JP6513030B2 - トホグリフロジンを含有する固形製剤及びその製造方法 - Google Patents

トホグリフロジンを含有する固形製剤及びその製造方法 Download PDF

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Publication number
JP6513030B2
JP6513030B2 JP2015555053A JP2015555053A JP6513030B2 JP 6513030 B2 JP6513030 B2 JP 6513030B2 JP 2015555053 A JP2015555053 A JP 2015555053A JP 2015555053 A JP2015555053 A JP 2015555053A JP 6513030 B2 JP6513030 B2 JP 6513030B2
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Prior art keywords
weight
tablet
tofogliflozin
starch
crystal
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Japanese (ja)
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JPWO2015099139A1 (ja
Inventor
健太 和田
健太 和田
智章 平山
智章 平山
憲一 酒井
憲一 酒井
志保 吉村
志保 吉村
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Chugai Pharmaceutical Co Ltd
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Chugai Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2015555053A 2013-12-27 2014-12-26 トホグリフロジンを含有する固形製剤及びその製造方法 Active JP6513030B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2013273060 2013-12-27
JP2013273060 2013-12-27
PCT/JP2014/084561 WO2015099139A1 (ja) 2013-12-27 2014-12-26 トホグリフロジンを含有する固形製剤及びその製造方法

Related Child Applications (1)

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JP2019030773A Division JP6759390B2 (ja) 2013-12-27 2019-02-22 トホグリフロジンを含有する固形製剤及びその製造方法

Publications (2)

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JPWO2015099139A1 JPWO2015099139A1 (ja) 2017-03-23
JP6513030B2 true JP6513030B2 (ja) 2019-05-15

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Application Number Title Priority Date Filing Date
JP2015555053A Active JP6513030B2 (ja) 2013-12-27 2014-12-26 トホグリフロジンを含有する固形製剤及びその製造方法
JP2019030773A Active JP6759390B2 (ja) 2013-12-27 2019-02-22 トホグリフロジンを含有する固形製剤及びその製造方法
JP2020147286A Pending JP2020203918A (ja) 2013-12-27 2020-09-02 トホグリフロジンを含有する固形製剤及びその製造方法
JP2022089651A Pending JP2022116267A (ja) 2013-12-27 2022-06-01 トホグリフロジンを含有する固形製剤及びその製造方法
JP2024030315A Pending JP2024063140A (ja) 2013-12-27 2024-02-29 トホグリフロジンを含有する固形製剤及びその製造方法

Family Applications After (4)

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JP2019030773A Active JP6759390B2 (ja) 2013-12-27 2019-02-22 トホグリフロジンを含有する固形製剤及びその製造方法
JP2020147286A Pending JP2020203918A (ja) 2013-12-27 2020-09-02 トホグリフロジンを含有する固形製剤及びその製造方法
JP2022089651A Pending JP2022116267A (ja) 2013-12-27 2022-06-01 トホグリフロジンを含有する固形製剤及びその製造方法
JP2024030315A Pending JP2024063140A (ja) 2013-12-27 2024-02-29 トホグリフロジンを含有する固形製剤及びその製造方法

Country Status (21)

Country Link
US (2) US10231930B2 (enExample)
EP (2) EP3087989B1 (enExample)
JP (5) JP6513030B2 (enExample)
KR (2) KR102395687B1 (enExample)
CN (2) CN105828826B (enExample)
AU (1) AU2014370847B2 (enExample)
BR (1) BR112016013164B1 (enExample)
CA (1) CA2934832C (enExample)
DK (1) DK3087989T3 (enExample)
ES (1) ES2704065T3 (enExample)
HR (1) HRP20182199T1 (enExample)
HU (1) HUE041983T2 (enExample)
LT (1) LT3087989T (enExample)
MX (2) MX370342B (enExample)
PL (1) PL3087989T3 (enExample)
PT (1) PT3087989T (enExample)
RU (1) RU2700164C2 (enExample)
SI (1) SI3087989T1 (enExample)
TR (1) TR201821042T4 (enExample)
TW (2) TWI774159B (enExample)
WO (1) WO2015099139A1 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
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PL2674428T3 (pl) 2006-04-07 2017-01-31 Vertex Pharmaceuticals Incorporated Modulatory transporterów z kasetą wiążącą ATP
US10231930B2 (en) * 2013-12-27 2019-03-19 Chugai Seiyaku Kabushiki Kaisha Solid preparations containing tofogliflozin and process of producing the same
CN108640958B (zh) * 2017-05-05 2021-03-30 镇江圣安医药有限公司 异苯并呋喃衍生物、其药物组合物和制剂以及用途
CN107811983A (zh) * 2017-12-04 2018-03-20 威海贯标信息科技有限公司 一种托格列净组合物
CN107759649A (zh) * 2017-12-12 2018-03-06 威海贯标信息科技有限公司 一种托格列净新晶型
JP2022146628A (ja) * 2021-03-22 2022-10-05 旭化成株式会社 錠剤及びその製造方法

