CA3064012A1 - In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin) - Google Patents

In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin) Download PDF

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Publication number
CA3064012A1
CA3064012A1 CA3064012A CA3064012A CA3064012A1 CA 3064012 A1 CA3064012 A1 CA 3064012A1 CA 3064012 A CA3064012 A CA 3064012A CA 3064012 A CA3064012 A CA 3064012A CA 3064012 A1 CA3064012 A1 CA 3064012A1
Authority
CA
Canada
Prior art keywords
aspirin
water
containing composition
lyophilized
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
CA3064012A
Other languages
English (en)
French (fr)
Inventor
Nagesh R. Palepu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Rhoshan Pharmaceuticals Inc
Original Assignee
Rhoshan Pharmaceuticals Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Rhoshan Pharmaceuticals Inc filed Critical Rhoshan Pharmaceuticals Inc
Publication of CA3064012A1 publication Critical patent/CA3064012A1/en
Pending legal-status Critical Current

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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)
  • 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)
CA3064012A 2017-05-30 2018-05-29 In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin) Pending CA3064012A1 (en)

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)

Publications (1)

Publication Number Publication Date
CA3064012A1 true CA3064012A1 (en) 2018-12-06

Family

ID=64455035

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3064012A Pending CA3064012A1 (en) 2017-05-30 2018-05-29 In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin)

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

Family Cites Families (36)

* Cited by examiner, † Cited by third party
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
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
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
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
CA2764331C (en) 2009-06-03 2018-07-17 Ex-Tek, Llc Anti-infective skin treatment compositions
EA021588B1 (ru) 2009-06-25 2015-07-30 Тетра Сиа Бетаиновые соли ацетилсалициловой кислоты
JP2013517294A (ja) * 2010-01-15 2013-05-16 リセラ，インク． 凍結乾燥ケーキ製剤
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
US10149823B2 (en) 2013-04-30 2018-12-11 Otitopic Inc. Dry powder formulations and methods of use
WO2014190800A1 (zh) * 2013-05-30 2014-12-04 海尔集团公司 蔬菜保鲜种植箱及蔬菜生态保鲜方法
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
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)
AU2017432640B2 (en) 2017-09-22 2023-11-30 Aspeya US Inc. Dry powder compositions with magnesium stearate

Also Published As

Publication number Publication date
US20220409636A1 (en) 2022-12-29
CN117379443A (zh) 2024-01-12
US12048708B2 (en) 2024-07-30
CN110996965A (zh) 2020-04-10
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
JP2025163015A (ja) 2025-10-28
US11911400B1 (en) 2024-02-27
WO2018222583A1 (en) 2018-12-06
US11096949B2 (en) 2021-08-24

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