JP2020527580A5 - - Google Patents
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- JP2020527580A5 JP2020527580A5 JP2020502476A JP2020502476A JP2020527580A5 JP 2020527580 A5 JP2020527580 A5 JP 2020527580A5 JP 2020502476 A JP2020502476 A JP 2020502476A JP 2020502476 A JP2020502476 A JP 2020502476A JP 2020527580 A5 JP2020527580 A5 JP 2020527580A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- patient
- weeks
- tablet
- bile acid
- 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.)
- Pending
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- 239000002552 dosage form Substances 0.000 claims description 42
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims description 37
- HSINOMROUCMIEA-FGVHQWLLSA-N (2s,4r)-4-[(3r,5s,6r,7r,8s,9s,10s,13r,14s,17r)-6-ethyl-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-17-yl]-2-methylpentanoic acid Chemical compound C([C@@]12C)C[C@@H](O)C[C@H]1[C@@H](CC)[C@@H](O)[C@@H]1[C@@H]2CC[C@]2(C)[C@@H]([C@H](C)C[C@H](C)C(O)=O)CC[C@H]21 HSINOMROUCMIEA-FGVHQWLLSA-N 0.000 claims description 34
- 239000003613 bile acid Substances 0.000 claims description 34
- 239000006186 oral dosage form Substances 0.000 claims description 27
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 26
- 239000002702 enteric coating Substances 0.000 claims description 25
- 238000009505 enteric coating Methods 0.000 claims description 25
- 239000002516 radical scavenger Substances 0.000 claims description 25
- 238000011282 treatment Methods 0.000 claims description 25
- 230000002496 gastric effect Effects 0.000 claims description 22
- 230000003442 weekly effect Effects 0.000 claims description 22
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims description 18
- 201000006549 dyspepsia Diseases 0.000 claims description 18
- 210000002784 stomach Anatomy 0.000 claims description 18
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims description 17
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims description 17
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims description 17
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 14
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 14
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims description 14
- 239000000945 filler Substances 0.000 claims description 14
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 14
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 14
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 14
- 208000024798 heartburn Diseases 0.000 claims description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims description 13
- 230000014759 maintenance of location Effects 0.000 claims description 13
- 208000024891 symptom Diseases 0.000 claims description 13
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 12
- VTAKZNRDSPNOAU-UHFFFAOYSA-M 2-(chloromethyl)oxirane;hydron;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;dichloride Chemical group Cl.[Cl-].NCC=C.ClCC1CO1.CCCCCCCCCCNCC=C.C[N+](C)(C)CCCCCCNCC=C VTAKZNRDSPNOAU-UHFFFAOYSA-M 0.000 claims description 10
- 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 description 10
- 229920002905 Colesevelam Polymers 0.000 claims description 10
- 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 description 10
- 229920002774 Maltodextrin Polymers 0.000 claims description 10
- 239000005913 Maltodextrin Substances 0.000 claims description 10
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 10
- 229920002472 Starch Polymers 0.000 claims description 10
- 239000008101 lactose Substances 0.000 claims description 10
- 229960001375 lactose Drugs 0.000 claims description 10
- 229940035034 maltodextrin Drugs 0.000 claims description 10
- 239000011159 matrix material Substances 0.000 claims description 10
- 239000008194 pharmaceutical composition Substances 0.000 claims description 10
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 10
- 229940126409 proton pump inhibitor Drugs 0.000 claims description 10
- 239000000612 proton pump inhibitor Substances 0.000 claims description 10
- 239000008107 starch Substances 0.000 claims description 10
- 235000019698 starch Nutrition 0.000 claims description 10
- LDVVTQMJQSCDMK-UHFFFAOYSA-N 1,3-dihydroxypropan-2-yl formate Chemical compound OCC(CO)OC=O LDVVTQMJQSCDMK-UHFFFAOYSA-N 0.000 claims description 8
- 229920000642 polymer Polymers 0.000 claims description 8
- 238000010992 reflux Methods 0.000 claims description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 7
- 229960003943 hypromellose Drugs 0.000 claims description 7
- 229940032147 starch Drugs 0.000 claims description 7
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 claims description 6
