JP2019081811A5 - - Google Patents
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- Publication number
- JP2019081811A5 JP2019081811A5 JP2019040987A JP2019040987A JP2019081811A5 JP 2019081811 A5 JP2019081811 A5 JP 2019081811A5 JP 2019040987 A JP2019040987 A JP 2019040987A JP 2019040987 A JP2019040987 A JP 2019040987A JP 2019081811 A5 JP2019081811 A5 JP 2019081811A5
- Authority
- JP
- Japan
- Prior art keywords
- component
- liquid pharmaceutical
- sodium
- pharmaceutical formulation
- acetate
- 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
Links
- 239000007788 liquid Substances 0.000 claims 5
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 108010049264 Teriparatide Proteins 0.000 claims 2
- JHJLBTNAGRQEKS-UHFFFAOYSA-M sodium bromide Chemical compound [Na+].[Br-] JHJLBTNAGRQEKS-UHFFFAOYSA-M 0.000 claims 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 1
- 239000011575 calcium Substances 0.000 claims 1
- 229910052791 calcium Inorganic materials 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 159000000003 magnesium salts Chemical class 0.000 claims 1
- BUUKFBVDKSFMHN-LKMAISLMSA-N parathar acetate Chemical compound CC(O)=O.C([C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CN=CN1 BUUKFBVDKSFMHN-LKMAISLMSA-N 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000001632 sodium acetate Substances 0.000 claims 1
- 235000017281 sodium acetate Nutrition 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000001509 sodium citrate Substances 0.000 claims 1
- 238000007920 subcutaneous administration Methods 0.000 claims 1
- OGBMKVWORPGQRR-UMXFMPSGSA-N teriparatide Chemical compound C([C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CNC=N1 OGBMKVWORPGQRR-UMXFMPSGSA-N 0.000 claims 1
- 229960005460 teriparatide Drugs 0.000 claims 1
- 229960000338 teriparatide acetate Drugs 0.000 claims 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 1
- 229940038773 trisodium citrate Drugs 0.000 claims 1
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2017182611 | 2017-09-22 | ||
| JP2017182611 | 2017-09-22 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018558440A Division JP6577683B2 (ja) | 2017-09-22 | 2018-09-20 | 安定性に優れるテリパラチド含有液状医薬組成物 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020201121A Division JP6851536B2 (ja) | 2017-09-22 | 2020-12-03 | 安定性に優れるテリパラチド含有液状医薬組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019081811A JP2019081811A (ja) | 2019-05-30 |
| JP2019081811A5 true JP2019081811A5 (https=) | 2019-11-14 |
| JP6826140B2 JP6826140B2 (ja) | 2021-02-03 |
Family
ID=65811407
Family Applications (17)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018558440A Active JP6577683B2 (ja) | 2017-09-22 | 2018-09-20 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019008790A Active JP6585317B2 (ja) | 2017-09-22 | 2019-01-22 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019008797A Active JP6714738B2 (ja) | 2017-09-22 | 2019-01-22 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019041011A Active JP6817358B2 (ja) | 2017-09-22 | 2019-03-06 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019040987A Active JP6826140B2 (ja) | 2017-09-22 | 2019-03-06 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057412A Active JP6781790B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057408A Active JP6634175B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057398A Active JP6581741B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057434A Active JP6646173B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057438A Pending JP2019089865A (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019085817A Active JP6825034B2 (ja) | 2017-09-22 | 2019-04-26 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019228968A Active JP6739612B2 (ja) | 2017-09-22 | 2019-12-19 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020053255A Active JP6766286B2 (ja) | 2017-09-22 | 2020-03-24 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020139570A Active JP6818928B2 (ja) | 2017-09-22 | 2020-08-20 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020201121A Active JP6851536B2 (ja) | 2017-09-22 | 2020-12-03 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020218741A Active JP6977137B2 (ja) | 2017-09-22 | 2020-12-28 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2021036829A Pending JP2021088606A (ja) | 2017-09-22 | 2021-03-09 | 安定性に優れるテリパラチド含有液状医薬組成物 |
Family Applications Before (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018558440A Active JP6577683B2 (ja) | 2017-09-22 | 2018-09-20 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019008790A Active JP6585317B2 (ja) | 2017-09-22 | 2019-01-22 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019008797A Active JP6714738B2 (ja) | 2017-09-22 | 2019-01-22 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019041011A Active JP6817358B2 (ja) | 2017-09-22 | 2019-03-06 | 安定性に優れるテリパラチド含有液状医薬組成物 |
Family Applications After (12)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019057412A Active JP6781790B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057408A Active JP6634175B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057398A Active JP6581741B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057434A Active JP6646173B2 (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019057438A Pending JP2019089865A (ja) | 2017-09-22 | 2019-03-25 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019085817A Active JP6825034B2 (ja) | 2017-09-22 | 2019-04-26 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2019228968A Active JP6739612B2 (ja) | 2017-09-22 | 2019-12-19 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020053255A Active JP6766286B2 (ja) | 2017-09-22 | 2020-03-24 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020139570A Active JP6818928B2 (ja) | 2017-09-22 | 2020-08-20 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020201121A Active JP6851536B2 (ja) | 2017-09-22 | 2020-12-03 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2020218741A Active JP6977137B2 (ja) | 2017-09-22 | 2020-12-28 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP2021036829A Pending JP2021088606A (ja) | 2017-09-22 | 2021-03-09 | 安定性に優れるテリパラチド含有液状医薬組成物 |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US20200289621A1 (https=) |
| EP (1) | EP3685849A4 (https=) |
| JP (17) | JP6577683B2 (https=) |
| CN (2) | CN116898955A (https=) |
| CA (1) | CA3075977C (https=) |
| WO (1) | WO2019059302A1 (https=) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP6577683B2 (ja) * | 2017-09-22 | 2019-09-18 | 旭化成ファーマ株式会社 | 安定性に優れるテリパラチド含有液状医薬組成物 |
| JP6618139B1 (ja) * | 2018-10-29 | 2019-12-11 | 旭化成ファーマ株式会社 | 週２回の頻度でテリパラチド又はその塩を投与することを特徴とする、骨粗鬆症の予防又は治療方法 |
| JP7240407B2 (ja) * | 2019-09-05 | 2023-03-15 | 旭化成ファーマ株式会社 | テリパラチド又はその塩を含有する無菌注射剤を製造する方法 |
| JP6965474B1 (ja) * | 2019-12-09 | 2021-11-10 | 旭化成ファーマ株式会社 | テリパラチド又はその塩を含有するプレフィルドシリンジまたはカートリッジ製剤の振盪による白濁を抑制する方法 |
| CA3157981C (en) * | 2019-12-18 | 2024-03-26 | Daewoong Pharmaceutical Co., Ltd. | Liquid pharmaceutical composition of 1-(5-(2,4-difluorophenyl)-1-((3-fluorophenyl)sulfonyl)-4-methoxy-1h-pyrrol-3-yl)-n-methylmethanamine |
