JP2023109959A5 - - Google Patents
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- Publication number
- JP2023109959A5 JP2023109959A5 JP2023086732A JP2023086732A JP2023109959A5 JP 2023109959 A5 JP2023109959 A5 JP 2023109959A5 JP 2023086732 A JP2023086732 A JP 2023086732A JP 2023086732 A JP2023086732 A JP 2023086732A JP 2023109959 A5 JP2023109959 A5 JP 2023109959A5
- Authority
- JP
- Japan
- Prior art keywords
- suspension
- fulvestrant
- aqueous
- microns
- aqueous fulvestrant
- 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
- VWUXBMIQPBEWFH-WCCTWKNTSA-N Fulvestrant Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3[C@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)CC2=C1 VWUXBMIQPBEWFH-WCCTWKNTSA-N 0.000 claims 101
- 229960002258 fulvestrant Drugs 0.000 claims 101
- 239000000725 suspension Substances 0.000 claims 91
- 239000003381 stabilizer Substances 0.000 claims 11
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 9
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 9
- 238000010255 intramuscular injection Methods 0.000 claims 8
- 239000007927 intramuscular injection Substances 0.000 claims 8
- 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 claims 6
- 229930195725 Mannitol Natural products 0.000 claims 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 6
- 239000000594 mannitol Substances 0.000 claims 6
- 235000010355 mannitol Nutrition 0.000 claims 6
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 6
- 229940068968 polysorbate 80 Drugs 0.000 claims 6
- 229920000053 polysorbate 80 Polymers 0.000 claims 6
- 229940069328 povidone Drugs 0.000 claims 6
- 206010006187 Breast cancer Diseases 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 5
- 239000002245 particle Substances 0.000 claims 5
- 208000026310 Breast neoplasm Diseases 0.000 claims 4
- 229920003078 Povidone K 12 Polymers 0.000 claims 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 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
- 229920006037 cross link polymer Polymers 0.000 claims 3
- 108091008039 hormone receptors Proteins 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 3
- 206010061818 Disease progression Diseases 0.000 claims 2
- 101001012157 Homo sapiens Receptor tyrosine-protein kinase erbB-2 Proteins 0.000 claims 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 2
- 102100030086 Receptor tyrosine-protein kinase erbB-2 Human genes 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 230000005750 disease progression Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000003792 electrolyte Substances 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims 1
- 206010055113 Breast cancer metastatic Diseases 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 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 claims 1
- 102000008100 Human Serum Albumin Human genes 0.000 claims 1
- 108091006905 Human Serum Albumin Proteins 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- 229920002507 Poloxamer 124 Polymers 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 229920003079 Povidone K 17 Polymers 0.000 claims 1
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 claims 1
- 239000007983 Tris buffer Substances 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical group [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 229940046836 anti-estrogen Drugs 0.000 claims 1
- 230000001833 anti-estrogenic effect Effects 0.000 claims 1
