JP2019510059A5 - - Google Patents
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- Publication number
- JP2019510059A5 JP2019510059A5 JP2018551287A JP2018551287A JP2019510059A5 JP 2019510059 A5 JP2019510059 A5 JP 2019510059A5 JP 2018551287 A JP2018551287 A JP 2018551287A JP 2018551287 A JP2018551287 A JP 2018551287A JP 2019510059 A5 JP2019510059 A5 JP 2019510059A5
- Authority
- JP
- Japan
- Prior art keywords
- acid
- solid dispersion
- dispersion according
- pharmaceutically acceptable
- high molecular
- 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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- 239000007962 solid dispersion Substances 0.000 claims 16
- 239000000463 material Substances 0.000 claims 6
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 claims 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 239000000126 substance Substances 0.000 claims 4
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 3
- 230000002378 acidificating effect Effects 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
- 239000011975 tartaric acid Substances 0.000 claims 3
- 235000002906 tartaric acid Nutrition 0.000 claims 3
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- AFVFQIVMOAPDHO-UHFFFAOYSA-N Methanesulfonic acid Chemical compound CS(O)(=O)=O AFVFQIVMOAPDHO-UHFFFAOYSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 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
- 239000002253 acid Substances 0.000 claims 2
- 125000001931 aliphatic group Chemical group 0.000 claims 2
- 125000003118 aryl group Chemical group 0.000 claims 2
- 229920001531 copovidone Polymers 0.000 claims 2
- 239000006185 dispersion Substances 0.000 claims 2
- SUMDYPCJJOFFON-UHFFFAOYSA-N isethionic acid Chemical compound OCCS(O)(=O)=O SUMDYPCJJOFFON-UHFFFAOYSA-N 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- 150000007522 mineralic acids Chemical class 0.000 claims 2
- 150000007524 organic acids Chemical class 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 239000007787 solid Substances 0.000 claims 2
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 claims 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 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
- 206010028980 Neoplasm Diseases 0.000 claims 1
- 229920003081 Povidone K 30 Polymers 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- SRSXLGNVWSONIS-UHFFFAOYSA-N benzenesulfonic acid Chemical compound OS(=O)(=O)C1=CC=CC=C1 SRSXLGNVWSONIS-UHFFFAOYSA-N 0.000 claims 1
- 229940092714 benzenesulfonic acid Drugs 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
- 201000011510 cancer Diseases 0.000 claims 1
- 235000015165 citric acid Nutrition 0.000 claims 1
- 238000004090 dissolution Methods 0.000 claims 1
- CCIVGXIOQKPBKL-UHFFFAOYSA-M ethanesulfonate Chemical compound CCS([O-])(=O)=O CCIVGXIOQKPBKL-UHFFFAOYSA-M 0.000 claims 1
- 239000001530 fumaric acid Substances 0.000 claims 1
- 235000011087 fumaric acid Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 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 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims 1
- 229940045996 isethionic acid Drugs 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000001630 malic acid Substances 0.000 claims 1
