CN102481248B - 固体制剂 - Google Patents

固体制剂 Download PDF

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Publication number
CN102481248B
CN102481248B CN2010800289702A CN201080028970A CN102481248B CN 102481248 B CN102481248 B CN 102481248B CN 2010800289702 A CN2010800289702 A CN 2010800289702A CN 201080028970 A CN201080028970 A CN 201080028970A CN 102481248 B CN102481248 B CN 102481248B
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CN
China
Prior art keywords
solid preparation
salt
granule
tablet
obtains
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Active
Application number
CN2010800289702A
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English (en)
Chinese (zh)
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CN102481248A (zh
Inventor
保科亘
福田诚人
丸中成之
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 Chemical Industries 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
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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=CN102481248(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Chemical Industries Ltd filed Critical Takeda Chemical Industries Ltd
Publication of CN102481248A publication Critical patent/CN102481248A/zh
Application granted granted Critical
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41641,3-Diazoles
    • A61K31/41841,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/44221,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

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)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (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)
CN2010800289702A 2009-04-30 2010-04-28 固体制剂 Active CN102481248B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
JP2009111381 2009-04-30
JP2009-111381 2009-04-30
JP2010068625 2010-03-24
JP2010-068625 2010-03-24
PCT/JP2010/057923 WO2010126168A2 (en) 2009-04-30 2010-04-28 Solid preparation

Publications (2)

Publication Number Publication Date
CN102481248A CN102481248A (zh) 2012-05-30
CN102481248B true CN102481248B (zh) 2013-12-11

Family

ID=43032637

Family Applications (1)

Application Number Title Priority Date Filing Date
CN2010800289702A Active CN102481248B (zh) 2009-04-30 2010-04-28 固体制剂

Country Status (24)

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

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL236001B1 (pl) 2012-12-21 2020-11-30 Adamed Spolka Z Ograniczona Odpowiedzialnoscia Złożona kompozycja farmaceutyczna zawierająca kandesartan cyleksetylu oraz amlodypinę, sposób jej wytwarzania oraz jednostkowa postać dawkowania zawierająca tę kompozycję
KR101535586B1 (ko) * 2014-08-01 2015-07-09 에스케이케미칼주식회사 무정형 또는 열역학적 준 안정형 리바록사반을 포함하는 약학 제제
WO2016122256A1 (ko) * 2015-01-30 2016-08-04 씨제이헬스케어 주식회사 칸데사르탄 및 암로디핀을 포함하는 약제학적 조성물
CN106668016B (zh) * 2015-11-11 2020-06-23 江苏先声药业有限公司 阿齐沙坦和苯磺酸氨氯地平组合物的固体制剂及其制备方法
JP2017210435A (ja) * 2016-05-25 2017-11-30 ダイト株式会社 イルベサルタン及びアムロジピンベシル酸塩配合錠の製造方法
JP2019001782A (ja) * 2017-06-14 2019-01-10 東和薬品株式会社 二層錠
JP7101464B2 (ja) * 2017-09-28 2022-07-15 エルメッド株式会社 アジルサルタン又はその塩及びアムロジピン又はその塩含有錠剤の品質向上方法、並びにアジルサルタン又はその塩及びアムロジピン又はその塩含有錠剤及びその製造方法
CN108210472A (zh) * 2017-12-15 2018-06-29 蚌埠丰原医药科技发展有限公司 一种西尼地平固体分散体片剂及其制备方法
CN108685925B (zh) * 2018-05-15 2019-12-06 徐州医科大学 一种化合物AB-38b在制备治疗糖尿病肾病药物方面的应用
JP2020075869A (ja) * 2018-11-05 2020-05-21 日本ケミファ株式会社 カルシウム拮抗剤及びアンジオテンシンii受容体拮抗剤を有効成分として含有する錠剤
JP2020090471A (ja) * 2018-12-07 2020-06-11 ニプロ株式会社 アジルサルタン及びアムロジピンを含有する医薬組成物及びその製造方法
JP7206872B2 (ja) * 2018-12-07 2023-01-18 ニプロ株式会社 アジルサルタン及びアムロジピンを含有する医薬組成物及びその製造方法
JP7441105B2 (ja) 2020-03-31 2024-02-29 日本ジェネリック株式会社 アジルサルタン及びアムロジピンベシル酸塩を含有するフィルムコーティング錠