- 239000012736 aqueous medium Substances 0.000 claims 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 claims 1
- 239000000872 buffer Substances 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 239000008121 dextrose Substances 0.000 claims 1
- 238000009261 endocrine therapy Methods 0.000 claims 1
- 229940034984 endocrine therapy antineoplastic and immunomodulating agent Drugs 0.000 claims 1
- 239000000328 estrogen antagonist Substances 0.000 claims 1
- IXCSERBJSXMMFS-UHFFFAOYSA-N hydrogen chloride Substances Cl.Cl IXCSERBJSXMMFS-UHFFFAOYSA-N 0.000 claims 1
- 239000000787 lecithin Substances 0.000 claims 1
- 235000010445 lecithin Nutrition 0.000 claims 1
- 229940067606 lecithin Drugs 0.000 claims 1
- AHJRHEGDXFFMBM-UHFFFAOYSA-N palbociclib Chemical compound N1=C2N(C3CCCC3)C(=O)C(C(=O)C)=C(C)C2=CN=C1NC(N=C1)=CC=C1N1CCNCC1 AHJRHEGDXFFMBM-UHFFFAOYSA-N 0.000 claims 1
- 229960004390 palbociclib Drugs 0.000 claims 1
- 229940093448 poloxamer 124 Drugs 0.000 claims 1
- 229920001993 poloxamer 188 Polymers 0.000 claims 1
- 229940044519 poloxamer 188 Drugs 0.000 claims 1
- 229920001992 poloxamer 407 Polymers 0.000 claims 1
- 229940044476 poloxamer 407 Drugs 0.000 claims 1
- -1 poly(vinyl alcohol) Polymers 0.000 claims 1
- 239000008389 polyethoxylated castor oil Substances 0.000 claims 1
- 229940050929 polyethylene glycol 3350 Drugs 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- PVGBHEUCHKGFQP-UHFFFAOYSA-N sodium;n-[5-amino-2-(4-aminophenyl)sulfonylphenyl]sulfonylacetamide Chemical compound [Na+].CC(=O)NS(=O)(=O)C1=CC(N)=CC=C1S(=O)(=O)C1=CC=C(N)C=C1 PVGBHEUCHKGFQP-UHFFFAOYSA-N 0.000 claims 1
- 229950003429 sorbitan palmitate Drugs 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 1
- 235000015112 vegetable and seed oil Nutrition 0.000 claims 1
- 239000008158 vegetable oil Substances 0.000 claims 1
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662332842P | 2016-05-06 | 2016-05-06 | |
| US62/332,842 | 2016-05-06 | ||
| US201662420555P | 2016-11-10 | 2016-11-10 | |
| US62/420,555 | 2016-11-10 | ||
| JP2019510578A JP2019516789A (ja) | 2016-05-06 | 2017-05-05 | フルベストラント配合物およびその使用方法 |
| JP2021118471A JP7312523B2 (ja) | 2016-05-06 | 2021-07-19 | フルベストラント配合物およびその使用方法 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021118471A Division JP7312523B2 (ja) | 2016-05-06 | 2021-07-19 | フルベストラント配合物およびその使用方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2023109959A JP2023109959A (ja) | 2023-08-08 |
| JP2023109959A5 true JP2023109959A5 (https=) | 2023-08-29 |
Family
ID=58709642
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019510578A Pending JP2019516789A (ja) | 2016-05-06 | 2017-05-05 | フルベストラント配合物およびその使用方法 |
| JP2021118471A Active JP7312523B2 (ja) | 2016-05-06 | 2021-07-19 | フルベストラント配合物およびその使用方法 |
| JP2023086732A Pending JP2023109959A (ja) | 2016-05-06 | 2023-05-26 | フルベストラント配合物およびその使用方法 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019510578A Pending JP2019516789A (ja) | 2016-05-06 | 2017-05-05 | フルベストラント配合物およびその使用方法 |
| JP2021118471A Active JP7312523B2 (ja) | 2016-05-06 | 2021-07-19 | フルベストラント配合物およびその使用方法 |
Country Status (15)
| Country | Link |
|---|---|
| US (2) | US20190134059A1 (https=) |
| EP (1) | EP3452011A1 (https=) |
| JP (3) | JP2019516789A (https=) |
| KR (1) | KR102438425B1 (https=) |
| CN (1) | CN109310621A (https=) |
| AU (2) | AU2017261321B2 (https=) |
| CA (1) | CA3022834A1 (https=) |
| CO (1) | CO2018013257A2 (https=) |
| IL (2) | IL285928B2 (https=) |
| MA (1) | MA44862A (https=) |
| MX (2) | MX2018013414A (https=) |
| MY (1) | MY205661A (https=) |
