WO2008081891A1 - 口腔内崩壊性固形製剤 - Google Patents

口腔内崩壊性固形製剤 Download PDF

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Publication number
WO2008081891A1
WO2008081891A1 PCT/JP2007/075179 JP2007075179W WO2008081891A1 WO 2008081891 A1 WO2008081891 A1 WO 2008081891A1 JP 2007075179 W JP2007075179 W JP 2007075179W WO 2008081891 A1 WO2008081891 A1 WO 2008081891A1
Authority
WO
WIPO (PCT)
Prior art keywords
solid preparation
orally disintegrating
disintegrating solid
fine granule
disclosed
Prior art date
Application number
PCT/JP2007/075179
Other languages
English (en)
French (fr)
Inventor
Takashi Kurasawa
Yasuko Watanabe
Yohko Akiyama
Original Assignee
Takeda Pharmaceutical Company Limited
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 Takeda Pharmaceutical Company Limited filed Critical Takeda Pharmaceutical Company Limited
Priority to JP2008552162A priority Critical patent/JP5366558B2/ja
Priority to US12/521,488 priority patent/US9486446B2/en
Priority to EP07860401.4A priority patent/EP2098250B1/en
Publication of WO2008081891A1 publication Critical patent/WO2008081891A1/ja

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    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

　打錠時における細粒の破損が抑制された口腔内崩壊性固形製剤であって、細粒の最外層が、ヒドロキシプロピルメチルセルロースおよび低置換度ヒドロキシプロピルセルロースを含有してなる被覆層で被覆され、医薬活性成分の放出が制御された細粒を含有する口腔内崩壊性固形製剤を提供する。
PCT/JP2007/075179 2006-12-28 2007-12-27 口腔内崩壊性固形製剤 WO2008081891A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2008552162A JP5366558B2 (ja) 2006-12-28 2007-12-27 口腔内崩壊性固形製剤
US12/521,488 US9486446B2 (en) 2006-12-28 2007-12-27 Orally disintegrating solid preparation
EP07860401.4A EP2098250B1 (en) 2006-12-28 2007-12-27 Orally disintegrating solid preparation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2006356405 2006-12-28
JP2006-356405 2006-12-28

Publications (1)

Publication Number Publication Date
WO2008081891A1 true WO2008081891A1 (ja) 2008-07-10

Family

ID=39588572

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2007/075179 WO2008081891A1 (ja) 2006-12-28 2007-12-27 口腔内崩壊性固形製剤

Country Status (4)

Country Link
US (1) US9486446B2 (ja)
EP (1) EP2098250B1 (ja)
JP (1) JP5366558B2 (ja)
WO (1) WO2008081891A1 (ja)

Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063916A1 (ja) * 2007-11-16 2009-05-22 Asahi Kasei Chemicals Corporation 水系フィルムコーティング液、および、フィルムコーティング顆粒、ならびに、これを用いた錠剤
JP2009256344A (ja) * 2008-03-27 2009-11-05 Sawai Pharmaceutical Co Ltd プロトンポンプ阻害剤を含有する被覆微粒子
WO2009158368A1 (en) * 2008-06-26 2009-12-30 Mcneil-Ppc, Inc. Coated particles containing pharmaceutically active agents
WO2009113703A3 (en) * 2008-03-11 2010-06-17 Takeda Pharmaceutical Company Limited Orally-disintegrating solid preparation
JP2010189384A (ja) * 2009-01-26 2010-09-02 Shin-Etsu Chemical Co Ltd 低置換度ヒドロキシプロピルセルロース水分散液を用いた湿式造粒打錠法
WO2011121823A1 (ja) * 2010-03-29 2011-10-06 アステラス製薬株式会社 経口投与用粒子状医薬組成物
WO2011121824A1 (ja) * 2010-03-29 2011-10-06 アステラス製薬株式会社 口腔内崩壊錠
JP2012025683A (ja) * 2010-07-21 2012-02-09 Ohara Yakuhin Kogyo Kk 苦味を有する生理活性物質含有粒子の製造方法
JP2012046454A (ja) * 2010-08-27 2012-03-08 Lion Corp 内服用錠剤およびその製造方法
WO2012091049A1 (ja) * 2010-12-28 2012-07-05 大鵬薬品工業株式会社 口腔内崩壊錠剤
JP2013507356A (ja) * 2009-10-09 2013-03-04 ユンジン・ファーム・カンパニー・リミテッド 速効性と持続性を同時に有する薬剤学的組成物
JP2013521334A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド 即時／遅延ドラッグデリバリー
JP2013521333A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド 遅延性持続ドラッグデリバリー
WO2013094682A1 (ja) * 2011-12-21 2013-06-27 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 局所投与型の嚥下障害改善用医薬品
WO2014189034A1 (ja) * 2013-05-21 2014-11-27 武田薬品工業株式会社 口腔内崩壊錠
WO2014199486A1 (ja) * 2013-06-13 2014-12-18 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 嚥下障害改善用医薬品
US9474719B2 (en) 2010-03-05 2016-10-25 University Of Strathclyde Pulsatile drug release
US9974768B2 (en) 2013-06-13 2018-05-22 Meiji Seika Pharma Co., Ltd. Pharmaceutical for improving dysphagia
JP2021084905A (ja) * 2019-11-29 2021-06-03 ニプロ株式会社 経口医薬製剤およびその製造方法

