NZ596395A - Stable solid benzimidazole derivative preparation having optimized dissolution property - Google Patents

Stable solid benzimidazole derivative preparation having optimized dissolution property

Info

Publication number
NZ596395A
NZ596395A NZ596395A NZ59639510A NZ596395A NZ 596395 A NZ596395 A NZ 596395A NZ 596395 A NZ596395 A NZ 596395A NZ 59639510 A NZ59639510 A NZ 59639510A NZ 596395 A NZ596395 A NZ 596395A
Authority
NZ
New Zealand
Prior art keywords
benzimidazole
biphenyl
ethoxy
methyl
stable solid
Prior art date
Application number
NZ596395A
Inventor
Wataru Hoshina
Makoto Fukuta
Shigeyuki Marunaka
Original Assignee
Takeda Pharmaceutical
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=43032637&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NZ596395(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical filed Critical Takeda Pharmaceutical
Publication of NZ596395A publication Critical patent/NZ596395A/en

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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • 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
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

ABSTRACT - 596395 The disclosure relates to a solid preparation comprising (i) compound selected from the group consisting of 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]benzimidazole-7-carboxylate, 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid, and 2-ethoxy-1-[[2'-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid or a salt thereof, (ii) a sugar alcohol selected from mannitol, sorbitol or erythritol, (iii) a dihydropyridine compound having calcium antagonistic activity, which is selected from azelnidipine, amlodipine, aranidipine, efonidipine, cilnidipine, nicardipine, nisoldipine, nitrendipine, nifedipine, nilvadipine, barnidipine, felodipine, benidipine, manidipine or a salt thereof. These solid preparations are stable and have an appropriately controlled dissolution rate of the active ingredient in the gastrointestinal tract.
NZ596395A 2009-04-30 2010-04-28 Stable solid benzimidazole derivative preparation having optimized dissolution property NZ596395A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2009111381 2009-04-30
JP2010068625 2010-03-24
PCT/JP2010/057923 WO2010126168A2 (en) 2009-04-30 2010-04-28 Solid preparation

Publications (1)

Publication Number Publication Date
NZ596395A true NZ596395A (en) 2013-06-28

Family

ID=43032637

Family Applications (1)

Application Number Title Priority Date Filing Date
NZ596395A NZ596395A (en) 2009-04-30 2010-04-28 Stable solid benzimidazole derivative preparation having optimized dissolution property

Country Status (24)

Country Link
EP (1) EP2424501A2 (en)
JP (1) JP5666471B2 (en)
KR (1) KR101797776B1 (en)
CN (1) CN102481248B (en)
AU (1) AU2010242308A1 (en)
BR (1) BRPI1014388A2 (en)
CA (1) CA2760073A1 (en)
CL (1) CL2011002662A1 (en)
CO (1) CO6470841A2 (en)
CR (1) CR20110581A (en)
DO (1) DOP2011000329A (en)
EA (1) EA201171329A1 (en)
EC (1) ECSP11011494A (en)
GE (1) GEP20135940B (en)
IL (1) IL215962A0 (en)
MA (1) MA33280B1 (en)
MX (1) MX2011011011A (en)
MY (1) MY158158A (en)
NZ (1) NZ596395A (en)
PE (1) PE20120315A1 (en)
SG (1) SG175794A1 (en)
TW (1) TWI438201B (en)
WO (1) WO2010126168A2 (en)
ZA (1) ZA201108375B (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL236001B1 (en) 2012-12-21 2020-11-30 Adamed Spolka Z Ograniczona Odpowiedzialnoscia Complex pharmaceutical composition comprising candesartan cilexetil and amlodipine, its preparation method and the unit dosage form comprising said composition,
KR101535586B1 (en) * 2014-08-01 2015-07-09 에스케이케미칼주식회사 Pharmaceutical preparation comprising amorphous or metastable form of rivaroxaban
WO2016122256A1 (en) * 2015-01-30 2016-08-04 씨제이헬스케어 주식회사 Pharmaceutical composition comprising candesartan and amlodipine
CN106668016B (en) * 2015-11-11 2020-06-23 江苏先声药业有限公司 Solid preparation of azilsartan and amlodipine besylate composition and preparation method thereof
JP2017210435A (en) * 2016-05-25 2017-11-30 ダイト株式会社 Method for producing irbesartan and amlodipine besylate-containing tablet
JP2019001782A (en) * 2017-06-14 2019-01-10 東和薬品株式会社 Bilayer tablet
JP7101464B2 (en) * 2017-09-28 2022-07-15 エルメッド株式会社 A method for improving the quality of azilsartan or a salt thereof and amlodipine or a salt-containing tablet thereof, and azilsartan or a salt thereof and amlodipine or a salt-containing tablet thereof and a method for producing the same.
CN108210472A (en) * 2017-12-15 2018-06-29 蚌埠丰原医药科技发展有限公司 A kind of Cilnidipine solid dispersions tablet and preparation method thereof
CN108685925B (en) * 2018-05-15 2019-12-06 徐州医科大学 application of compound AB-38b in preparation of medicine for treating diabetic nephropathy
JP2020075869A (en) * 2018-11-05 2020-05-21 日本ケミファ株式会社 Tablet containing angiotensin ii receptor antagonist and calcium antagonist as active ingredients
JP2020090471A (en) * 2018-12-07 2020-06-11 ニプロ株式会社 Pharmaceutical composition containing azilsartan and amlodipine and method for producing the same
JP7206872B2 (en) * 2018-12-07 2023-01-18 ニプロ株式会社 Pharmaceutical composition containing azilsartan and amlodipine and method for producing the same
JP7441105B2 (en) 2020-03-31 2024-02-29 日本ジェネリック株式会社 Film-coated tablets containing azilsartan and amlodipine besilate

