JPWO2023145486A5 - - Google Patents
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- Publication number
- JPWO2023145486A5 JPWO2023145486A5 JP2023576781A JP2023576781A JPWO2023145486A5 JP WO2023145486 A5 JPWO2023145486 A5 JP WO2023145486A5 JP 2023576781 A JP2023576781 A JP 2023576781A JP 2023576781 A JP2023576781 A JP 2023576781A JP WO2023145486 A5 JPWO2023145486 A5 JP WO2023145486A5
- Authority
- JP
- Japan
- Prior art keywords
- fesoterodine fumarate
- amount
- fumarate
- fesoterodine
- containing formulation
- 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
Links
- MWHXMIASLKXGBU-RNCYCKTQSA-N (e)-but-2-enedioic acid;[2-[(1r)-3-[di(propan-2-yl)amino]-1-phenylpropyl]-4-(hydroxymethyl)phenyl] 2-methylpropanoate Chemical compound OC(=O)\C=C\C(O)=O.C1([C@@H](CCN(C(C)C)C(C)C)C=2C(=CC=C(CO)C=2)OC(=O)C(C)C)=CC=CC=C1 MWHXMIASLKXGBU-RNCYCKTQSA-N 0.000 description 111
- 229960004524 fesoterodine fumarate Drugs 0.000 description 110
- 239000000203 mixture Substances 0.000 description 62
- 238000009472 formulation Methods 0.000 description 51
- 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 description 31
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 31
- -1 are not cheap Chemical compound 0.000 description 31
- 239000000126 substance Substances 0.000 description 31
- 238000002360 preparation method Methods 0.000 description 30
- 235000014113 dietary fatty acids Nutrition 0.000 description 29
- 239000000194 fatty acid Substances 0.000 description 29
- 229930195729 fatty acid Natural products 0.000 description 29
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 29
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 29
- 229920002678 cellulose Polymers 0.000 description 28
- 239000001913 cellulose Substances 0.000 description 28
- 238000004519 manufacturing process Methods 0.000 description 28
- 238000000034 method Methods 0.000 description 27
- 235000011187 glycerol Nutrition 0.000 description 24
- 239000008187 granular material Substances 0.000 description 22
- 239000003826 tablet Substances 0.000 description 19
- 229960004977 anhydrous lactose Drugs 0.000 description 18
- 238000007908 dry granulation Methods 0.000 description 18
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 18
- 239000000314 lubricant Substances 0.000 description 18
- 229960003943 hypromellose Drugs 0.000 description 17
- 238000007907 direct compression Methods 0.000 description 15
- 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 description 13
- 229920003091 Methocel™ Polymers 0.000 description 13
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 13
- 229960001375 lactose Drugs 0.000 description 13
- 239000008101 lactose Substances 0.000 description 13
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 13
- 239000000811 xylitol Substances 0.000 description 13
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 13
- 235000010447 xylitol Nutrition 0.000 description 13
- 229960002675 xylitol Drugs 0.000 description 13
- 229910052623 talc Inorganic materials 0.000 description 12
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 11
- 239000004372 Polyvinyl alcohol Substances 0.000 description 11
- 230000000052 comparative effect Effects 0.000 description 11
- 229920002451 polyvinyl alcohol Polymers 0.000 description 11
- 238000005550 wet granulation Methods 0.000 description 11
- 239000000454 talc Substances 0.000 description 8
- DMBUODUULYCPAK-UHFFFAOYSA-N 1,3-bis(docosanoyloxy)propan-2-yl docosanoate Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCCCCCCCC)COC(=O)CCCCCCCCCCCCCCCCCCCCC DMBUODUULYCPAK-UHFFFAOYSA-N 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- 229930006000 Sucrose Natural products 0.000 description 6
- 238000005469 granulation Methods 0.000 description 6
- 230000003179 granulation Effects 0.000 description 6
- 239000005720 sucrose Substances 0.000 description 6
- 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 description 5
- 239000000654 additive Substances 0.000 description 5
- 235000010724 Wisteria floribunda Nutrition 0.000 description 4
- 239000003086 colorant Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 239000003381 stabilizer Substances 0.000 description 4
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 4
- 229920002554 vinyl polymer Polymers 0.000 description 4
- 239000004386 Erythritol Substances 0.000 description 3
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 230000000996 additive effect Effects 0.000 description 3
- 229920003086 cellulose ether Polymers 0.000 description 3
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 description 3
