JP2020534305A5 - - Google Patents
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- JP2020534305A5 JP2020534305A5 JP2020516437A JP2020516437A JP2020534305A5 JP 2020534305 A5 JP2020534305 A5 JP 2020534305A5 JP 2020516437 A JP2020516437 A JP 2020516437A JP 2020516437 A JP2020516437 A JP 2020516437A JP 2020534305 A5 JP2020534305 A5 JP 2020534305A5
- Authority
- JP
- Japan
- Prior art keywords
- item
- unit dosage
- valbenazine
- dosage form
- composition according
- 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
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- 239000002552 dosage form Substances 0.000 claims description 97
- GEJDGVNQKABXKG-CFKGEZKQSA-N [(2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1h-benzo[a]quinolizin-2-yl] (2s)-2-amino-3-methylbutanoate Chemical compound C1CN2C[C@@H](CC(C)C)[C@H](OC(=O)[C@@H](N)C(C)C)C[C@@H]2C2=C1C=C(OC)C(OC)=C2 GEJDGVNQKABXKG-CFKGEZKQSA-N 0.000 claims description 96
- 229950006411 valbenazine Drugs 0.000 claims description 96
- 150000003839 salts Chemical class 0.000 claims description 89
- 238000000034 method Methods 0.000 claims description 74
- 239000008194 pharmaceutical composition Substances 0.000 claims description 61
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 58
- 239000007787 solid Substances 0.000 claims description 56
- 239000008247 solid mixture Substances 0.000 claims description 56
- 208000035475 disorder Diseases 0.000 claims description 53
- 239000000203 mixture Substances 0.000 claims description 44
- 239000012458 free base Substances 0.000 claims description 37
- 208000019022 Mood disease Diseases 0.000 claims description 20
- 208000020016 psychiatric disease Diseases 0.000 claims description 20
- 208000011580 syndromic disease Diseases 0.000 claims description 20
- 239000002775 capsule Substances 0.000 claims description 19
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 18
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 17
- 208000023105 Huntington disease Diseases 0.000 claims description 15
- 208000012902 Nervous system disease Diseases 0.000 claims description 14
- 230000000926 neurological effect Effects 0.000 claims description 14
- 239000000314 lubricant Substances 0.000 claims description 12
- 206010008748 Chorea Diseases 0.000 claims description 11
- 208000012601 choreatic disease Diseases 0.000 claims description 11
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims description 10
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 10
- 206010044565 Tremor Diseases 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 10
- 239000000945 filler Substances 0.000 claims description 10
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 239000000905 isomalt Substances 0.000 claims description 10
- 235000010439 isomalt Nutrition 0.000 claims description 10
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims description 10
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- 239000007884 disintegrant Substances 0.000 claims description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims description 9
- 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 description 8
- 239000000377 silicon dioxide Substances 0.000 claims description 8
- 229920002261 Corn starch Polymers 0.000 claims description 7
- 239000008120 corn starch Substances 0.000 claims description 7
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- 206010043118 Tardive Dyskinesia Diseases 0.000 claims description 5
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- 201000010099 disease Diseases 0.000 claims description 5
- 208000010118 dystonia Diseases 0.000 claims description 5
- 230000000925 erythroid effect Effects 0.000 claims description 5
- 210000003141 lower extremity Anatomy 0.000 claims description 5
- 230000009251 neurologic dysfunction Effects 0.000 claims description 5
- 208000015015 neurological dysfunction Diseases 0.000 claims description 5
- 125000005490 tosylate group Chemical group 0.000 claims description 4
- 229940126701 oral medication Drugs 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 description 14
- 239000008187 granular material Substances 0.000 description 10
- 239000003085 diluting agent Substances 0.000 description 9
- 238000002156 mixing Methods 0.000 description 8
- 239000002245 particle Substances 0.000 description 7
- 208000010543 22q11.2 deletion syndrome Diseases 0.000 description 6
- 102100040999 Catechol O-methyltransferase Human genes 0.000 description 6
- 108020002739 Catechol O-methyltransferase Proteins 0.000 description 6
- 208000000398 DiGeorge Syndrome Diseases 0.000 description 6
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- 229920002472 Starch Polymers 0.000 description 5
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- 208000001914 Fragile X syndrome Diseases 0.000 description 4
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- 208000016620 Tourette disease Diseases 0.000 description 4
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 description 2
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 206010063006 Facial spasm Diseases 0.000 description 2
- 208000004095 Hemifacial Spasm Diseases 0.000 description 2
- 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 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 238000011978 dissolution method Methods 0.000 description 2
- 238000007908 dry granulation Methods 0.000 description 2
- 229960003943 hypromellose Drugs 0.000 description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 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 description 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 229920002785 Croscarmellose sodium Polymers 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-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 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
