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MA32722B1 - Formulation galénique renfermant de l'aliskirène et procédé associé de préparation par granulation par fusion-extrusion - Google Patents

Formulation galénique renfermant de l'aliskirène et procédé associé de préparation par granulation par fusion-extrusion

Info

Publication number
MA32722B1
MA32722B1 MA33785A MA33785A MA32722B1 MA 32722 B1 MA32722 B1 MA 32722B1 MA 33785 A MA33785 A MA 33785A MA 33785 A MA33785 A MA 33785A MA 32722 B1 MA32722 B1 MA 32722B1
Authority
MA
Morocco
Prior art keywords
aliskirene
fusion
extrusion granulation
galenic formulation
associated preparation
Prior art date
Application number
MA33785A
Other languages
Arabic (ar)
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 MA32722B1 publication Critical patent/MA32722B1/fr

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
    • 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
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Psychiatry (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

LA PRÉSENTE INVENTION PORTE SUR DES FORMULATIONS GALÉNIQUES DANS LESQUELLES L'INGRÉDIENT ACTIF EST L'ALISKIRÈNE, DE PRÉFÉRENCE UN SEL HÉMI-FUMARATE CORRESPONDANT, SEUL OU EN COMBINAISON AVEC UN AUTRE INGRÉDIENT ACTIF, PRÉPARÉ PAR GRANULATION PAR FUSION ET PRÉSENT DANS UNE QUANTITÉ SUPÉRIEURE À 20 % EN POIDS SUR LA BASE DU POIDS TOTAL DE LA FORME POSOLOGIQUE ORALE. L'INVENTION PORTE ÉGALEMENT SUR UN PROCÉDÉ DE PRÉPARATION DE LADITE FORME POSOLOGIQUE ORALE SOLIDE.
MA33785A 2008-09-24 2011-04-20 Formulation galénique renfermant de l'aliskirène et procédé associé de préparation par granulation par fusion-extrusion MA32722B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US9959508P 2008-09-24 2008-09-24
US16179909P 2009-03-20 2009-03-20
PCT/US2009/057993 WO2010036686A1 (fr) 2008-09-24 2009-09-23 Formulation galénique renfermant de l’aliskirène et procédé associé de préparation par granulation par fusion-extrusion

Publications (1)

Publication Number Publication Date
MA32722B1 true MA32722B1 (fr) 2011-10-02

Family

ID=41323516

Family Applications (1)

Application Number Title Priority Date Filing Date
MA33785A MA32722B1 (fr) 2008-09-24 2011-04-20 Formulation galénique renfermant de l'aliskirène et procédé associé de préparation par granulation par fusion-extrusion

Country Status (19)

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

Families Citing this family (5)

* 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 (fr) * 2010-04-21 2011-11-02 ratiopharm GmbH Aliskiren sous forme d'une dispersion solide
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
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

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
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 (fr) * 2007-03-23 2008-09-24 Krka Formes de dosage solide comportant de l'aliskiren et ses sels pharmaceutiques acceptables
PE20090654A1 (es) * 2007-09-28 2009-06-27 Novartis Ag Formulaciones galenicas que contienen alisquireno y valsartan
WO2009040427A1 (fr) * 2007-09-28 2009-04-02 Novartis Ag Formulations galéniques de composés organiques
EP2062874B1 (fr) * 2007-11-20 2014-12-17 KRKA, tovarna zdravil, d.d., Novo mesto Procédé et intermédiaires pour la préparation d'aliskiren

Also Published As

Publication number Publication date
TW201016210A (en) 2010-05-01
ECSP11010998A (es) 2011-06-30
EP2328562A1 (fr) 2011-06-08
PE20110925A1 (es) 2012-01-13
CA2736259A1 (fr) 2010-04-01
BRPI0919077A2 (pt) 2015-12-15
AU2009296718A1 (en) 2010-04-01
CN102164584A (zh) 2011-08-24
RU2011116122A (ru) 2012-10-27
AR073651A1 (es) 2010-11-24
CL2011000614A1 (es) 2011-11-04
KR20110063684A (ko) 2011-06-13
MX2011003077A (es) 2011-08-03
ZA201101686B (en) 2012-01-25
US20110177166A1 (en) 2011-07-21
JP2012503665A (ja) 2012-02-09
WO2010036686A1 (fr) 2010-04-01
CO6351712A2 (es) 2011-12-20

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