[go: up one dir, main page]

WO2007001065A3 - Method for the preparation of a wet granulated drug product - Google Patents

Method for the preparation of a wet granulated drug product Download PDF

Info

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
French (fr)
Other versions
WO2007001065A2 (en
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/en
Publication of WO2007001065A2 publication Critical patent/WO2007001065A2/en
Publication of WO2007001065A3 publication Critical patent/WO2007001065A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/2022—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
    • A61K31/33—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
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • 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
    • A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
    • 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
    • A61P9/06—Antiarrhythmics
    • 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
    • A61P9/10—Drugs 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes 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

The invention relates to a method for the preparation of a solid dosage form comprising an angiotensin II receptor antagonist and a calcium channel blocker, said method comprising a step of preparing by wet granulation a composition comprising said angiotensin II receptor antagonist and said calcium channel blocker. The solid dosage form obtainable by the method of the present invention demonstrates improved dissolution properties.
PCT/JP2006/313174 2005-06-27 2006-06-26 Method for the preparation of a wet granulated drug product Ceased WO2007001065A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2007558254A JP5063370B2 (en) 2005-06-27 2006-06-26 Method for preparing wet granulated pharmaceutical

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 (en) 2007-01-04
WO2007001065A3 true WO2007001065A3 (en) 2007-05-03

Family

ID=37114405

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2006/313174 Ceased WO2007001065A2 (en) 2005-06-27 2006-06-26 Method for the preparation of a wet granulated drug product

Country Status (3)

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

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0713371A2 (en) * 2006-06-27 2012-03-13 Daiichi Sankyo Company, Limited method for producing a medicament containing olmesartan medoxomil, and medicament containing olmesartan medoxomil
TWI399223B (en) * 2006-09-15 2013-06-21 Daiichi Sankyo Co Ltd Solid dosage form of olmesartan and amlodipine
TWI488658B (en) * 2006-12-26 2015-06-21 Daiichi Sankyo Co Ltd Method for improvement of elution
TWI402083B (en) * 2006-12-26 2013-07-21 Daiichi Sankyo Co Ltd Solid dosage form and stabilization method thereof
TWI414310B (en) * 2006-12-26 2013-11-11 Daiichi Sankyo Co Ltd Elution-improved pharmaceutical preparation
CN101416966B (en) * 2007-10-22 2010-11-10 鲁南制药集团股份有限公司 Medical composition capable of treating hypertension
US20110038898A1 (en) * 2008-03-13 2011-02-17 Shuichi Yada Dissolution properties of drug products containing olmesartan medoxomil
JP5296456B2 (en) * 2008-08-26 2013-09-25 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition with good dissolution and orally disintegrating tablet
WO2010085014A1 (en) 2009-01-23 2010-07-29 Hanmi Pharm. Co., Ltd. Solid pharmaceutical composition comprising amlodipine and losartan and process for producing same
MA33280B1 (en) * 2009-04-30 2012-05-02 Takeda Pharmaceutical Solid product
CN101596195B (en) * 2009-05-15 2011-09-28 迪沙药业集团有限公司 Oral medicine composite for reducing blood pressure
MA33463B1 (en) * 2009-06-30 2012-07-03 Sanofi Sa FIXED SOLID PHARMACEUTICAL DOSE COMPOSITIONS COMPRISING IRBESARTAN AND AMLODIPINE, PREPARATION THEREOF AND THERAPEUTIC APPLICATION THEREOF
JP5421945B2 (en) * 2010-03-10 2014-02-19 大日本住友製薬株式会社 Pharmaceutical composition containing irbesartan and amlodipine or a salt thereof
EP2425859A1 (en) * 2010-08-08 2012-03-07 Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi Olmesartan formulations
KR101931489B1 (en) * 2012-10-12 2018-12-24 이에이 파마 가부시키가이샤 Method for producing pharmaceutical preparation containing calcium antagonist/angiotensin ii receptor antagonist
MX2013001277A (en) * 2013-01-31 2014-07-30 Miguel Ángel García Pérez Pharmaceutical composition comprising an angiotensin ii-receptor antagonist and a calcium channel blocker for the treatment of arterial hypertension.
CN103127110A (en) * 2013-03-18 2013-06-05 吉林省博大伟业制药有限公司 Compound preparation containing angiotensin II receptor antagonist and calcium channel blocker
JP5714652B2 (en) * 2013-06-13 2015-05-07 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition with good dissolution and orally disintegrating tablet
CN104434823A (en) * 2013-09-17 2015-03-25 许昌恒生制药有限公司 Manidipine hydrochloride tablets and preparation method thereof
EP2883539A1 (en) 2013-12-12 2015-06-17 Sanovel Ilac Sanayi ve Ticaret A.S. Pharmaceutical combinations of olmesartan and amlodipine
JP5978335B2 (en) * 2015-03-11 2016-08-24 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition with good dissolution and orally disintegrating tablet
JP6445923B2 (en) * 2015-04-22 2018-12-26 ダイト株式会社 Preparation of irbesartan-containing tablets
CN109875972B (en) * 2015-07-08 2021-08-03 南京正大天晴制药有限公司 Olmesartan medoxomil and amlodipine pharmaceutical composition
JP2017210435A (en) * 2016-05-25 2017-11-30 ダイト株式会社 Method for producing irbesartan and amlodipine besylate-containing tablet
JP6151413B2 (en) * 2016-07-25 2017-06-21 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition with good dissolution and orally disintegrating tablet
CN106580992A (en) * 2016-11-10 2017-04-26 许昌恒生制药有限公司 Manidipine hydrochloride and irbesartan compound tablet for treating high blood pressure and preparation method
JP2017141299A (en) * 2017-05-24 2017-08-17 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition showing excellent elution, and orally disintegrable tablet
JP2018168185A (en) * 2018-07-05 2018-11-01 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition and orally disintegrable tablet with excellent elution
JP2019203031A (en) * 2019-09-06 2019-11-28 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition showing excellent elution, and orally disintegrable tablet

