CN110996965A - 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 PDF

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Publication number
CN110996965A
CN110996965A CN201880036512.XA CN201880036512A CN110996965A CN 110996965 A CN110996965 A CN 110996965A CN 201880036512 A CN201880036512 A CN 201880036512A CN 110996965 A CN110996965 A CN 110996965A
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China
Prior art keywords
aspirin
water
liquid composition
containing liquid
lyophilized
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
Application number
CN201880036512.XA
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English (en)
Chinese (zh)
Inventor
N·R·帕利普
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Luoshan Pharmaceutical Co ltd
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Luoshan Pharmaceutical Co ltd
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Priority to CN202310937648.0A priority Critical patent/CN117379443A/zh
Publication of CN110996965A publication Critical patent/CN110996965A/zh
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/612Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201880036512.XA 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 Pending CN110996965A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310937648.0A 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

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
CN202310937648.0A Division 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

Publications (1)

Publication Number Publication Date
CN110996965A true CN110996965A (zh) 2020-04-10

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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
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

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Country Status (6)

Country Link
US (4) US11096949B2 (enExample)
EP (1) EP3630120A4 (enExample)
JP (3) JP7335232B2 (enExample)
CN (2) CN110996965A (enExample)
CA (1) CA3064012A1 (enExample)
WO (1) WO2018222583A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3064012A1 (en) * 2017-05-30 2018-12-06 Rhoshan Pharmaceuticals, Inc. In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin)
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

Citations (2)

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WO2001066115A2 (de) * 2000-03-07 2001-09-13 Bayer Aktiengesellschaft Acetylsalicylsäure-lösungen
US20020091108A1 (en) * 2000-07-18 2002-07-11 Gerhard Franckowiak Stable salts of O-acetylsalicylic acid with basic amino acids

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US20050152979A1 (en) * 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
JP2007508297A (ja) 2003-10-10 2007-04-05 オリックス 経皮の高分子量化合物及び低分子量化合物
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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
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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
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Also Published As

Publication number Publication date
US20220409636A1 (en) 2022-12-29
CN117379443A (zh) 2024-01-12
US12048708B2 (en) 2024-07-30
US20200188417A1 (en) 2020-06-18
US10959955B1 (en) 2021-03-30
JP2020522577A (ja) 2020-07-30
JP7335232B2 (ja) 2023-08-29
EP3630120A1 (en) 2020-04-08
EP3630120A4 (en) 2021-01-13
JP2023116657A (ja) 2023-08-22
CA3064012A1 (en) 2018-12-06
JP2025163015A (ja) 2025-10-28
US11911400B1 (en) 2024-02-27
WO2018222583A1 (en) 2018-12-06
US11096949B2 (en) 2021-08-24

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