CN102164584A - 包含阿利吉仑的盖仑制剂及通过熔融挤出制粒的其制备方法 - Google Patents

包含阿利吉仑的盖仑制剂及通过熔融挤出制粒的其制备方法 Download PDF

Info

Publication number
CN102164584A
CN102164584A CN2009801373641A CN200980137364A CN102164584A CN 102164584 A CN102164584 A CN 102164584A CN 2009801373641 A CN2009801373641 A CN 2009801373641A CN 200980137364 A CN200980137364 A CN 200980137364A CN 102164584 A CN102164584 A CN 102164584A
Authority
CN
China
Prior art keywords
dosage form
oral dosage
solid oral
aliskiren
form according
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.)
Pending
Application number
CN2009801373641A
Other languages
English (en)
Chinese (zh)
Inventor
I·高希
J·科瓦尔斯基
J·斯奈德
W-Q·童
S·维帕贡塔
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 CN102164584A publication Critical patent/CN102164584A/zh
Pending legal-status Critical Current

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
    • A61K9/20—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (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)
CN2009801373641A 2008-09-24 2009-09-23 包含阿利吉仑的盖仑制剂及通过熔融挤出制粒的其制备方法 Pending CN102164584A (zh)

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 (1)

Publication Number Publication Date
CN102164584A true CN102164584A (zh) 2011-08-24

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2009801373641A Pending CN102164584A (zh) 2008-09-24 2009-09-23 包含阿利吉仑的盖仑制剂及通过熔融挤出制粒的其制备方法

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 (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109963554A (zh) * 2016-09-15 2019-07-02 优尼特尔制药公司 非聚集固体颗粒形式的包含两种不同类型颗粒的快速摄入且便于吞咽的固体组合物

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102348452A (zh) * 2009-03-20 2012-02-08 诺瓦提斯公司 缬沙坦和阿利吉仑的固定剂量组合的盖仑制剂
EP2382967A1 (de) * 2010-04-21 2011-11-02 ratiopharm GmbH Aliskiren in Form einer festen Dispersion
TWI736135B (zh) * 2013-03-01 2021-08-11 美商英塞特控股公司 吡唑并嘧啶衍生物治療PI3Kδ相關病症之用途
KR102898913B1 (ko) * 2020-09-04 2025-12-10 상하이 파마슈티컬스 홀딩 컴퍼니 리미티드 질소 함유 포화 헤테로사이클릭 화합물의 응용

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY144477A (en) * 2004-03-17 2011-09-30 Novartis Ag Galenic formulations of organic compounds
AR050615A1 (es) * 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral
US20080075772A1 (en) * 2006-04-13 2008-03-27 Lawrence Solomon Pharmaceutical compositions having novel scoring patterns and methods of using those compositions
US8119841B2 (en) * 2006-11-07 2012-02-21 Novartis Ag Crystalline forms of aliskiren hemifumarate
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109963554A (zh) * 2016-09-15 2019-07-02 优尼特尔制药公司 非聚集固体颗粒形式的包含两种不同类型颗粒的快速摄入且便于吞咽的固体组合物

Also Published As

Publication number Publication date
JP2012503665A (ja) 2012-02-09
MA32722B1 (fr) 2011-10-02
US20110177166A1 (en) 2011-07-21
BRPI0919077A2 (pt) 2015-12-15
RU2011116122A (ru) 2012-10-27
AR073651A1 (es) 2010-11-24
CL2011000614A1 (es) 2011-11-04
MX2011003077A (es) 2011-08-03
WO2010036686A1 (en) 2010-04-01
AU2009296718A1 (en) 2010-04-01
ECSP11010998A (es) 2011-06-30
PE20110925A1 (es) 2012-01-13
EP2328562A1 (en) 2011-06-08
CO6351712A2 (es) 2011-12-20
KR20110063684A (ko) 2011-06-13
ZA201101686B (en) 2012-01-25
CA2736259A1 (en) 2010-04-01
TW201016210A (en) 2010-05-01

Similar Documents

Publication Publication Date Title
JP5054000B2 (ja) イマチニブおよび放出遅延剤を含む医薬組成物
AU2008309058B2 (en) Galenical formulations of Aliskiren and Valsartan
KR101434906B1 (ko) Ｎｓａｉｄ 및 파라세타몰을 포함하는 조성물
EA030982B1 (ru) Твердая галеновая форма с высоким содержанием фексофенадина и способ ее получения
US20110177166A1 (en) Galenical Formulation Comprising Aliskiren and Process for its Preparation by Melt Extrusion Granulation
AU2016343851A1 (en) Eflornithine and sulindac, fixed dose combination formulation
JP2015091830A (ja) 有機化合物のガレヌス製剤
TWI436760B (zh) 阿利克侖之蓋崙（ｇａｌｅｎｉｃａｌ）調配物
TWI745598B (zh) 非布司他控釋組合物及其製備方法
WO2004091600A1 (ja) 経口固形製剤
EP2793853A2 (en) Pharmaceutical formulations of flurbiprofen and glucosamin
TWI810656B (zh) 二氟甲基鳥氨酸及舒林酸（ｓｕｌｉｎｄａｃ），固定劑量組合調配物
JP2025526729A (ja) ナポラフェニブを含む非晶質固体分散体
CN102348452A (zh) 缬沙坦和阿利吉仑的固定剂量组合的盖仑制剂
CN101951902A (zh) 缬沙坦固体口服剂型以及制备该制剂的方法
WO2018093289A1 (ru) Пероральная твердая лекарственная форма и способ ее получения

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20110824