JP2020522577A5 - - Google Patents
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- Publication number
- JP2020522577A5 JP2020522577A5 JP2020517288A JP2020517288A JP2020522577A5 JP 2020522577 A5 JP2020522577 A5 JP 2020522577A5 JP 2020517288 A JP2020517288 A JP 2020517288A JP 2020517288 A JP2020517288 A JP 2020517288A JP 2020522577 A5 JP2020522577 A5 JP 2020522577A5
- Authority
- JP
- Japan
- Prior art keywords
- aspirin
- amount
- liquid
- containing composition
- water
- 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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- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 claims description 67
- 229960001138 acetylsalicylic acid Drugs 0.000 claims description 67
- 239000000203 mixture Substances 0.000 claims description 42
- 239000007788 liquid Substances 0.000 claims description 28
- DKGAVHZHDRPRBM-UHFFFAOYSA-N Tert-Butanol Chemical compound CC(C)(C)O DKGAVHZHDRPRBM-UHFFFAOYSA-N 0.000 claims description 22
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 13
- 238000010253 intravenous injection Methods 0.000 claims description 8
- 239000004094 surface-active agent Substances 0.000 claims description 7
- 239000006184 cosolvent Substances 0.000 claims description 6
- 239000003960 organic solvent Substances 0.000 claims description 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 6
- 229920000053 polysorbate 80 Polymers 0.000 claims description 6
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical group OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 5
- 229930195725 Mannitol Natural products 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 239000000594 mannitol Substances 0.000 claims description 5
- 235000010355 mannitol Nutrition 0.000 claims description 5
- 150000007530 organic bases Chemical class 0.000 claims description 5
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 4
- 150000001413 amino acids Chemical class 0.000 claims description 4
- 150000007529 inorganic bases Chemical class 0.000 claims description 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 4
- 229940068968 polysorbate 80 Drugs 0.000 claims description 4
- 238000002560 therapeutic procedure Methods 0.000 claims description 4
- 241000124008 Mammalia Species 0.000 claims description 3
- 239000007983 Tris buffer Substances 0.000 claims description 3
- 238000004090 dissolution Methods 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- 238000004519 manufacturing process Methods 0.000 claims description 3
- 229910052783 alkali metal Inorganic materials 0.000 claims description 2
- 150000001340 alkali metals Chemical class 0.000 claims description 2
- 150000001447 alkali salts Chemical class 0.000 claims description 2
- 229940061607 dibasic sodium phosphate Drugs 0.000 claims description 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- 239000000243 solution Substances 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 claims description 2
- 238000001990 intravenous administration Methods 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 2
- 239000002610 basifying agent Substances 0.000 claims 1
- 239000004067 bulking agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 8
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 6
- 238000002844 melting Methods 0.000 description 6
- 230000008018 melting Effects 0.000 description 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 description 4
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 3
- 239000004471 Glycine Substances 0.000 description 2
- 238000002441 X-ray diffraction Methods 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000008364 bulk solution Substances 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 239000000155 melt Substances 0.000 description 2
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 2
- 229960004889 salicylic acid Drugs 0.000 description 2
- 150000005846 sugar alcohols Chemical class 0.000 description 2
- 239000004475 Arginine Substances 0.000 description 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 1
