WO2008120548A2 - 口腔内崩壊錠 - Google Patents

口腔内崩壊錠 Download PDF

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Publication number
WO2008120548A2
WO2008120548A2 PCT/JP2008/054529 JP2008054529W WO2008120548A2 WO 2008120548 A2 WO2008120548 A2 WO 2008120548A2 JP 2008054529 W JP2008054529 W JP 2008054529W WO 2008120548 A2 WO2008120548 A2 WO 2008120548A2
Authority
WO
WIPO (PCT)
Prior art keywords
tablet
agent selected
group
disintegrating tablet
disintegrating
Prior art date
Application number
PCT/JP2008/054529
Other languages
English (en)
French (fr)
Other versions
WO2008120548A3 (ja
Inventor
Makoto Matsuoka
Hiroyuki Nishii
Maki Kawamura
Original Assignee
Dainippon Sumitomo Pharma 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 Dainippon Sumitomo Pharma Co., Ltd. filed Critical Dainippon Sumitomo Pharma Co., Ltd.
Priority to US12/531,150 priority Critical patent/US8778392B2/en
Priority to BRPI0808889-6A2A priority patent/BRPI0808889A2/pt
Priority to CA002680536A priority patent/CA2680536A1/en
Priority to JP2009507445A priority patent/JP5537927B2/ja
Priority to RU2009137794/15A priority patent/RU2478375C2/ru
Priority to EP08721945A priority patent/EP2133096A4/en
Publication of WO2008120548A2 publication Critical patent/WO2008120548A2/ja
Publication of WO2008120548A3 publication Critical patent/WO2008120548A3/ja
Priority to US14/295,646 priority patent/US9980915B2/en

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    • 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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

　（１）Ｄ－マンニトール、（２）活性成分、（３）クロスポビドン及びカルメロースからなる群より選ばれる１種以上の崩壊剤、ならびに（４）フマル酸ステアリルナトリウム及びショ糖脂肪酸エステルからなる群より選ばれる１種以上の滑沢剤を含有する口腔内崩壊錠。本発明の口腔内崩壊錠は、特殊な製剤技術を必要とせず一般的な設備で容易に製造可能であり、流通過程で崩れない適度な強度を有し、かつ、口腔内において速やかな崩壊性および、苦味やざらつき感等を大きく軽減した良好な服用感を併せ持つ等の優れた特性を有することにより、例えば、高齢者、小児及び重症患者に適した剤形として好適に用いることができる。
PCT/JP2008/054529 2007-03-13 2008-03-12 口腔内崩壊錠 WO2008120548A2 (ja)

Priority Applications (7)

Application Number Priority Date Filing Date Title
US12/531,150 US8778392B2 (en) 2007-03-13 2008-03-12 Oral disintegrating tablet
BRPI0808889-6A2A BRPI0808889A2 (pt) 2007-03-13 2008-03-12 Comprimido desintegrante oral
CA002680536A CA2680536A1 (en) 2007-03-13 2008-03-12 Oral disintegrating tablet
JP2009507445A JP5537927B2 (ja) 2007-03-13 2008-03-12 口腔内崩壊錠
RU2009137794/15A RU2478375C2 (ru) 2007-03-13 2008-03-12 Распадающаяся во рту таблетка
EP08721945A EP2133096A4 (en) 2007-03-13 2008-03-12 IN THE MOUTHING TABLET
US14/295,646 US9980915B2 (en) 2007-03-13 2014-06-04 Oral disintegrating tablet

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007063913 2007-03-13
JP2007-063913 2007-03-13

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/531,150 A-371-Of-International US8778392B2 (en) 2007-03-13 2008-03-12 Oral disintegrating tablet
US14/295,646 Continuation US9980915B2 (en) 2007-03-13 2014-06-04 Oral disintegrating tablet

Publications (2)

Publication Number Publication Date
WO2008120548A2 true WO2008120548A2 (ja) 2008-10-09
WO2008120548A3 WO2008120548A3 (ja) 2008-12-18

Family

ID=39808792

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2008/054529 WO2008120548A2 (ja) 2007-03-13 2008-03-12 口腔内崩壊錠

Country Status (9)

