PE20110925A1 - 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
PE20110925A1
PE20110925A1 PE2011000667A PE2011000667A PE20110925A1 PE 20110925 A1 PE20110925 A1 PE 20110925A1 PE 2011000667 A PE2011000667 A PE 2011000667A PE 2011000667 A PE2011000667 A PE 2011000667A PE 20110925 A1 PE20110925 A1 PE 20110925A1
Authority
PE
Peru
Prior art keywords
alisquirene
preparation
felted
dosage form
formulation including
Prior art date
Application number
PE2011000667A
Other languages
English (en)
Inventor
Indrajit Ghossh
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 PE20110925A1 publication Critical patent/PE20110925A1/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)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (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)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (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)

Abstract

REFERIDA A UNA FORMA DE DOSIFICACION ORAL SOLIDA QUE COMPRENDE ALISQUIRENO O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, SOLO O EN COMBINACION CON OTRO AGENTE ACTIVO, DONDE EL ALISQUIRENO SE OBTIENE POR GRANULACION DE FUSION O EXTRUSION CON UNO O MAS POLIMEROS TAL COMO N-VINILHIDROXI-PROPIL-METIL-CELULOSA, HIDROXI-PROPIL-CELULOSA O POLIVINIL-PIRROLIDONA. DICHA FORMA DE DOSIFICACION ORAL ESTA BAJO LA FORMA DE UNA TABLETA DE DOS CAPAS, DONDE UNA CAPA COMPRENDE ALISQUIRENO Y OTRA CAPA COMPRENDE VALSARTAN. TAMBIEN ESTA REFERIDA A UN PROCESO DE PREPARACION DE DICHA FORMA DE DOSIFICACION
PE2011000667A 2008-09-24 2009-09-23 Formulacion galenica que comprende alisquireno y proceso para su preparacion mediante granulacion de extrusion fundida PE20110925A1 (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
PE20110925A1 true PE20110925A1 (es) 2012-01-13

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2011000667A PE20110925A1 (es) 2008-09-24 2009-09-23 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
JP2012520895A (ja) * 2009-03-20 2012-09-10 ノバルティス アーゲー バルサルタンおよびアリスキレンの一定用量の組合せのガレヌス製剤
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

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR048431A1 (es) * 2004-03-17 2006-04-26 Novartis Ag Formulaciones galenicas de compuestos organicos
PE20060652A1 (es) * 2004-08-27 2006-08-11 Novartis Ag Composiciones farmaceuticas de liberacion inmediata que comprenden granulos de fusion
US20080075772A1 (en) * 2006-04-13 2008-03-27 Lawrence Solomon Pharmaceutical compositions having novel scoring patterns and methods of using those compositions
CN101594857B (zh) * 2006-11-07 2012-10-31 诺瓦提斯公司 阿利吉仑半富马酸盐的晶形
EP1972335A1 (en) * 2007-03-23 2008-09-24 Krka Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof
WO2009040427A1 (en) * 2007-09-28 2009-04-02 Novartis Ag Galenical formulations of organic compounds
US20100209480A1 (en) * 2007-09-28 2010-08-19 Ralf Altenburger 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
CN102164584A (zh) 2011-08-24
EP2328562A1 (en) 2011-06-08
RU2011116122A (ru) 2012-10-27
CL2011000614A1 (es) 2011-11-04
ECSP11010998A (es) 2011-06-30
TW201016210A (en) 2010-05-01
AR073651A1 (es) 2010-11-24
MA32722B1 (fr) 2011-10-02
WO2010036686A1 (en) 2010-04-01
CA2736259A1 (en) 2010-04-01
BRPI0919077A2 (pt) 2015-12-15
CO6351712A2 (es) 2011-12-20
MX2011003077A (es) 2011-08-03
KR20110063684A (ko) 2011-06-13
ZA201101686B (en) 2012-01-25
AU2009296718A1 (en) 2010-04-01
JP2012503665A (ja) 2012-02-09
US20110177166A1 (en) 2011-07-21

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