CA3023478C - Method for manufacturing acetaminophen preparation - Google Patents
Method for manufacturing acetaminophen preparation Download PDFInfo
- Publication number
- CA3023478C CA3023478C CA3023478A CA3023478A CA3023478C CA 3023478 C CA3023478 C CA 3023478C CA 3023478 A CA3023478 A CA 3023478A CA 3023478 A CA3023478 A CA 3023478A CA 3023478 C CA3023478 C CA 3023478C
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- CA
- Canada
- Prior art keywords
- manufacturing
- acetaminophen
- tablets
- dispersant
- weight
- 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.)
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 title claims abstract description 366
- 229960005489 paracetamol Drugs 0.000 title claims abstract description 182
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 139
- 238000000034 method Methods 0.000 title claims abstract description 116
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 97
- 239000000654 additive Substances 0.000 claims description 70
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- 235000019814 powdered cellulose Nutrition 0.000 description 1
- 229940088417 precipitated calcium carbonate Drugs 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 238000000790 scattering method Methods 0.000 description 1
- 229940083542 sodium Drugs 0.000 description 1
- 229940080313 sodium starch Drugs 0.000 description 1
- 239000007944 soluble tablet Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000006190 sub-lingual tablet Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 235000010965 sucrose esters of fatty acids Nutrition 0.000 description 1
- 239000001959 sucrose esters of fatty acids Substances 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 239000007940 sugar coated tablet Substances 0.000 description 1
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- 239000004094 surface-active agent Substances 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
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- 235000020357 syrup Nutrition 0.000 description 1
- 229960005196 titanium dioxide Drugs 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A61K9/2072—Pills, 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
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- A61K31/167—Amides, 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
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- 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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic 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
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- 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
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- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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- 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
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- A61K9/2022—Organic macromolecular compounds
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
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- 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)
Applications Claiming Priority (7)
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| JP2016094764 | 2016-05-10 | ||
| JP2016-094764 | 2016-05-10 | ||
| JP2016165993 | 2016-08-26 | ||
| JP2016-165993 | 2016-08-26 | ||
| JP2016201560 | 2016-10-13 | ||
| JP2016-201560 | 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 |
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| CA3023478A1 CA3023478A1 (en) | 2017-11-16 |
| CA3023478C true CA3023478C (en) | 2024-02-06 |
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| CA3023478A Active CA3023478C (en) | 2016-05-10 | 2017-05-09 | Method for manufacturing acetaminophen preparation |
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| EP (1) | EP3456324B1 (enExample) |
| JP (2) | JP6310164B1 (enExample) |
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| 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 |
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| 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 |
| 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 |
| US6264983B1 (en) * | 1999-09-16 | 2001-07-24 | Rhodia, Inc. | Directly compressible, ultra fine acetaminophen compositions and process for producing 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 |
| JP5974469B2 (ja) * | 2010-12-24 | 2016-08-23 | ライオン株式会社 | 錠剤の製造方法 |
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2017
- 2017-05-09 US US16/099,961 patent/US11033501B2/en active Active
- 2017-05-09 KR KR1020187035431A patent/KR102408085B1/ko active Active
- 2017-05-09 SG SG11201809835UA patent/SG11201809835UA/en unknown
- 2017-05-09 EP EP17796157.0A patent/EP3456324B1/en active Active
- 2017-05-09 CN CN201780029088.1A patent/CN109069455B/zh active Active
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- 2017-05-09 JP JP2017545607A patent/JP6310164B1/ja active Active
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2021
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Also Published As
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| 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 |
| 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 |
| JP6310164B1 (ja) | 2018-04-11 |
| CN109069455B (zh) | 2020-10-09 |
| US11033501B2 (en) | 2021-06-15 |
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