CN113939289A - 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 - Google Patents
一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 Download PDFInfo
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- CN113939289A CN113939289A CN202080042382.8A CN202080042382A CN113939289A CN 113939289 A CN113939289 A CN 113939289A CN 202080042382 A CN202080042382 A CN 202080042382A CN 113939289 A CN113939289 A CN 113939289A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
提供了一种含有(S)‑7‑[4‑(1‑丙烯酰基哌啶)]‑2‑(4‑苯氧基苯基)‑4,5,6,7‑四氢吡唑并[1,5‑a]嘧啶‑3‑甲酰胺的口服固体片剂及其制备方法。所述口服固体片剂具有良好的药物释放特性,且用药方便,释放迅速高效,对设备无特殊要求,制剂工艺简单,能够保证制剂稳定性,便于运输和储藏,适合规模化生产。
Description
PCT国内申请,说明书已公开。
Claims (21)
- PCT国内申请,权利要求书已公开。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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CN2019090541 | 2019-06-10 | ||
CNPCT/CN2019/090541 | 2019-06-10 | ||
PCT/CN2020/095352 WO2020249001A1 (zh) | 2019-06-10 | 2020-06-10 | 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 |
Publications (1)
Publication Number | Publication Date |
---|---|
CN113939289A true CN113939289A (zh) | 2022-01-14 |
Family
ID=73781786
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN202080042382.8A Pending CN113939289A (zh) | 2019-06-10 | 2020-06-10 | 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 |
Country Status (6)
Country | Link |
---|---|
US (2) | US20220249491A1 (zh) |
EP (1) | EP3981399A4 (zh) |
JP (1) | JP2022538214A (zh) |
CN (1) | CN113939289A (zh) |
TW (1) | TW202112376A (zh) |
WO (1) | WO2020249001A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112057427A (zh) * | 2019-06-10 | 2020-12-11 | 百济神州(苏州)生物科技有限公司 | 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112457403B (zh) | 2013-09-13 | 2022-11-29 | 广州百济神州生物制药有限公司 | 抗pd1抗体及其作为治疗剂与诊断剂的用途 |
CN106604742B (zh) | 2014-07-03 | 2019-01-11 | 百济神州有限公司 | 抗pd-l1抗体及其作为治疗剂及诊断剂的用途 |
TWI760356B (zh) | 2016-08-16 | 2022-04-11 | 英屬開曼群島商百濟神州有限公司 | (s)-7-(1-丙烯醯基六氫吡啶-4-基)-2-(4-苯氧基苯基)-4,5,6,7-四氫吡唑並[1,5-a]嘧啶-3-甲醯胺的晶型、其製備和用途 |
CN110087680B (zh) | 2016-08-19 | 2024-03-19 | 百济神州有限公司 | 使用包含btk抑制剂的组合产品治疗癌症 |
EP3645569A4 (en) | 2017-06-26 | 2021-03-24 | BeiGene, Ltd. | IMMUNOTHERAPY FOR LIVER CELL CARCINOMA |
CN111801334B (zh) | 2017-11-29 | 2023-06-09 | 百济神州瑞士有限责任公司 | 使用包含btk抑制剂的组合治疗惰性或侵袭性b-细胞淋巴瘤 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107530348A (zh) * | 2016-02-19 | 2018-01-02 | 江苏恒瑞医药股份有限公司 | 一种含有jak激酶抑制剂或其可药用盐的药物组合物 |
WO2018033853A2 (en) * | 2016-08-16 | 2018-02-22 | Beigene, Ltd. | Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
CN108778281A (zh) * | 2016-11-25 | 2018-11-09 | 江苏恒瑞医药股份有限公司 | 一种吡啶酮类衍生物药物组合物及其制备方法 |
WO2019183226A1 (en) * | 2018-03-21 | 2019-09-26 | Mei Pharma, Inc. | Combination therapy |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK2989106T3 (en) | 2013-04-25 | 2017-03-20 | Beigene Ltd | CONDENSED HETEROCYCLIC COMPOUNDS AS PROTEINKINASE INHIBITORS |