- 235000011090 malic acid Nutrition 0.000 claims 1
- 229940098779 methanesulfonic acid Drugs 0.000 claims 1
- 235000005985 organic acids Nutrition 0.000 claims 1
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 1
- ODLHGICHYURWBS-LKONHMLTSA-N trappsol cyclo Chemical compound CC(O)COC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](COCC(C)O)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)COCC(O)C)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1COCC(C)O ODLHGICHYURWBS-LKONHMLTSA-N 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610187046.8A CN105816437B (zh) | 2016-03-29 | 2016-03-29 | 一种帕布昔利布的药物制剂及其制备方法 |
| CN201610187046.8 | 2016-03-29 | ||
| PCT/CN2016/086546 WO2017166451A1 (zh) | 2016-03-29 | 2016-06-21 | 一种帕布昔利布的药物制剂及其制备方法 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020191821A Division JP2021046410A (ja) | 2016-03-29 | 2020-11-18 | パルボシクリブの医薬製剤およびその調製方法 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019510059A JP2019510059A (ja) | 2019-04-11 |
| JP2019510059A5 true JP2019510059A5 (OSRAM) | 2019-07-25 |
| JP6799612B2 JP6799612B2 (ja) | 2020-12-16 |
Family
ID=56525006
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018551287A Active JP6799612B2 (ja) | 2016-03-29 | 2016-06-21 | パルボシクリブの医薬製剤およびその調製方法 |
| JP2020191821A Pending JP2021046410A (ja) | 2016-03-29 | 2020-11-18 | パルボシクリブの医薬製剤およびその調製方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020191821A Pending JP2021046410A (ja) | 2016-03-29 | 2020-11-18 | パルボシクリブの医薬製剤およびその調製方法 |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20230226063A1 (OSRAM) |
| EP (1) | EP3437637B1 (OSRAM) |
| JP (2) | JP6799612B2 (OSRAM) |
| KR (1) | KR102386665B1 (OSRAM) |
| CN (2) | CN109078006B (OSRAM) |
| AU (1) | AU2016400468B2 (OSRAM) |
| CA (1) | CA3019257C (OSRAM) |
| EA (1) | EA201892173A1 (OSRAM) |
| ES (1) | ES2968132T3 (OSRAM) |
| GB (2) | GB2564793B (OSRAM) |
| IL (1) | IL261989B2 (OSRAM) |
| WO (1) | WO2017166451A1 (OSRAM) |
Families Citing this family (20)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113616606A (zh) | 2015-06-04 | 2021-11-09 | 辉瑞公司 | 帕博西尼的固体剂型 |
| US10449195B2 (en) | 2016-03-29 | 2019-10-22 | Shenzhen Pharmacin Co., Ltd. | Pharmaceutical formulation of palbociclib and a preparation method thereof |
| CN109078006B (zh) * | 2016-03-29 | 2021-04-20 | 深圳市药欣生物科技有限公司 | 一种帕布昔利布的药物制剂及其制备方法 |
| CN108017629A (zh) * | 2016-11-04 | 2018-05-11 | 上海奥博生物医药技术有限公司 | 一种帕博西尼无定形态 |
| CN108210454A (zh) * | 2016-12-14 | 2018-06-29 | 深圳市华力康生物医药有限公司 | 一种帕布昔利布的口服乳剂及其制备方法 |
| CN110573183A (zh) * | 2017-04-21 | 2019-12-13 | 上海方楠生物科技有限公司 | 一种帕博西林组合物及其制备方法 |
| WO2019056163A1 (zh) * | 2017-09-19 | 2019-03-28 | 浙江华海药业股份有限公司 | N-甲酰基帕博西尼及其制备方法和用途以及帕博西尼制剂及其质量控制方法 |
| CN108014343A (zh) * | 2017-12-21 | 2018-05-11 | 孟斯琴 | 一种治疗乳腺癌的药物组合物及其制备方法 |
| CN108066312B (zh) * | 2017-12-29 | 2020-03-20 | 山东裕欣药业有限公司 | 一种帕博西尼药物组合物及其制备方法 |
| CN108066303A (zh) * | 2017-12-31 | 2018-05-25 | 湖南博隽生物医药有限公司 | 一种抗癌药物组合物及其制备方法 |
| CN108653222A (zh) * | 2018-07-03 | 2018-10-16 | 威海贯标信息科技有限公司 | 一种帕博西尼片剂组合物 |
| CN109288806A (zh) * | 2018-08-22 | 2019-02-01 | 深圳市华力康生物医药有限公司 | 一种帕布昔利布的泡腾片及其应用 |
| KR20230034207A (ko) * | 2020-07-02 | 2023-03-09 | 아사무 세라퓨틱스 가부시키가이샤 | 경구용 의약 조성물 및 그 제조 방법 |
