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WO2007001065A3 - Methode pour preparer un produit medicamenteux se presentant sous forme de granules humides - Google Patents

Methode pour preparer un produit medicamenteux se presentant sous forme de granules humides Download PDF

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Publication number
WO2007001065A3
WO2007001065A3 PCT/JP2006/313174 JP2006313174W WO2007001065A3 WO 2007001065 A3 WO2007001065 A3 WO 2007001065A3 JP 2006313174 W JP2006313174 W JP 2006313174W WO 2007001065 A3 WO2007001065 A3 WO 2007001065A3
Authority
WO
WIPO (PCT)
Prior art keywords
preparation
drug product
wet granulated
granulated drug
angiotensin
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.)
Ceased
Application number
PCT/JP2006/313174
Other languages
English (en)
Other versions
WO2007001065A2 (fr
Inventor
Takeshi Hamaura
Mitsuru Kanno
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.)
Sankyo Co Ltd
Original Assignee
Sankyo 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 Sankyo Co Ltd filed Critical Sankyo Co Ltd
Priority to JP2007558254A priority Critical patent/JP5063370B2/ja
Publication of WO2007001065A2 publication Critical patent/WO2007001065A2/fr
Publication of WO2007001065A3 publication Critical patent/WO2007001065A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/2022Organic 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
    • 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
    • A61K31/41781,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/04Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/06Antiarrhythmics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une méthode pour préparer une forme dosifiée solide comprenant un antagoniste du récepteur II d'angiotensine et un bloqueur de canal de calcium. Cette méthode comprend une étape consistant à préparer, par granulation humide, une composition comprenant l'antagoniste du récepteur II d'angiotensine susmentionné et le bloqueur de canal de calcium susmentionné. La forme dosifiée solide de l'invention obtenue par la méthode de l'invention présente des propriétés de dissolution accrues.
PCT/JP2006/313174 2005-06-27 2006-06-26 Methode pour preparer un produit medicamenteux se presentant sous forme de granules humides Ceased WO2007001065A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2007558254A JP5063370B2 (ja) 2005-06-27 2006-06-26 湿式造粒製薬の調製方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2005-187212 2005-06-27
JP2005187212 2005-06-27

Publications (2)

Publication Number Publication Date
WO2007001065A2 WO2007001065A2 (fr) 2007-01-04
WO2007001065A3 true WO2007001065A3 (fr) 2007-05-03

Family

ID=37114405

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2006/313174 Ceased WO2007001065A2 (fr) 2005-06-27 2006-06-26 Methode pour preparer un produit medicamenteux se presentant sous forme de granules humides

Country Status (3)

Country Link
JP (1) JP5063370B2 (fr)
TW (1) TWI407978B (fr)
WO (1) WO2007001065A2 (fr)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0713371A2 (pt) * 2006-06-27 2012-03-13 Daiichi Sankyo Company, Limited método para a produção de um produto medicamentoso contendo olmesartan medoxomil, e, produto medicamentoso contendo olmesartan medoxomil
TWI399223B (zh) * 2006-09-15 2013-06-21 Daiichi Sankyo Co Ltd 奧美沙坦酯及氨氯地平之固體劑型
TWI488658B (zh) * 2006-12-26 2015-06-21 Daiichi Sankyo Co Ltd 溶出性之改善方法
TWI402083B (zh) * 2006-12-26 2013-07-21 Daiichi Sankyo Co Ltd 固形製劑及其安定化方法
TWI414310B (zh) * 2006-12-26 2013-11-11 Daiichi Sankyo Co Ltd 溶出性改善之醫藥品組成物
CN101416966B (zh) * 2007-10-22 2010-11-10 鲁南制药集团股份有限公司 一种治疗高血压的药物组合物
US20110038898A1 (en) * 2008-03-13 2011-02-17 Shuichi Yada Dissolution properties of drug products containing olmesartan medoxomil
JP5296456B2 (ja) * 2008-08-26 2013-09-25 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
WO2010085014A1 (fr) 2009-01-23 2010-07-29 Hanmi Pharm. Co., Ltd. Composition pharmaceutique solide comprenant de l'amlodipine et du losartan et son procédé de fabrication
MA33280B1 (fr) * 2009-04-30 2012-05-02 Takeda Pharmaceutical Preparation solide
CN101596195B (zh) * 2009-05-15 2011-09-28 迪沙药业集团有限公司 降低血压的口服药物组合物
MA33463B1 (fr) * 2009-06-30 2012-07-03 Sanofi Sa Compositions à dose pharmaceutique solide fixe comprenant de l'irbésartan et de l'amlodipine, leur préparation et leur application thérapeutique
JP5421945B2 (ja) * 2010-03-10 2014-02-19 大日本住友製薬株式会社 イルベサルタンとアムロジピンまたはその塩を含有する医薬組成物
EP2425859A1 (fr) * 2010-08-08 2012-03-07 Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi Formulations de l'olmesartane
KR101931489B1 (ko) * 2012-10-12 2018-12-24 이에이 파마 가부시키가이샤 칼슘 길항약/안지오텐신 ii 수용체 길항약 함유 의약 제제의 제조 방법
MX2013001277A (es) * 2013-01-31 2014-07-30 Miguel Ángel García Pérez Composicion farmaceutica con un antagonista de los receptores de la angiotensina ii y un bloqueador de los canales de calcio para el tratamiento de la hipertension arterial.
CN103127110A (zh) * 2013-03-18 2013-06-05 吉林省博大伟业制药有限公司 含有血管紧张素ⅱ受体拮抗剂和钙通道阻断剂的复方制剂
JP5714652B2 (ja) * 2013-06-13 2015-05-07 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
CN104434823A (zh) * 2013-09-17 2015-03-25 许昌恒生制药有限公司 一种盐酸马尼地平片剂及其制备方法
EP2883539A1 (fr) 2013-12-12 2015-06-17 Sanovel Ilac Sanayi ve Ticaret A.S. Combinaisons pharmaceutiques d'olmésartan et d'amlodipine
JP5978335B2 (ja) * 2015-03-11 2016-08-24 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
JP6445923B2 (ja) * 2015-04-22 2018-12-26 ダイト株式会社 イルベサルタン含有錠剤の調製方法
CN109875972B (zh) * 2015-07-08 2021-08-03 南京正大天晴制药有限公司 一种奥美沙坦酯氨氯地平药物组合物
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
JP6151413B2 (ja) * 2016-07-25 2017-06-21 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
CN106580992A (zh) * 2016-11-10 2017-04-26 许昌恒生制药有限公司 一种用于治疗高血压的盐酸马尼地平和厄贝沙坦复合片剂及制备方法
JP2017141299A (ja) * 2017-05-24 2017-08-17 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
JP2018168185A (ja) * 2018-07-05 2018-11-01 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠
JP2019203031A (ja) * 2019-09-06 2019-11-28 大日本住友製薬株式会社 溶出が良好なイルベサルタン含有医薬組成物および口腔内崩壊錠

