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WO2010126168A3 - Solid preparation - Google Patents

Solid preparation Download PDF

Info

Publication number
WO2010126168A3
WO2010126168A3 PCT/JP2010/057923 JP2010057923W WO2010126168A3 WO 2010126168 A3 WO2010126168 A3 WO 2010126168A3 JP 2010057923 W JP2010057923 W JP 2010057923W WO 2010126168 A3 WO2010126168 A3 WO 2010126168A3
Authority
WO
WIPO (PCT)
Prior art keywords
solid preparation
superior
symbol
iii
salt
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2010/057923
Other languages
French (fr)
Other versions
WO2010126168A2 (en
Inventor
Wataru Hoshina
Makoto Fukuta
Shigeyuki Marunaka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co Ltd
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=WO2010126168(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to NZ596395A priority Critical patent/NZ596395A/en
Priority to CA2760073A priority patent/CA2760073A1/en
Priority to EA201171329A priority patent/EA201171329A1/en
Priority to SG2011078391A priority patent/SG175794A1/en
Priority to US13/138,950 priority patent/US20120115837A1/en
Priority to CN2010800289702A priority patent/CN102481248B/en
Priority to AU2010242308A priority patent/AU2010242308A1/en
Priority to MA34358A priority patent/MA33280B1/en
Priority to KR1020117027421A priority patent/KR101797776B1/en
Application filed by Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Priority to BRPI1014388A priority patent/BRPI1014388A2/en
Priority to EP10719654A priority patent/EP2424501A2/en
Priority to MX2011011011A priority patent/MX2011011011A/en
Priority to JP2011545129A priority patent/JP5666471B2/en
Publication of WO2010126168A2 publication Critical patent/WO2010126168A2/en
Publication of WO2010126168A3 publication Critical patent/WO2010126168A3/en
Priority to TNP2011000538A priority patent/TN2011000538A1/en
Priority to IL215962A priority patent/IL215962A0/en
Anticipated expiration legal-status Critical
Priority to ZA2011/08375A priority patent/ZA201108375B/en
Ceased legal-status Critical Current

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
    • A61K9/28—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (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

Provided is a solid preparation comprising (i) a compound represented by the formula (I): wherein each symbol is as defined in the specification, or a salt thereof, (ii) a sugar alcohol, and (iii) a calcium antagonist, which is superior in the dissolution property and stability.
PCT/JP2010/057923 2009-04-30 2010-04-28 Solid preparation Ceased WO2010126168A2 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
JP2011545129A JP5666471B2 (en) 2009-04-30 2010-04-28 Solid preparation
BRPI1014388A BRPI1014388A2 (en) 2009-04-30 2010-04-28 solid preparation.
EA201171329A EA201171329A1 (en) 2009-04-30 2010-04-28 HARD PREPARATION
SG2011078391A SG175794A1 (en) 2009-04-30 2010-04-28 Solid preparation
US13/138,950 US20120115837A1 (en) 2009-04-30 2010-04-28 Solid Preparation
CN2010800289702A CN102481248B (en) 2009-04-30 2010-04-28 Solid preparation
AU2010242308A AU2010242308A1 (en) 2009-04-30 2010-04-28 Solid preparation
MA34358A MA33280B1 (en) 2009-04-30 2010-04-28 Solid product
KR1020117027421A KR101797776B1 (en) 2009-04-30 2010-04-28 Solid preparation
NZ596395A NZ596395A (en) 2009-04-30 2010-04-28 Stable solid benzimidazole derivative preparation having optimized dissolution property
MX2011011011A MX2011011011A (en) 2009-04-30 2010-04-28 Solid preparation.
CA2760073A CA2760073A1 (en) 2009-04-30 2010-04-28 Solid preparation
EP10719654A EP2424501A2 (en) 2009-04-30 2010-04-28 Solid preparation
TNP2011000538A TN2011000538A1 (en) 2009-04-30 2011-10-24 Solid preparation
IL215962A IL215962A0 (en) 2009-04-30 2011-10-26 Soilid preparation
ZA2011/08375A ZA201108375B (en) 2009-04-30 2011-11-15 Solid preparation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2009-111381 2009-04-30
JP2009111381 2009-04-30
JP2010068625 2010-03-24
JP2010-068625 2010-03-24

Publications (2)

