CA2877444C - Pharmaceutical composition comprising fimasartan and hydrochlorothiazide - Google Patents

Pharmaceutical composition comprising fimasartan and hydrochlorothiazide Download PDF

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Publication number
CA2877444C
CA2877444C CA2877444A CA2877444A CA2877444C CA 2877444 C CA2877444 C CA 2877444C CA 2877444 A CA2877444 A CA 2877444A CA 2877444 A CA2877444 A CA 2877444A CA 2877444 C CA2877444 C CA 2877444C
Authority
CA
Canada
Prior art keywords
hydrochlorothiazide
pharmaceutical composition
tablet
fimasartan
hydrate
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
CA2877444A
Other languages
English (en)
French (fr)
Other versions
CA2877444A1 (en
Inventor
Je Hak Kim
Kyung Wan Nam
Seo Hun PARK
Ju Won Kim
Sang Yeop Kim
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.)
Boryung Pharmaceutical Co Ltd
Original Assignee
Boryung 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
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Application filed by Boryung Pharmaceutical Co Ltd filed Critical Boryung Pharmaceutical Co Ltd
Publication of CA2877444A1 publication Critical patent/CA2877444A1/en
Application granted granted Critical
Publication of CA2877444C publication Critical patent/CA2877444C/en
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Classifications

    • 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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/549—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame having two or more nitrogen atoms in the same ring, e.g. hydrochlorothiazide
    • 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • 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
    • 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
    • A61K2121/00—Preparations for use in therapy

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2877444A 2012-06-28 2013-04-30 Pharmaceutical composition comprising fimasartan and hydrochlorothiazide Active CA2877444C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2012-0070359 2012-06-28
KR20120070359A KR101414873B1 (ko) 2012-06-28 2012-06-28 피마살탄 및 히드로클로로티아지드가 함유된 약제학적 조성물
PCT/KR2013/003734 WO2014003305A1 (ko) 2012-06-28 2013-04-30 피마살탄 및 히드로클로로티아지드가 함유된 약제학적 조성물

Publications (2)

Publication Number Publication Date
CA2877444A1 CA2877444A1 (en) 2014-01-03
CA2877444C true CA2877444C (en) 2017-08-01

Family

ID=49783403

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2877444A Active CA2877444C (en) 2012-06-28 2013-04-30 Pharmaceutical composition comprising fimasartan and hydrochlorothiazide

Country Status (21)