- 239000001856 Ethyl cellulose Substances 0.000 description 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 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229920000084 Gum arabic Polymers 0.000 description 1
- 206010026749 Mania Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000000205 acacia gum Substances 0.000 description 1
- 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 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 235000010216 calcium carbonate Nutrition 0.000 description 1
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 description 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 description 1
- 239000008116 calcium stearate Substances 0.000 description 1
- 235000013539 calcium stearate Nutrition 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
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- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
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- 229960005168 croscarmellose Drugs 0.000 description 1
- 229960000913 crospovidone Drugs 0.000 description 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 235000019700 dicalcium phosphate Nutrition 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 229910021485 fumed silica Inorganic materials 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920001206 natural gum Polymers 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 1
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- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
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Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762561629P | 2017-09-21 | 2017-09-21 | |
| US62/561,629 | 2017-09-21 | ||
| US201762564951P | 2017-09-28 | 2017-09-28 | |
| US62/564,951 | 2017-09-28 | ||
| PCT/US2018/051579 WO2019060322A2 (en) | 2017-09-21 | 2018-09-18 | HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS AND KITS THEREOF |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020534305A JP2020534305A (ja) | 2020-11-26 |
| JP2020534305A5 true JP2020534305A5 (https=) | 2021-11-04 |
| JP7250006B2 JP7250006B2 (ja) | 2023-03-31 |
Family
ID=63794661
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020516437A Active JP7250006B2 (ja) | 2017-09-21 | 2018-09-18 | 高投与量バルベナジン製剤ならびにそれに関連する組成物、方法およびキット |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US20200276184A1 (https=) |
| EP (1) | EP3684333B1 (https=) |
| JP (1) | JP7250006B2 (https=) |
| CN (1) | CN111372567B (https=) |
| AU (1) | AU2018335259B2 (https=) |
| BR (1) | BR112020005373A2 (https=) |
| CA (1) | CA3076000A1 (https=) |
| DK (1) | DK3684333T3 (https=) |
| ES (1) | ES3024958T3 (https=) |
| FI (1) | FI3684333T3 (https=) |
| HR (1) | HRP20250561T1 (https=) |
| HU (1) | HUE071873T2 (https=) |
| IL (3) | IL309802A (https=) |
| LT (1) | LT3684333T (https=) |
| MA (1) | MA50175B1 (https=) |
| MD (1) | MD3684333T2 (https=) |
| MX (1) | MX2020002841A (https=) |
| PL (1) | PL3684333T3 (https=) |
| PT (1) | PT3684333T (https=) |
| RS (1) | RS66714B1 (https=) |
| SI (1) | SI3684333T1 (https=) |
| SM (1) | SMT202500305T1 (https=) |
| TW (1) | TWI875681B (https=) |
| WO (1) | WO2019060322A2 (https=) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MY193767A (en) | 2015-10-30 | 2022-10-27 | Neurocrine Biosciences Inc | Valbenazine salts and polymorphs thereof |
| CN108925135B (zh) | 2015-12-23 | 2025-09-19 | 纽罗克里生物科学有限公司 | 制备(S)-(2R,3R,11bR)-3-异丁基-9,10-二甲氧基-2,3,4,6,7,11b-六氢-1H-吡啶并[2,1-a]异喹啉-2-基2-氨基-3-甲基丁酸酯二(4-甲基苯磺酸盐)的合成方法 |
| WO2018140092A1 (en) | 2017-01-27 | 2018-08-02 | Obrien Christopher F | Methods for the administration of certain vmat2 inhibitors |
| ES3024958T3 (en) | 2017-09-21 | 2025-06-05 | Neurocrine Biosciences Inc | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
| KR20250070134A (ko) | 2017-10-10 | 2025-05-20 | 뉴로크린 바이오사이언시즈 인코퍼레이티드 | 특정 vmat2 억제제의 투여 방법 |
| JP2021502959A (ja) | 2017-10-10 | 2021-02-04 | ニューロクライン バイオサイエンシーズ，インコーポレイテッド | 特定のｖｍａｔ２インヒビターを投与するための方法 |
| CA3086611C (en) | 2017-12-26 | 2023-07-25 | Crystal Pharmaceutical (Suzhou) Co., Ltd. | A crystalline form of valbenazine ditosylate, processes for preparation thereof and use thereof |
| MX2020013004A (es) | 2018-06-14 | 2021-02-17 | Neurocrine Biosciences Inc | Compuestos inhibidores del transportador de monoamina 2 (vmat2), composiciones, y metodos relacionados con los mismos. |
| SG11202100303QA (en) | 2018-08-15 | 2021-02-25 | Neurocrine Biosciences Inc | Methods for the administration of certain vmat2 inhibitors |
| US10940141B1 (en) | 2019-08-23 | 2021-03-09 | Neurocrine Biosciences, Inc. | Methods for the administration of certain VMAT2 inhibitors |
| JP2022547990A (ja) | 2019-09-13 | 2022-11-16 | ニューロクライン バイオサイエンシーズ，インコーポレイテッド | バルベナジンの合成のための方法 |
| US20240239791A1 (en) | 2021-04-26 | 2024-07-18 | Neurocrine Biosciences, Inc. | Processes for the synthesis of valbenazine |
| WO2025038938A1 (en) | 2023-08-17 | 2025-02-20 | Neurocrine Biosciences, Inc. | Valbenazine for use in the treatment of huntington's chorea |
| WO2025038959A1 (en) | 2023-08-17 | 2025-02-20 | Neurocrine Biosciences, Inc. | Methods for the administration of certain vmat2 inhibitors |
| WO2026050236A1 (en) | 2024-08-27 | 2026-03-05 | Neurocrine Biosciences, Inc. | Muscarinic receptor agonist in combination with a vesicular monoamine transporter 2 inhibitor, for use in the treatment of a neurological or psychiatric disorder |
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