JP2020511419A5 - - Google Patents
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- Publication number
- JP2020511419A5 JP2020511419A5 JP2019533101A JP2019533101A JP2020511419A5 JP 2020511419 A5 JP2020511419 A5 JP 2020511419A5 JP 2019533101 A JP2019533101 A JP 2019533101A JP 2019533101 A JP2019533101 A JP 2019533101A JP 2020511419 A5 JP2020511419 A5 JP 2020511419A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- pivoxil
- core
- tebi
- penem
- 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.)
- Granted
Links
- 239000002552 dosage form Substances 0.000 claims 23
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 7
- SNUDIPVBUUXCDG-QHSBEEBCSA-N tebipenem pivoxil Chemical compound C=1([C@H](C)[C@@H]2[C@H](C(N2C=1C(=O)OCOC(=O)C(C)(C)C)=O)[C@H](O)C)SC(C1)CN1C1=NCCS1 SNUDIPVBUUXCDG-QHSBEEBCSA-N 0.000 claims 6
- 229950007537 tebipenem pivoxil Drugs 0.000 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 4
- 229960000913 crospovidone Drugs 0.000 claims 4
- 239000000314 lubricant Substances 0.000 claims 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 4
- 239000006186 oral dosage form Substances 0.000 claims 4
- 229950009297 pivoxil Drugs 0.000 claims 4
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 3
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 3
- 239000007884 disintegrant Substances 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 1
- 208000035143 Bacterial infection Diseases 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 239000008351 acetate buffer Substances 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical group [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 208000022362 bacterial infectious disease Diseases 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 239000004203 carnauba wax Substances 0.000 claims 1
- 235000013869 carnauba wax Nutrition 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000000194 fatty acid Substances 0.000 claims 1
- 229930195729 fatty acid Natural products 0.000 claims 1
- -1 fatty acid ester Chemical class 0.000 claims 1
- 239000012458 free base Substances 0.000 claims 1
- 229940049654 glyceryl behenate Drugs 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 229940037627 magnesium lauryl sulfate Drugs 0.000 claims 1
- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 239000003921 oil Substances 0.000 claims 1
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims 1
- 235000010234 sodium benzoate Nutrition 0.000 claims 1
- 239000004299 sodium benzoate Substances 0.000 claims 1
- 229960003885 sodium benzoate Drugs 0.000 claims 1
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 239000008107 starch Substances 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 235000019698 starch Nutrition 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 229940033134 talc Drugs 0.000 claims 1
- 208000019206 urinary tract infection Diseases 0.000 claims 1
- 239000002023 wood Substances 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022089414A JP7431886B2 (ja) | 2016-12-15 | 2022-06-01 | 新規テビペネムピボキシルの即放性および調節放出性経口剤形 |
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662434643P | 2016-12-15 | 2016-12-15 | |
| US62/434,643 | 2016-12-15 | ||
| US201662438071P | 2016-12-22 | 2016-12-22 | |
| US62/438,071 | 2016-12-22 | ||
| PCT/US2017/066729 WO2018112372A1 (en) | 2016-12-15 | 2017-12-15 | Novel tebipenem pivoxil immediate and modified release oral dosage forms |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022089414A Division JP7431886B2 (ja) | 2016-12-15 | 2022-06-01 | 新規テビペネムピボキシルの即放性および調節放出性経口剤形 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020511419A JP2020511419A (ja) | 2020-04-16 |
