CN117379443A - 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 - Google Patents
稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 Download PDFInfo
- Publication number
- CN117379443A CN117379443A CN202310937648.0A CN202310937648A CN117379443A CN 117379443 A CN117379443 A CN 117379443A CN 202310937648 A CN202310937648 A CN 202310937648A CN 117379443 A CN117379443 A CN 117379443A
- Authority
- CN
- China
- Prior art keywords
- aspirin
- asa
- water
- solution
- tba
- 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
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Dispersion Chemistry (AREA)
- Rheumatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (4)
| 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) |
| CN201880036512.XA CN110996965A (zh) | 2017-05-30 | 2018-05-29 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880036512.XA Division CN110996965A (zh) | 2017-05-30 | 2018-05-29 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117379443A true CN117379443A (zh) | 2024-01-12 |
Family
ID=64455035
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310937648.0A Pending CN117379443A (zh) | 2017-05-30 | 2018-05-29 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
| CN201880036512.XA Pending CN110996965A (zh) | 2017-05-30 | 2018-05-29 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880036512.XA Pending CN110996965A (zh) | 2017-05-30 | 2018-05-29 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
Country Status (6)
| Country | Link |
|---|---|
| US (4) | US11096949B2 (enExample) |
| EP (1) | EP3630120A4 (enExample) |
| JP (3) | JP7335232B2 (enExample) |
| CN (2) | CN117379443A (enExample) |
| CA (1) | CA3064012A1 (enExample) |
| WO (1) | WO2018222583A1 (enExample) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117379443A (zh) * | 2017-05-30 | 2024-01-12 | 罗山制药股份有限公司 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
| 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 (enExample) * | 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 |
| WO1999003474A1 (de) | 1997-07-15 | 1999-01-28 | Walter Burghart | Verfahren zum herstellen von stabilen acetylsalicylsäure-lösungen |
| 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 |
| WO2005039464A1 (en) * | 2003-10-10 | 2005-05-06 | Oryxe | Transdermal high and low molecular weight compounds |
| US20070196364A1 (en) * | 2004-07-27 | 2007-08-23 | Human Genome Sciences, Inc. | Pharmaceutical Formulation and Process |
| US20080096947A1 (en) | 2004-10-15 | 2008-04-24 | Heidelberg Pharma Ag | Parenteral Forms Of Administration Of Imexon And Method For The Production Thereof |
| 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 |
| CN102480945A (zh) * | 2009-06-03 | 2012-05-30 | 艾克斯特克有限责任公司 | 皮肤处理组合物 |
| EA021588B1 (ru) | 2009-06-25 | 2015-07-30 | Тетра Сиа | Бетаиновые соли ацетилсалициловой кислоты |
| KR20120113267A (ko) * | 2010-01-15 | 2012-10-12 | 리쎄라 인코오포레이티드 | 동결건조 케이크 제제 |
| 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 |
| JP2016518388A (ja) | 2013-04-30 | 2016-06-23 | オティトピック インク. | 乾燥粉末配合および使用方法 |
| EP3005877B1 (en) * | 2013-05-30 | 2019-08-28 | Haier Group Corporation | Vegetable freshness-preservation and growing case and ecological vegetable freshness-preservation method |
| BR112015032262A2 (pt) * | 2013-06-28 | 2017-07-25 | Rexahn Pharmaceuticals Inc | composições de nanopartículas e formulações de compostos de piperazina |
| 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 |
| CN117379443A (zh) * | 2017-05-30 | 2024-01-12 | 罗山制药股份有限公司 | 稳定、无菌和结晶的邻乙酰水杨酸(阿司匹林)的小瓶内沉积物 |
| KR102507987B1 (ko) | 2017-09-22 | 2023-03-21 | 벡추라 인코포레이티드 | 스테아르산마그네슘을 갖는 건조 분말 조성물 |
-
2018
- 2018-05-29 CN CN202310937648.0A patent/CN117379443A/zh active Pending
- 2018-05-29 JP JP2020517288A patent/JP7335232B2/ja active Active
- 2018-05-29 CA CA3064012A patent/CA3064012A1/en active Pending
- 2018-05-29 US US16/617,958 patent/US11096949B2/en active Active
- 2018-05-29 CN CN201880036512.XA patent/CN110996965A/zh active Pending
- 2018-05-29 WO PCT/US2018/034866 patent/WO2018222583A1/en not_active Ceased
- 2018-05-29 EP EP18808709.2A patent/EP3630120A4/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
Also Published As
| Publication number | Publication date |
|---|---|
| US11096949B2 (en) | 2021-08-24 |
| WO2018222583A1 (en) | 2018-12-06 |
| CN110996965A (zh) | 2020-04-10 |
| JP2023116657A (ja) | 2023-08-22 |
| CA3064012A1 (en) | 2018-12-06 |
| US10959955B1 (en) | 2021-03-30 |
| US20220409636A1 (en) | 2022-12-29 |
| JP2020522577A (ja) | 2020-07-30 |
| US12048708B2 (en) | 2024-07-30 |
| JP7335232B2 (ja) | 2023-08-29 |
| JP2025163015A (ja) | 2025-10-28 |
| EP3630120A1 (en) | 2020-04-08 |
| EP3630120A4 (en) | 2021-01-13 |
| US11911400B1 (en) | 2024-02-27 |
| US20200188417A1 (en) | 2020-06-18 |
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