Country Link
US (2) US8778392B2 (ja)
EP (1) EP2133096A4 (ja)
JP (7) JP5537927B2 (ja)
KR (1) KR20090119993A (ja)
CN (1) CN101646461A (ja)
BR (1) BRPI0808889A2 (ja)
CA (1) CA2680536A1 (ja)
RU (1) RU2478375C2 (ja)
WO (1) WO2008120548A2 (ja)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010061846A1 (ja) * 2008-11-25 2010-06-03 田辺三菱製薬株式会社 口腔内速崩壊性錠及びその製造方法
JP2012036140A (ja) * 2010-08-10 2012-02-23 Kyoto Pharmaceutical Industries Ltd 苦味を抑制した速崩壊錠
WO2012108266A1 (ja) * 2011-02-08 2012-08-16 富士フイルム株式会社 口腔内崩壊型錠及びその製造方法
CN102666590A (zh) * 2009-11-24 2012-09-12 日本曹达株式会社 羟烷基纤维素微粒
US8426461B2 (en) 2011-01-17 2013-04-23 Takeda Pharmaceutical Company Limited Orally dispersible tablet
JPWO2012029838A1 (ja) * 2010-08-31 2013-10-31 協和発酵キリン株式会社 口腔内崩壊錠
JP2013544849A (ja) * 2010-12-02 2013-12-19 アプタリス ファーマテク，インコーポレイテッド 迅速分散顆粒、口腔内崩壊錠、および方法
US8642649B2 (en) 2011-01-17 2014-02-04 Takeda Pharmaceutical Company Limited Orally dispersible tablet
JP2014080382A (ja) * 2012-10-15 2014-05-08 Mitsubishi Shoji Foodtech Co Ltd 圧縮成形に用いるためのマンニトール賦形剤及びこれを含有する錠剤
WO2015070156A1 (en) * 2013-11-11 2015-05-14 Impax Laboratories, Inc. Rapidly disintegrating formulations and methods of use
JP2017002045A (ja) * 2015-06-12 2017-01-05 ゼリア新薬工業株式会社 口腔内崩壊錠
WO2017217494A1 (ja) * 2016-06-16 2017-12-21 東和薬品株式会社 口腔内崩壊錠
JP2018058911A (ja) * 2007-03-13 2018-04-12 大日本住友製薬株式会社 口腔内崩壊錠
JP2018521040A (ja) * 2015-07-27 2018-08-02 ユニケム ラボラトリーズ リミテッド トファシチニブ口腔内崩壊錠

Families Citing this family (8)

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FR2933299B1 (fr) * 2008-07-04 2012-02-03 Roquette Freres Mannitol orodispersible
LT3057580T (lt) * 2013-10-17 2021-04-12 Bayer Pharma Aktiengesellschaft Farmacinės dozavimo formos, kurių sudėtyje yra natrio-1-[6-(morfolin-4-il)pirimidin-4-il]-4-(1h-1,2,3-triazol-1-il)-1h-pirazoil-5-olatas
WO2016209061A1 (ko) 2015-06-26 2016-12-29 한국유나이티드제약 주식회사 모사프리드와 라베프라졸의 복합제제
US20200268650A1 (en) * 2016-01-18 2020-08-27 Daicel Corporation Intraoral retentive disintegrating solid preparation, method for producing same and powder composition used in said production method
JP7182356B2 (ja) * 2017-07-05 2022-12-02 日本ケミファ株式会社 口腔内崩壊錠及びその製造方法
RU2732291C1 (ru) * 2020-02-13 2020-09-15 Открытое акционерное общество "Фармстандарт-Лексредства" (ОАО "Фармстандарт-Лексредства") Лекарственный препарат на основе травы алтея лекарственного для лечения простудных и острых респираторных заболеваний
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN116615184A (zh) * 2020-12-23 2023-08-18 住友制药株式会社 口服固体制剂

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JP2020125358A (ja) * 2007-03-13 2020-08-20 大日本住友製薬株式会社 口腔内崩壊錠
JP2019081789A (ja) * 2007-03-13 2019-05-30 大日本住友製薬株式会社 口腔内崩壊錠
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JP2017002045A (ja) * 2015-06-12 2017-01-05 ゼリア新薬工業株式会社 口腔内崩壊錠
JP2018521040A (ja) * 2015-07-27 2018-08-02 ユニケム ラボラトリーズ リミテッド トファシチニブ口腔内崩壊錠
WO2017217494A1 (ja) * 2016-06-16 2017-12-21 東和薬品株式会社 口腔内崩壊錠
JPWO2017217494A1 (ja) * 2016-06-16 2019-04-04 東和薬品株式会社 口腔内崩壊錠
US10881610B2 (en) 2016-06-16 2021-01-05 Towa Pharmaceutical Co., Ltd. Orally disintegrating tablet

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CA2680536A1 (en) 2008-10-09
RU2009137794A (ru) 2011-04-20
JP2020125358A (ja) 2020-08-20
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US20140300025A1 (en) 2014-10-09
US20100098756A1 (en) 2010-04-22
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WO2008120548A3 (ja) 2008-12-18
JP5537927B2 (ja) 2014-07-02
JPWO2008120548A1 (ja) 2010-07-15
EP2133096A4 (en) 2011-11-16
JP2015147812A (ja) 2015-08-20
KR20090119993A (ko) 2009-11-23
JP6092936B2 (ja) 2017-03-08
EP2133096A2 (en) 2009-12-16
CN101646461A (zh) 2010-02-10
BRPI0808889A2 (pt) 2014-11-11
US8778392B2 (en) 2014-07-15
RU2478375C2 (ru) 2013-04-10

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