CN104244930A - 口腔崩解片及其制造方法 - Google Patents

口腔崩解片及其制造方法 Download PDF

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Publication number
CN104244930A
CN104244930A CN201380021692.1A CN201380021692A CN104244930A CN 104244930 A CN104244930 A CN 104244930A CN 201380021692 A CN201380021692 A CN 201380021692A CN 104244930 A CN104244930 A CN 104244930A
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CN
China
Prior art keywords
orally disintegrating
disintegrating tablet
drug
tablet according
crystalline cellulose
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
CN201380021692.1A
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English (en)
Chinese (zh)
Inventor
关口学
早川良一
原佳宏
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.)
Daiichi Sankyo Co Ltd
Original Assignee
Daiichi 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 Daiichi Sankyo Co Ltd filed Critical Daiichi Sankyo Co Ltd
Priority to CN201710256576.8A priority Critical patent/CN106913553A/zh
Publication of CN104244930A publication Critical patent/CN104244930A/zh
Pending legal-status Critical Current

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    • 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201380021692.1A 2012-04-24 2013-04-23 口腔崩解片及其制造方法 Pending CN104244930A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201710256576.8A CN106913553A (zh) 2012-04-24 2013-04-23 口腔崩解片及其制造方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2012098770 2012-04-24
JP2012-098770 2012-04-24
PCT/JP2013/061936 WO2013161823A1 (ja) 2012-04-24 2013-04-23 口腔内崩壊錠及びその製造方法

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201710256576.8A Division CN106913553A (zh) 2012-04-24 2013-04-23 口腔崩解片及其制造方法

Publications (1)

Publication Number Publication Date
CN104244930A true CN104244930A (zh) 2014-12-24

Family

ID=49483132

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201380021692.1A Pending CN104244930A (zh) 2012-04-24 2013-04-23 口腔崩解片及其制造方法
CN201710256576.8A Pending CN106913553A (zh) 2012-04-24 2013-04-23 口腔崩解片及其制造方法

Family Applications After (1)

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CN201710256576.8A Pending CN106913553A (zh) 2012-04-24 2013-04-23 口腔崩解片及其制造方法

Country Status (11)

Country Link
US (1) US9827200B2 (https=)
EP (1) EP2842549B1 (https=)
JP (4) JP6066351B2 (https=)
KR (1) KR101943686B1 (https=)
CN (2) CN104244930A (https=)
BR (1) BR112014026292B1 (https=)
CA (1) CA2870868C (https=)
ES (1) ES2694224T3 (https=)
IN (1) IN2014MN02029A (https=)
TW (1) TWI572371B (https=)
WO (1) WO2013161823A1 (https=)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066304A (zh) * 2016-11-16 2018-05-25 深圳万和制药有限公司 具有缓释性能的坦索罗辛口腔崩解片组合物
CN109996542A (zh) * 2016-12-01 2019-07-09 第一三共株式会社 包含二胺衍生物的口腔崩解片
CN110613691A (zh) * 2018-06-19 2019-12-27 北京万全德众医药生物技术有限公司 一种含有peg-dspe-盐酸美金刚复合物的口崩片
CN113332252A (zh) * 2021-06-07 2021-09-03 大桐制药(中国)有限责任公司 一种洛索洛芬钠片的制备方法
CN115803020A (zh) * 2020-07-27 2023-03-14 第一三共株式会社 含有苯磺酸米洛巴林的口腔崩解片剂

Families Citing this family (24)