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2814513B2 (en) * 1988-02-03 1998-10-22 吉富製薬株式会社 Pharmaceutical composition with improved dissolution
CA2125251C (en) * 1993-06-07 2005-04-26 Yoshiyuki Inada A pharmaceutical composition for angiotensin ii-mediated diseases
JP3057471B2 (en) * 1993-06-07 2000-06-26 武田薬品工業株式会社 Agent for preventing or treating angiotensin II-mediated diseases
US20030187023A1 (en) 2000-07-17 2003-10-02 Keiji Kubo Sulfone derivatives, process for their production and use thereof
US20040121008A1 (en) * 2001-03-16 2004-06-24 Keiko Shiraishi Process for producing sustained release preparation
AU2002349673A1 (en) * 2001-12-03 2003-06-17 Takeda Chemical Industries, Ltd. Insulin resistance improving agents
WO2003097102A1 (en) * 2002-05-22 2003-11-27 Shionogi & Co., Ltd. Pharmaceutical preparation improved in dissolving property of drug slightly soluble in water
CA2507026A1 (en) 2002-11-22 2004-06-10 Takeda Pharmaceutical Company Limited Imidazole derivatives, their production and use
US7534887B2 (en) 2003-09-30 2009-05-19 Takeda Pharmaceutical Company Limited Thiazoline derivative and use of the same
EP1695961A4 (en) 2003-12-17 2007-10-24 Takeda Pharmaceutical Urea derivative, process for producing the same, and use
TWI396686B (en) 2004-05-21 2013-05-21 Takeda Pharmaceutical Cyclic amide derivative, and its production and use
JP2006321726A (en) * 2005-05-17 2006-11-30 Sysmex Corp Method for controlling elution property of tablet
WO2007001066A1 (en) * 2005-06-27 2007-01-04 Daiichi Sankyo Company, Limited Pharmaceutical preparation containing an angiotensin ii receptor antagonist and a calcium channel blocker
TWI407978B (en) * 2005-06-27 2013-09-11 Sankyo Co Method for the preparation of a wet granulated drug product
DE102005031577A1 (en) * 2005-07-06 2007-01-11 Bayer Healthcare Ag Pharmaceutical dosage forms containing a combination of nifedipine and / or nisoldipine and an angiotensin II antagonist
ES2644803T5 (en) * 2007-03-29 2024-02-26 Daiichi Sankyo Co Ltd Pharmaceutical composition
UY32126A (en) * 2008-09-25 2010-04-30 Takeda Pharmaceutical SOLID PHARMACEUTICAL COMPOSITION

Also Published As

Publication number Publication date
EP2424501A2 (en) 2012-03-07
BRPI1014388A2 (en) 2016-04-05
SG175794A1 (en) 2011-12-29
TW201041873A (en) 2010-12-01
JP2012525323A (en) 2012-10-22
CN102481248B (en) 2013-12-11
CL2011002662A1 (en) 2012-06-15
CO6470841A2 (en) 2012-06-29
MA33280B1 (en) 2012-05-02
CR20110581A (en) 2012-01-19
CA2760073A1 (en) 2010-11-04
MY158158A (en) 2016-09-15
ZA201108375B (en) 2013-01-30
GEP20135940B (en) 2013-10-10
MX2011011011A (en) 2011-11-02
KR101797776B1 (en) 2017-11-14
AU2010242308A1 (en) 2011-12-01
PE20120315A1 (en) 2012-04-07
TWI438201B (en) 2014-05-21
EA201171329A1 (en) 2012-05-30
ECSP11011494A (en) 2011-12-30
KR20120026060A (en) 2012-03-16
CN102481248A (en) 2012-05-30
WO2010126168A2 (en) 2010-11-04
DOP2011000329A (en) 2011-11-15
JP5666471B2 (en) 2015-02-12
IL215962A0 (en) 2012-01-31
WO2010126168A3 (en) 2011-03-03

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Effective date: 20140327

LAPS Patent lapsed