UY27134A1 - Formulación parenteral para análogos de epotilona - Google Patents

Formulación parenteral para análogos de epotilona

Info

Publication number
UY27134A1
UY27134A1 UY27134A UY27134A UY27134A1 UY 27134 A1 UY27134 A1 UY 27134A1 UY 27134 A UY27134 A UY 27134A UY 27134 A UY27134 A UY 27134A UY 27134 A1 UY27134 A1 UY 27134A1
Authority
UY
Uruguay
Prior art keywords
diluent
epothilone
small bottle
bottle
mixture
Prior art date
Application number
UY27134A
Other languages
English (en)
Inventor
Timothy M Malloy
Rebanta Bandyopadhyay
Andrea Panaggio
Krishnaswamy Srinivas Raghavan
Sailesh Amilal Varia
Original Assignee
Bristol Myers Squibb Co
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23005123&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=UY27134(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of UY27134A1 publication Critical patent/UY27134A1/es

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D491/00Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00
    • C07D491/02Heterocyclic compounds containing in the condensed ring system both one or more rings having oxygen atoms as the only ring hetero atoms and one or more rings having nitrogen atoms as the only ring hetero atoms, not provided for by groups C07D451/00 - C07D459/00, C07D463/00, C07D477/00 or C07D489/00 in which the condensed system contains two hetero rings
    • C07D491/04Ortho-condensed systems
    • C07D491/044Ortho-condensed systems with only one oxygen atom as ring hetero atom in the oxygen-containing ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/427Thiazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se describe un procedimiento para formular ciertos análogos de epotilona para administración parenteral en donde el análogo es disuelto en una mezcla de al menos 50% en volumen de butanol terciario en agua, la mezcla es liofilizada, el producto liofilizado resultante es empacado en un frasco pequeno con una cantidad suficiente de solvente que comprende etanol anhidro y un agente tensioactivo no iónico adecuado en un segundo frasco pequeno. Todos los pasos son llevados a cabo bajo protección de la luz. Durante el uso, los contenidos del segundo frasco pequeno o el frasco del diluyente son agregados al producto liofilizado y mezclados para constituir el análogo de epotilona y la solución resultante es diluida con un diluyente adecuado para producir una solución para inyección intravenosa que contiene el análogo de epotilona en una concentración desde aproximadamente 0.1 mg/ml hasta aproximadamente 0.9/ mg/ml. Un agente tensioactivo preferido es el aceite de ricino polietoxilado y un diluyente preferido es la Inyección de Ringer tratada con Lactato.
UY27134A 2001-01-25 2002-01-25 Formulación parenteral para análogos de epotilona UY27134A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US26422801P 2001-01-25 2001-01-25

Publications (1)

Publication Number Publication Date
UY27134A1 true UY27134A1 (es) 2002-08-30

Family

ID=23005123

Family Applications (1)

Application Number Title Priority Date Filing Date
UY27134A UY27134A1 (es) 2001-01-25 2002-01-25 Formulación parenteral para análogos de epotilona

Country Status (24)

Country Link
US (5) US7022330B2 (es)
EP (1) EP1353667A1 (es)
JP (1) JP2004521122A (es)
KR (1) KR20030071853A (es)
CN (2) CN1489466A (es)
AR (2) AR032408A1 (es)
BG (1) BG108019A (es)
BR (1) BR0206511A (es)
CA (2) CA2434566A1 (es)
CZ (1) CZ20032022A3 (es)
EE (1) EE200300323A (es)
HU (1) HUP0302567A2 (es)
IL (1) IL156580A0 (es)
IS (1) IS6890A (es)
MX (1) MXPA03006485A (es)
NO (1) NO20033342L (es)
PE (1) PE20020733A1 (es)
PL (1) PL367260A1 (es)
RU (1) RU2003126171A (es)
SI (1) SI1353668T1 (es)
SK (1) SK8552003A3 (es)
UY (1) UY27134A1 (es)
WO (1) WO2002062338A1 (es)
ZA (3) ZA200305123B (es)

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JP2004521122A (ja) 2004-07-15
IS6890A (is) 2003-07-24
CZ20032022A3 (cs) 2004-04-14
CA2434566A1 (en) 2002-08-15
IL156580A0 (en) 2004-01-04
US20090069393A1 (en) 2009-03-12
EP1353667A1 (en) 2003-10-22
CA2681962C (en) 2012-06-12
CN101112373B (zh) 2012-06-20
US7022330B2 (en) 2006-04-04
CA2681962A1 (en) 2002-08-01
SK8552003A3 (en) 2004-06-08
NO20033342D0 (no) 2003-07-24
CN1489466A (zh) 2004-04-14
US20140107169A1 (en) 2014-04-17
BG108019A (en) 2004-09-30
ZA200305126B (en) 2004-10-01
KR20030071853A (ko) 2003-09-06
AR098109A2 (es) 2016-05-04
AR032408A1 (es) 2003-11-05
CN101112373A (zh) 2008-01-30
BR0206511A (pt) 2003-10-21
WO2002062338A1 (en) 2002-08-15
ZA200305123B (en) 2004-10-01
ZA200305536B (en) 2004-09-06
SI1353668T1 (sl) 2008-08-31
MXPA03006485A (es) 2003-09-22
US20150218179A1 (en) 2015-08-06
RU2003126171A (ru) 2005-02-27
US8632788B2 (en) 2014-01-21
HUP0302567A2 (hu) 2003-12-29
EE200300323A (et) 2003-10-15
US20020143038A1 (en) 2002-10-03
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US20060013836A1 (en) 2006-01-19

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