JP2012503665A - アリスキレンを含むガレヌス製剤および溶融押出し造粒によるその調製方法 - Google Patents

アリスキレンを含むガレヌス製剤および溶融押出し造粒によるその調製方法 Download PDF

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Publication number
JP2012503665A
JP2012503665A JP2011529177A JP2011529177A JP2012503665A JP 2012503665 A JP2012503665 A JP 2012503665A JP 2011529177 A JP2011529177 A JP 2011529177A JP 2011529177 A JP2011529177 A JP 2011529177A JP 2012503665 A JP2012503665 A JP 2012503665A
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JP
Japan
Prior art keywords
dosage form
oral dosage
solid oral
aliskiren
pharmaceutically acceptable
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Pending
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JP2011529177A
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English (en)
Japanese (ja)
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JP2012503665A5 (enExample
Inventor
ゴシュ，インドラジト
コワルスキ，ジェームズ
スナイダー，ジェニファー
トン，ウエィ−キン
ビッパグンタ，スダ
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ノバルティス アーゲー
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Publication of JP2012503665A publication Critical patent/JP2012503665A/ja
Publication of JP2012503665A5 publication Critical patent/JP2012503665A5/ja
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    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Psychiatry (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2011529177A 2008-09-24 2009-09-23 アリスキレンを含むガレヌス製剤および溶融押出し造粒によるその調製方法 Pending JP2012503665A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US9959508P 2008-09-24 2008-09-24
US61/099,595 2008-09-24
US16179909P 2009-03-20 2009-03-20
US61/161,799 2009-03-20
PCT/US2009/057993 WO2010036686A1 (en) 2008-09-24 2009-09-23 Galenical formulation comprising aliskiren and process for its preparation by melt extrusion granulation

Publications (2)

Publication Number Publication Date
JP2012503665A true JP2012503665A (ja) 2012-02-09
JP2012503665A5 JP2012503665A5 (enExample) 2012-11-08

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011529177A Pending JP2012503665A (ja) 2008-09-24 2009-09-23 アリスキレンを含むガレヌス製剤および溶融押出し造粒によるその調製方法

Country Status (19)

Country Link
US (1) US20110177166A1 (enExample)
EP (1) EP2328562A1 (enExample)
JP (1) JP2012503665A (enExample)
KR (1) KR20110063684A (enExample)
CN (1) CN102164584A (enExample)
AR (1) AR073651A1 (enExample)
AU (1) AU2009296718A1 (enExample)
BR (1) BRPI0919077A2 (enExample)
CA (1) CA2736259A1 (enExample)
CL (1) CL2011000614A1 (enExample)
CO (1) CO6351712A2 (enExample)
EC (1) ECSP11010998A (enExample)
MA (1) MA32722B1 (enExample)
MX (1) MX2011003077A (enExample)
PE (1) PE20110925A1 (enExample)
RU (1) RU2011116122A (enExample)
TW (1) TW201016210A (enExample)
WO (1) WO2010036686A1 (enExample)
ZA (1) ZA201101686B (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021020914A (ja) * 2013-03-01 2021-02-18 インサイト・ホールディングス・コーポレイションＩｎｃｙｔｅ Ｈｏｌｄｉｎｇｓ Ｃｏｒｐｏｒａｔｉｏｎ ＰＩ３Ｋδ関連障害治療のためのピラゾロピリミジン誘導体の使用
JP2023539779A (ja) * 2020-09-04 2023-09-19 シャンハイ ファーマシューティカルズ ホールディング カンパニー，リミティド 窒素含有飽和複素環化合物の使用

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR075880A1 (es) * 2009-03-20 2011-05-04 Novartis Ag Formulaciones galenicas de compuestos organicos que comprenden alisquireno y valsartan. uso. metodo.
EP2382967A1 (de) * 2010-04-21 2011-11-02 ratiopharm GmbH Aliskiren in Form einer festen Dispersion
FR3055800B1 (fr) * 2016-09-15 2020-06-26 Unither Pharmaceuticals Composition solide a ingestion rapide et deglutition facilitee, sous forme de particules solides non agglomerees, comprenant deux differents types de particules

