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

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

Info

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
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

Links

Classifications

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

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

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 (https=) * 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.
CA2336789A1 (en) * 1998-07-09 2000-01-20 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
MXPA06003887A (es) * 2003-10-10 2006-08-11 Oryxe Compuestos transdermicos de alto y bajo peso molecular.
US20070196364A1 (en) * 2004-07-27 2007-08-23 Human Genome Sciences, Inc. Pharmaceutical Formulation and Process
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
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
EP2437596B1 (en) * 2009-06-03 2017-05-03 Ex-Tek, LLC Skin treatment compositions
BRPI1009600A2 (https=) 2009-06-25 2016-03-22 Tetra S A
GB2487868B (en) * 2010-01-15 2014-12-10 Neothetics Inc Lyophilized cake formulations
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
AU2013388034B2 (en) 2013-04-30 2019-08-15 Aspeya US Inc. Dry powder formulations and methods of use
US10321696B2 (en) * 2013-05-30 2019-06-18 Haier Group Corporation Vegetable preservation and growing case and vegetable preservation method
JP6063090B2 (ja) * 2013-06-28 2017-01-18 レクサン ファーマシューティカルズ インコーポレイテッド ナノ粒子状組成物およびピペラジン化合物の製剤
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
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)
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
JP2020522577A (ja) 2020-07-30
US12048708B2 (en) 2024-07-30
EP3630120A4 (en) 2021-01-13
CN117379443A (zh) 2024-01-12
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

Similar Documents

Publication Publication Date Title
US12048708B2 (en) In-vial deposition of a stable, sterile and crystalline o-acetyl salicylic acid (aspirin)
ES2259289T3 (es) Formulacion de benzamida con actividad inhibidora de la histona desacetilasa.
ES2642676T3 (es) Preparación liofilizada de dipéptidos citotóxicos
JPH08500104A (ja) 結晶質アミホスチン組成物及びその調製方法並びに使用
ES2648367T3 (es) Procedimiento de preparación de una composición farmacéutica liofilizada que contiene mitomicina C
ES2940443T3 (es) Composición para inyección
JP6942182B2 (ja) カルグルミン酸を含有する非経口的薬剤配合物
WO2009051626A1 (en) Cephalosporin derivative formulation
ES2657944T3 (es) Sal estable de arginina de pemetrexed y composiciones que la comprenden
ES2286177T3 (es) Procedimiento para la preparacion de piroxicam: compuestos de inclusion de betaciclodextrina.
ES2282628T3 (es) Composicon farmaceutica que contiene particulas de lamotrigina de morfologia definida.
JP6165986B2 (ja) ボルテゾミブを含む医薬組成物
AU2018294561B2 (en) New oral formulations of belinostat
JP2011137048A (ja) 新たな用途の薬学的調製物およびその調製物を製造するためのプロセス
JP2010105965A (ja) バンコマイシン製剤
WO2001047542A1 (en) Vancomycin preparations
EP4203919B1 (en) Lipid-based composition for oral administration of bradykinin b2-receptor antagonists
ES2813979T3 (es) Preparación liofilizada de dipéptidos citotóxicos
ES2864096T3 (es) Método nuevo para mejorar la biodisponibilidad de fármacos de baja solubilidad acuosa
WO2017037737A1 (en) Parenteral formulations of levosimendan
US11793748B1 (en) Pharmaceutical compositions of aspirin for parenteral administration
JPH0321252A (ja) シスプラチン高張液
WO2023214433A1 (en) Stable parenteral compositions of parecoxib
HK40088043A (en) Lipid-based composition for oral administration of bradykinin b2-receptor antagonists
HK40088043B (en) Lipid-based composition for oral administration of bradykinin b2-receptor antagonists

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20230516

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT RECEIVED - RESPONSE TO EXAMINER'S REQUISITION

Effective date: 20241002

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20241021

P11 Amendment of application requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P11-P102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: AMENDMENT DETERMINED COMPLIANT

Effective date: 20250425

P13 Application amended

Free format text: ST27 STATUS EVENT CODE: A-2-2-P10-P13-X000 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: APPLICATION AMENDED

Effective date: 20250425

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 7TH ANNIV.) - STANDARD

Year of fee payment: 7

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250523

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250523

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20251016