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 |
| EP3706719A1 (en) | 2017-11-08 | 2020-09-16 | Eagle Pharmaceuticals, Inc. | Fulvestrant formulations and methods of their use |
| 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 |
| CN114504551B (zh) * | 2020-11-16 | 2024-01-02 | 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 |
| JP2024545690A (ja) * | 2021-12-20 | 2024-12-10 | サムヤン、ホールディングス、コーポレーション | 溶解度が改善されたフルベストラントの医薬組成物及びその製造方法 |
| 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 |
| WO2001087262A2 (en) | 2000-05-15 | 2001-11-22 | Pharmacia Italia S.P.A. | Stabilized steroidal suspension |
| PL367624A1 (en) * | 2001-07-07 | 2005-03-07 | Astrazeneca Ab | Pharmaceutical formulation 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 |
| CA2575906C (en) * | 2004-08-04 | 2014-04-15 | Camurus Ab | Compositions forming non-lamellar dispersions |
| KR101429774B1 (ko) | 2005-05-09 | 2014-10-02 | 바이오스피어 메디칼 에스.에이. | 마이크로스피어 및 비이온성 조영제를 사용하는 조성물 및방법 |
| WO2007069272A2 (en) | 2005-10-21 | 2007-06-21 | Panacea Biotec Limited | Pharmaceutical composition comprising at least one anticancer drug and at least one polymer |
| 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 |
| SI2200588T1 (sl) | 2007-09-25 | 2019-08-30 | Solubest Ltd. | Sestavki, ki obsegajo lipofilne aktivne spojine, in postopek za njihovo pripravo |
| 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 |
| MX2011013797A (es) | 2009-06-18 | 2012-01-30 | Abbott Lab | Suspension de farmaco estable de nanoparticula. |
| WO2011022861A1 (zh) * | 2009-08-31 | 2011-03-03 | 西安力邦医药科技有限责任公司 | 氟维司群纳米球/微球及其制备方法和用途 |
| WO2011011978A1 (zh) * | 2009-07-31 | 2011-02-03 | 西安力邦医药科技有限责任公司 | 微球药物载体、其制备方法、组合物及应用 |
| WO2012021791A2 (en) | 2010-08-13 | 2012-02-16 | Scidose Llc | Aqueous formulation with improved stability |
| CN103221052A (zh) | 2010-09-16 | 2013-07-24 | 施摩达生物技术有限公司 | 氟维司群组合物及使用方法 |
| 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 |
| EP2661281B1 (en) | 2011-01-09 | 2021-03-10 | ANP Technologies, Inc. | Hydrophobic molecule-induced branched polymer aggregates and their use |
| EP2711010B1 (en) * | 2011-05-20 | 2018-10-31 | Capital, Business Y Gestión De Finanzas, S.L | Pharmaceutical composition |
| 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 |
| US11179468B2 (en) * | 2012-04-09 | 2021-11-23 | Eagle Pharmaceuticals, Inc. | Fulvestrant formulations |
| CA2869377C (en) | 2012-04-09 | 2022-11-08 | Scidose, Llc | Fulvestrant formulations |
| WO2013182668A1 (en) * | 2012-06-08 | 2013-12-12 | F. Hoffmann-La Roche Ag | Mutant selectivity and combinations of a phosphoinositide 3 kinase inhibitor compound and chemotherapeutic agents for the treatment of cancer |
| 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 |
| WO2015033302A2 (en) * | 2013-09-06 | 2015-03-12 | Salah Uddin Ahmed | Fulvestrant compositions |
| JP2016536282A (ja) * | 2013-10-03 | 2016-11-24 | ミレニアム ファーマシューティカルズ， インコーポレイテッドＭｉｌｌｅｎｎｉｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | ＰＩ３Ｋα阻害剤を使用する強化された治療レジメン |
| 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 |
| JP6235755B2 (ja) | 2014-07-02 | 2017-11-22 | ザ リサーチ ファウンデイション フォー ザ ステイト ユニバーシティー オブ ニューヨーク | 高いカーゴ対サーファクタント比を有するサーファクタント除去ミセル組成物 |
| CN104434808A (zh) | 2014-07-03 | 2015-03-25 | 石药集团中奇制药技术（石家庄）有限公司 | 一种治疗性纳米粒子及其制备方法 |
-
2017
- 2017-05-04 IL IL285928A patent/IL285928B2/en unknown
- 2017-05-05 US US16/099,265 patent/US20190134059A1/en not_active Abandoned
- 2017-05-05 KR KR1020187034942A patent/KR102438425B1/ko active Active
- 2017-05-05 MX MX2018013414A patent/MX2018013414A/es unknown
- 2017-05-05 CA CA3022834A patent/CA3022834A1/en active Pending
- 2017-05-05 JP JP2019510578A patent/JP2019516789A/ja active Pending
- 2017-05-05 WO PCT/US2017/031376 patent/WO2017193048A1/en not_active Ceased
- 2017-05-05 EP EP17723902.7A patent/EP3452011A1/en active Pending
- 2017-05-05 AU AU2017261321A patent/AU2017261321B2/en active Active
- 2017-05-05 MY MYPI2018703903A patent/MY205661A/en unknown
- 2017-05-05 CN CN201780027809.5A patent/CN109310621A/zh active Pending
- 2017-05-05 MA MA044862A patent/MA44862A/fr unknown
- 2017-05-05 UA UAA201812019A patent/UA125514C2/uk unknown
-
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 US US17/379,534 patent/US12370199B2/en active Active
- 2021-07-19 JP JP2021118471A patent/JP7312523B2/ja 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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