WO2016123504A1 (en) * | 2015-01-30 | 2016-08-04 | Pharmacyclics Llc | Btk inhibitor combinations and multidrug-resistance |
US9717745B2 (en) * | 2015-03-19 | 2017-08-01 | Zhejiang DTRM Biopharma Co. Ltd. | Pharmaceutical compositions and their use for treatment of cancer and autoimmune diseases |
CN110087680B (zh) * | 2016-08-19 | 2024-03-19 | 百济神州有限公司 | 使用包含btk抑制剂的组合产品治疗癌症 |
CA3108065A1 (en) * | 2018-07-31 | 2020-02-06 | Loxo Oncology, Inc. | Spray-dried dispersions, formulations, and polymorphs of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide |
-
2020
- 2020-06-10 JP JP2021572296A patent/JP2022538214A/ja active Pending
- 2020-06-10 TW TW109119515A patent/TW202112376A/zh unknown
- 2020-06-10 EP EP20822605.0A patent/EP3981399A4/en active Pending
- 2020-06-10 WO PCT/CN2020/095352 patent/WO2020249001A1/zh unknown
- 2020-06-10 CN CN202080042382.8A patent/CN113939289A/zh active Pending
- 2020-06-10 US US17/617,530 patent/US20220249491A1/en not_active Abandoned
-
2023
- 2023-11-13 US US18/388,898 patent/US20240075039A1/en active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107530348A (zh) * | 2016-02-19 | 2018-01-02 | 江苏恒瑞医药股份有限公司 | 一种含有jak激酶抑制剂或其可药用盐的药物组合物 |
WO2018033853A2 (en) * | 2016-08-16 | 2018-02-22 | Beigene, Ltd. | Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof |
CN108778281A (zh) * | 2016-11-25 | 2018-11-09 | 江苏恒瑞医药股份有限公司 | 一种吡啶酮类衍生物药物组合物及其制备方法 |
WO2019183226A1 (en) * | 2018-03-21 | 2019-09-26 | Mei Pharma, Inc. | Combination therapy |
Non-Patent Citations (6)
Title |
---|
BEIGENE: "Efficacy and Safety of BGB-3111 in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma", 《HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03206918》 * |
BEIGENE: "Efficacy and Safety of BGB-3111 in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma", 《HTTPS://CLINICALTRIALS.GOV/CT2/SHOW/NCT03206918》, 2 July 2017 (2017-07-02) * |
TAM C.S.等: "A Head-to-head Phase III Study Comparing Zanubrutinib Versus Ibrutinib in Patients with Waldenstrom macroglobulinemia", 《FUTURE ONCOLOGY》, vol. 14, no. 22, 5 June 2018 (2018-06-05), pages 2229 - 2237, XP055765166, DOI: 10.2217/fon-2018-0163 * |
关志宇主编: "《药物制剂辅料与包装材料》", 中国医药科技出版社, pages: 87 * |
百济神州(北京)生物科技有限公司: "评估BTK抑制剂BGB-3111在中国B淋巴细胞肿瘤患者的安全性、耐受性以及药代/药效动力学特征的I期临床研究", 《HTTP://WWW.CHINADRUGTRIALS.ORG.CN》 * |
百济神州(北京)生物科技有限公司: "评估BTK抑制剂BGB-3111在中国B淋巴细胞肿瘤患者的安全性、耐受性以及药代/药效动力学特征的I期临床研究", 《HTTP://WWW.CHINADRUGTRIALS.ORG.CN》, 13 May 2016 (2016-05-13) * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112057427A (zh) * | 2019-06-10 | 2020-12-11 | 百济神州(苏州)生物科技有限公司 | 一种含有布鲁顿氏酪氨酸激酶抑制剂的口服固体片剂及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
US20240075039A1 (en) | 2024-03-07 |
US20220249491A1 (en) | 2022-08-11 |
EP3981399A1 (en) | 2022-04-13 |
TW202112376A (zh) | 2021-04-01 |
EP3981399A4 (en) | 2023-05-31 |
JP2022538214A (ja) | 2022-09-01 |
WO2020249001A1 (zh) | 2020-12-17 |
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