JP2019151657A5 - - Google Patents

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Publication number
JP2019151657A5
JP2019151657A5 JP2019093861A JP2019093861A JP2019151657A5 JP 2019151657 A5 JP2019151657 A5 JP 2019151657A5 JP 2019093861 A JP2019093861 A JP 2019093861A JP 2019093861 A JP2019093861 A JP 2019093861A JP 2019151657 A5 JP2019151657 A5 JP 2019151657A5
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JP
Japan
Prior art keywords
pharmaceutical composition
composition according
content
irbesartan
amlodipine
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.)
Pending
Application number
JP2019093861A
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Japanese (ja)
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JP2019151657A (en
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Publication date
Application filed filed Critical
Publication of JP2019151657A publication Critical patent/JP2019151657A/en
Publication of JP2019151657A5 publication Critical patent/JP2019151657A5/ja
Priority to JP2021070089A priority Critical patent/JP2021152003A/en
Pending legal-status Critical Current

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Claims (11)

(a)イルベサルタン、
(b)D-マンニトール及び結晶セルロースからなる賦形剤、並びに
(c)ヒドロキシプロピルメチルセルロース、ヒドロキシプロピルセルロース及びポリビニルアルコールからなる群から選ばれる1種又は2種以上からなる結合剤
を含有する医薬組成物であって、
(d)アムロジピンまたはその塩、及び、(e)クロスカルメロースナトリウム及び/又は低置換度ヒドロキシプロピルセルロースからなる崩壊剤をさらに含み、
前記イルベサルタンの含量が48.8w/w%〜65w/w%であり、前記アムロジピンまたはその塩の含量が1w/w%〜10w/w%であることを特徴とする、医薬組成物。
(a) Irbesartan,
(b) an excipient comprising D-mannitol and crystalline cellulose , and
(c) a binder consisting of one or more selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylcellulose and polyvinyl alcohol ,
A pharmaceutical composition comprising:
(d) further comprising a disintegrant comprising amlodipine or a salt thereof, and (e) croscarmellose sodium and / or low-substituted hydroxypropylcellulose,
A pharmaceutical composition, wherein the content of irbesartan is 48.8 w / w% to 65 w / w%, and the content of amlodipine or a salt thereof is 1 w / w% to 10 w / w% .
前記イルベサルタンの配合変化及び/又は色相変化の誘発が防止されている、請求項1に記載の医薬組成物。  The pharmaceutical composition according to claim 1, wherein induction of a change in the composition of irbesartan and / or a change in hue is prevented. ステアリン酸マグネシウムである滑沢剤をさらに含む、請求項1又は2に記載の医薬組成物。  The pharmaceutical composition according to claim 1 or 2, further comprising a lubricant which is magnesium stearate. 前記賦形剤の含量が、10w/w%〜50w/w%である、請求項1〜3のいずれか1項に記載の医薬組成物。  The pharmaceutical composition according to any one of claims 1 to 3, wherein the content of the excipient is 10 w / w% to 50 w / w%. 前記結合剤の含量が、0.01w/w%〜10w/w%である、請求項1〜4のいずれか1項に記載の医薬組成物。  The pharmaceutical composition according to any one of claims 1 to 4, wherein the content of the binder is 0.01 w / w% to 10 w / w%. 前記崩壊剤の含量が、1w/w%〜20w/w%である、請求項1〜5のいずれか1項に記載の医薬組成物。  The pharmaceutical composition according to any one of claims 1 to 5, wherein the content of the disintegrant is 1 w / w% to 20 w / w%. フィルムコーティング層をさらに含む、請求項1〜6のいずれか1項に記載の医薬組成物。  The pharmaceutical composition according to any one of claims 1 to 6, further comprising a film coating layer. 前記フィルムコーティング層が、コーティング剤、可塑剤、及び着色剤を含む、請求項7に記載の医薬組成物。  The pharmaceutical composition according to claim 7, wherein the film coating layer comprises a coating agent, a plasticizer, and a colorant. 前記コーティング剤が、ヒドロキシプロピルメチルセルロースである、請求項8に記載の医薬組成物。  The pharmaceutical composition according to claim 8, wherein the coating agent is hydroxypropylmethylcellulose. 前記可塑剤が、プロピレングリコールである、請求項8又は9に記載の医薬組成物。  The pharmaceutical composition according to claim 8 or 9, wherein the plasticizer is propylene glycol. 前記着色剤が、酸化チタン、黄色三二酸化鉄、及び三二酸化鉄からなる群から選択される少なくとも1種である、請求項8〜10のいずれか1項に記載の医薬組成物。  The pharmaceutical composition according to any one of claims 8 to 10, wherein the colorant is at least one selected from the group consisting of titanium oxide, yellow ferric oxide, and ferric oxide.
JP2019093861A 2011-09-13 2019-05-17 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof Pending JP2019151657A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021070089A JP2021152003A (en) 2011-09-13 2021-04-19 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011199987 2011-09-13
JP2011199987 2011-09-13

