CA2934832C - Solid preparations containing tofogliflozin and process of producing the same - Google Patents

Solid preparations containing tofogliflozin and process of producing the same Download PDF

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Publication number
CA2934832C
CA2934832C CA2934832A CA2934832A CA2934832C CA 2934832 C CA2934832 C CA 2934832C CA 2934832 A CA2934832 A CA 2934832A CA 2934832 A CA2934832 A CA 2934832A CA 2934832 C CA2934832 C CA 2934832C
Authority
CA
Canada
Prior art keywords
tofogliflozin
tablet
starch
crystal form
weight ratio
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.)
Active
Application number
CA2934832A
Other languages
English (en)
French (fr)
Other versions
CA2934832A1 (en
Inventor
Kenta Wada
Tomoaki Hirayama
Kenichi Sakai
Shiho YOSHIMURA
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.)
Chugai Pharmaceutical Co Ltd
Original Assignee
Chugai 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
Application filed by Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Publication of CA2934832A1 publication Critical patent/CA2934832A1/en
Application granted granted Critical
Publication of CA2934832C publication Critical patent/CA2934832C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA2934832A 2013-12-27 2014-12-26 Solid preparations containing tofogliflozin and process of producing the same Active CA2934832C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2013273060 2013-12-27
JP2013-273060 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

Publications (2)

Publication Number Publication Date
CA2934832A1 CA2934832A1 (en) 2015-07-02
CA2934832C true CA2934832C (en) 2022-03-15

Family

ID=53478978

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2934832A Active CA2934832C (en) 2013-12-27 2014-12-26 Solid preparations containing tofogliflozin and process of producing the same

Country Status (21)

Country Link
US (2) US10231930B2 (https=)
EP (2) EP3087989B1 (https=)
JP (6) JP6513030B2 (https=)
KR (2) KR20210082557A (https=)
CN (2) CN113058038B (https=)
AU (1) AU2014370847B2 (https=)
BR (1) BR112016013164B1 (https=)
CA (1) CA2934832C (https=)
DK (1) DK3087989T3 (https=)
ES (1) ES2704065T3 (https=)
HR (1) HRP20182199T1 (https=)
HU (1) HUE041983T2 (https=)
LT (1) LT3087989T (https=)
MX (2) MX390480B (https=)
PL (1) PL3087989T3 (https=)
PT (1) PT3087989T (https=)
RU (1) RU2700164C2 (https=)
SI (1) SI3087989T1 (https=)
TR (1) TR201821042T4 (https=)
TW (2) TWI715523B (https=)
WO (1) WO2015099139A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2674428B1 (en) 2006-04-07 2016-04-06 Vertex Pharmaceuticals Incorporated Modulators of ATP-binding cassette transporters
AU2014370847B2 (en) * 2013-12-27 2020-02-20 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

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US8507000B2 (en) 2003-05-06 2013-08-13 Nostrum Pharmaceuticals, Inc. Controlled release formulation of erythromycin derivatives
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
AR065809A1 (es) * 2007-03-22 2009-07-01 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
KR101921934B1 (ko) * 2009-02-13 2018-11-26 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
BR112013031032A2 (pt) * 2011-06-03 2016-11-29 Boehringer Ingelheim Int inibidores de sglt-2 para o tratamento de distúrbios metabólicos em pacientes tratados com agentes neurolépticos
DK2981269T3 (da) * 2013-04-04 2023-10-23 Boehringer Ingelheim Vetmedica Gmbh Behandling af stofskifteforstyrrelser hos hestedyr
AU2014370847B2 (en) * 2013-12-27 2020-02-20 Chugai Seiyaku Kabushiki Kaisha Solid preparations containing tofogliflozin and process of producing the same

Also Published As

Publication number Publication date
JP2022116267A (ja) 2022-08-09
US20190151248A1 (en) 2019-05-23
DK3087989T3 (en) 2019-03-25
JPWO2015099139A1 (ja) 2017-03-23
RU2700164C2 (ru) 2019-09-13
HUE041983T2 (hu) 2019-06-28
AU2014370847A1 (en) 2016-06-16
JP6513030B2 (ja) 2019-05-15
RU2016130602A3 (https=) 2018-06-08
ES2704065T3 (es) 2019-03-14
CA2934832A1 (en) 2015-07-02
US10231930B2 (en) 2019-03-19
WO2015099139A1 (ja) 2015-07-02
BR112016013164B1 (pt) 2022-07-26
SI3087989T1 (sl) 2019-03-29
MX2019008865A (es) 2019-09-13
CN113058038A (zh) 2021-07-02
EP3087989A1 (en) 2016-11-02
LT3087989T (lt) 2019-02-11
EP3482748A1 (en) 2019-05-15
US10398653B2 (en) 2019-09-03
JP2026016750A (ja) 2026-02-03
KR20210082557A (ko) 2021-07-05
JP2020203918A (ja) 2020-12-24
TW202126311A (zh) 2021-07-16
KR102395687B1 (ko) 2022-05-06
MX2016008527A (es) 2016-09-13
TR201821042T4 (tr) 2019-01-21
BR112016013164A2 (https=) 2017-08-08
TWI774159B (zh) 2022-08-11
PL3087989T3 (pl) 2019-07-31
JP6759390B2 (ja) 2020-09-23
CN105828826A (zh) 2016-08-03
CN113058038B (zh) 2024-01-12
TW201609194A (zh) 2016-03-16
PT3087989T (pt) 2019-02-26
HK1224221A1 (zh) 2017-08-18
JP2024063140A (ja) 2024-05-10
HRP20182199T1 (hr) 2019-02-22
KR20160101719A (ko) 2016-08-25
MX390480B (es) 2025-03-20
MX370342B (es) 2019-12-10
US20160324786A1 (en) 2016-11-10
RU2016130602A (ru) 2018-02-01
TWI715523B (zh) 2021-01-11
EP3087989B1 (en) 2018-12-19
AU2014370847B2 (en) 2020-02-20
JP2019112424A (ja) 2019-07-11
CN105828826B (zh) 2021-04-06
EP3087989A4 (en) 2017-09-20

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