CO6180428A2 - Formas cristalinas de hemifumarato de aliskiren - Google Patents

Formas cristalinas de hemifumarato de aliskiren

Info

Publication number
CO6180428A2
CO6180428A2 CO09057907A CO09057907A CO6180428A2 CO 6180428 A2 CO6180428 A2 CO 6180428A2 CO 09057907 A CO09057907 A CO 09057907A CO 09057907 A CO09057907 A CO 09057907A CO 6180428 A2 CO6180428 A2 CO 6180428A2
Authority
CO
Colombia
Prior art keywords
crystal form
aliskiren hemifumarate
diffraction pattern
ray powder
powder diffraction
Prior art date
Application number
CO09057907A
Other languages
English (en)
Inventor
Frank Stowasser
Stephanie Monnier
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37907983&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CO6180428(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of CO6180428A2 publication Critical patent/CO6180428A2/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C237/00—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups
    • C07C237/02—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups having the carbon atoms of the carboxamide groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C237/22—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups having the carbon atoms of the carboxamide groups bound to acyclic carbon atoms of the carbon skeleton having nitrogen atoms of amino groups bound to the carbon skeleton of the acid part, further acylated
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C237/00—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups
    • C07C237/02—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups having the carbon atoms of the carboxamide groups bound to acyclic carbon atoms of the carbon skeleton
    • C07C237/20—Carboxylic acid amides, the carbon skeleton of the acid part being further substituted by amino groups having the carbon atoms of the carboxamide groups bound to acyclic carbon atoms of the carbon skeleton the carbon skeleton containing six-membered aromatic rings
    • 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
    • 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
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/06—Antihyperlipidemics
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Child & Adolescent Psychology (AREA)
  • Psychiatry (AREA)
  • Vascular Medicine (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Epidemiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

1.- Una forma de cristal de hemifumarato de aliskiren, incluyendo el término "forma de cristal" una forma de solvato. 2.- Una forma de cristal tal y como se describe en la reivindicación 1, caracterizada porque tiene una temperatura de fusión en un rango de 80°C a 110°C. 3.- Una forma de cristal tal y como se describe en la reivindicación 1, caracterizada porque tiene una temperatura de fusión en un rango de 90°C a 105°C. 4.- Una forma de cristal tal y como se describe en cualquiera de las reivindicaciones de la 1 a la 3, denominada Modificación A, caracterizada por un patrón de difracción de polvo de Rayos X que muestra los siguientes picos principales proporcionados en grados 2Teta +/- 0.3 grados: 6.0, 7.3, 8.6, 9.2, 9.9, 15.0, 17.2 y 17.9. 5.- Una forma de cristal tal y como se describe en cualquiera de las reivindicaciones de la 1 a la 4, denominada Modificación A, caracterizada por un patrón de difracción de polvo de Rayos X que muestra los siguientes picos principales proporcionados en grados 2Teta +/- 0.3 grados: 6.0, 7.3, 8.6, 9.2, 9.9, 15.0, 17.2, 17.9, 19.2, 19.7, 20.1. 6.- Una forma de cristal tal y como se describe en la reivindicación 5, caracterizada porque tiene un patrón de difracción de polvo de Rayos X tal como se muestra en la figura 1. 7.- Una forma de cristal tal y como se describe en cualquiera de las reivindicaciones de la 4 a la 6, caracterizada porque tiene un punto de fusión en el rango de 90°C a 100°C, especialmente de 96°C a 98°C, y preferentemente en un índice de calentamiento de 10 K/min. 8.- Una forma de cristal tal y como se describe en cualquiera de las reivindicaciones de la 4 a la 7, caracterizada porque tiene una pureza del 20% en peso preferentemente del 30% o más, especialmente del 40% o más, relacionada con la cantidad total de hemifumarato de aliskiren.
CO09057907A 2006-11-07 2009-06-04 Formas cristalinas de hemifumarato de aliskiren CO6180428A2 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP06123642 2006-11-07

Publications (1)

Publication Number Publication Date
CO6180428A2 true CO6180428A2 (es) 2010-07-19

Family

ID=37907983

Family Applications (1)

Application Number Title Priority Date Filing Date
CO09057907A CO6180428A2 (es) 2006-11-07 2009-06-04 Formas cristalinas de hemifumarato de aliskiren

Country Status (25)

