CA2736259A1 - Galenical formulation comprising aliskiren and process for its preparation by melt extrusion granulation - Google Patents

Galenical formulation comprising aliskiren and process for its preparation by melt extrusion granulation Download PDF

Info

Publication number
CA2736259A1
CA2736259A1 CA2736259A CA2736259A CA2736259A1 CA 2736259 A1 CA2736259 A1 CA 2736259A1 CA 2736259 A CA2736259 A CA 2736259A CA 2736259 A CA2736259 A CA 2736259A CA 2736259 A1 CA2736259 A1 CA 2736259A1
Authority
CA
Canada
Prior art keywords
dosage form
oral dosage
aliskiren
solid oral
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.)
Abandoned
Application number
CA2736259A
Other languages
English (en)
French (fr)
Inventor
Indrajit Ghosh
James Kowalski
Jennifer Snyder
Wei-Qin Tong
Sudha Vippagunta
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 CA2736259A1 publication Critical patent/CA2736259A1/en
Abandoned 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; 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

Landscapes

  • 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)
CA2736259A 2008-09-24 2009-09-23 Galenical formulation comprising aliskiren and process for its preparation by melt extrusion granulation Abandoned CA2736259A1 (en)

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
CA2736259A1 true CA2736259A1 (en) 2010-04-01

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2736259A Abandoned CA2736259A1 (en) 2008-09-24 2009-09-23 Galenical formulation comprising aliskiren and process for its preparation by melt extrusion granulation

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)

Families Citing this family (5)

* 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
TWI657090B (zh) * 2013-03-01 2019-04-21 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
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
CN114129569A (zh) * 2020-09-04 2022-03-04 上海医药集团股份有限公司 一种含氮的饱和杂环化合物的应用

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20110121A1 (es) * 2004-03-17 2011-02-28 Novartis Ag Composiciones farmaceuticas de aliskiren
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
PE20081157A1 (es) * 2006-11-07 2008-09-26 Novartis Ag Forma cristalina de hemifumarato de alisquireno
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

Also Published As

Publication number Publication date
ECSP11010998A (es) 2011-06-30
ZA201101686B (en) 2012-01-25
TW201016210A (en) 2010-05-01
JP2012503665A (ja) 2012-02-09
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
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

Similar Documents

Publication Publication Date Title
AU2008309058B2 (en) Galenical formulations of Aliskiren and Valsartan
EP3897586B1 (en) Pharmaceutical composition comprising apixaban
US20110177166A1 (en) Galenical Formulation Comprising Aliskiren and Process for its Preparation by Melt Extrusion Granulation
JP2015091830A (ja) 有機化合物のガレヌス製剤
AU2008303504B2 (en) Galenical formulations of Aliskiren
CN116801867A (zh) 利地利唑的固体片剂剂型
US20120003308A1 (en) Pharmaceutical Composition Comprising Aliskiren
US20120009257A1 (en) Galenical Formulations of a Fixed Dose Combination of Valsartan and Aliskiren

Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20140923