JP6310164B1 - アセトアミノフェン製剤の製造方法 - Google Patents

アセトアミノフェン製剤の製造方法 Download PDF

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Publication number
JP6310164B1
JP6310164B1 JP2017545607A JP2017545607A JP6310164B1 JP 6310164 B1 JP6310164 B1 JP 6310164B1 JP 2017545607 A JP2017545607 A JP 2017545607A JP 2017545607 A JP2017545607 A JP 2017545607A JP 6310164 B1 JP6310164 B1 JP 6310164B1
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Prior art keywords
acetaminophen
weight
tablet
production method
dispersant
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JP2017545607A
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Japanese (ja)
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JPWO2017195796A1 (ja
Inventor
坂本 浩
浩 坂本
邦男 駒居
邦男 駒居
賢司 ▲榊▼原
賢司 ▲榊▼原
宏和 番場
宏和 番場
清 福田
清 福田
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Nippon Zoki Pharmaceutical Co Ltd
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Nippon Zoki Pharmaceutical Co Ltd
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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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2022Organic 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; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Rheumatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2017545607A 2016-05-10 2017-05-09 アセトアミノフェン製剤の製造方法 Active JP6310164B1 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2018048354A JP6966780B2 (ja) 2016-05-10 2018-03-15 アセトアミノフェン製剤の製造方法

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
JP2016094764 2016-05-10
JP2016094764 2016-05-10
JP2016165993 2016-08-26
JP2016165993 2016-08-26
JP2016201560 2016-10-13
JP2016201560 2016-10-13
PCT/JP2017/017603 WO2017195796A1 (ja) 2016-05-10 2017-05-09 アセトアミノフェン製剤の製造方法

Related Child Applications (1)

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JP2018048354A Division JP6966780B2 (ja) 2016-05-10 2018-03-15 アセトアミノフェン製剤の製造方法

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JP6310164B1 true JP6310164B1 (ja) 2018-04-11
JPWO2017195796A1 JPWO2017195796A1 (ja) 2018-05-24

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JP2018048354A Active JP6966780B2 (ja) 2016-05-10 2018-03-15 アセトアミノフェン製剤の製造方法

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US (2) US11033501B2 (enExample)
EP (1) EP3456324B1 (enExample)
JP (2) JP6310164B1 (enExample)
KR (1) KR102408085B1 (enExample)
CN (1) CN109069455B (enExample)
CA (1) CA3023478C (enExample)
SG (1) SG11201809835UA (enExample)
TW (1) TWI742078B (enExample)
WO (1) WO2017195796A1 (enExample)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7105473B2 (ja) * 2017-04-19 2022-07-25 日本臓器製薬株式会社 プレミックス原薬の製造方法
WO2020004393A1 (ja) * 2018-06-26 2020-01-02 日本臓器製薬株式会社 粒子サイズが不揃いな原薬粒子の処理方法
WO2020131795A1 (en) * 2018-12-18 2020-06-25 DDP Specialty Electronic Materials US, Inc. A sustained release composition comprising a hydroxyalkyl methylcellulose
JP7360460B2 (ja) * 2019-06-07 2023-10-12 あゆみ製薬株式会社 口腔内崩壊錠及びその製造方法
CN111920774B (zh) * 2020-08-06 2022-08-12 河北君临药业有限公司 一种对乙酰氨基酚片及其制备方法
CN114432256A (zh) * 2021-12-31 2022-05-06 陕西必康制药集团控股有限公司 对乙酰氨基酚包衣片及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61145111A (ja) * 1984-12-20 1986-07-02 Lion Corp アセトアミノフェン含有錠剤の製造方法
JP2003509368A (ja) * 1999-09-16 2003-03-11 ローディア・インコーポレイテッド 直接圧縮可能な超微粒アセトアミノフェン組成物及びその製造方法
JP2012144520A (ja) * 2010-12-24 2012-08-02 Lion Corp 錠剤

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5733578A (en) * 1995-11-15 1998-03-31 Edward Mendell Co., Inc. Directly compressible high load acetaminophen formulations
AU2944700A (en) 1999-03-15 2000-10-04 Kaken Pharmaceutical Co., Ltd. Quickly disintegrating tablets and process for producing the same
JP4925526B2 (ja) 2001-09-10 2012-04-25 旭化成ケミカルズ株式会社 薬物の混合方法
US20110268798A1 (en) * 2009-01-16 2011-11-03 Add Advanced Drug Delivery Technologies Ltd Orally disntegrating tablets for the treatment of pain
US20120129878A1 (en) 2009-07-28 2012-05-24 Takeda Pharmaceutical Company Limited Tablet

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS61145111A (ja) * 1984-12-20 1986-07-02 Lion Corp アセトアミノフェン含有錠剤の製造方法
JP2003509368A (ja) * 1999-09-16 2003-03-11 ローディア・インコーポレイテッド 直接圧縮可能な超微粒アセトアミノフェン組成物及びその製造方法
JP2012144520A (ja) * 2010-12-24 2012-08-02 Lion Corp 錠剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
医薬品添加物事典 2007, vol. 第1刷, JPN6017047514, 25 July 2007 (2007-07-25), JP, pages 65 - 67, ISSN: 0003700229 *

Also Published As

Publication number Publication date
EP3456324A1 (en) 2019-03-20
US20190142754A1 (en) 2019-05-16
WO2017195796A1 (ja) 2017-11-16
US20210220283A1 (en) 2021-07-22
EP3456324A4 (en) 2019-12-11
TW201808272A (zh) 2018-03-16
CN109069455A (zh) 2018-12-21
TWI742078B (zh) 2021-10-11
CA3023478C (en) 2024-02-06
EP3456324B1 (en) 2023-04-05
SG11201809835UA (en) 2018-12-28
JP2018090638A (ja) 2018-06-14
CA3023478A1 (en) 2017-11-16
JP6966780B2 (ja) 2021-11-17
KR102408085B1 (ko) 2022-06-13
JPWO2017195796A1 (ja) 2018-05-24
KR20190005939A (ko) 2019-01-16
US11433031B2 (en) 2022-09-06
CN109069455B (zh) 2020-10-09
US11033501B2 (en) 2021-06-15

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