| UA (1) | UA125514C2 (https=) |
| WO (1) | WO2017193048A1 (https=) |
| ZA (1) | ZA201807031B (https=) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11590077B2 (en) | 2016-05-06 | 2023-02-28 | Eagle Pharmaceuticals, Inc. | Fulvestrant formulations and methods of their use |
| JP7220712B2 (ja) * | 2017-11-08 | 2023-02-10 | イーグル ファーマスーティカルズ、インク． | フルベストラント製剤とその使用方法 |
| EP4074304A4 (en) * | 2019-12-11 | 2024-01-10 | Shanghai Bocimed Pharmaceutical Co., Ltd. | PHARMACEUTICAL COMPOSITION OF FULVESTRANT, PREPARATION METHOD AND APPLICATION THEREOF |
| CN113694017B (zh) * | 2020-05-11 | 2024-04-02 | 鲁南制药集团股份有限公司 | 一种氟维司群注射制剂及其制备方法 |
| WO2022100750A1 (zh) * | 2020-11-16 | 2022-05-19 | 北京厚燊维康科技有限责任公司 | 可用于光动力治疗或诊断的制剂 |
| CN120284882A (zh) * | 2020-12-10 | 2025-07-11 | 上海云晟研新生物科技有限公司 | 氟维司群药物组合物、其制备方法及应用 |
| KR20230094172A (ko) * | 2021-12-20 | 2023-06-27 | 주식회사 삼양홀딩스 | 용해도가 개선된 풀베스트란트의 약학 조성물 및 그 제조 방법 |
| KR20240105964A (ko) * | 2022-12-29 | 2024-07-08 | 주식회사 삼양홀딩스 | 약동학적 특성이 우수한 풀베스트란트의 약학 조성물 및 그 제조 방법 |
Family Cites Families (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8853260B2 (en) | 1997-06-27 | 2014-10-07 | Abraxis Bioscience, Llc | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof |
| GB0000313D0 (en) | 2000-01-10 | 2000-03-01 | Astrazeneca Uk Ltd | Formulation |
| US6495534B2 (en) * | 2000-05-15 | 2002-12-17 | Pharmacia & Upjohn Spa | Stabilized aqueous suspensions for parenteral use |
| JP2003533464A (ja) | 2000-05-15 | 2003-11-11 | フアルマシア・イタリア・エツセ・ピー・アー | 安定化ステロイド懸濁液 |
| HUP0400115A3 (en) * | 2001-07-07 | 2005-11-28 | Astrazeneca Ab | Pharmaceutical composition for the intramuscular administration of fulvestrant |
| GB0116619D0 (en) * | 2001-07-07 | 2001-08-29 | Astrazeneca Ab | Formulation |
| JP2003298516A (ja) | 2002-03-29 | 2003-10-17 | Fujitsu Ltd | 波長分散補償装置 |
| PL1778187T3 (pl) * | 2004-08-04 | 2012-09-28 | Camurus Ab | Kompozycje tworzące nielamelarne dyspersje |
| KR20140090270A (ko) | 2005-05-09 | 2014-07-16 | 바이오스피어 메디칼 에스.에이. | 마이크로스피어 및 비이온성 조영제를 사용하는 조성물 및 방법 |
| BRPI0617663A2 (pt) | 2005-10-21 | 2011-08-02 | Panacea Biotec Ltd | composições aperfeiçoadas para terapia de cáncer |
| US8158152B2 (en) | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| CN101108168B (zh) * | 2007-08-03 | 2010-12-08 | 西安力邦医药科技有限责任公司 | 一种氟维司群缓释微球的制备方法 |
| DK2200588T3 (da) | 2007-09-25 | 2019-07-01 | Solubest Ltd | Sammensætninger, som omfatter lipofile aktive forbindelser, og fremgangsmåde til fremstilling deraf |
| JP2011514349A (ja) | 2008-03-07 | 2011-05-06 | サイドース・エルエルシー | フルベストラント配合物 |
| TW201016220A (en) * | 2008-10-31 | 2010-05-01 | Scinopharm Taiwan Ltd | Micronization form of 7α-[9-(4,4,5,5,5-pentafluoropentylsufinyl)nonyl]estra-1,3,5(10)-triene-3,17β-diol and process for the preparation thereof |
| KR20120052937A (ko) * | 2009-06-18 | 2012-05-24 | 아보트 러보러터리즈 | 안정한 나노입자형 약물 현탁액 |
| AU2010278601A1 (en) * | 2009-07-31 | 2012-02-23 | Xi'an Libang Medical Technology Co., Ltd | Nanosphere or microsphere drug carrier, preparation method, composition and use thereof |
| EP2417975A4 (en) * | 2009-08-31 | 2012-11-14 | Xi An Libang Medical Technology Co Ltd | FULVESTRANT NANOPERLENES / MICROPERLES AND MANUFACTURING METHOD AND USE |
| WO2012021791A2 (en) | 2010-08-13 | 2012-02-16 | Scidose Llc | Aqueous formulation with improved stability |
| CA2811258C (en) | 2010-09-16 | 2019-10-15 | Shimoda Biotech (Pty) Ltd | Fulvestrant compositions and methods of use |