- 239000001506 calcium phosphate Substances 0.000 claims description 6
- 235000019739 Dicalciumphosphate Nutrition 0.000 claims description 5
- 208000008469 Peptic Ulcer Diseases 0.000 claims description 5
- 229960001152 colesevelam Drugs 0.000 claims description 5
- 229960000674 colesevelam hydrochloride Drugs 0.000 claims description 5
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 claims description 5
- 229910000390 dicalcium phosphate Inorganic materials 0.000 claims description 5
- 229940038472 dicalcium phosphate Drugs 0.000 claims description 5
- 229940057948 magnesium stearate Drugs 0.000 claims description 5
- 208000011906 peptic ulcer disease Diseases 0.000 claims description 5
- 206010063655 Erosive oesophagitis Diseases 0.000 claims description 4
- 201000010099 disease Diseases 0.000 claims description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 4
- 210000003238 esophagus Anatomy 0.000 claims description 4
- 238000012806 monitoring device Methods 0.000 claims description 4
- 238000012544 monitoring process Methods 0.000 claims description 4
- 238000002560 therapeutic procedure Methods 0.000 claims description 4
- 239000004134 Dicalcium diphosphate Substances 0.000 claims description 3
- 206010030216 Oesophagitis Diseases 0.000 claims description 3
- 206010067171 Regurgitation Diseases 0.000 claims description 3
- JUNWLZAGQLJVLR-UHFFFAOYSA-J calcium diphosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])(=O)OP([O-])([O-])=O JUNWLZAGQLJVLR-UHFFFAOYSA-J 0.000 claims description 3
- 229910000393 dicalcium diphosphate Inorganic materials 0.000 claims description 3
- 235000019821 dicalcium diphosphate Nutrition 0.000 claims description 3
- 208000006881 esophagitis Diseases 0.000 claims description 3
- KHWUKFBQNNLWIV-KPNWGBFJSA-N (3S,8S,9S,10R,13R,14S,17R)-10,13-dimethyl-17-[(2R)-6-methylheptan-2-yl]-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3-ol hydrochloride Chemical compound Cl.C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 KHWUKFBQNNLWIV-KPNWGBFJSA-N 0.000 claims description 2
- 208000023514 Barrett esophagus Diseases 0.000 claims description 2
- 208000023665 Barrett oesophagus Diseases 0.000 claims description 2
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims description 2
- 201000008197 Laryngitis Diseases 0.000 claims description 2
- 206010030155 Oesophageal carcinoma Diseases 0.000 claims description 2
- 201000007100 Pharyngitis Diseases 0.000 claims description 2
- 208000005718 Stomach Neoplasms Diseases 0.000 claims description 2
- 208000009956 adenocarcinoma Diseases 0.000 claims description 2
- 239000003814 drug Substances 0.000 claims description 2
- 238000001839 endoscopy Methods 0.000 claims description 2
- 201000004101 esophageal cancer Diseases 0.000 claims description 2
- 206010017758 gastric cancer Diseases 0.000 claims description 2
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims description 2
- -1 hypromerose Chemical compound 0.000 claims description 2
- 230000005980 lung dysfunction Effects 0.000 claims description 2
- 230000001575 pathological effect Effects 0.000 claims description 2
- 229920001484 poly(alkylene) Polymers 0.000 claims description 2
- 201000011549 stomach cancer Diseases 0.000 claims description 2
- 229940124597 therapeutic agent Drugs 0.000 claims description 2
- 229920000080 bile acid sequestrant Polymers 0.000 claims 9
- 229940096699 bile acid sequestrants Drugs 0.000 claims 9
- 239000013066 combination product Substances 0.000 claims 4
- 229940127555 combination product Drugs 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 230000000717 retained effect Effects 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 2
- 208000025865 Ulcer Diseases 0.000 claims 1
- OGBUMNBNEWYMNJ-UHFFFAOYSA-N batilol Chemical class CCCCCCCCCCCCCCCCCCOCC(O)CO OGBUMNBNEWYMNJ-UHFFFAOYSA-N 0.000 claims 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical group [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims 1
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 1
- 235000011010 calcium phosphates Nutrition 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 229940099371 diacetylated monoglycerides Drugs 0.000 claims 1
- 238000006389 diacetylation reaction Methods 0.000 claims 1
- 235000019700 dicalcium phosphate Nutrition 0.000 claims 1
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 claims 1
- 239000008203 oral pharmaceutical composition Substances 0.000 claims 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 1
- 231100000397 ulcer Toxicity 0.000 claims 1
- 238000000034 method Methods 0.000 description 34
- 238000012986 modification Methods 0.000 description 5
- 230000004048 modification Effects 0.000 description 5