Related Parent Applications (1)

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JP2018171042A Division JP6530845B2 (en) 2011-09-13 2018-09-13 Method of Stabilizing a Pharmaceutical Composition Comprising Irbesartan and Amlodipine or a Salt Thereof

Related Child Applications (1)

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JP2021070089A Division JP2021152003A (en) 2011-09-13 2021-04-19 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof

Publications (2)

Publication Number Publication Date
JP2019151657A JP2019151657A (en) 2019-09-12
JP2019151657A5 true JP2019151657A5 (en) 2019-12-05

Family

ID=48479652

Family Applications (5)

Application Number Title Priority Date Filing Date
JP2012201332A Active JP6041591B2 (en) 2011-09-13 2012-09-13 Stabilized pharmaceutical composition comprising irbesartan and amlodipine or a salt thereof
JP2016218298A Active JP6404886B2 (en) 2011-09-13 2016-11-08 Method for stabilizing pharmaceutical compositions containing irbesartan and amlodipine or a salt thereof
JP2018171042A Active JP6530845B2 (en) 2011-09-13 2018-09-13 Method of Stabilizing a Pharmaceutical Composition Comprising Irbesartan and Amlodipine or a Salt Thereof
JP2019093861A Pending JP2019151657A (en) 2011-09-13 2019-05-17 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof
JP2021070089A Pending JP2021152003A (en) 2011-09-13 2021-04-19 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof

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JP2012201332A Active JP6041591B2 (en) 2011-09-13 2012-09-13 Stabilized pharmaceutical composition comprising irbesartan and amlodipine or a salt thereof
JP2016218298A Active JP6404886B2 (en) 2011-09-13 2016-11-08 Method for stabilizing pharmaceutical compositions containing irbesartan and amlodipine or a salt thereof
JP2018171042A Active JP6530845B2 (en) 2011-09-13 2018-09-13 Method of Stabilizing a Pharmaceutical Composition Comprising Irbesartan and Amlodipine or a Salt Thereof

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JP2021070089A Pending JP2021152003A (en) 2011-09-13 2021-04-19 Method for stabilizing pharmaceutical composition containing irbesartan and amlodipine or salt thereof

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Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6041591B2 (en) * 2011-09-13 2016-12-14 大日本住友製薬株式会社 Stabilized pharmaceutical composition comprising irbesartan and amlodipine or a salt thereof
JP6238921B2 (en) * 2014-02-17 2017-11-29 大原薬品工業株式会社 Tablets containing irbesartan
JP6199922B2 (en) * 2015-03-20 2017-09-20 大原薬品工業株式会社 Irbesartan-containing tablets with improved chemical stability
CN105412029A (en) * 2015-12-03 2016-03-23 南京多宝生物科技有限公司 Anti-hypertension benzene sulfonic acid levamlodipine besylate tablet
JP6321131B2 (en) * 2016-02-12 2018-05-09 大原薬品工業株式会社 Dissolution improvement method of amlodipine-containing combination tablets
JP2017210435A (en) * 2016-05-25 2017-11-30 ダイト株式会社 Method for producing irbesartan and amlodipine besylate-containing tablet
JP6233911B2 (en) * 2017-08-22 2017-11-22 大原薬品工業株式会社 Irbesartan-containing tablets with improved chemical stability
JP2018009032A (en) * 2017-10-19 2018-01-18 大原薬品工業株式会社 Tablet containing irbesartan with improved chemical stability
CN112022817B (en) * 2020-08-04 2022-08-26 河北君临药业有限公司 Nifedipine tablet composition and preparation method thereof

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GB9408117D0 (en) * 1994-04-23 1994-06-15 Smithkline Beecham Corp Pharmaceutical formulations
CN101068546A (en) * 2004-10-06 2007-11-07 卫材R&D管理有限公司 Medicinal composition, process for producing the same, and method of stabilizing dihydropyridine compound in medicinal composition
US20100016378A1 (en) * 2005-04-28 2010-01-21 Toshio Suzuki Method of preventing dihydropyridine compound from degradation
JP5110697B2 (en) * 2005-06-27 2012-12-26 第一三共株式会社 Solid preparation
WO2009084003A1 (en) * 2007-12-31 2009-07-09 Lupin Limited Pharmaceutical compositions of amlodipine and valsartan
JP2009196940A (en) * 2008-02-22 2009-09-03 Takada Seiyaku Kk Tablet quickly disintegrating in oral cavity and its production method
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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
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CA2766884C (en) * 2009-06-30 2016-08-23 Sanofi Solid pharmaceutical fixed dose compositions comprising irbesartan and amlodipine, their preparation and their therapeutic application
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
JP6041591B2 (en) * 2011-09-13 2016-12-14 大日本住友製薬株式会社 Stabilized pharmaceutical composition comprising irbesartan and amlodipine or a salt thereof

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