- 235000019414 erythritol Nutrition 0.000 description 3
- 229940009714 erythritol Drugs 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000007941 film coated tablet Substances 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000008194 pharmaceutical composition Substances 0.000 description 3
- 229920005862 polyol Polymers 0.000 description 3
- 150000003077 polyols Chemical class 0.000 description 3
- 150000005846 sugar alcohols Chemical class 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 108010009736 Protein Hydrolysates Proteins 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000000413 hydrolysate Substances 0.000 description 2
- 238000004811 liquid chromatography Methods 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000004570 mortar (masonry) Substances 0.000 description 2
- 239000003605 opacifier Substances 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000004014 plasticizer Substances 0.000 description 2
- 229920000058 polyacrylate Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229920001059 synthetic polymer Polymers 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- 102220487426 Actin-related protein 2/3 complex subunit 3_K15M_mutation Human genes 0.000 description 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 description 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 description 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010020853 Hypertonic bladder Diseases 0.000 description 1
- 208000009722 Overactive Urinary Bladder Diseases 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 150000008280 chlorinated hydrocarbons Chemical class 0.000 description 1
- 150000001860 citric acid derivatives Chemical class 0.000 description 1
- 239000003240 coconut oil Substances 0.000 description 1
- 235000019864 coconut oil Nutrition 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 229940099371 diacetylated monoglycerides Drugs 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000000975 dye Substances 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 125000000524 functional group Chemical group 0.000 description 1
- 125000005456 glyceride group Chemical group 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 239000001087 glyceryl triacetate Substances 0.000 description 1
- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 230000036571 hydration Effects 0.000 description 1
- 238000006703 hydration reaction Methods 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 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 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 150000002895 organic esters Chemical class 0.000 description 1
- 208000020629 overactive bladder Diseases 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 125000005498 phthalate group Chemical class 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002522 swelling effect Effects 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022011565 | 2022-01-28 | ||
| PCT/JP2023/000786 WO2023145486A1 (ja) | 2022-01-28 | 2023-01-13 | フェソテロジンフマル酸塩含有製剤の製造方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPWO2023145486A1 JPWO2023145486A1 (zh) | 2023-08-03 |
| JPWO2023145486A5 true JPWO2023145486A5 (zh) | 2024-06-26 |
Family
ID=87471342
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023576781A Pending JPWO2023145486A1 (zh) | 2022-01-28 | 2023-01-13 |
Country Status (3)
| Country | Link |
|---|---|
| JP (1) | JPWO2023145486A1 (zh) |
| TW (1) | TWI836872B (zh) |
| WO (1) | WO2023145486A1 (zh) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101466371B (zh) * | 2006-06-09 | 2011-10-05 | 施瓦茨制药有限公司 | 含非索罗定的稳定的药用组合物 |
| EP2508175A1 (en) * | 2011-04-08 | 2012-10-10 | LEK Pharmaceuticals d.d. | Pharmaceutical composition comprising fesoterodine or a salt or a solvate thereof |
| EP4272735A1 (en) * | 2015-06-30 | 2023-11-08 | Genentech, Inc. | Immediate-release tablets containing a drug and processes for forming the tablets |
| JP2018184375A (ja) * | 2017-04-27 | 2018-11-22 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | ダビガトランエテキシラート又は医薬的に許容されるその塩を含む錠剤及びその製造方法 |
| EP3784217A1 (en) * | 2018-04-26 | 2021-03-03 | Rontis Hellas S.A. | Extended release pharmaceutical composition containing fesoterodine and process for the preparation thereof |
| JPWO2020090969A1 (ja) * | 2018-10-31 | 2021-09-16 | 富士フイルム株式会社 | 抗腫瘍剤を含む医薬組成物の包装体 |
-
2023
- 2023-01-13 WO PCT/JP2023/000786 patent/WO2023145486A1/ja unknown
- 2023-01-13 JP JP2023576781A patent/JPWO2023145486A1/ja active Pending
- 2023-01-18 TW TW112102169A patent/TWI836872B/zh active
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