JP2020523335A5 - - Google Patents
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- Publication number
- JP2020523335A5 JP2020523335A5 JP2019568138A JP2019568138A JP2020523335A5 JP 2020523335 A5 JP2020523335 A5 JP 2020523335A5 JP 2019568138 A JP2019568138 A JP 2019568138A JP 2019568138 A JP2019568138 A JP 2019568138A JP 2020523335 A5 JP2020523335 A5 JP 2020523335A5
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutical composition
- acid
- solid pharmaceutical
- composition according
- caliprazin
- 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
- 239000008194 pharmaceutical composition Substances 0.000 claims 20
- 239000007787 solid Substances 0.000 claims 18
- 239000003795 chemical substances by application Substances 0.000 claims 8
- 150000003839 salts Chemical class 0.000 claims 7
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 5
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 4
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- BMYNFMYTOJXKLE-UHFFFAOYSA-N 3-azaniumyl-2-hydroxypropanoate Chemical compound NCC(O)C(O)=O BMYNFMYTOJXKLE-UHFFFAOYSA-N 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 2
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 2
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- KPWSJANDNDDRMB-QAQDUYKDSA-N cariprazine Chemical compound C1C[C@@H](NC(=O)N(C)C)CC[C@@H]1CCN1CCN(C=2C(=C(Cl)C=CC=2)Cl)CC1 KPWSJANDNDDRMB-QAQDUYKDSA-N 0.000 claims 2
- 229920001477 hydrophilic polymer Polymers 0.000 claims 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 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 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 229940098779 methanesulfonic acid Drugs 0.000 claims 2
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 claims 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 2
- QBYIENPQHBMVBV-HFEGYEGKSA-N (2R)-2-hydroxy-2-phenylacetic acid Chemical compound O[C@@H](C(O)=O)c1ccccc1.O[C@@H](C(O)=O)c1ccccc1 QBYIENPQHBMVBV-HFEGYEGKSA-N 0.000 claims 1
- 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
- MIOPJNTWMNEORI-GMSGAONNSA-N (S)-camphorsulfonic acid Chemical compound C1C[C@@]2(CS(O)(=O)=O)C(=O)C[C@@H]1C2(C)C MIOPJNTWMNEORI-GMSGAONNSA-N 0.000 claims 1
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical compound COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 claims 1
- 239000005711 Benzoic acid Substances 0.000 claims 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 1
- 229920001479 Hydroxyethyl methyl cellulose Polymers 0.000 claims 1
- OFOBLEOULBTSOW-UHFFFAOYSA-N Propanedioic acid Natural products OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 1
- IWYDHOAUDWTVEP-UHFFFAOYSA-N R-2-phenyl-2-hydroxyacetic acid Natural products OC(=O)C(O)C1=CC=CC=C1 IWYDHOAUDWTVEP-UHFFFAOYSA-N 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- 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 1
- 239000002253 acid Substances 0.000 claims 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- 235000010233 benzoic acid Nutrition 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
- 150000004649 carbonic acid derivatives Chemical class 0.000 claims 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229960005123 cariprazine Drugs 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000002474 experimental method Methods 0.000 claims 1
- 238000005187 foaming Methods 0.000 claims 1
- 235000019253 formic acid Nutrition 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000001530 fumaric acid Substances 0.000 claims 1
- 229960002598 fumaric acid Drugs 0.000 claims 1
- 210000001035 gastrointestinal tract Anatomy 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 229920001600 hydrophobic polymer Polymers 0.000 claims 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims 1
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims 1
- 239000011976 maleic acid Substances 0.000 claims 1
- 229960002510 mandelic acid Drugs 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 235000006408 oxalic acid Nutrition 0.000 claims 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 230000036470 plasma concentration Effects 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 229960004889 salicylic acid Drugs 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- 230000002459 sustained effect Effects 0.000 claims 1
- 229940095064 tartrate Drugs 0.000 claims 1
- 238000011287 therapeutic dose Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HUP1700253 | 2017-06-13 | ||
| HUP1700253 HUP1700253A1 (hu) | 2017-06-13 | 2017-06-13 | Szilárd orális gyógyszerkészítmények |
| PCT/IB2018/054227 WO2018229641A1 (en) | 2017-06-13 | 2018-06-12 | Solid preparation of cariprazine for oral administration |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020523335A JP2020523335A (ja) | 2020-08-06 |