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EA201691422A1 (ru) * 2014-02-05 2017-02-28 Сановел Иладж Санайи Ве Тиджарет А.С. Перорально распадающиеся таблетированные составы мемантина
RU2690685C2 (ru) * 2014-10-03 2019-06-05 Новартис Аг Фармацевтические композиции, содержащие алпелисиб
JP5827428B1 (ja) * 2015-01-15 2015-12-02 日新製薬株式会社 テルミサルタン含有錠剤
JP2016141630A (ja) * 2015-01-30 2016-08-08 富士フイルム株式会社 口腔内崩壊錠
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
JP7009288B2 (ja) * 2017-05-18 2022-01-25 エルメッド株式会社 湿製錠剤の製造方法及び湿製錠剤の品質向上方法
JP7023186B2 (ja) * 2017-05-29 2022-02-21 第一三共株式会社 認知症治療薬を含有する口腔内崩壊性錠剤
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
JP7198575B2 (ja) * 2017-07-11 2023-01-04 キョーリンリメディオ株式会社 メマンチン塩酸塩含有口腔内崩壊錠
JP7148319B2 (ja) * 2017-08-17 2022-10-05 第一三共株式会社 プラスグレルを含む口腔内崩壊錠
TWI795462B (zh) 2017-11-17 2023-03-11 日商鹽野義製藥股份有限公司 光安定性及溶出性優異的醫藥製劑
US20210059948A1 (en) * 2017-12-26 2021-03-04 Towa Pharmaceutical Co., Ltd. Cyclic orally disintegrating tablet
JP7138666B2 (ja) * 2018-01-24 2022-09-16 大原薬品工業株式会社 γ-アミノ酪酸誘導体含有錠剤の化学的安定性を改善する方法
TWI826474B (zh) 2018-06-27 2023-12-21 日商第一三共股份有限公司 包含二胺衍生物之顆粒劑、以及其用途及製造方法
JP2020105173A (ja) * 2018-12-27 2020-07-09 日本ケミファ株式会社 2種以上の薬物を含有する口腔内崩壊錠及びその製造方法
CN109512790A (zh) * 2018-12-28 2019-03-26 金日制药(中国)有限公司 一种口腔崩解片的处方及制备工艺
WO2021095092A1 (ja) * 2019-11-11 2021-05-20 大塚製薬株式会社 口腔内崩壊錠
WO2022004871A1 (ja) * 2020-07-03 2022-01-06 あゆみ製薬株式会社 錠剤およびその製造方法
JPWO2022102457A1 (https=) * 2020-11-10 2022-05-19
CN115837012A (zh) * 2021-01-18 2023-03-24 广州一品红制药有限公司 一种氨氯地平干混悬剂及其制备方法
JP2022135317A (ja) * 2021-03-05 2022-09-15 日医工株式会社 リナグリプチン製剤
CN113181125B (zh) * 2021-04-27 2022-07-19 海南通用三洋药业有限公司 一种西他沙星片剂及其制备方法
JP7210794B2 (ja) * 2021-06-16 2023-01-23 日本ジェネリック株式会社 リナグリプチン含有製剤及びリナグリプチン含有口腔内崩壊性錠剤
CN113244238B (zh) * 2021-06-16 2022-05-20 北京斯利安药业有限公司 含盐酸苯海索和叶酸的口崩片及其制备方法

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CN1805737A (zh) * 2003-06-16 2006-07-19 欧乐根公司 美金刚胺(memantine)口服剂型
EP2050448A1 (en) * 2006-08-08 2009-04-22 Kissei Pharmaceutical Co., Ltd. Oral disintegrating tablet having masked bitter taste and method for production thereof

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CN1805737A (zh) * 2003-06-16 2006-07-19 欧乐根公司 美金刚胺(memantine)口服剂型
EP2050448A1 (en) * 2006-08-08 2009-04-22 Kissei Pharmaceutical Co., Ltd. Oral disintegrating tablet having masked bitter taste and method for production thereof

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108066304A (zh) * 2016-11-16 2018-05-25 深圳万和制药有限公司 具有缓释性能的坦索罗辛口腔崩解片组合物
CN108066304B (zh) * 2016-11-16 2022-09-16 深圳万和制药有限公司 具有缓释性能的坦索罗辛口腔崩解片组合物
CN109996542A (zh) * 2016-12-01 2019-07-09 第一三共株式会社 包含二胺衍生物的口腔崩解片
CN110613691A (zh) * 2018-06-19 2019-12-27 北京万全德众医药生物技术有限公司 一种含有peg-dspe-盐酸美金刚复合物的口崩片
CN115803020A (zh) * 2020-07-27 2023-03-14 第一三共株式会社 含有苯磺酸米洛巴林的口腔崩解片剂
CN113332252A (zh) * 2021-06-07 2021-09-03 大桐制药(中国)有限责任公司 一种洛索洛芬钠片的制备方法

Also Published As

Publication number Publication date
IN2014MN02029A (https=) 2015-08-14
JP2018058910A (ja) 2018-04-12
TW201347792A (zh) 2013-12-01
CN106913553A (zh) 2017-07-04
CA2870868C (en) 2018-02-20
BR112014026292A2 (pt) 2017-06-27
EP2842549A4 (en) 2015-09-23
JP6066351B2 (ja) 2017-01-25
EP2842549B1 (en) 2018-08-08
JP2019151670A (ja) 2019-09-12
JP2017008112A (ja) 2017-01-12
WO2013161823A1 (ja) 2013-10-31
US9827200B2 (en) 2017-11-28
HK1206983A1 (en) 2016-01-22
JP6325627B2 (ja) 2018-05-16
JPWO2013161823A1 (ja) 2015-12-24
US20150110880A1 (en) 2015-04-23
EP2842549A1 (en) 2015-03-04
TWI572371B (zh) 2017-03-01
KR20150003740A (ko) 2015-01-09
JP7028829B2 (ja) 2022-03-02
ES2694224T3 (es) 2018-12-19
CA2870868A1 (en) 2013-10-31
KR101943686B1 (ko) 2019-01-29
JP6545839B2 (ja) 2019-07-17
BR112014026292B1 (pt) 2022-09-27

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