Citations (4)

* 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
CN101247832A (zh) * 2005-06-27 2008-08-20 第一三共株式会社 含有血管紧张素ⅱ受体拮抗剂和钙通道阻断剂的药物制剂

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2814513B2 (ja) * 1988-02-03 1998-10-22 吉富製薬株式会社 溶出性の改良された製剤組成物
JP3057471B2 (ja) * 1993-06-07 2000-06-26 武田薬品工業株式会社 アンジオテンシンii介在性諸疾患の予防または治療剤
US20030187023A1 (en) 2000-07-17 2003-10-02 Keiji Kubo Sulfone derivatives, process for their production and use thereof
WO2003097102A1 (fr) * 2002-05-22 2003-11-27 Shionogi & Co., Ltd. Preparation pharmaceutique dans laquelle la propriete de dissolution d'un medicament faiblement soluble dans l'eau est amelioree
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, METHOD FOR THE PRODUCTION AND THEIR USE
TWI396686B (zh) 2004-05-21 2013-05-21 Takeda Pharmaceutical 環狀醯胺衍生物、以及其製品和用法
JP2006321726A (ja) * 2005-05-17 2006-11-30 Sysmex Corp 錠剤の溶出性調整方法
TWI407978B (zh) * 2005-06-27 2013-09-11 Sankyo Co 濕粒狀藥物之製備方法
DE102005031577A1 (de) * 2005-07-06 2007-01-11 Bayer Healthcare Ag Pharmazeutische Darreichungsformen enthaltend eine Wirkstoffkombination von Nifedipin und/oder Nisoldipin und einem Angiotensin-II Antagonisten
ES2644803T5 (es) * 2007-03-29 2024-02-26 Daiichi Sankyo Co Ltd Composición farmacéutica
UY32126A (es) * 2008-09-25 2010-04-30 Takeda Pharmaceutical Composición farmacéutica sólida

Patent Citations (4)

* 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
CN101247832A (zh) * 2005-06-27 2008-08-20 第一三共株式会社 含有血管紧张素ⅱ受体拮抗剂和钙通道阻断剂的药物制剂

Also Published As

Publication number Publication date
EP2424501A2 (en) 2012-03-07
BRPI1014388A2 (pt) 2016-04-05
SG175794A1 (en) 2011-12-29
TW201041873A (en) 2010-12-01
JP2012525323A (ja) 2012-10-22
CL2011002662A1 (es) 2012-06-15
CO6470841A2 (es) 2012-06-29
NZ596395A (en) 2013-06-28
MA33280B1 (fr) 2012-05-02
CR20110581A (es) 2012-01-19
CA2760073A1 (en) 2010-11-04
MY158158A (en) 2016-09-15
ZA201108375B (en) 2013-01-30
GEP20135940B (en) 2013-10-10
MX2011011011A (es) 2011-11-02
KR101797776B1 (ko) 2017-11-14
AU2010242308A1 (en) 2011-12-01
PE20120315A1 (es) 2012-04-07
TWI438201B (zh) 2014-05-21
EA201171329A1 (ru) 2012-05-30
ECSP11011494A (es) 2011-12-30
KR20120026060A (ko) 2012-03-16
CN102481248A (zh) 2012-05-30
WO2010126168A2 (en) 2010-11-04
DOP2011000329A (es) 2011-11-15
JP5666471B2 (ja) 2015-02-12
IL215962A0 (en) 2012-01-31
WO2010126168A3 (en) 2011-03-03

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SE01 Entry into force of request for substantive examination
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