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 125000003158 alcohol group Chemical group 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 238000002447 crystallographic data Methods 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 125000000185 sucrose group Chemical group 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical group OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2023096643A JP2023116657A (ja) | 2017-05-30 | 2023-06-13 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| JP2025112118A JP2025163015A (ja) | 2017-05-30 | 2025-07-02 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762512367P | 2017-05-30 | 2017-05-30 | |
| US62/512,367 | 2017-05-30 | ||
| PCT/US2018/034866 WO2018222583A1 (en) | 2017-05-30 | 2018-05-29 | In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin) |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023096643A Division JP2023116657A (ja) | 2017-05-30 | 2023-06-13 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020522577A JP2020522577A (ja) | 2020-07-30 |
| JP2020522577A5 true JP2020522577A5 (cg-RX-API-DMAC10.html) | 2021-08-12 |
| JP7335232B2 JP7335232B2 (ja) | 2023-08-29 |
Family
ID=64455035
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020517288A Active JP7335232B2 (ja) | 2017-05-30 | 2018-05-29 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| JP2023096643A Pending JP2023116657A (ja) | 2017-05-30 | 2023-06-13 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| JP2025112118A Pending JP2025163015A (ja) | 2017-05-30 | 2025-07-02 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2023096643A Pending JP2023116657A (ja) | 2017-05-30 | 2023-06-13 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| JP2025112118A Pending JP2025163015A (ja) | 2017-05-30 | 2025-07-02 | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
Country Status (6)
| Country | Link |
|---|---|
| US (4) | US11096949B2 (cg-RX-API-DMAC10.html) |
| EP (1) | EP3630120A4 (cg-RX-API-DMAC10.html) |
| JP (3) | JP7335232B2 (cg-RX-API-DMAC10.html) |
| CN (2) | CN110996965A (cg-RX-API-DMAC10.html) |
| CA (1) | CA3064012A1 (cg-RX-API-DMAC10.html) |
| WO (1) | WO2018222583A1 (cg-RX-API-DMAC10.html) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7335232B2 (ja) * | 2017-05-30 | 2023-08-29 | ローシャン ファーマシューティカルズ，インコーポレーテッド | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| US11793748B1 (en) | 2019-04-05 | 2023-10-24 | Good Health, Llc | Pharmaceutical compositions of aspirin for parenteral administration |
| WO2023198294A1 (en) * | 2022-04-14 | 2023-10-19 | Hyloris Developments Sa | Acetyl salicylic acid composition for intravenous administration, its storage, production and use |
Family Cites Families (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB912894A (en) | 1959-11-02 | 1962-12-12 | Guy Leopold Van Moorleghem | Method for the preparing a solution of aspirin for injection and product obtained thereby |
| GB993682A (en) * | 1962-07-09 | 1965-06-02 | Haessle Ab | Salts of acetylsalicylic acid, their production and pharmaceutical preparations containing them |
| JPS4856815A (cg-RX-API-DMAC10.html) * | 1971-11-13 | 1973-08-09 | ||
| US4117603A (en) * | 1976-12-28 | 1978-10-03 | Smith Walton J | High vacuum freeze-drying |
| CA1131245A (en) | 1978-07-12 | 1982-09-07 | Walton J. Smith | Freeze dried pharmaceuticals |
| JPS5610110A (en) | 1979-07-06 | 1981-02-02 | Green Cross Corp:The | Acetyl salicylate salt preparation for injection |
| US4975269A (en) | 1989-07-31 | 1990-12-04 | Leonard Chavkin | Shelf stable aspirin solutions |
| DE4440337A1 (de) | 1994-11-11 | 1996-05-15 | Dds Drug Delivery Services Ges | Pharmazeutische Nanosuspensionen zur Arzneistoffapplikation als Systeme mit erhöhter Sättigungslöslichkeit und Lösungsgeschwindigkeit |
| ES2196574T3 (es) | 1997-07-15 | 2003-12-16 | Walter Burghart | Procedimiento para la preparacion de soluciones estables de acido acetilsalicilico. |
| EP1094819A1 (en) * | 1998-07-09 | 2001-05-02 | Alexander Galat | Injectable sodium acetylsalicylate composition and method |
| DE10011032A1 (de) * | 2000-03-07 | 2001-09-13 | Bayer Ag | Acetylsalicylsäure-Lösungen |
| DE10034802A1 (de) | 2000-07-18 | 2002-01-31 | Bayer Ag | Stabile Salze von O-Acetylsalicylsäure mit basischen Aminosäuren |