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010049384A1 (en) * 1999-07-08 2001-12-06 Webb Randy Lee Method of treatment and pharmaceutical composition
WO2003097045A1 (fr) * 2002-05-17 2003-11-27 Novartis Ag Combinaison de composes organiques
US20040198789A1 (en) * 2003-02-28 2004-10-07 Recordati Ireland Limited Lercanidipine/ARB/diuretic therapeutic combinations
WO2006079496A1 (fr) * 2005-01-26 2006-08-03 Lek Pharmaceuticals D.D. Nouvelle composition pharmaceutique contenant candesartan cilexetil en tant que substance cristalline lipophile

Family Cites Families (2)

* Cited by examiner, † Cited by third party
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JP2003034655A (ja) * 2001-05-15 2003-02-07 Takeda Chem Ind Ltd 速崩壊性固形製剤
JP2003104888A (ja) * 2001-09-28 2003-04-09 Taiyo Yakuhin Kogyo Kk ジヒドロピリジン誘導体の錠剤

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010049384A1 (en) * 1999-07-08 2001-12-06 Webb Randy Lee Method of treatment and pharmaceutical composition
WO2003097045A1 (fr) * 2002-05-17 2003-11-27 Novartis Ag Combinaison de composes organiques
US20040198789A1 (en) * 2003-02-28 2004-10-07 Recordati Ireland Limited Lercanidipine/ARB/diuretic therapeutic combinations
WO2006079496A1 (fr) * 2005-01-26 2006-08-03 Lek Pharmaceuticals D.D. Nouvelle composition pharmaceutique contenant candesartan cilexetil en tant que substance cristalline lipophile

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BAUER, FRÖMMING, FÜHRER: "Pharmazeutische Technologie", 1997, GUSTAV FISCHER, XP002414403 *
RUMP L C ET AL: "COMBINATION OF THE ANGIOTENSIN II-RECEPTOR ANTAGONIST OLMESARTAN MEDOXOMIL WITH AMLODIPINE: PHARMACOKINETICS, SAFETY AND TOLERABILITY IN HEALTHY MALE SUBJECTS", JOURNAL OF HYPERTENSION, CURRENT SCIENCE, PHILADELPHIA, PA, US, vol. 22, no. SUPPL 1, 18 February 2004 (2004-02-18), pages 145S, XP008058906, ISSN: 0263-6352 *

Also Published As

Publication number Publication date
JP2008543727A (ja) 2008-12-04
TWI407978B (zh) 2013-09-11
TW200730200A (en) 2007-08-16
WO2007001065A2 (fr) 2007-01-04
JP5063370B2 (ja) 2012-10-31

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