| WO2021229835A1 (ja) * | 2020-05-11 | 2021-11-18 | 旭化成ファーマ株式会社 | テリパラチド又はその塩を含有する安定な液状医薬製剤 |
| CN114306249A (zh) * | 2020-09-28 | 2022-04-12 | 深圳翰宇药业股份有限公司 | 一种特立帕肽冻干药物组合物及其制备方法 |
| CN114031680B (zh) * | 2021-09-01 | 2024-03-26 | 浙江湃肽生物有限公司 | 一种索玛鲁肽钠盐及其制备方法与应用 |
| CN114316021A (zh) * | 2021-12-29 | 2022-04-12 | 江苏诺泰澳赛诺生物制药股份有限公司 | 一种特立帕肽及的纯化方法 |
| WO2025032376A1 (en) * | 2023-08-04 | 2025-02-13 | Precise Biopharma Pvt Ltd | A room temperature stable solution for injection of abaloparatide |
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| WO2008124166A2 (en) * | 2007-04-09 | 2008-10-16 | The Board Of Trustees Of The University Of Arkansas | Fusion proteins of collagen-binding domain and parathyroid hormone |
| WO2009006097A1 (en) * | 2007-06-29 | 2009-01-08 | Johnson & Johnson Regenerative Therapeutics, Llc | Liquid protein formulations comprising gdf-5 for use at elevated temperatures |
| EP2052736A1 (en) * | 2007-10-26 | 2009-04-29 | Nycomed Danmark ApS | Parathyroid hormone formulations und uses thereof |
| BRPI0911048A2 (pt) * | 2008-04-14 | 2015-12-29 | Atrm Llc | formulações líquidas tamponadas de gdf-5 |
| BRPI0918978A2 (pt) * | 2008-09-10 | 2015-12-01 | Genentech Inc | composições e métodos a prevenção da degradação oxidativa das proteínas |
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| EP2837685B1 (en) * | 2012-04-09 | 2020-09-09 | Daiichi Sankyo Company, Limited | Anti-fgfr2 antibody |
| CN103301058A (zh) * | 2013-06-17 | 2013-09-18 | 深圳翰宇药业股份有限公司 | 一种特立帕肽注射用组合物及其制备方法和制剂 |
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| JP6634758B2 (ja) * | 2015-09-25 | 2020-01-22 | ニプロ株式会社 | 液体組成物及び凍結乾燥製剤 |
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| JP6577683B2 (ja) * | 2017-09-22 | 2019-09-18 | 旭化成ファーマ株式会社 | 安定性に優れるテリパラチド含有液状医薬組成物 |
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2018
- 2018-09-20 JP JP2018558440A patent/JP6577683B2/ja active Active
- 2018-09-20 US US16/649,254 patent/US20200289621A1/en not_active Abandoned
- 2018-09-20 CN CN202311111773.2A patent/CN116898955A/zh active Pending
- 2018-09-20 CA CA3075977A patent/CA3075977C/en active Active
- 2018-09-20 WO PCT/JP2018/034887 patent/WO2019059302A1/ja not_active Ceased
- 2018-09-20 EP EP18859204.2A patent/EP3685849A4/en not_active Withdrawn
- 2018-09-20 CN CN201880053788.9A patent/CN110996988A/zh active Pending
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2019
- 2019-01-22 JP JP2019008790A patent/JP6585317B2/ja active Active
- 2019-01-22 JP JP2019008797A patent/JP6714738B2/ja active Active
- 2019-03-06 JP JP2019041011A patent/JP6817358B2/ja active Active
- 2019-03-06 JP JP2019040987A patent/JP6826140B2/ja active Active
- 2019-03-25 JP JP2019057412A patent/JP6781790B2/ja active Active
- 2019-03-25 JP JP2019057408A patent/JP6634175B2/ja active Active
- 2019-03-25 JP JP2019057398A patent/JP6581741B2/ja active Active
- 2019-03-25 JP JP2019057434A patent/JP6646173B2/ja active Active
- 2019-03-25 JP JP2019057438A patent/JP2019089865A/ja active Pending
- 2019-04-26 JP JP2019085817A patent/JP6825034B2/ja active Active
- 2019-12-19 JP JP2019228968A patent/JP6739612B2/ja active Active
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2020
- 2020-03-24 JP JP2020053255A patent/JP6766286B2/ja active Active
- 2020-08-20 JP JP2020139570A patent/JP6818928B2/ja active Active
- 2020-12-03 JP JP2020201121A patent/JP6851536B2/ja active Active
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2021
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- 2021-03-19 US US17/206,987 patent/US20210205418A1/en active Pending
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