TWI438201B - 固體製劑 - Google Patents

固體製劑 Download PDF

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Publication number
TWI438201B
TWI438201B TW099113442A TW99113442A TWI438201B TW I438201 B TWI438201 B TW I438201B TW 099113442 A TW099113442 A TW 099113442A TW 99113442 A TW99113442 A TW 99113442A TW I438201 B TWI438201 B TW I438201B
Authority
TW
Taiwan
Prior art keywords
binder
mixed
granules
compound
salt
Prior art date
Application number
TW099113442A
Other languages
English (en)
Chinese (zh)
Other versions
TW201041873A (en
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=TWI438201(B) "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 TW201041873A publication Critical patent/TW201041873A/zh
Application granted granted Critical
Publication of TWI438201B publication Critical patent/TWI438201B/zh

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)
  • Emergency Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (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)
TW099113442A 2009-04-30 2010-04-28 固體製劑 TWI438201B (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2009111381 2009-04-30
JP2010068625 2010-03-24

Publications (2)

Publication Number Publication Date
TW201041873A TW201041873A (en) 2010-12-01
TWI438201B true TWI438201B (zh) 2014-05-21

Family

ID=43032637

Family Applications (1)

Application Number Title Priority Date Filing Date
TW099113442A TWI438201B (zh) 2009-04-30 2010-04-28 固體製劑

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

Family Cites Families (17)

* 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
CA2125251C (en) * 1993-06-07 2005-04-26 Yoshiyuki Inada A pharmaceutical composition for angiotensin ii-mediated diseases
CA2416384A1 (en) 2000-07-17 2003-01-16 Takeda Chemical Industries, Ltd. Sulfone derivatives, their production and use
WO2002074340A1 (fr) * 2001-03-16 2002-09-26 Takeda Chemical Industries, Ltd. Procede de fabrication d'une preparation a liberation continue
EP1452176A4 (en) * 2001-12-03 2009-01-21 Takeda Pharmaceutical MEANS FOR IMPROVING INSULIN RESISTANCE
AU2003235395A1 (en) * 2002-05-22 2003-12-02 Shionogi And 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
EP1669352A4 (en) 2003-09-30 2008-12-17 Takeda Pharmaceutical THIAZOLINE DERIVATIVE AND ITS USE
WO2005058823A1 (ja) 2003-12-17 2005-06-30 Takeda Pharmaceutical Company Limited ウレア誘導体、その製造法及び用途
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
JP5063370B2 (ja) * 2005-06-27 2012-10-31 第一三共株式会社 湿式造粒製薬の調製方法
EP1898951B1 (en) * 2005-06-27 2013-02-27 Daiichi Sankyo Company, Limited Pharmaceutical preparation containing an angiotensin ii receptor antagonist and a calcium channel blocker
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
BRPI0809205B8 (pt) * 2007-03-29 2021-05-25 Daiichi Sankyo Co Ltd composição farmacêutica
TW201014850A (en) * 2008-09-25 2010-04-16 Takeda Pharmaceutical Solid pharmaceutical composition

Also Published As

Publication number Publication date
EP2424501A2 (en) 2012-03-07
CL2011002662A1 (es) 2012-06-15
ZA201108375B (en) 2013-01-30
WO2010126168A2 (en) 2010-11-04
ECSP11011494A (es) 2011-12-30
KR101797776B1 (ko) 2017-11-14
DOP2011000329A (es) 2011-11-15
PE20120315A1 (es) 2012-04-07
CA2760073A1 (en) 2010-11-04
NZ596395A (en) 2013-06-28
KR20120026060A (ko) 2012-03-16
MA33280B1 (fr) 2012-05-02
MY158158A (en) 2016-09-15
TW201041873A (en) 2010-12-01
CN102481248A (zh) 2012-05-30
IL215962A0 (en) 2012-01-31
BRPI1014388A2 (pt) 2016-04-05
WO2010126168A3 (en) 2011-03-03
GEP20135940B (en) 2013-10-10
SG175794A1 (en) 2011-12-29
JP2012525323A (ja) 2012-10-22
EA201171329A1 (ru) 2012-05-30
AU2010242308A1 (en) 2011-12-01
CN102481248B (zh) 2013-12-11
CR20110581A (es) 2012-01-19
CO6470841A2 (es) 2012-06-29
MX2011011011A (es) 2011-11-02
JP5666471B2 (ja) 2015-02-12

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