KR102253849B1 - 복합 조립물 및 속방성 정제, 및 이들의 제조 방법 - Google Patents

복합 조립물 및 속방성 정제, 및 이들의 제조 방법 Download PDF

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Publication number
KR102253849B1
KR102253849B1 KR1020140157082A KR20140157082A KR102253849B1 KR 102253849 B1 KR102253849 B1 KR 102253849B1 KR 1020140157082 A KR1020140157082 A KR 1020140157082A KR 20140157082 A KR20140157082 A KR 20140157082A KR 102253849 B1 KR102253849 B1 KR 102253849B1
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South Korea
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mannitol
mass
granulated product
composite granulated
aqueous dispersion
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Korean (ko)
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KR20150056474A (ko
Inventor
야스유키 히라마
나오스케 마루야마
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신에쓰 가가꾸 고교 가부시끼가이샤
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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
    • A61K9/2004—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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/166—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
    • 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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K9/2095—Tabletting processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
KR1020140157082A 2013-11-15 2014-11-12 복합 조립물 및 속방성 정제, 및 이들의 제조 방법 Active KR102253849B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2013237000 2013-11-15
JPJP-P-2013-237000 2013-11-15

Publications (2)

Publication Number Publication Date
KR20150056474A KR20150056474A (ko) 2015-05-26
KR102253849B1 true KR102253849B1 (ko) 2021-05-21

Family

ID=51951602

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020140157082A Active KR102253849B1 (ko) 2013-11-15 2014-11-12 복합 조립물 및 속방성 정제, 및 이들의 제조 방법

Country Status (6)

Country Link
US (2) US20150141517A1 (https=)
EP (1) EP2873415B1 (https=)
JP (1) JP6307417B2 (https=)
KR (1) KR102253849B1 (https=)
CN (1) CN104644581A (https=)
IN (1) IN2014DE03239A (https=)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2016098459A1 (ja) * 2014-12-17 2017-09-28 株式会社ダイセル 遅延崩壊性粒子組成物
MY204603A (en) * 2019-04-03 2024-09-05 Astellas Pharma Inc Pharmaceutical composition
CN115379861A (zh) * 2020-04-10 2022-11-22 日本瓦姆&珀巴尔株式会社 缓释性主剂
EP4134103A4 (en) * 2020-04-10 2024-04-24 Japan Vam & Poval Co., Ltd. BINDER
AU2021311722A1 (en) 2020-07-24 2023-02-02 Elanco Us Inc. Process for making an isoxazoline compound and intermediate thereof
JP7414668B2 (ja) * 2020-08-28 2024-01-16 信越化学工業株式会社 ポリビニルアルコール含有造粒物及び固形製剤
JP7590950B2 (ja) * 2020-12-18 2024-11-27 大鵬薬品工業株式会社 ビラスチンを含有する口腔内崩壊錠
KR20230146800A (ko) 2022-04-13 2023-10-20 주식회사 산흥이지 도로교통 표지판의 각도 조절장치
JP2023173283A (ja) * 2022-05-25 2023-12-07 フロイント産業株式会社 顆粒及びその製造方法、並びに錠剤
CN116510026B (zh) * 2023-07-04 2023-09-19 山东天力药业有限公司 一种甘露醇复合药用辅料及其制备方法
CN121941489A (zh) * 2023-10-12 2026-04-28 迪辅益制药有限及两合公司 用于制备附聚赋形剂颗粒的方法和系统

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2210591A2 (en) 2009-01-26 2010-07-28 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
JP2012031138A (ja) * 2010-07-08 2012-02-16 Sawai Pharmaceutical Co Ltd ロラタジン含有口腔内崩壊錠の製造方法
EP2465495A1 (en) 2009-08-11 2012-06-20 Dainippon Sumitomo Pharma Co., Ltd. Tablet that disintegrates rapidly in the mouth and that contains two or more types of particles
WO2013058409A1 (en) 2011-10-21 2013-04-25 Takeda Pharmaceutical Company Limited Sustained-release preparation
EP2674149A1 (en) 2012-06-15 2013-12-18 Shin-Etsu Chemical Co., Ltd. Method for preparing composite granule comprising low-substituted hydroxypropyl cellulose and rapid release preparation

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3864406A (en) * 1973-04-25 1975-02-04 Suomen Sokeri Oy Process for the production of mannitol and sorbitol
PT1260215E (pt) * 2000-03-01 2009-09-03 Eisai R&D Man Co Ltd Comprimido de desintegração rápida que contém poli(álcool vinílico)
JP3595765B2 (ja) * 2000-09-27 2004-12-02 信越化学工業株式会社 低置換度ヒドロキシプロピルセルロースを含む乾式直打用基剤
JP4279220B2 (ja) * 2004-09-09 2009-06-17 日信工業株式会社 複合材料及びその製造方法、複合金属材料及びその製造方法
TWI383809B (zh) * 2005-06-29 2013-02-01 Otsuka Pharma Co Ltd 含有西洛他唑（ｃｉｌｏｓｔａｚｏｌ）之口腔崩解粉末
CN102988318A (zh) * 2008-11-25 2013-03-27 田边三菱制药株式会社 口腔速崩片及其制备方法
CN103282051A (zh) * 2010-12-28 2013-09-04 大鹏药品工业株式会社 口腔内崩解片剂
JP2012236823A (ja) * 2011-04-28 2012-12-06 Fuji Chem Ind Co Ltd 耐湿安定性に優れた錠剤
WO2013098576A1 (en) * 2011-12-31 2013-07-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi Immediate release pharmaceutical composition of valsartan

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2210591A2 (en) 2009-01-26 2010-07-28 Shin-Etsu Chemical Co., Ltd. Wet granulation tableting method using aqueous dispersion of low-substituted hydroxypropyl cellulose
EP2465495A1 (en) 2009-08-11 2012-06-20 Dainippon Sumitomo Pharma Co., Ltd. Tablet that disintegrates rapidly in the mouth and that contains two or more types of particles
JP2012031138A (ja) * 2010-07-08 2012-02-16 Sawai Pharmaceutical Co Ltd ロラタジン含有口腔内崩壊錠の製造方法
WO2013058409A1 (en) 2011-10-21 2013-04-25 Takeda Pharmaceutical Company Limited Sustained-release preparation
EP2674149A1 (en) 2012-06-15 2013-12-18 Shin-Etsu Chemical Co., Ltd. Method for preparing composite granule comprising low-substituted hydroxypropyl cellulose and rapid release preparation
KR102011518B1 (ko) 2012-06-15 2019-08-16 신에쓰 가가꾸 고교 가부시끼가이샤 저치환도 히드록시프로필셀룰로오스를 포함하는 복합 조립물의 제조 방법 및 속방성 제제

Also Published As

Publication number Publication date
CN104644581A (zh) 2015-05-27
US11723872B2 (en) 2023-08-15
KR20150056474A (ko) 2015-05-26
EP2873415B1 (en) 2018-08-29
JP6307417B2 (ja) 2018-04-04
US20150141517A1 (en) 2015-05-21
JP2015117240A (ja) 2015-06-25
US20200038333A1 (en) 2020-02-06
EP2873415A1 (en) 2015-05-20
IN2014DE03239A (https=) 2015-07-17

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