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130202688A1 (en) * 2010-05-04 2013-08-08 Sunilendu Bhushan Roy Delayed release oral disintegrating pharmaceutical compositions of lansoprazole
SG190905A1 (en) * 2010-12-27 2013-07-31 Takeda Pharmaceutical Orally disintegrating tablet
EP3218349A2 (en) 2014-11-14 2017-09-20 Gemphire Therapeutics Inc. Processes and intermediates for preparing , -dicarboxylic acid-terminated dialkane ethers
US10426732B2 (en) * 2014-12-25 2019-10-01 Daicel Corporation Rapidly disintegrating tablet, and method for producing same
US20170042806A1 (en) 2015-04-29 2017-02-16 Dexcel Pharma Technologies Ltd. Orally disintegrating compositions
US20160331689A1 (en) 2015-05-12 2016-11-17 SE Tylose USA, Inc. Aqueous enteric coating composition
CN108136035A (zh) * 2015-09-04 2018-06-08 株式会社大赛璐 超速崩解片剂及其制备方法
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
AR111786A1 (es) * 2017-05-11 2019-08-21 Gemphire Therapeutics Inc Composiciones de gemcabeno y su uso
WO2020139203A1 (en) * 2018-12-28 2020-07-02 Neutec Ar-Ge Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ A formulation comprising dexrabeprazole

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5753100B2 (ja) 1974-11-28 1982-11-11
JPS6150978A (ja) 1984-08-16 1986-03-13 Takeda Chem Ind Ltd ピリジン誘導体およびその製造法
JPS61213201A (ja) 1985-03-20 1986-09-22 Fuji Paudaru Kk 微結晶セルロ−ス球形顆粒及びその製造法
JPS63301816A (ja) 1987-01-29 1988-12-08 Takeda Chem Ind Ltd 有核顆粒およびその製造法
JPH0592918A (ja) 1991-03-07 1993-04-16 Takeda Chem Ind Ltd 有核散剤およびその製造方法
JPH05271054A (ja) 1992-01-29 1993-10-19 Takeda Chem Ind Ltd 口腔内溶解型錠剤およびその製造法
JPH06502194A (ja) 1991-07-22 1994-03-10 ラボラトワール　プログラファルム 急速崩壊性多粒子状錠剤
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JPH0948726A (ja) 1995-08-07 1997-02-18 Tanabe Seiyaku Co Ltd 口腔内速崩壊性製剤およびその製法
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WO2001083473A1 (fr) 2000-04-28 2001-11-08 Takeda Chemical Industries, Ltd. Procede de production d'un derive de sulfoxide optiquement actif
WO2001087874A1 (fr) 2000-05-15 2001-11-22 Takeda Chemical Industries, Ltd. Procede de production d'un cristal
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WO2006036007A2 (en) * 2004-09-30 2006-04-06 Takeda Pharmaceutical Company Limited Modified-release preparation