Country Link
US (1) US9457094B2 (2)
EP (1) EP2868316B1 (2)
JP (1) JP6145506B2 (2)
KR (1) KR101414873B1 (2)
CN (2) CN104602676A (2)
AU (1) AU2013281582B2 (2)
BR (1) BR112014032764B1 (2)
CA (1) CA2877444C (2)
CL (1) CL2014003525A1 (2)
CO (1) CO7240413A2 (2)
ES (1) ES2654207T3 (2)
IN (1) IN2015DN00645A (2)
MX (1) MX351521B (2)
MY (1) MY165075A (2)
PE (1) PE20150607A1 (2)
PH (1) PH12014502876B1 (2)
RU (1) RU2613900C2 (2)
SG (1) SG11201408666SA (2)
UA (1) UA111434C2 (2)
WO (1) WO2014003305A1 (2)
ZA (1) ZA201409508B (2)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105395552A (zh) * 2014-09-05 2016-03-16 南京华威医药科技开发有限公司 一种含非马沙坦及其盐的固体制剂
KR101545268B1 (ko) 2015-02-05 2015-08-20 보령제약 주식회사 정제 및 이의 제조방법
WO2017091041A1 (ko) * 2015-11-26 2017-06-01 보령제약 주식회사 피마살탄의 신규 염
MX387327B (es) * 2016-01-27 2025-03-18 Boryung Pharm Composición farmacéutica para prevenir o tratar nefropatía diabética
KR102233673B1 (ko) * 2016-01-27 2021-03-30 보령제약 주식회사 당뇨병성 신장질환의 예방 또는 치료용 약학적 조성물
CN105784867B (zh) * 2016-03-28 2019-01-01 北京睿创康泰医药研究院有限公司 用于分析非马沙坦有关物质的hplc方法及这些杂质作参比标准的用途
KR102201396B1 (ko) * 2017-11-30 2021-01-11 보령제약 주식회사 피마살탄을 포함하는 약학적 조성물
KR20220162456A (ko) * 2021-06-01 2022-12-08 주식회사 보령 고혈압을 동반한 당뇨병성 신장질환의 예방 또는 치료용 약학적 조성물
CN120037195B (zh) * 2023-09-28 2025-11-28 浙江百代医药科技有限公司 一种硫辛酸药物组合物及其制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4107831B2 (ja) * 2000-11-21 2008-06-25 第一三共株式会社 医薬組成物
CN101352421A (zh) * 2002-01-16 2009-01-28 贝林格尔英格海姆法玛两合公司 一种制备基本上非结晶形式的替米沙坦的方法
KR100678421B1 (ko) * 2005-02-11 2007-02-02 주식회사 씨티씨바이오 염산 탐스로신 함유 방출조절 제제
ATE499090T1 (de) 2006-06-16 2011-03-15 Lek Pharmaceuticals Pharmazeutische zusammensetzung mit hydrochlorothiazid und telmisartan
EP2203158A4 (en) 2007-10-30 2012-12-26 Reddys Lab Ltd Dr PHARMACEUTICAL FORMULATIONS WITH TELMISARTAN AND HYDROCHLORTHIAZIDE
ES2364011B1 (es) * 2009-11-20 2013-01-24 Gp Pharm, S.A. Cápsulas de principios activos farmacéuticos y ésteres de ácidos grasos poliinsaturados para el tratamiento de enfermedades cardiovasculares.
KR101058284B1 (ko) 2010-01-22 2011-08-22 보령제약 주식회사 2-(2-ｎ-부틸-4-히드록시-6-메틸-피리미딘-5-일)-Ｎ,Ｎ-디메틸아세트아미드의 신규한 제조방법
TR201004754A1 (tr) * 2010-06-11 2012-01-23 Sanovel �La� San. Ve T�C. A.�. Yeni Farmasötik Kombinasyonlar
CN102397278A (zh) * 2010-09-19 2012-04-04 鲁南制药集团股份有限公司 一种抗高血压药物组合物
CN102485227B (zh) * 2010-12-02 2015-06-10 鲁南制药集团股份有限公司 一种药物组合物及其用途
CN102485228B (zh) * 2010-12-02 2015-06-10 鲁南制药集团股份有限公司 一种药物组合物及其用途
CN102058602B (zh) * 2010-12-21 2013-04-10 中国药科大学 一种稳定的含氯沙坦钾和氢氯噻嗪的口服固体制剂

Also Published As

Publication number Publication date
CN104602676A (zh) 2015-05-06
BR112014032764A2 (pt) 2017-06-27
CN110496122A (zh) 2019-11-26
US9457094B2 (en) 2016-10-04
CL2014003525A1 (es) 2015-04-10
KR101414873B1 (ko) 2014-07-03
EP2868316A4 (en) 2016-02-17
UA111434C2 (uk) 2016-04-25
EP2868316B1 (en) 2017-12-06
MX2014015841A (es) 2015-07-17
WO2014003305A1 (ko) 2014-01-03
BR112014032764B1 (pt) 2021-12-07
MY165075A (en) 2018-02-28
ZA201409508B (en) 2016-08-31
IN2015DN00645A (2) 2015-06-26
AU2013281582A1 (en) 2015-02-05
PH12014502876A1 (en) 2015-02-23
JP2015525745A (ja) 2015-09-07
JP6145506B2 (ja) 2017-06-14
MX351521B (es) 2017-10-18
ES2654207T3 (es) 2018-02-12
SG11201408666SA (en) 2015-03-30
EP2868316A1 (en) 2015-05-06
RU2613900C2 (ru) 2017-03-21
KR20140006233A (ko) 2014-01-16
CA2877444A1 (en) 2014-01-03
PE20150607A1 (es) 2015-05-16
RU2015102553A (ru) 2016-08-20
PH12014502876B1 (en) 2015-02-23
CO7240413A2 (es) 2015-04-17
AU2013281582B2 (en) 2016-06-09
US20150147394A1 (en) 2015-05-28

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