| JP2020511419A5 true JP2020511419A5 (https=) | 2020-11-26 |
| JP7083828B2 JP7083828B2 (ja) | 2022-06-13 |
Family
ID=60937949
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019533101A Active JP7083828B2 (ja) | 2016-12-15 | 2017-12-15 | 新規テビペネムピボキシルの即放性および調節放出性経口剤形 |
| JP2022089414A Active JP7431886B2 (ja) | 2016-12-15 | 2022-06-01 | 新規テビペネムピボキシルの即放性および調節放出性経口剤形 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2022089414A Active JP7431886B2 (ja) | 2016-12-15 | 2022-06-01 | 新規テビペネムピボキシルの即放性および調節放出性経口剤形 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US12226403B2 (https=) |
| EP (2) | EP3554484B1 (https=) |
| JP (2) | JP7083828B2 (https=) |
| KR (1) | KR102640532B1 (https=) |
| CN (2) | CN110072520A (https=) |
| AU (2) | AU2017377062B2 (https=) |
| BR (1) | BR112019012171B1 (https=) |
| CA (1) | CA3045566C (https=) |
| CO (1) | CO2019006183A2 (https=) |
| ES (1) | ES3037252T3 (https=) |
| IL (1) | IL267219B2 (https=) |
| MX (3) | MX2019007136A (https=) |
| PH (1) | PH12019501234A1 (https=) |
| WO (1) | WO2018112372A1 (https=) |
| ZA (1) | ZA201903309B (https=) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110072520A (zh) | 2016-12-15 | 2019-07-30 | 斯派尔治疗有限公司 | 新型替比培南匹伏酯速释和调释口服剂型 |
| NZ753781A (en) * | 2017-02-06 | 2022-10-28 | Spero Therapeutics Inc | Tebipenem pivoxil crystalline forms, compositions including the same, methods of manufacture, and methods of use |
| CN109432044B (zh) * | 2018-11-27 | 2021-05-11 | 山东省药学科学院 | 一种替比培南酯细粒剂及其制备方法 |
| EP4243783A1 (en) * | 2020-11-11 | 2023-09-20 | Spero Therapeutics, Inc. | High dosage tebipenem pivoxil tablet formulation |
| CN115969815A (zh) * | 2023-02-10 | 2023-04-18 | 鲁南贝特制药有限公司 | 一种替比培南酯口服制剂及其制备方法 |
| CN118526466B (zh) * | 2024-07-22 | 2024-11-05 | 山东则正医药技术有限公司 | 一种替比培南匹伏酯颗粒制剂及其制备方法 |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4851230A (en) * | 1983-04-07 | 1989-07-25 | Bristol-Myers Company | Capsule shaped tablets |
| AU682510B2 (en) | 1993-07-01 | 1997-10-09 | Pfizer Japan Inc. | 2-(1-(1,3-thiazolin-2-yl)azetidin-3-yl)thio-carbapenem derivatives |
| JP3317604B2 (ja) | 1994-12-28 | 2002-08-26 | 日本ワイスレダリー株式会社 | 結晶形態のカルバペネム化合物 |
| TW420681B (en) | 1995-12-08 | 2001-02-01 | Lederle Japan Ltd | Carbapenem-3-carboxylic acid ester derivatives |
| JP2847093B2 (ja) | 1996-03-11 | 1999-01-13 | ソニー株式会社 | ビデオカメラ |
| JP3317649B2 (ja) | 1997-01-13 | 2002-08-26 | 日本ワイスレダリー株式会社 | 結晶形態のカルバペネム化合物 |
| JP2003171277A (ja) | 2001-12-07 | 2003-06-17 | Wyeth Lederle Japan Ltd | 薬物放出時間制御型固形製剤 |
| CA2476201C (en) * | 2002-02-21 | 2009-09-01 | Biovail Laboratories Incorporated | Modified release formulations of at least one form of tramadol |
| JP2004035517A (ja) * | 2002-07-08 | 2004-02-05 | Wyeth Lederle Japan Ltd | カルバペネム系抗生剤含有経口製剤 |
| JP2004035518A (ja) | 2002-07-08 | 2004-02-05 | Wyeth Lederle Japan Ltd | 苦味をマスキングしたカルバペネム系抗生剤含有経口顆粒製剤 |
| US20060099253A1 (en) * | 2004-10-20 | 2006-05-11 | Wyeth | Antibiotic product formulation |
| WO2007070164A1 (en) * | 2005-10-19 | 2007-06-21 | The Curators Of The University Of Missouri | Pharmaceutical composition comprising a proton pump inhibitor, a buffering agent and an anti-h. pylori active substance and methods of using same |
| US20080069879A1 (en) | 2006-05-02 | 2008-03-20 | Ravishekhar Bhiwgade | Stable solid dosage form containing amorphous cefditoren pivoxil and process for preparation thereof |
| CN101868460A (zh) * | 2007-11-23 | 2010-10-20 | 国际药品工业株式会社 | 2-芳基甲基吖丁啶-碳青霉烯-3-羧酸酯衍生物或其盐、其制备方法以及包含上述的药物组合物 |