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 206010030201 Oesophageal ulcer Diseases 0.000 description 1
- 208000007107 Stomach Ulcer Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 208000028299 esophageal disease Diseases 0.000 description 1
- 208000019064 esophageal ulcer Diseases 0.000 description 1
- 201000005917 gastric ulcer Diseases 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 230000004043 responsiveness Effects 0.000 description 1
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762534591P | 2017-07-19 | 2017-07-19 | |
| US62/534,591 | 2017-07-19 | ||
| US201862681633P | 2018-06-06 | 2018-06-06 | |
| US62/681,633 | 2018-06-06 | ||
| PCT/US2018/042904 WO2019018656A1 (en) | 2017-07-19 | 2018-07-19 | EFFICACY OF A DOSAGE FORM OF BILIARY ACID SEQUESTERING AGENT WITH GASTRIC RETENTION |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020527580A JP2020527580A (ja) | 2020-09-10 |
| JP2020527580A5 true JP2020527580A5 (https=) | 2021-08-26 |
Family
ID=65015306
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020502476A Pending JP2020527580A (ja) | 2017-07-19 | 2018-07-19 | 胃滞留性胆汁酸捕捉剤剤形の有効性 |
Country Status (9)
| Country | Link |
|---|---|
| US (2) | US20200138854A1 (https=) |
| EP (1) | EP3654953A4 (https=) |
| JP (1) | JP2020527580A (https=) |
| CN (2) | CN111050755A (https=) |
| AU (1) | AU2018302255A1 (https=) |
| BR (1) | BR112020001071A2 (https=) |
| CA (1) | CA3070082A1 (https=) |
| MA (1) | MA49653A (https=) |
| WO (2) | WO2019018639A1 (https=) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110579541B (zh) * | 2019-08-29 | 2022-04-08 | 北京悦康科创医药科技股份有限公司 | 一种兰索拉唑有关物质的检测方法 |
| CN110596295A (zh) * | 2019-10-21 | 2019-12-20 | 上海百趣生物医学科技有限公司 | 一种检测胆汁酸的方法 |
| CN111005074A (zh) * | 2019-12-19 | 2020-04-14 | 江西海普洛斯医学检验实验室有限公司 | 一种基于illumina测序平台的DNA文库构建试剂盒、文库构建方法和应用 |
| CN111060643B (zh) * | 2020-01-16 | 2021-04-02 | 博莱克科技（武汉）有限公司 | 一种含有同分异构体胆汁酸代谢组分分离方法 |
| CN111812264B (zh) * | 2020-07-09 | 2021-06-15 | 苏州旭辉检测有限公司 | 一种去氧胆酸类化合物的生物样品分析方法 |
| CN114146184A (zh) * | 2021-12-03 | 2022-03-08 | 成都施桂行医药科技有限责任公司 | 阳离子聚合物在制备药物中的应用 |
| CN114235995A (zh) * | 2021-12-03 | 2022-03-25 | 天津国科医工科技发展有限公司 | 检测血清中15种胆汁酸的方法 |
| CN115201357A (zh) * | 2022-06-17 | 2022-10-18 | 陕西盘龙医药研究院 | 一种小儿咽扁颗粒中猪去氧胆酸的限量检测方法 |
| WO2025043046A1 (en) * | 2023-08-22 | 2025-02-27 | GlycosBio, INC. | Latex-compatible oil-based compositions |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009158625A2 (en) * | 2008-06-26 | 2009-12-30 | Ironwood Pharmaceuticals, Inc. | Compositions and methods for treating or preventing gastrointestinal disorders and gerd-related respiratory disorders |
| US20120009130A1 (en) * | 2010-05-06 | 2012-01-12 | Nanoaxis | Viral Therapy and Prophylaxis Using Nanotechnology Delivery Techniques |
| WO2011157655A1 (en) * | 2010-06-15 | 2011-12-22 | Biocrates Life Sciences Ag | Use of bile acids for prediction of an onset of sepsis |
| WO2012027331A1 (en) * | 2010-08-27 | 2012-03-01 | Ironwood Pharmaceuticals, Inc. | Compositions and methods for treating or preventing metabolic syndrome and related diseases and disorders |
| MX346224B (es) * | 2011-02-04 | 2017-03-10 | Biocopea Ltd | Composiciones y metodos para el tratamiento de inflamacion cronica y enfermedades inflamatorias. |
| CN102729224B (zh) * | 2012-07-05 | 2016-04-27 | 南京德朔实业有限公司 | 具有辅助弹出电池包功能的电动工具 |
| CA2898362C (en) * | 2013-01-15 | 2020-09-01 | Ironwood Pharmaceuticals, Inc. | Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant |
| US20180015118A1 (en) * | 2015-02-03 | 2018-01-18 | Ironwood Pharmaceuticals, Inc. | Methods of treating upper gastrointestinal disorders in ppi refractory gerd |
| WO2017070114A2 (en) * | 2015-10-18 | 2017-04-27 | Wei Jia | Diabetes-related biomarkers and treatment of diabetes-related conditions |
-
2018
- 2018-07-19 JP JP2020502476A patent/JP2020527580A/ja active Pending
- 2018-07-19 CN CN201880048426.0A patent/CN111050755A/zh active Pending
- 2018-07-19 MA MA049653A patent/MA49653A/fr unknown
- 2018-07-19 AU AU2018302255A patent/AU2018302255A1/en not_active Abandoned
- 2018-07-19 EP EP18835584.6A patent/EP3654953A4/en not_active Withdrawn
- 2018-07-19 WO PCT/US2018/042881 patent/WO2019018639A1/en not_active Ceased
- 2018-07-19 CA CA3070082A patent/CA3070082A1/en active Pending
- 2018-07-19 US US16/631,214 patent/US20200138854A1/en not_active Abandoned
- 2018-07-19 US US16/631,208 patent/US20230190662A1/en not_active Abandoned
- 2018-07-19 CN CN202210282827.0A patent/CN114767646A/zh active Pending
- 2018-07-19 WO PCT/US2018/042904 patent/WO2019018656A1/en not_active Ceased
- 2018-07-19 BR BR112020001071-5A patent/BR112020001071A2/pt not_active IP Right Cessation
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