KR102408085B1 - 아세트아미노펜 제제의 제조 방법 - Google Patents

아세트아미노펜 제제의 제조 방법 Download PDF

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KR102408085B1
KR102408085B1 KR1020187035431A KR20187035431A KR102408085B1 KR 102408085 B1 KR102408085 B1 KR 102408085B1 KR 1020187035431 A KR1020187035431 A KR 1020187035431A KR 20187035431 A KR20187035431 A KR 20187035431A KR 102408085 B1 KR102408085 B1 KR 102408085B1
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acetaminophen
tablet
manufacturing
weight
crushing
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KR20190005939A (ko
Inventor
히로시 사카모토
쿠니오 코마이
켄지 사카키바라
히로카즈 반바
키요시 후쿠다
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니폰 조키 세야쿠 가부시키가이샤
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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
    • A61K9/2095Tabletting processes
    • 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
    • A61K9/2072Pills, 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
    • 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)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (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)
KR1020187035431A 2016-05-10 2017-05-09 아세트아미노펜 제제의 제조 방법 Expired - Fee Related KR102408085B1 (ko)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
JPJP-P-2016-094764 2016-05-10
JP2016094764 2016-05-10
JP2016165993 2016-08-26
JPJP-P-2016-165993 2016-08-26
JPJP-P-2016-201560 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

Publications (2)

Publication Number Publication Date
KR20190005939A KR20190005939A (ko) 2019-01-16
KR102408085B1 true KR102408085B1 (ko) 2022-06-13

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KR1020187035431A Expired - Fee Related KR102408085B1 (ko) 2016-05-10 2017-05-09 아세트아미노펜 제제의 제조 방법

Country Status (9)

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

Families Citing this family (7)

* 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
CN112351772B (zh) * 2018-06-26 2023-05-16 日本脏器制药株式会社 颗粒尺寸不一致的原料药颗粒的处理方法
US20220088037A1 (en) * 2018-12-18 2022-03-24 DDP Specialty Electronic Materials US, Inc. A sustained release composition comprising a hydroxyalkyl methylcellulose
WO2020246120A1 (ja) * 2019-06-07 2020-12-10 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
WO2022065361A1 (ja) * 2020-09-25 2022-03-31 日本臓器製薬株式会社 造粒物の製造方法
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
WO1997017947A1 (en) 1995-11-15 1997-05-22 Edward Mendell Co., Inc. Directly compressible high load acetaminophen formulations
US20010044472A1 (en) 1999-09-16 2001-11-22 Upadhyay Ajay Hasmukhlal Directly compressible acetaminophen compositions
WO2010081722A2 (en) 2009-01-16 2010-07-22 Add Technologies Ltd. Orally disintegrating tablets for the treatment of pain

Family Cites Families (5)

* 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
WO2000054752A1 (fr) 1999-03-15 2000-09-21 Kaken Pharmaceutical Co., Ltd. Comprimes a delitement rapide et procede de fabrication
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
EA201270204A1 (ru) 2009-07-28 2012-08-30 Такеда Фармасьютикал Компани Лимитед Таблетка
JP5974469B2 (ja) * 2010-12-24 2016-08-23 ライオン株式会社 錠剤の製造方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997017947A1 (en) 1995-11-15 1997-05-22 Edward Mendell Co., Inc. Directly compressible high load acetaminophen formulations
US20010044472A1 (en) 1999-09-16 2001-11-22 Upadhyay Ajay Hasmukhlal Directly compressible acetaminophen compositions
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
WO2010081722A2 (en) 2009-01-16 2010-07-22 Add Technologies Ltd. Orally disintegrating tablets for the treatment of pain

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
Journal of Dispersion Science and Technology Vol.23, no.5, pp.631-662 (2002.1.1.)

Also Published As

Publication number Publication date
TW201808272A (zh) 2018-03-16
US11433031B2 (en) 2022-09-06
EP3456324B1 (en) 2023-04-05
JPWO2017195796A1 (ja) 2018-05-24
EP3456324A4 (en) 2019-12-11
SG11201809835UA (en) 2018-12-28
WO2017195796A1 (ja) 2017-11-16
EP3456324A1 (en) 2019-03-20
TWI742078B (zh) 2021-10-11
CN109069455B (zh) 2020-10-09
CN109069455A (zh) 2018-12-21
US20190142754A1 (en) 2019-05-16
KR20190005939A (ko) 2019-01-16
JP2018090638A (ja) 2018-06-14
JP6966780B2 (ja) 2021-11-17
CA3023478A1 (en) 2017-11-16
US20210220283A1 (en) 2021-07-22
JP6310164B1 (ja) 2018-04-11
US11033501B2 (en) 2021-06-15
CA3023478C (en) 2024-02-06

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