| WO2022063119A1 (zh) * | 2020-09-24 | 2022-03-31 | 南京济群医药科技股份有限公司 | 一种羟乙磺酸哌柏西利的组合物及药物 |
| CN114306245A (zh) * | 2020-09-29 | 2022-04-12 | 深圳市药欣生物科技有限公司 | 无定形固体分散体的药物组合物及其制备方法 |
| CN117815184A (zh) * | 2020-12-28 | 2024-04-05 | 上海云晟研新生物科技有限公司 | 帕博西尼固体分散体、其制备方法及应用 |
| TW202345842A (zh) | 2022-03-25 | 2023-12-01 | 大陸商深圳市藥欣生物科技有限公司 | Ｐｒｏｔａｃ化合物之醫藥組合物及其用途 |
| WO2024242504A1 (ko) * | 2023-05-25 | 2024-11-28 | 주식회사 삼양홀딩스 | 팔보시클립의 경구용 조성물 |
| KR20250062261A (ko) | 2023-10-30 | 2025-05-08 | 신풍제약주식회사 | 향상된 용해도 및 안정성을 가지는 팔보시클립의 제약학적 조성물 및 이의 제조방법 |
| WO2025156193A1 (en) * | 2024-01-25 | 2025-07-31 | Zhejiang Qizheng Pharmaceutical Co., Ltd. | Palbociclib dosage form |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2000309588A (ja) * | 1999-04-28 | 2000-11-07 | Taisho Pharmaceut Co Ltd | 固体分散体 |
| EP1740184A1 (en) * | 2004-03-30 | 2007-01-10 | Pfizer Products Incorporated | Combinations of signal transduction inhibitors |
| KR100627687B1 (ko) * | 2005-04-20 | 2006-09-25 | 주식회사 씨티씨바이오 | 시부트라민 유리염기 함유 조성물 및 이의 제조방법 |
| ZA200806496B (en) * | 2006-01-27 | 2009-12-30 | Eurand Inc | Drug delivery systems comprising weakly basic drugs and organic acids |
| CN102106806B (zh) * | 2009-12-29 | 2013-04-17 | 上海中西制药有限公司 | 一种固体制剂的制备方法及所得固体制剂 |
| CN102106807B (zh) * | 2009-12-29 | 2013-03-27 | 上海中西制药有限公司 | 一种固体制剂的制备方法及所得固体制剂 |
| CN103002880B (zh) * | 2010-06-09 | 2015-01-28 | Abbvie公司 | 含有激酶抑制剂的固态分散体 |
| CN105616419A (zh) * | 2014-11-07 | 2016-06-01 | 江苏豪森药业集团有限公司 | 含有细胞周期蛋白抑制剂固体分散体的药物组合物及其制备方法 |
| CN104434809B (zh) * | 2014-12-10 | 2018-10-16 | 北京科莱博医药开发有限责任公司 | 一种奥拉帕尼固体分散体制剂及其制备方法 |
| WO2016156070A1 (en) * | 2015-04-02 | 2016-10-06 | Sandoz Ag | Modified particles of palbociclib |
| CN104887641B (zh) * | 2015-04-08 | 2017-12-01 | 上海鲁源医药科技有限公司 | 帕布昔利布胃漂浮片及其制备方法 |
| CN113616606A (zh) * | 2015-06-04 | 2021-11-09 | 辉瑞公司 | 帕博西尼的固体剂型 |
| EP3331881B1 (en) * | 2015-08-05 | 2019-05-15 | ratiopharm GmbH | New crystalline form and acetic acid adducts of palbociclib |
| WO2017036390A1 (zh) * | 2015-09-01 | 2017-03-09 | 上海方楠生物科技有限公司 | 帕博西林或其药学上可接受的盐与药用辅料的组合物及其制备方法 |
| CN109078006B (zh) * | 2016-03-29 | 2021-04-20 | 深圳市药欣生物科技有限公司 | 一种帕布昔利布的药物制剂及其制备方法 |
-
2016
- 2016-03-29 CN CN201810902418.XA patent/CN109078006B/zh active Active
- 2016-03-29 CN CN201610187046.8A patent/CN105816437B/zh active Active
- 2016-06-21 EA EA201892173A patent/EA201892173A1/ru unknown
- 2016-06-21 AU AU2016400468A patent/AU2016400468B2/en active Active
- 2016-06-21 GB GB1817116.5A patent/GB2564793B/en active Active
- 2016-06-21 IL IL261989A patent/IL261989B2/en unknown
- 2016-06-21 EP EP16896224.9A patent/EP3437637B1/en active Active
- 2016-06-21 KR KR1020187031357A patent/KR102386665B1/ko active Active
- 2016-06-21 WO PCT/CN2016/086546 patent/WO2017166451A1/zh not_active Ceased
- 2016-06-21 ES ES16896224T patent/ES2968132T3/es active Active
- 2016-06-21 GB GB2010241.4A patent/GB2583425B/en active Active
- 2016-06-21 JP JP2018551287A patent/JP6799612B2/ja active Active
- 2016-06-21 CA CA3019257A patent/CA3019257C/en active Active
-
2020
- 2020-11-18 JP JP2020191821A patent/JP2021046410A/ja active Pending
-
2022
- 2022-09-28 US US17/954,421 patent/US20230226063A1/en not_active Abandoned
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