| KR100950699B1 (ko) | 2008-03-28 | 2010-03-31 | 국제약품공업주식회사 | 2-아릴메틸아제티딘-카바페넴-3-카복실산 에스테르유도체의 산부가염, 이의 제조방법 및 이를 포함하는 약학조성물 |
| CN102558181B (zh) | 2010-12-15 | 2015-04-22 | 石药集团中奇制药技术（石家庄）有限公司 | 一种碳青霉烯抗生素的制备方法 |
| CN102731507B (zh) | 2011-04-13 | 2015-04-01 | 石药集团中奇制药技术（石家庄）有限公司 | 泰比培南晶型、其制备方法及其在制备药物中的应用 |
| CN102276611B (zh) | 2011-05-18 | 2013-01-09 | 深圳万乐药业有限公司 | 一种替比培南酯的重结晶精制方法 |
| CN102860985B (zh) * | 2011-07-06 | 2015-02-25 | 石药集团中奇制药技术（石家庄）有限公司 | 一种泰比培南酯口服制剂及其制备方法 |
| CN103371977A (zh) * | 2012-04-25 | 2013-10-30 | 秦引林 | 一种泰比培南酯颗粒及其制备方法 |
| CN102885811B (zh) | 2012-08-27 | 2014-05-28 | 南京华威医药科技开发有限公司 | 含有泰比培南酯的口服制剂 |
| CN103664948B (zh) | 2012-09-05 | 2015-12-16 | 凌沛学 | 一种替比培南酯的中间体的结晶及其制备方法 |
| CN103664949A (zh) | 2012-09-12 | 2014-03-26 | 高瑞耀业(北京)科技有限公司 | 替比培南匹伏酯结晶及其制备方法 |
| CN102836130A (zh) | 2012-09-19 | 2012-12-26 | 山东罗欣药业股份有限公司 | 一种替比培南匹伏酯颗粒剂 |
| CN103655483A (zh) | 2012-09-26 | 2014-03-26 | 扬州市星斗药业有限公司 | 一种含有替比培南的颗粒及其制备方法 |
| CN103054815B (zh) * | 2013-02-04 | 2015-12-02 | 南京卡文迪许生物工程技术有限公司 | 替比培南酯口服固体制剂及其制备方法 |
| CN104224725A (zh) | 2013-06-14 | 2014-12-24 | 北京济美堂医药研究有限公司 | 一种替比培南酯颗粒剂及其制备方法 |
| CN104027310B (zh) | 2013-12-26 | 2016-02-03 | 青岛大学 | 一种法罗培南钠颗粒剂及其制备方法 |
| CN104013583B (zh) * | 2014-06-27 | 2019-02-26 | 国药集团致君（深圳）制药有限公司 | 一种泰比培南酯组合物的药物制剂及其制备方法 |
| CN105193742A (zh) | 2015-10-30 | 2015-12-30 | 海口市制药厂有限公司 | 替比培南酯颗粒剂组合物、其制备方法及应用 |
| CN105997891A (zh) * | 2016-05-20 | 2016-10-12 | 郑州明泽医药科技有限公司 | 一种替比培南酯制剂及其制备方法 |
| CN105963261A (zh) | 2016-07-08 | 2016-09-28 | 河南全宇制药股份有限公司 | 一种替比培南酯颗粒剂及其制备方法 |
| CN110072520A (zh) | 2016-12-15 | 2019-07-30 | 斯派尔治疗有限公司 | 新型替比培南匹伏酯速释和调释口服剂型 |
| NZ753781A (en) | 2017-02-06 | 2022-10-28 | Spero Therapeutics Inc | Tebipenem pivoxil crystalline forms, compositions including the same, methods of manufacture, and methods of use |
| CN107737107B (zh) | 2017-12-02 | 2020-05-29 | 北京达因高科儿童药物研究院有限公司 | 一种含替比培南酯组合物的口服制剂及其制备方法 |
| EP4243783A1 (en) | 2020-11-11 | 2023-09-20 | Spero Therapeutics, Inc. | High dosage tebipenem pivoxil tablet formulation |
-
2017
- 2017-12-15 CN CN201780077794.3A patent/CN110072520A/zh active Pending
- 2017-12-15 ES ES17826092T patent/ES3037252T3/es active Active
- 2017-12-15 MX MX2019007136A patent/MX2019007136A/es unknown
- 2017-12-15 CA CA3045566A patent/CA3045566C/en active Active
- 2017-12-15 BR BR112019012171-4A patent/BR112019012171B1/pt active IP Right Grant
- 2017-12-15 KR KR1020197019796A patent/KR102640532B1/ko active Active
- 2017-12-15 IL IL267219A patent/IL267219B2/en unknown
- 2017-12-15 EP EP17826092.3A patent/EP3554484B1/en active Active
- 2017-12-15 JP JP2019533101A patent/JP7083828B2/ja active Active
- 2017-12-15 US US16/470,058 patent/US12226403B2/en active Active
- 2017-12-15 CN CN202210913933.4A patent/CN115192533A/zh active Pending
- 2017-12-15 WO PCT/US2017/066729 patent/WO2018112372A1/en not_active Ceased
- 2017-12-15 EP EP22160275.8A patent/EP4032531A1/en active Pending
- 2017-12-15 AU AU2017377062A patent/AU2017377062B2/en active Active
-
2019
- 2019-05-24 ZA ZA2019/03309A patent/ZA201903309B/en unknown
- 2019-06-03 PH PH12019501234A patent/PH12019501234A1/en unknown
- 2019-06-13 CO CONC2019/0006183A patent/CO2019006183A2/es unknown
- 2019-06-14 MX MX2022006971A patent/MX2022006971A/es unknown
- 2019-06-14 MX MX2022014095A patent/MX2022014095A/es unknown
-
2020
- 2020-12-03 AU AU2020281095A patent/AU2020281095B2/en active Active
-
2022
- 2022-06-01 JP JP2022089414A patent/JP7431886B2/ja active Active
-
2024
- 2024-09-18 US US18/888,372 patent/US20250009718A1/en active Pending
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