JPWO2024024865A5 - - Google Patents
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- Publication number
- JPWO2024024865A5 JPWO2024024865A5 JP2024537209A JP2024537209A JPWO2024024865A5 JP WO2024024865 A5 JPWO2024024865 A5 JP WO2024024865A5 JP 2024537209 A JP2024537209 A JP 2024537209A JP 2024537209 A JP2024537209 A JP 2024537209A JP WO2024024865 A5 JPWO2024024865 A5 JP WO2024024865A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- granules
- oral administration
- release portion
- levodopa
- 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
- 239000008187 granular material Substances 0.000 claims 18
- 239000008194 pharmaceutical composition Substances 0.000 claims 17
- 238000007922 dissolution test Methods 0.000 claims 15
- WTDRDQBEARUVNC-LURJTMIESA-N L-DOPA Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-LURJTMIESA-N 0.000 claims 10
- WTDRDQBEARUVNC-UHFFFAOYSA-N L-Dopa Natural products OC(=O)C(N)CC1=CC=C(O)C(O)=C1 WTDRDQBEARUVNC-UHFFFAOYSA-N 0.000 claims 10
- 229960004502 levodopa Drugs 0.000 claims 10
- 238000013268 sustained release Methods 0.000 claims 9
- 239000012730 sustained-release form Substances 0.000 claims 9
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims 8
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 8
- 238000004090 dissolution Methods 0.000 claims 7
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 7
- 229920000642 polymer Polymers 0.000 claims 7
- 238000000034 method Methods 0.000 claims 6
- IVTMXOXVAHXCHI-YXLMWLKOSA-N (2s)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid;(2s)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid Chemical compound OC(=O)[C@@H](N)CC1=CC=C(O)C(O)=C1.NN[C@@](C(O)=O)(C)CC1=CC=C(O)C(O)=C1 IVTMXOXVAHXCHI-YXLMWLKOSA-N 0.000 claims 5
- 239000000314 lubricant Substances 0.000 claims 5
- 239000008203 oral pharmaceutical composition Substances 0.000 claims 5
- 229920000881 Modified starch Polymers 0.000 claims 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 4
- 238000012812 general test Methods 0.000 claims 4
- 239000007788 liquid 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
- 229920003169 water-soluble polymer Polymers 0.000 claims 4
- 229920001577 copolymer Polymers 0.000 claims 3
- 239000007884 disintegrant Substances 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 229960003943 hypromellose Drugs 0.000 claims 3
- 229920002554 vinyl polymer Polymers 0.000 claims 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 208000018737 Parkinson disease Diseases 0.000 claims 2
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 2
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 claims 2
- 239000004480 active ingredient Substances 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 229920003147 ammonioalkyl methacrylate copolymer Polymers 0.000 claims 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 2
- 235000013539 calcium stearate Nutrition 0.000 claims 2
- 239000008116 calcium stearate Substances 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 229950008138 carmellose Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 235000019359 magnesium stearate Nutrition 0.000 claims 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims 2
- 239000000377 silicon dioxide Substances 0.000 claims 2
- 235000012239 silicon dioxide Nutrition 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- 238000012360 testing method Methods 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 239000006169 McIlvaine's buffer solution Substances 0.000 claims 1
- 206010034010 Parkinsonism Diseases 0.000 claims 1
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 239000011575 calcium Substances 0.000 claims 1
- 229910052791 calcium Inorganic materials 0.000 claims 1
- 235000001465 calcium Nutrition 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 229960004205 carbidopa Drugs 0.000 claims 1
- TZFNLOMSOLWIDK-JTQLQIEISA-N carbidopa (anhydrous) Chemical compound NN[C@@](C(O)=O)(C)CC1=CC=C(O)C(O)=C1 TZFNLOMSOLWIDK-JTQLQIEISA-N 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose 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
- 238000011156 evaluation Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000001341 hydroxy propyl starch Substances 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 235000013828 hydroxypropyl starch Nutrition 0.000 claims 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 claims 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 1
- 238000000691 measurement method Methods 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 229960002900 methylcellulose Drugs 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000003921 oil Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 230000000144 pharmacologic effect Effects 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 229940068984 polyvinyl alcohol Drugs 0.000 claims 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 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
- -1 sticks Substances 0.000 claims 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2025084015A JP2025122084A (ja) | 2022-07-28 | 2025-05-20 | レボドパ持続性製剤 |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2022120247 | 2022-07-28 | ||
| PCT/JP2023/027466 WO2024024865A1 (ja) | 2022-07-28 | 2023-07-26 | レボドパ持続性製剤 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2025084015A Division JP2025122084A (ja) | 2022-07-28 | 2025-05-20 | レボドパ持続性製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPWO2024024865A1 JPWO2024024865A1 (https=) | 2024-02-01 |
| JPWO2024024865A5 true JPWO2024024865A5 (https=) | 2024-08-22 |
Family
ID=89706575
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024537209A Pending JPWO2024024865A1 (https=) | 2022-07-28 | 2023-07-26 | |
| JP2025084015A Pending JP2025122084A (ja) | 2022-07-28 | 2025-05-20 | レボドパ持続性製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2025084015A Pending JP2025122084A (ja) | 2022-07-28 | 2025-05-20 | レボドパ持続性製剤 |
Country Status (2)
| Country | Link |
|---|---|
| JP (2) | JPWO2024024865A1 (https=) |
| WO (1) | WO2024024865A1 (https=) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030224045A1 (en) * | 2002-05-29 | 2003-12-04 | Chien-Hsuan Han | Combination immediate release sustained release levodopa/carbidopa dosage forms |
| CN102149369B (zh) * | 2008-04-18 | 2016-08-10 | 因泰克制药有限公司 | 卡比多巴/左旋多巴胃滞留给药 |
| CN102202656A (zh) * | 2008-08-15 | 2011-09-28 | 蒂宝制药公司 | 治疗和预防cns障碍的胃滞留药用组合物 |
| CN105658211A (zh) * | 2013-10-07 | 2016-06-08 | 怡百克制药公司 | 左旋多巴和/或左旋多巴的酯的粘膜粘附性、控制释放调配物和其用途 |
-
2023
- 2023-07-26 JP JP2024537209A patent/JPWO2024024865A1/ja active Pending
- 2023-07-26 WO PCT/JP2023/027466 patent/WO2024024865A1/ja not_active Ceased
-
2025
- 2025-05-20 JP JP2025084015A patent/JP2025122084A/ja active Pending
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