AU2006244213B2 - Extrusion process for making compositions with poorly compressible therapeutic compounds - Google Patents

Extrusion process for making compositions with poorly compressible therapeutic compounds Download PDF

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Publication number
AU2006244213B2
AU2006244213B2 AU2006244213A AU2006244213A AU2006244213B2 AU 2006244213 B2 AU2006244213 B2 AU 2006244213B2 AU 2006244213 A AU2006244213 A AU 2006244213A AU 2006244213 A AU2006244213 A AU 2006244213A AU 2006244213 B2 AU2006244213 B2 AU 2006244213B2
Authority
AU
Australia
Prior art keywords
therapeutic compound
mixture
granules
extruder
pharmaceutical composition
Prior art date
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.)
Ceased
Application number
AU2006244213A
Other languages
English (en)
Other versions
AU2006244213A1 (en
Inventor
Yatindra Joshi
James Kowalski
Jay Lakshman
Abu T. M. Serajuddin
Wei-Qin Tong
Madhav Vasanthavada
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
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 AU2006244213A1 publication Critical patent/AU2006244213A1/en
Application granted granted Critical
Publication of AU2006244213B2 publication Critical patent/AU2006244213B2/en
Priority to AU2010212296A priority Critical patent/AU2010212296B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
AU2006244213A 2005-05-10 2006-05-08 Extrusion process for making compositions with poorly compressible therapeutic compounds Ceased AU2006244213B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2010212296A AU2010212296B2 (en) 2005-05-10 2010-08-12 Extrusion process for making compositions with poorly compressible therapeutic compounds

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2010212296A Division AU2010212296B2 (en) 2005-05-10 2010-08-12 Extrusion process for making compositions with poorly compressible therapeutic compounds

Publications (2)

Publication Number Publication Date
AU2006244213A1 AU2006244213A1 (en) 2006-11-16
AU2006244213B2 true AU2006244213B2 (en) 2010-05-13

Family

ID=37022916

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2006244213A Ceased AU2006244213B2 (en) 2005-05-10 2006-05-08 Extrusion process for making compositions with poorly compressible therapeutic compounds
AU2010212296A Ceased AU2010212296B2 (en) 2005-05-10 2010-08-12 Extrusion process for making compositions with poorly compressible therapeutic compounds

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2010212296A Ceased AU2010212296B2 (en) 2005-05-10 2010-08-12 Extrusion process for making compositions with poorly compressible therapeutic compounds

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) NZ562304A (enExample)
RU (1) RU2405539C2 (enExample)
TN (1) TNSN07415A1 (enExample)
WO (1) WO2006122021A1 (enExample)

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US7776314B2 (en) 2002-06-17 2010-08-17 Grunenthal Gmbh Abuse-proofed dosage system
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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
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
GB2447898B (en) * 2007-03-24 2011-08-17 Reckitt Benckiser Healthcare A tablet having improved stability with at least two actives
JP5774853B2 (ja) 2008-01-25 2015-09-09 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 医薬投薬形
EP2280681A1 (en) * 2008-04-30 2011-02-09 Novartis AG Continuous process for making pharmaceutical compositions
CA2729596A1 (en) * 2008-07-03 2010-01-07 Novartis Ag Melt granulation process
PL2997965T3 (pl) 2009-07-22 2019-06-28 Grünenthal GmbH Odporna na manipulacje postać dawkowania opioidów wrażliwych na utlenianie
WO2011009602A1 (en) 2009-07-22 2011-01-27 Grünenthal GmbH Hot-melt extruded controlled release dosage form
EP2611426B1 (en) 2010-09-02 2014-06-25 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
ES2487244T3 (es) 2010-09-02 2014-08-20 Grünenthal GmbH Forma de dosificación resistente a la manipulación que comprende un polímero aniónico
CA2839123A1 (en) 2011-07-29 2013-02-07 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
US20130028972A1 (en) 2011-07-29 2013-01-31 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
JP6117249B2 (ja) 2012-02-28 2017-04-19 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 薬理学的に活性な化合物および陰イオン性ポリマーを含むタンパーレジスタント剤形
HRP20181716T1 (hr) 2012-04-18 2018-12-28 Grünenthal GmbH Farmaceutski oblik doziranja otporan na zlonamjernu uporabu i naglo oslobađanje cjelokupne doze
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
WO2014191397A1 (en) 2013-05-29 2014-12-04 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
WO2015004245A1 (en) 2013-07-12 2015-01-15 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
WO2015023675A2 (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
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
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.
AU2015290098B2 (en) 2014-07-17 2018-11-01 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
AU2015336065A1 (en) 2014-10-20 2017-05-04 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
JP2018513872A (ja) 2015-04-24 2018-05-31 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 異なる粒子から２種の薬物の急速放出をもたらすタンパレジスタントな固定用量組合せ
WO2016170094A1 (en) 2015-04-24 2016-10-27 Grünenthal GmbH Tamper-resistant fixed dose combination providing fast release of two drugs from particles
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
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
EP3346991A1 (en) 2015-09-10 2018-07-18 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
WO2022120194A1 (en) 2020-12-03 2022-06-09 Battelle Memorial Institute Polymer nanoparticle and dna nanostructure compositions and methods for non-viral delivery
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WO2023088962A1 (en) * 2021-11-16 2023-05-25 Dsm Ip Assets B.V. Granule comprising encapsulated active ingredients
JP2024543839A (ja) * 2021-11-16 2024-11-26 ディーエスエム アイピー アセッツ ビー．ブイ． 連続溶融造粒により取得できる高い効力の顆粒
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
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Citations (7)

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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
WO2005084666A1 (en) * 2004-03-02 2005-09-15 Abeille Pharmaceuticals, Inc. Co-formulations of kits of bioactive agents
WO2006082099A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste darreichungsformen mit retardierter freisetzung

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Patent Citations (7)

* 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
WO2005084666A1 (en) * 2004-03-02 2005-09-15 Abeille Pharmaceuticals, Inc. Co-formulations of kits of bioactive agents
WO2006082099A1 (de) * 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste darreichungsformen mit retardierter freisetzung

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Also Published As

Publication number Publication date
TNSN07415A1 (en) 2009-03-17
KR20130135403A (ko) 2013-12-10
NZ562304A (en) 2010-06-25
RU2405539C2 (ru) 2010-12-10
IL186456A0 (en) 2008-01-20
RU2007145522A (ru) 2009-06-20
AU2010212296B2 (en) 2011-06-16
AU2010212296A1 (en) 2010-09-02
CA2607624A1 (en) 2006-11-16
JP5400377B2 (ja) 2014-01-29
EP1881819A1 (en) 2008-01-30
US20120077879A1 (en) 2012-03-29
KR20080007357A (ko) 2008-01-18
WO2006122021A1 (en) 2006-11-16
BRPI0608609A2 (pt) 2010-01-19
AU2006244213A1 (en) 2006-11-16
MX2007014041A (es) 2008-02-11
US20100152299A1 (en) 2010-06-17
NO20076298L (no) 2007-12-06
CN102552162A (zh) 2012-07-11
NZ585116A (en) 2011-12-22
JP2008540540A (ja) 2008-11-20
MA29465B1 (fr) 2008-05-02

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