| ES2189639B1 (es) * | 2001-05-22 | 2005-02-01 | Jesus Angel Hernandez Cordon | Composicion acuosa que contiene acido acetilsalicilico. |
| US20050152979A1 (en) * | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
| CN1874740A (zh) * | 2003-10-10 | 2006-12-06 | 奥来克西公司 | 经皮高分子量和低分子量化合物 |
| US20070196364A1 (en) | 2004-07-27 | 2007-08-23 | Human Genome Sciences, Inc. | Pharmaceutical Formulation and Process |
| WO2006042662A1 (de) | 2004-10-15 | 2006-04-27 | Heidelberg Pharma Gmbh | Parenterale darreichungsformen von imexon sowie verfahren zu deren herstellung |
| DE102005025283A1 (de) | 2005-06-02 | 2006-12-07 | Bayer Healthcare Ag | Stabiler Wirkstoffkomplex von Salzen der o-Acetylsalicylsäure mit basischen Aminosäuren und Glycin |
| US8158152B2 (en) | 2005-11-18 | 2012-04-17 | Scidose Llc | Lyophilization process and products obtained thereby |
| US7202229B1 (en) | 2005-12-30 | 2007-04-10 | Alan James Group, Llc. | Aspirin formulation for cardiovascular health |
| US8481600B2 (en) * | 2007-05-16 | 2013-07-09 | Academic Pharmaceuticals, Inc. | Formulation of aspirin that is stable and showing minimal hydrolysis for parenteral administration for the treatment of cardiovascular and other disease states |
| DE202007007241U1 (de) * | 2007-05-21 | 2007-09-20 | Temmen Gmbh | Krebsprävention an Säugern durch Aktivierung embryonaler Zellen im Verlaufe der ontogenetischen Entwicklung mit Hilfe von Zellwachstumsregulatoren (Auxine) in Kombination mit einem Trägerstoff aus Phospholipiden und Pflanzenölen |
| EP2437596B1 (en) * | 2009-06-03 | 2017-05-03 | Ex-Tek, LLC | Skin treatment compositions |
| CA2766048A1 (en) | 2009-06-25 | 2010-12-29 | Tetra, Sia | Novel acetylsalicylic acid salts |
| MX2012008171A (es) * | 2010-01-15 | 2012-12-17 | Lithera Inc | Formulaciones aglomeradas liofilizadas. |
| RO128007A2 (ro) * | 2011-06-01 | 2012-12-28 | Institutul Naţional De Cercetare-Dezvoltare Pentru Tehnologii Izotopice Şi Moleculare | Procedeu de obţinere a ansamblurilor funcţionale micro/nano-structurate de chitosan şi substanţe active antiinflamatoare prin autoasamblare simultană |
| US9757529B2 (en) | 2012-12-20 | 2017-09-12 | Otitopic Inc. | Dry powder inhaler and methods of use |
| CN105473133A (zh) | 2013-04-30 | 2016-04-06 | 欧缇托匹克公司 | 干粉制剂及使用方法 |
| EP3005877B1 (en) * | 2013-05-30 | 2019-08-28 | Haier Group Corporation | Vegetable freshness-preservation and growing case and ecological vegetable freshness-preservation method |
| US9744167B2 (en) * | 2013-06-28 | 2017-08-29 | Rexahn Pharmaceuticals, Inc. | Nanoparticulate compositions and formulations of piperazine compounds |
| US9553620B2 (en) * | 2014-07-16 | 2017-01-24 | Raytheon Company | Signal detection and characterization |
| CN104546678A (zh) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | 一种阿司匹林组合物冻干片及其制备方法 |
| CN104546680A (zh) * | 2014-12-25 | 2015-04-29 | 海南卫康制药(潜山)有限公司 | 一种阿司匹林组合物冻干片及其制备方法 |
| DE102015002709A1 (de) | 2015-03-04 | 2016-09-08 | Cfso Gmbh | Neue Verwendung von Acetylsalicylsäure und einem Derivat davon |
| JP7335232B2 (ja) * | 2017-05-30 | 2023-08-29 | ローシャン ファーマシューティカルズ，インコーポレーテッド | 安定な滅菌性且つ結晶性ｏ－アセチルサリチル酸（アスピリン）のバイアル内堆積物 |
| WO2019059953A2 (en) | 2017-09-22 | 2019-03-28 | Otitopic Inc. | DRY POWDER COMPOSITIONS CONTAINING MAGNESIUM STEARATE |
-
2018
- 2018-05-29 JP JP2020517288A patent/JP7335232B2/ja active Active
- 2018-05-29 CN CN201880036512.XA patent/CN110996965A/zh active Pending
- 2018-05-29 EP EP18808709.2A patent/EP3630120A4/en active Pending
- 2018-05-29 US US16/617,958 patent/US11096949B2/en active Active
- 2018-05-29 WO PCT/US2018/034866 patent/WO2018222583A1/en not_active Ceased
- 2018-05-29 CN CN202310937648.0A patent/CN117379443A/zh active Pending
- 2018-05-29 CA CA3064012A patent/CA3064012A1/en active Pending
-
2019
- 2019-11-27 US US16/698,386 patent/US10959955B1/en active Active
-
2021
- 2021-03-17 US US17/204,559 patent/US11911400B1/en active Active
- 2021-08-19 US US17/406,285 patent/US12048708B2/en active Active
-
2023
- 2023-06-13 JP JP2023096643A patent/JP2023116657A/ja active Pending
-
2025
- 2025-07-02 JP JP2025112118A patent/JP2025163015A/ja active Pending
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