| JP2020523335A5 true JP2020523335A5 (https=) | 2021-07-26 |
Family
ID=89992469
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019568138A Pending JP2020523335A (ja) | 2017-06-13 | 2018-06-12 | 経口投与用固形製剤 |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US20200222391A1 (https=) |
| EP (1) | EP3638210A1 (https=) |
| JP (1) | JP2020523335A (https=) |
| KR (1) | KR20200016378A (https=) |
| CN (1) | CN110769815A (https=) |
| AR (1) | AR112137A1 (https=) |
| AU (1) | AU2018284138A1 (https=) |
| BR (1) | BR112019025214A2 (https=) |
| CA (1) | CA3064694A1 (https=) |
| CL (1) | CL2019003619A1 (https=) |
| CO (1) | CO2020000168A2 (https=) |
| EA (1) | EA202090029A1 (https=) |
| HU (1) | HUP1700253A1 (https=) |
| IL (1) | IL271108A (https=) |
| MX (1) | MX2019015206A (https=) |
| PE (1) | PE20200334A1 (https=) |
| PH (1) | PH12019502566A1 (https=) |
| TW (1) | TW201906608A (https=) |
| WO (1) | WO2018229641A1 (https=) |
| ZA (1) | ZA201908454B (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL2317852T3 (pl) | 2008-07-16 | 2015-05-29 | Richter Gedeon Nyrt | Preparaty farmaceutyczne zawierające ligandy receptora dopaminy |
| US11274087B2 (en) | 2016-07-08 | 2022-03-15 | Richter Gedeon Nyrt. | Industrial process for the preparation of cariprazine |
| US11547707B2 (en) | 2019-04-10 | 2023-01-10 | Richter Gedeon Nyrt. | Carbamoyl cyclohexane derivatives for treating autism spectrum disorder |
| US11344503B2 (en) * | 2019-12-13 | 2022-05-31 | Halo Science LLC | Cariprazine release formulations |
| EP4206191B1 (en) * | 2020-08-26 | 2025-12-17 | Shanghai Aurora Biotechnology Co., Ltd. | Pharmaceutically acceptable salt of cariprazine and crystal form thereof, and preparation method therefor and use thereof |
| CN114748428B (zh) * | 2020-12-25 | 2023-05-23 | 上海京新生物医药有限公司 | 一种高载药量的盐酸卡利拉嗪长效缓释微球及其制备方法 |
| CN114681406B (zh) * | 2020-12-25 | 2023-10-13 | 上海京新生物医药有限公司 | 一种卡利拉嗪长效缓释微球及其制备方法 |
| CN116675654B (zh) * | 2022-02-22 | 2025-06-13 | 上海云晟研新生物科技有限公司 | 卡利拉嗪药用盐及其晶型、药物组合物、制备方法和用途 |
| IL315074A (en) | 2022-03-17 | 2024-10-01 | Mapi Pharma Ltd | Storage systems containing cryprazine or its salts |
| HU231682B1 (hu) * | 2022-08-05 | 2025-10-28 | Richter Gedeon Nyrt. | Kariprazin tartalmú szájban diszpergálódó tabletta |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6248618A (ja) * | 1985-08-27 | 1987-03-03 | Zeria Shinyaku Kogyo Kk | 徐放性製剤およびその製造法 |
| US5910319A (en) | 1997-05-29 | 1999-06-08 | Eli Lilly And Company | Fluoxetine enteric pellets and methods for their preparation and use |
| HU227534B1 (en) | 2003-08-04 | 2011-08-29 | Richter Gedeon Nyrt | (thio)carbamoyl-cyclohexane derivatives, process for producing them and pharmaceutical compositions containing them |
| GB0618879D0 (en) | 2006-09-26 | 2006-11-01 | Zysis Ltd | Pharmaceutical compositions |
| CN101815519B (zh) * | 2007-08-03 | 2013-08-21 | 吉瑞工厂 | 包含多巴胺受体配体的药物组合物和使用多巴胺受体配体的治疗方法 |
| KR101563383B1 (ko) | 2008-02-21 | 2015-10-26 | 미쓰비시 타나베 파마 코퍼레이션 | 경구 투여용 고형 제제 |
| PL2317852T3 (pl) * | 2008-07-16 | 2015-05-29 | Richter Gedeon Nyrt | Preparaty farmaceutyczne zawierające ligandy receptora dopaminy |
| US10166183B2 (en) * | 2014-02-07 | 2019-01-01 | Auspex Pharmaceuticals, Inc. | Pharmaceutical formulations |
| CN106692149A (zh) * | 2015-11-13 | 2017-05-24 | 天津市汉康医药生物技术有限公司 | 一种卡利拉嗪药物口服制剂及其制备方法 |
-
2017
- 2017-06-13 HU HUP1700253 patent/HUP1700253A1/hu unknown
-
2018
- 2018-05-30 TW TW107118464A patent/TW201906608A/zh unknown
- 2018-06-12 WO PCT/IB2018/054227 patent/WO2018229641A1/en not_active Ceased
- 2018-06-12 EA EA202090029A patent/EA202090029A1/ru unknown
- 2018-06-12 PE PE2019002491A patent/PE20200334A1/es unknown
- 2018-06-12 KR KR1020207001040A patent/KR20200016378A/ko not_active Ceased
- 2018-06-12 CA CA3064694A patent/CA3064694A1/en not_active Abandoned
- 2018-06-12 MX MX2019015206A patent/MX2019015206A/es unknown
- 2018-06-12 AR ARP180101591A patent/AR112137A1/es unknown
- 2018-06-12 CN CN201880040070.6A patent/CN110769815A/zh active Pending
- 2018-06-12 BR BR112019025214-2A patent/BR112019025214A2/pt not_active Application Discontinuation
- 2018-06-12 AU AU2018284138A patent/AU2018284138A1/en not_active Abandoned
- 2018-06-12 US US16/622,020 patent/US20200222391A1/en not_active Abandoned
- 2018-06-12 JP JP2019568138A patent/JP2020523335A/ja active Pending
- 2018-06-12 EP EP18734306.6A patent/EP3638210A1/en not_active Withdrawn
-
2019
- 2019-11-15 PH PH12019502566A patent/PH12019502566A1/en unknown
- 2019-12-02 IL IL271108A patent/IL271108A/en unknown
- 2019-12-11 CL CL2019003619A patent/CL2019003619A1/es unknown
- 2019-12-18 ZA ZA2019/08454A patent/ZA201908454B/en unknown
-
2020
- 2020-01-09 CO CONC2020/0000168A patent/CO2020000168A2/es unknown
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