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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    • 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)
  • 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)
  • 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)
  • 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)
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
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
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 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 (https=)
EP (1) EP3630120A4 (https=)
JP (3) JP7335232B2 (https=)
CN (2) CN117379443A (https=)
CA (1) CA3064012A1 (https=)
WO (1) WO2018222583A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018222583A1 (en) * 2017-05-30 2018-12-06 Rho Pharmaceuticals, Llc 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

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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
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US4117603A (en) * 1976-12-28 1978-10-03 Smith Walton J High vacuum freeze-drying
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JPS5610110A (en) 1979-07-06 1981-02-02 Green Cross Corp:The Acetyl salicylate salt preparation for injection
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ES2196574T3 (es) 1997-07-15 2003-12-16 Walter Burghart Procedimiento para la preparacion de soluciones estables de acido acetilsalicilico.
CA2336789A1 (en) * 1998-07-09 2000-01-20 Alexander Galat Injectable sodium acetylsalicylate composition and method
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US20050152979A1 (en) * 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
MXPA06003887A (es) * 2003-10-10 2006-08-11 Oryxe Compuestos transdermicos de alto y bajo peso molecular.
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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
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JP7493449B2 (ja) 2017-09-22 2024-05-31 ヴェクチュラ インコーポレイテッド ステアリン酸マグネシウムを含む乾燥粉末組成物

Also Published As

Publication number Publication date
JP7335232B2 (ja) 2023-08-29
EP3630120A1 (en) 2020-04-08
US11911400B1 (en) 2024-02-27
CA3064012A1 (en) 2018-12-06
JP2020522577A (ja) 2020-07-30
US12048708B2 (en) 2024-07-30
EP3630120A4 (en) 2021-01-13
US11096949B2 (en) 2021-08-24
US10959955B1 (en) 2021-03-30
US20220409636A1 (en) 2022-12-29
JP2025163015A (ja) 2025-10-28
CN110996965A (zh) 2020-04-10
US20200188417A1 (en) 2020-06-18
JP2023116657A (ja) 2023-08-22
WO2018222583A1 (en) 2018-12-06

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