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 (en) * 2002-05-17 2003-11-27 Novartis Ag Combination of organic compounds
US20040198789A1 (en) * 2003-02-28 2004-10-07 Recordati Ireland Limited Lercanidipine/ARB/diuretic therapeutic combinations
WO2006079496A1 (en) * 2005-01-26 2006-08-03 Lek Pharmaceuticals D.D. New pharmaceutical composition containing candesartan cilexetil as lipophilic crystalline substance

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003034655A (en) * 2001-05-15 2003-02-07 Takeda Chem Ind Ltd Fast disintegrating solid preparation
JP2003104888A (en) * 2001-09-28 2003-04-09 Taiyo Yakuhin Kogyo Kk Tablet of dihydropyridine derivative

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 (en) * 2002-05-17 2003-11-27 Novartis Ag Combination of organic compounds
US20040198789A1 (en) * 2003-02-28 2004-10-07 Recordati Ireland Limited Lercanidipine/ARB/diuretic therapeutic combinations
WO2006079496A1 (en) * 2005-01-26 2006-08-03 Lek Pharmaceuticals D.D. New pharmaceutical composition containing candesartan cilexetil as lipophilic crystalline substance

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 (en) 2008-12-04
TWI407978B (en) 2013-09-11
TW200730200A (en) 2007-08-16
WO2007001065A2 (en) 2007-01-04
JP5063370B2 (en) 2012-10-31

Similar Documents

Publication Publication Date Title
WO2007001065A3 (en) Method for the preparation of a wet granulated drug product
TW200740459A (en) Pharmaceutical preparation containing an angiotensin II receptor antagonist and a calcium channel blocker
WO2007001067A3 (en) Solid dosage form comprising an angiotensin ii receptor antagonist and a calcium channel blocker
WO2008037716A3 (en) Pharmaceutical compositions comprising nilotinib or its salt
WO2009022354A3 (en) Modified dosage forms of tacrolimus
WO2007052289A3 (en) Novel dispersible tablet composition
WO2008051942A3 (en) Farnesoid x receptor agonists
WO2007076260A3 (en) Farnesoid x receptor agonists
PL2054411T3 (en) Novel compounds, isomer thereof, or pharmaceutically acceptable salts thereof as vanilloid receptor antagonist; and pharmaceutical compositions containing the same
AP2006003521A0 (en) Y-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it.
AP2303A (en) d-Crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it.
IL195514A (en) Substituted pyridyl compounds, pharmaceutical compositions comprising them, uses thereof as modulators of the histamine h3 receptor and method for their preparation
WO2010146179A3 (en) Solid pharmaceutical composition comprising rivaroxaban
WO2006082523A3 (en) Pharmaceutical sustained release composition of metformin
AP2006003522A0 (en) Yd-crystalline form of ivabradine hydrochloride, a process for its preparation adn pharmaceutical compositions containing it.
MX2010000801A (en) Improved pharmaceutical composition containing dihydropyridine calcium channel antagonist and method for the preparation thereof.
WO2011062437A3 (en) Gonadotropin releasing hormone receptor antagonists, manufacturing method thereof, and pharmaceutical composition containing same
WO2006074951A3 (en) Orally disintegrating composition of olanzapine or donepezil
WO2007050802A3 (en) Novel opioid antagonists
WO2010049449A3 (en) Novel salts of sunitinib
WO2007044796A3 (en) Pyridazinone compounds as calcilytics
WO2010070677A3 (en) A process for the preparation of prasugrel and its pharmaceutically acceptable salts thereof
WO2007097770A8 (en) Metoprolol succinate e.r. tablets and methods for their preparation
WO2010012459A3 (en) A process for the preparation of solifenacin salts and their inclusion into pharmaceutical dosage forms
WO2010079506A3 (en) Pharmaceutical composition of aripiprazole

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application
ENP Entry into the national phase

Ref document number: 2007558254

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 06767752

Country of ref document: EP

Kind code of ref document: A2