Publication Number Publication Date
WO2010126168A2 WO2010126168A2 (en) 2010-11-04
WO2010126168A3 true WO2010126168A3 (en) 2011-03-03

Family

ID=43032637

Family Applications (1)

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

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
KR101806004B1 (en) * 2015-01-30 2017-12-08 씨제이헬스케어 주식회사 A 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 a compound AB-38b in the preparation of drugs 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
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
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
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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0753301A1 (en) * 1993-06-07 1997-01-15 Takeda Chemical Industries, Ltd. Combination of benzimidazoles having angiotensin-II antagonistic activity with diuretics
EP1369130A1 (en) * 2001-03-16 2003-12-10 Takeda Chemical Industries, Ltd. Process for producing sustained release preparation
EP1452176A1 (en) * 2001-12-03 2004-09-01 Takeda Chemical Industries, Ltd. Insulin resistance improving agents
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
WO2010035806A1 (en) * 2008-09-25 2010-04-01 武田薬品工業株式会社 Solid pharmaceutical composition

Family Cites Families (12)

* 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
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
EP1302462A4 (en) 2000-07-17 2007-07-18 Takeda Pharmaceutical Sulphonic derivatives, process for their preparation and their use
TW200306868A (en) * 2002-05-22 2003-12-01 Shionogi & Co Composition of hardly soluble medicine with improved solubility
EP1564213A4 (en) 2002-11-22 2009-05-27 Takeda Pharmaceutical IMIDAZOLE DERIVATIVES, PROCESS FOR THE PRODUCTION AND USE THEREOF
EP1669352A4 (en) 2003-09-30 2008-12-17 Takeda Pharmaceutical THIAZOLINE DERIVATIVE AND USE
CA2550012A1 (en) 2003-12-17 2005-06-30 Takeda Pharmaceutical Company Limited Urea derivative, process for producing the same and use
TWI396686B (en) 2004-05-21 2013-05-21 Takeda Pharmaceutical Cyclic guanamine derivatives, as well as their products and usage
JP2006321726A (en) * 2005-05-17 2006-11-30 Sysmex Corp Method for controlling elution property of tablet
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
PL2140867T5 (en) * 2007-03-29 2023-10-30 Daiichi Sankyo Company, Limited Pharmaceutical composition

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0753301A1 (en) * 1993-06-07 1997-01-15 Takeda Chemical Industries, Ltd. Combination of benzimidazoles having angiotensin-II antagonistic activity with diuretics
EP1844774A2 (en) * 1993-06-07 2007-10-17 Takeda Pharmaceutical Company Limited A pharmaceutical composition for angiotensin II-mediated diseases
EP1369130A1 (en) * 2001-03-16 2003-12-10 Takeda Chemical Industries, Ltd. Process for producing sustained release preparation
EP1452176A1 (en) * 2001-12-03 2004-09-01 Takeda Chemical Industries, Ltd. Insulin resistance improving agents
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
WO2010035806A1 (en) * 2008-09-25 2010-04-01 武田薬品工業株式会社 Solid pharmaceutical composition

Also Published As

Publication number Publication date
CN102481248B (en) 2013-12-11
AU2010242308A1 (en) 2011-12-01
CO6470841A2 (en) 2012-06-29
CL2011002662A1 (en) 2012-06-15
EP2424501A2 (en) 2012-03-07
BRPI1014388A2 (en) 2016-04-05
ECSP11011494A (en) 2011-12-30
EA201171329A1 (en) 2012-05-30
KR20120026060A (en) 2012-03-16
ZA201108375B (en) 2013-01-30
DOP2011000329A (en) 2011-11-15
SG175794A1 (en) 2011-12-29
PE20120315A1 (en) 2012-04-07
MX2011011011A (en) 2011-11-02
WO2010126168A2 (en) 2010-11-04
TW201041873A (en) 2010-12-01
MY158158A (en) 2016-09-15
CN102481248A (en) 2012-05-30
JP2012525323A (en) 2012-10-22
CR20110581A (en) 2012-01-19
TWI438201B (en) 2014-05-21
IL215962A0 (en) 2012-01-31
JP5666471B2 (en) 2015-02-12
CA2760073A1 (en) 2010-11-04
GEP20135940B (en) 2013-10-10
MA33280B1 (en) 2012-05-02
KR101797776B1 (en) 2017-11-14
NZ596395A (en) 2013-06-28

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