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JPS56145214A (en) 1980-04-11 1981-11-11 Taiho Yakuhin Kogyo Kk Ubidecarenone tablet
JP2626975B2 (ja) 1987-03-30 1997-07-02 エーザイ株式会社 低融点油性物質含有錠剤
ES2082723B1 (es) 1994-07-20 1996-10-01 Lilly Sa Formulacion farmaceutica de fluoxetina en forma dispersable.
JPH10287561A (ja) 1997-04-11 1998-10-27 Taisho Pharmaceut Co Ltd イブプロフェン配合固形製剤及びその製造方法
JP2000239185A (ja) 1999-02-16 2000-09-05 Taisho Pharmaceut Co Ltd 医薬組成物
JP2006528689A (ja) 2003-05-06 2006-12-21 ムルイェ、ニルマル エリスロマイシン誘導体の徐放製剤
JP2005104934A (ja) 2003-10-01 2005-04-21 Eisai Co Ltd 新規組成物及びその製造方法
JP4997741B2 (ja) 2004-11-12 2012-08-08 大正製薬株式会社 低融点薬物含有粉粒体及びその製造方法
TW200637869A (en) 2005-01-28 2006-11-01 Chugai Pharmaceutical Co Ltd The spiroketal derivatives and the use as therapeutical agent for diabetes of the same
PE20090185A1 (es) * 2007-03-22 2009-02-28 Bristol Myers Squibb Co Formulaciones farmaceuticas que contienen un inhibidor sglt2
JP4072195B2 (ja) 2007-10-18 2008-04-09 キッセイ薬品工業株式会社 速放性経口医薬組成物
TW201011043A (en) * 2008-06-20 2010-03-16 Chugai Pharmaceutical Co Ltd Crystal of spiroketal derivatives and process for preparation of spiroketal derivatives
KR20110126614A (ko) * 2009-02-13 2011-11-23 베링거 인겔하임 인터내셔날 게엠베하 글루코피라노실 디페닐메탄 유도체를 포함하는 약제학적 조성물, 이들의 약제학적 용량형, 이들의 제조방법 및 환자에서의 개선된 당 조절을 위한 이들의 용도
US20130035281A1 (en) * 2011-02-09 2013-02-07 Boehringer Ingelheim International Gmbh Pharmaceutical composition, methods for treating and uses thereof
WO2012115249A1 (ja) * 2011-02-25 2012-08-30 中外製薬株式会社 スピロケタール誘導体の結晶
MX2013014135A (es) * 2011-06-03 2014-01-23 Boehringer Ingelheim Int Inhibidores de sglt2 para tratar trastornos metabolicos en pacientes tratados con agentes neurolepticos.
PL2981269T3 (pl) * 2013-04-04 2024-02-05 Boehringer Ingelheim Vetmedica Gmbh Leczenie zaburzeń metabolicznych u zwierząt koniowatych
US10231930B2 (en) * 2013-12-27 2019-03-19 Chugai Seiyaku Kabushiki Kaisha Solid preparations containing tofogliflozin and process of producing the same

Also Published As

Publication number Publication date
MX2019008865A (es) 2019-09-13
JPWO2015099139A1 (ja) 2017-03-23
MX370342B (es) 2019-12-10
CN113058038A (zh) 2021-07-02
BR112016013164B1 (pt) 2022-07-26
PT3087989T (pt) 2019-02-26
CA2934832A1 (en) 2015-07-02
WO2015099139A1 (ja) 2015-07-02
KR102395687B1 (ko) 2022-05-06
MX2016008527A (es) 2016-09-13
JP2022116267A (ja) 2022-08-09
RU2016130602A3 (enExample) 2018-06-08
US20160324786A1 (en) 2016-11-10
EP3087989A1 (en) 2016-11-02
EP3087989A4 (en) 2017-09-20
TW202126311A (zh) 2021-07-16
RU2700164C2 (ru) 2019-09-13
KR20160101719A (ko) 2016-08-25
JP2019112424A (ja) 2019-07-11
EP3482748A1 (en) 2019-05-15
RU2016130602A (ru) 2018-02-01
US20190151248A1 (en) 2019-05-23
SI3087989T1 (sl) 2019-03-29
HUE041983T2 (hu) 2019-06-28
PL3087989T3 (pl) 2019-07-31
TWI774159B (zh) 2022-08-11
TWI715523B (zh) 2021-01-11
MX390480B (es) 2025-03-20
HK1224221A1 (zh) 2017-08-18
CN105828826B (zh) 2021-04-06
JP2020203918A (ja) 2020-12-24
TW201609194A (zh) 2016-03-16
CN113058038B (zh) 2024-01-12
TR201821042T4 (tr) 2019-01-21
US10398653B2 (en) 2019-09-03
EP3087989B1 (en) 2018-12-19
US10231930B2 (en) 2019-03-19
LT3087989T (lt) 2019-02-11
CN105828826A (zh) 2016-08-03
AU2014370847A1 (en) 2016-06-16
ES2704065T3 (es) 2019-03-14
DK3087989T3 (en) 2019-03-25
CA2934832C (en) 2022-03-15
KR20210082557A (ko) 2021-07-05
BR112016013164A2 (enExample) 2017-08-08
HRP20182199T1 (hr) 2019-02-22
AU2014370847B2 (en) 2020-02-20
JP6759390B2 (ja) 2020-09-23
JP2024063140A (ja) 2024-05-10

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