CO6351712A2 - Formulacion galenica que comprende alisquireno y proceso para su preparacion mediante granulacion de extrusion fundida - Google Patents

Formulacion galenica que comprende alisquireno y proceso para su preparacion mediante granulacion de extrusion fundida

Info

Publication number
CO6351712A2
CO6351712A2 CO11036970A CO11036970A CO6351712A2 CO 6351712 A2 CO6351712 A2 CO 6351712A2 CO 11036970 A CO11036970 A CO 11036970A CO 11036970 A CO11036970 A CO 11036970A CO 6351712 A2 CO6351712 A2 CO 6351712A2
Authority
CO
Colombia
Prior art keywords
alisquirene
preparation
granulation
galenic formulation
fused extrusion
Prior art date
Application number
CO11036970A
Other languages
English (en)
Inventor
Indrajit Ghosh
James Kowalski
Jennifer Snyder
Wei-Qin Tong
Sudha Vippagunta
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 CO6351712A2 publication Critical patent/CO6351712A2/es

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)
  • 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)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se refiere a formulaciones galénicas, en donde el ingrediente activo de alisquireno, de preferencia una sal de hemi-fumarato del mismo, solo o en combinación con otro ingrediente activo, se granula por fusión, y está presente en una cantidad de más del 20 por ciento en peso, basándose en el peso total de la forma de dosificación oral, así como a un proceso para la preparación de esta forma de dosificación oral sólida.
CO11036970A 2008-09-24 2011-03-25 Formulacion galenica que comprende alisquireno y proceso para su preparacion mediante granulacion de extrusion fundida CO6351712A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9959508P 2008-09-24 2008-09-24
US16179909P 2009-03-20 2009-03-20

Publications (1)

Publication Number Publication Date
CO6351712A2 true CO6351712A2 (es) 2011-12-20

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
CO11036970A CO6351712A2 (es) 2008-09-24 2011-03-25 Formulacion galenica que comprende alisquireno y proceso para su preparacion mediante granulacion de extrusion fundida

Country Status (19)

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

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
TW202214254A (zh) * 2013-03-01 2022-04-16 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
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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PE20142101A1 (es) * 2004-03-17 2014-12-27 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
JP2010508370A (ja) * 2006-11-07 2010-03-18 ノバルティス アーゲー ヘミフマル酸アリスキレンの結晶形
EP1972335A1 (en) * 2007-03-23 2008-09-24 Krka Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
AU2008309058B2 (en) * 2007-09-28 2012-08-09 Novartis Ag Galenical formulations of Aliskiren and Valsartan
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
WO2010036686A1 (en) 2010-04-01
MA32722B1 (fr) 2011-10-02
CN102164584A (zh) 2011-08-24
CL2011000614A1 (es) 2011-11-04
MX2011003077A (es) 2011-08-03
US20110177166A1 (en) 2011-07-21
TW201016210A (en) 2010-05-01
KR20110063684A (ko) 2011-06-13
RU2011116122A (ru) 2012-10-27
JP2012503665A (ja) 2012-02-09
ZA201101686B (en) 2012-01-25
ECSP11010998A (es) 2011-06-30
AR073651A1 (es) 2010-11-24
EP2328562A1 (en) 2011-06-08
PE20110925A1 (es) 2012-01-13
AU2009296718A1 (en) 2010-04-01
BRPI0919077A2 (pt) 2015-12-15
CA2736259A1 (en) 2010-04-01

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