06-02 Warner Lambert Co Formas de dosificación farmacéuticas sólidas
DE19934610A1 (de) * 1999-07-23 2001-01-25 Bayer Ag Schnellfreisetzende Extrudate und Verfahren zu ihrer Herstellung sowie daraus erhältliche Zubereitungen
WO2003004009A1 (en) * 2001-07-02 2003-01-16 Geneva Pharmaceuticals, Inc. Pharmaceutical composition
IN192180B (enExample) * 2001-09-28 2004-03-06 Ranbaxy Lab
RU2004108219A (ru) * 2001-09-28 2005-03-10 Сан Фармасьютикл Индастриз Лимитид (In) Лекарственная форма для лечения сахарного диабета
FR2858556B1 (fr) * 2003-08-06 2006-03-10 Galenix Innovations Composition pharmaceutique solide dispersible et/ou orodispersible non pelliculee contenant au moins le principe actif metformine, et procede de preparation
DE102005005446A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US20070098778A1 (en) * 2004-03-02 2007-05-03 Abeille Pharmaceuticals, Inc. Co-formulations or kits of bioactive agents
JOP20180109A1 (ar) * 2005-09-29 2019-01-30 Novartis Ag تركيبة جديدة
EP1968553A2 (en) * 2005-11-09 2008-09-17 Novartis AG Process for making pharmaceutical compositions with a transient plasticizer

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5160680A (en) * 1984-10-03 1992-11-03 Roquette Freres Method for the preparation of directly compressible granular manitol
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
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BRABANDER DE C ET AL: "MATRIX MINI-TABLETS BASED ON STARCH/MICROCRYSTALLINE WAX MIXTURES", INTERNATIONAL JOURNAL OF PHARMACEUTICS, AMSTERDAM, NL, vol.199, no.2, 20 April 2000 (2000-04-20), pages 195-203, XP001146289, ISSN: 0378-5173, abstract. *
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
CN102552162A (zh) 2012-07-11
AU2010212296A1 (en) 2010-09-02
EP1881819A1 (en) 2008-01-30
JP2008540540A (ja) 2008-11-20
MA29465B1 (fr) 2008-05-02
IL186456A0 (en) 2008-01-20
JP5400377B2 (ja) 2014-01-29
KR20130135403A (ko) 2013-12-10
US20100152299A1 (en) 2010-06-17
AU2006244213B2 (en) 2010-05-13
KR20080007357A (ko) 2008-01-18
NZ585116A (en) 2011-12-22
US20120077879A1 (en) 2012-03-29
AU2006244213A1 (en) 2006-11-16
CA2607624A1 (en) 2006-11-16
AU2010212296B2 (en) 2011-06-16
TNSN07415A1 (en) 2009-03-17
WO2006122021A1 (en) 2006-11-16
BRPI0608609A2 (pt) 2010-01-19
MX2007014041A (es) 2008-02-11
NZ562304A (en) 2010-06-25
NO20076298L (no) 2007-12-06
RU2007145522A (ru) 2009-06-20

Similar Documents

Publication Publication Date Title
RU2405539C2 (ru) Экструзионный способ приготовления композиций, содержащих плохо прессующиеся лекарственные соединения
EP2309987B1 (en) Melt granulation process
US12178912B2 (en) Twin-screw dry granulation for producing solid formulations
JP2519296B2 (ja) イブプロフェン除放性錠剤及びその製造方法
US20110071137A1 (en) Process for preparing sustained release tablets
WO2006122022A2 (en) Modified release famciclovir pharmaceutical compositions
CN101166517B (zh) 制备含有可压性差的治疗性化合物的组合物的挤压方法
AU2011224098B2 (en) Extrusion process for making compositions with poorly compressible therapeutic compounds

Legal Events

Date Code Title Description
MM4A The patent is invalid due to non-payment of fees

Effective date: 20140509