Country Link
US (1) US8119841B2 (es)
EP (1) EP2079463A1 (es)
JP (1) JP2010508370A (es)
KR (1) KR20090083918A (es)
CN (1) CN101594857B (es)
AR (1) AR063560A1 (es)
AU (1) AU2007323465B2 (es)
BR (1) BRPI0718546A2 (es)
CA (1) CA2668828A1 (es)
CL (1) CL2007003194A1 (es)
CO (1) CO6180428A2 (es)
EC (1) ECSP099385A (es)
GT (1) GT200900116A (es)
IL (1) IL198470A0 (es)
MA (1) MA30921B1 (es)
MX (1) MX2009004885A (es)
MY (1) MY148758A (es)
NO (1) NO20092102L (es)
NZ (1) NZ577320A (es)
PE (2) PE20121179A1 (es)
RU (1) RU2466982C2 (es)
TN (1) TN2009000174A1 (es)
TW (1) TW200827326A (es)
WO (1) WO2008061622A1 (es)
ZA (1) ZA200902941B (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120029083A1 (en) * 2007-11-13 2012-02-02 Teva Pharmaceutical Industries, Ltd. Polymorphic forms of aliskiren hemifumarate and process for preparation thereof
CA2712087A1 (en) 2008-01-23 2009-07-30 Novartis Ag Method of optimizing the treatment of proliferative diseases mediated by the tyrosine kinase receptor kit with imatinib
EP2143425A1 (de) * 2008-07-11 2010-01-13 Ratiopharm GmbH Direktverpresste Aliskiren-Tabletten
JO3239B1 (ar) * 2008-09-22 2018-03-08 Novartis Ag تركيبات جالينية من مركبات عضوية
AR073651A1 (es) * 2008-09-24 2010-11-24 Novartis Ag Formulaciones galenicas de compuestos organicos
KR20170062554A (ko) * 2008-12-18 2017-06-07 노파르티스 아게 1-［4-［1-(4-시클로헥실-3-트리플루오로메틸-벤질옥시이미노)-에틸］-2-에틸-벤질］-아제티딘-3-카르복실산의 헤미푸마레이트 염
EP2393489B1 (en) 2009-02-05 2014-10-08 Krka, tovarna zdravil, d.d., Novo mesto Moisture-activated granulation process
US8148576B2 (en) * 2009-02-05 2012-04-03 Teva Pharmaceutical Industries Ltd. Solid state forms of aliskiren compounds
WO2011028919A2 (en) 2009-09-03 2011-03-10 Teva Pharmaceutical Industries Ltd. Solid forms of aliskiren hemifumarate and processes for preparation thereof
CN102617392B (zh) * 2011-01-28 2015-04-01 博瑞生物医药技术(苏州)有限公司 一种阿利克仑半富马酸盐晶型ⅰ的制备方法
ITMI20111291A1 (it) * 2011-07-11 2013-01-12 Djada Pharmaceutical Sa Aliskiren emifumarato etil acetato solvato
ITMI20111290A1 (it) * 2011-07-11 2013-01-12 Djada Pharmaceutical Sa Aliskiren emifumarato, forma cristallina e solido amorfo
CN103172533B (zh) * 2011-12-20 2016-05-04 博瑞生物医药（苏州）股份有限公司 一种阿利克仑半富马酸盐的新晶型及其制备方法和用途
JP6007096B2 (ja) * 2011-12-28 2016-10-12 エルメッド エーザイ株式会社 安定化カンデサルタンシレキセチル含有物の製造方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY119161A (en) * 1994-04-18 2005-04-30 Novartis Ag Delta-amino-gamma-hydroxy-omega-aryl-alkanoic acid amides with enzyme especially renin inhibiting activities
BR0112362B1 (pt) * 2000-07-05 2013-12-31 Processo para a preparação de octanoil amidas substituídas e compostos intermediários
RU2316318C2 (ru) * 2002-05-17 2008-02-10 Новартис Аг Фармацевтическая композиция, включающая ингибитор ренина, блокатор кальциевых каналов и диуретик
PE20110121A1 (es) * 2004-03-17 2011-02-28 Novartis Ag Composiciones farmaceuticas de aliskiren
GB0419361D0 (en) * 2004-08-31 2004-10-06 Novartis Ag Organic compounds

Also Published As

Publication number Publication date
AU2007323465A1 (en) 2008-05-29
MX2009004885A (es) 2009-05-19
RU2009121651A (ru) 2010-12-20
PE20121179A1 (es) 2012-09-13
ECSP099385A (es) 2009-07-31
CN101594857A (zh) 2009-12-02
NO20092102L (no) 2009-07-30
JP2010508370A (ja) 2010-03-18
CA2668828A1 (en) 2008-05-29
CL2007003194A1 (es) 2008-06-13
US8119841B2 (en) 2012-02-21
AU2007323465B2 (en) 2011-08-04
PE20081157A1 (es) 2008-09-26
MA30921B1 (fr) 2009-11-02
MY148758A (en) 2013-05-31
WO2008061622A1 (en) 2008-05-29
TN2009000174A1 (en) 2010-10-18
GT200900116A (es) 2011-06-07
AR063560A1 (es) 2009-02-04
TW200827326A (en) 2008-07-01
EP2079463A1 (en) 2009-07-22
CN101594857B (zh) 2012-10-31
US20100048716A1 (en) 2010-02-25
NZ577320A (en) 2012-01-12
ZA200902941B (en) 2010-03-31
RU2466982C2 (ru) 2012-11-20
KR20090083918A (ko) 2009-08-04
IL198470A0 (en) 2010-02-17
BRPI0718546A2 (pt) 2013-11-19

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