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 PDF

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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
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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
Application number
CN202310937648.0A
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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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Publication date
Application filed by Luoshan Pharmaceutical Co ltd filed Critical Luoshan Pharmaceutical Co ltd
Publication of CN117379443A publication Critical patent/CN117379443A/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

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)
CN202310937648.0A 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 CN117379443A (zh)

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)

* Cited by examiner, † Cited by third party
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

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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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