| EP2468258A1 (en) | 2010-12-22 | 2012-06-27 | LEK Pharmaceuticals d.d. | Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient |
| JP6092121B2 (ja) | 2011-01-09 | 2017-03-08 | エイエヌピー テクノロジーズ， インコーポレイテッド | 疎水性分子に誘起された分岐ポリマー凝集体及びその使用 |
| ES2708302T3 (es) * | 2011-05-20 | 2019-04-09 | Capital Business Y Gestion De Finanzas S L | Composición farmacéutica |
| CN102915088A (zh) | 2011-08-03 | 2013-02-06 | 鸿富锦精密工业（深圳）有限公司 | 资料存储器固定装置 |
| ES2983451T3 (es) | 2012-04-09 | 2024-10-23 | Eagle Pharmaceuticals Inc | Formulaciones de Fulvestrant |
| US11179468B2 (en) * | 2012-04-09 | 2021-11-23 | Eagle Pharmaceuticals, Inc. | Fulvestrant formulations |
| BR112014028376A2 (pt) * | 2012-06-08 | 2018-04-24 | Hoffmann La Roche | métodos para o tratamento de um distúrbio hiperproliferativo, para a determinação dos compostos, para monitorar, para optimizar a eficácia terapêutica e de identificação de um biomarcador; formulação farmacêutica; utilização de uma combinação terapêutica e de gdc-0032, artigo de manufatura, produto e invenção |
| CN104337761B (zh) * | 2013-08-07 | 2019-03-26 | 江苏豪森药业集团有限公司 | 氟维司群药物组合物 |
| JP2016529308A (ja) * | 2013-09-06 | 2016-09-23 | サラー ウッディン アハメド， | フルベストラント組成物 |
| CN105745207A (zh) * | 2013-10-03 | 2016-07-06 | 千年药物公司 | 使用PI3Kα抑制剂的增强的治疗方案 |
| HUP1300646A2 (en) | 2013-11-12 | 2015-05-28 | Druggability Technologies Ip Holdco Jersey Ltd | Complexes of fulvestrant and its derivatives, process for the preparation thereof and pharmaceutical compositions containing them |
| PT107433B (pt) | 2014-01-28 | 2018-12-04 | Hovione Farm S A | Processo de redução e controlo do tamanho de partícula |
| US9271990B2 (en) | 2014-02-14 | 2016-03-01 | Fresenius Kabi Usa, Llc | Fulvestrant formulations |
| CA2954064C (en) | 2014-07-02 | 2018-10-30 | The Research Foundation For The State University Of New York | Surfactant-stripped micelle compositions with high cargo to surfactant ratio |
| WO2015018380A2 (en) | 2014-07-03 | 2015-02-12 | Cspc Zhongqi Pharmaceutical Technology(Shijiazhuang)Co., Ltd. | Therapeutic nanoparticles and the preparation methods thereof |
-
2017
- 2017-05-04 IL IL285928A patent/IL285928B2/en unknown
- 2017-05-05 JP JP2019510578A patent/JP2019516789A/ja active Pending
- 2017-05-05 EP EP17723902.7A patent/EP3452011A1/en active Pending
- 2017-05-05 AU AU2017261321A patent/AU2017261321B2/en active Active
- 2017-05-05 UA UAA201812019A patent/UA125514C2/uk unknown
- 2017-05-05 MA MA044862A patent/MA44862A/fr unknown
- 2017-05-05 WO PCT/US2017/031376 patent/WO2017193048A1/en not_active Ceased
- 2017-05-05 KR KR1020187034942A patent/KR102438425B1/ko active Active
- 2017-05-05 US US16/099,265 patent/US20190134059A1/en not_active Abandoned
- 2017-05-05 MX MX2018013414A patent/MX2018013414A/es unknown
- 2017-05-05 CA CA3022834A patent/CA3022834A1/en active Pending
- 2017-05-05 MY MYPI2018703903A patent/MY205661A/en unknown
- 2017-05-05 CN CN201780027809.5A patent/CN109310621A/zh active Pending
-
2018
- 2018-10-18 IL IL262465A patent/IL262465A/en unknown
- 2018-10-22 ZA ZA2018/07031A patent/ZA201807031B/en unknown
- 2018-11-01 MX MX2022013199A patent/MX2022013199A/es unknown
- 2018-12-06 CO CONC2018/0013257A patent/CO2018013257A2/es unknown
-
2021
- 2021-07-19 JP JP2021118471A patent/JP7312523B2/ja active Active
- 2021-07-19 US US17/379,534 patent/US12370199B2/en active Active
-
2023
- 2023-05-26 JP JP2023086732A patent/JP2023109959A/ja active Pending
- 2023-05-31 AU AU2023203392A patent/AU2023203392A1/en not_active Abandoned
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