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007529456A (ja) * 2004-03-17 2007-10-25 ノバルティス アクチエンゲゼルシャフト 有機化合物のガレヌス製剤
JP2008510764A (ja) * 2004-08-27 2008-04-10 ノバルティス アクチエンゲゼルシャフト 湿気感受性薬剤の溶融顆粒を含む即時放出型組成物およびその製造法
WO2008061622A1 (en) * 2006-11-07 2008-05-29 Novartis Ag Crystalline forms of aliskiren hemifumarate

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080075772A1 (en) * 2006-04-13 2008-03-27 Lawrence Solomon Pharmaceutical compositions having novel scoring patterns and methods of using those compositions
EP1972335A1 (en) * 2007-03-23 2008-09-24 Krka Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
AR066168A1 (es) * 2007-09-28 2009-07-29 Novartis Ag Formulaciones galenicas de compuestos organicos
WO2009040427A1 (en) * 2007-09-28 2009-04-02 Novartis Ag Galenical formulations of organic compounds
EP2062874B1 (en) * 2007-11-20 2014-12-17 KRKA, tovarna zdravil, d.d., Novo mesto Process and intermediates for the preparation of aliskiren

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007529456A (ja) * 2004-03-17 2007-10-25 ノバルティス アクチエンゲゼルシャフト 有機化合物のガレヌス製剤
JP2008510764A (ja) * 2004-08-27 2008-04-10 ノバルティス アクチエンゲゼルシャフト 湿気感受性薬剤の溶融顆粒を含む即時放出型組成物およびその製造法
WO2008061622A1 (en) * 2006-11-07 2008-05-29 Novartis Ag Crystalline forms of aliskiren hemifumarate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
JPN5012000944; ＡＺＩＺＩ　Ｍ: 'ＰＨＡＲＭＡＣＯＬＯＧＩＣ　ＤＥＭＯＮＳＴＲＡＴＩＯＮ　ＯＦ　ＴＨＥ　ＳＹＮＥＲＧＩＳＴＩＣ　ＥＦＦＥＣＴＳ　ＯＦ　Ａ　ＣＯＭＢＩＮＡＴＩＯＮ　以下備考' ＪＯＵＲＮＡＬ　ＯＦ　ＴＨＥ　ＡＭＥＲＩＣＡＮ　ＳＯＣＩＥＴＹ　ＯＦ　ＮＥＰＨＲＯＬＯＧＹ Ｖ１５　Ｎ１２, 20041201, Ｐ３１２６-３１３３, ＷＩＬＬＩＡＭＳ　ＡＮＤ　ＷＩＬＫＩＮＳ *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021020914A (ja) * 2013-03-01 2021-02-18 インサイト・ホールディングス・コーポレイションＩｎｃｙｔｅ Ｈｏｌｄｉｎｇｓ Ｃｏｒｐｏｒａｔｉｏｎ ＰＩ３Ｋδ関連障害治療のためのピラゾロピリミジン誘導体の使用
JP7189185B2 (ja) 2013-03-01 2022-12-13 インサイト・ホールディングス・コーポレイション ＰＩ３Ｋδ関連障害治療のためのピラゾロピリミジン誘導体の使用
JP2023539779A (ja) * 2020-09-04 2023-09-19 シャンハイ ファーマシューティカルズ ホールディング カンパニー，リミティド 窒素含有飽和複素環化合物の使用
JP7579967B2 (ja) 2020-09-04 2024-11-08 シャンハイ ファーマシューティカルズ ホールディング カンパニー，リミティド 窒素含有飽和複素環化合物の使用

Also Published As

Publication number Publication date
ECSP11010998A (es) 2011-06-30
ZA201101686B (en) 2012-01-25
TW201016210A (en) 2010-05-01
MA32722B1 (fr) 2011-10-02
WO2010036686A1 (en) 2010-04-01
AR073651A1 (es) 2010-11-24
PE20110925A1 (es) 2012-01-13
KR20110063684A (ko) 2011-06-13
EP2328562A1 (en) 2011-06-08
US20110177166A1 (en) 2011-07-21
CA2736259A1 (en) 2010-04-01
BRPI0919077A2 (pt) 2015-12-15
MX2011003077A (es) 2011-08-03
CN102164584A (zh) 2011-08-24
CO6351712A2 (es) 2011-12-20
CL2011000614A1 (es) 2011-11-04
RU2011116122A (ru) 2012-10-27
AU2009296718A1 (en) 2010-04-01

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