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DE60236850D1 (de) * 2001-02-15 2010-08-12 Mitsubishi Tanabe Pharma Corp Tabletten, die in der mundhöhle schnell zerfallen
DK2258351T3 (da) * 2001-10-17 2013-08-26 Takeda Pharmaceutical Granula indeholdende lansoprazol i stor mængde
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JPS5753100B2 (ja) 1974-11-28 1982-11-11
JPS6150978A (ja) 1984-08-16 1986-03-13 Takeda Chem Ind Ltd ピリジン誘導体およびその製造法
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JPS61213201A (ja) 1985-03-20 1986-09-22 Fuji Paudaru Kk 微結晶セルロ−ス球形顆粒及びその製造法
JPS63301816A (ja) 1987-01-29 1988-12-08 Takeda Chem Ind Ltd 有核顆粒およびその製造法
JPH0592918A (ja) 1991-03-07 1993-04-16 Takeda Chem Ind Ltd 有核散剤およびその製造方法
US5464632C1 (en) 1991-07-22 2001-02-20 Prographarm Lab Rapidly disintegratable multiparticular tablet
JPH06502194A (ja) 1991-07-22 1994-03-10 ラボラトワール　プログラファルム 急速崩壊性多粒子状錠剤
US5464632A (en) 1991-07-22 1995-11-07 Laboratoires Prographarm Rapidly disintegratable multiparticular tablet
JPH05271054A (ja) 1992-01-29 1993-10-19 Takeda Chem Ind Ltd 口腔内溶解型錠剤およびその製造法
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JPH0948726A (ja) 1995-08-07 1997-02-18 Tanabe Seiyaku Co Ltd 口腔内速崩壊性製剤およびその製法
JPH10195068A (ja) 1996-11-14 1998-07-28 Takeda Chem Ind Ltd ２−（２−ピリジルメチルスルフィニル）ベンズイミダゾール系化合物の結晶およびその製造法
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JP2000281564A (ja) 1998-05-18 2000-10-10 Takeda Chem Ind Ltd 医薬製剤
JP2000103731A (ja) 1998-07-28 2000-04-11 Takeda Chem Ind Ltd 速崩壊性固形製剤
WO2000078745A2 (en) 1999-06-17 2000-12-28 Takeda Chemical Industries, Ltd. Crystalline form of (r)-2-[[[3-methyl- 4- (2,2,2,- trifluoroethoxy) -2- pyridinyl] methyl] sulfinyl] -1h-benzimidazole
WO2001083473A1 (fr) 2000-04-28 2001-11-08 Takeda Chemical Industries, Ltd. Procede de production d'un derive de sulfoxide optiquement actif
WO2001087874A1 (fr) 2000-05-15 2001-11-22 Takeda Chemical Industries, Ltd. Procede de production d'un cristal
WO2002044167A1 (en) 2000-12-01 2002-06-06 Takeda Chemical Industries, Ltd. Process for the crystallization of (r)- or (s)-lansoprazole
WO2006036007A2 (en) * 2004-09-30 2006-04-06 Takeda Pharmaceutical Company Limited Modified-release preparation

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See also references of EP2098250A4 *

Cited By (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009063916A1 (ja) * 2007-11-16 2009-05-22 Asahi Kasei Chemicals Corporation 水系フィルムコーティング液、および、フィルムコーティング顆粒、ならびに、これを用いた錠剤
US8268356B2 (en) 2007-11-16 2012-09-18 Asahi Kasei Chemicals Corporation Aqueous film coating solution, film coated granule and tablet using the same
US9241910B2 (en) 2008-03-11 2016-01-26 Takeda Pharmaceutical Company Limited Orally-disintegrating solid preparation
WO2009113703A3 (en) * 2008-03-11 2010-06-17 Takeda Pharmaceutical Company Limited Orally-disintegrating solid preparation
JP2011513204A (ja) * 2008-03-11 2011-04-28 武田薬品工業株式会社 口腔内崩壊性固形製剤
EA021792B1 (ru) * 2008-03-11 2015-09-30 Такеда Фармасьютикал Компани Лимитед Твердый препарат, растворяющийся во рту
JP2009256344A (ja) * 2008-03-27 2009-11-05 Sawai Pharmaceutical Co Ltd プロトンポンプ阻害剤を含有する被覆微粒子
WO2009158368A1 (en) * 2008-06-26 2009-12-30 Mcneil-Ppc, Inc. Coated particles containing pharmaceutically active agents
US8282957B2 (en) 2008-06-26 2012-10-09 Mcneil-Ppc, Inc. Coated particles containing pharmaceutically active agents
JP2010189384A (ja) * 2009-01-26 2010-09-02 Shin-Etsu Chemical Co Ltd 低置換度ヒドロキシプロピルセルロース水分散液を用いた湿式造粒打錠法
JP2014133766A (ja) * 2009-01-26 2014-07-24 Shin Etsu Chem Co Ltd 低置換度ヒドロキシプロピルセルロース水分散液を用いた湿式造粒打錠法
JP2013507356A (ja) * 2009-10-09 2013-03-04 ユンジン・ファーム・カンパニー・リミテッド 速効性と持続性を同時に有する薬剤学的組成物
US9180101B2 (en) 2009-10-09 2015-11-10 Yungjin Pharm Co., Ltd. Pharmaceutical composition simultaneously having rapid-acting property and long-acting property
JP2013521334A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド 即時／遅延ドラッグデリバリー
US9474719B2 (en) 2010-03-05 2016-10-25 University Of Strathclyde Pulsatile drug release
JP2013521333A (ja) * 2010-03-05 2013-06-10 ユニヴァーシティー オヴ ストラスクライド 遅延性持続ドラッグデリバリー
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