CA2149150A1 - Injectable taxol composition with improved stability - Google Patents

Injectable taxol composition with improved stability

Info

Publication number
CA2149150A1
CA2149150A1 CA2149150A CA2149150A CA2149150A1 CA 2149150 A1 CA2149150 A1 CA 2149150A1 CA 2149150 A CA2149150 A CA 2149150A CA 2149150 A CA2149150 A CA 2149150A CA 2149150 A1 CA2149150 A1 CA 2149150A1
Authority
CA
Canada
Prior art keywords
taxol
solution
composition
improved stability
acid
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.)
Granted
Application number
CA2149150A
Other languages
French (fr)
Other versions
CA2149150C (en
Inventor
David R. Carver
Timothy R. Prout
Hernita Ewald
Robyn Elliott
Paul Handreck
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.)
Mayne Pharma USA Inc
Original Assignee
David R. Carver
Timothy R. Prout
Hernita Ewald
Robyn Elliott
Paul Handreck
Napro Biotherapeutics, Inc.
Mayne Pharma (Usa) 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25644377&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2149150(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by David R. Carver, Timothy R. Prout, Hernita Ewald, Robyn Elliott, Paul Handreck, Napro Biotherapeutics, Inc., Mayne Pharma (Usa) Inc filed Critical David R. Carver
Priority to CA002308082A priority Critical patent/CA2308082A1/en
Publication of CA2149150A1 publication Critical patent/CA2149150A1/en
Application granted granted Critical
Publication of CA2149150C publication Critical patent/CA2149150C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/44—Oils, 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

Abstract

A composition of taxol and polyethoxylated castor oil is pH balanced to have a pH less than 8.1 to improve stability. This composition can include an acid, preferably citric acid, to adjust the pH value. The invention includes a method of formulating a taxol solution for injection by mixing an acid with a carrier material, such as castor oil, to form a carrier solution after which taxol is mixed with the carrier solution to form the taxol solution at a pH of less than 8.1. The method may include the step of slurrying the taxol in alcohol before mixing with the carrier solution.
CA002149150A 1992-11-27 1993-11-18 Injectable taxol composition with improved stability Expired - Lifetime CA2149150C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA002308082A CA2308082A1 (en) 1992-11-27 1993-11-18 Injectable compostion

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
AUPL607492 1992-11-27
AUPL6074 1992-11-27
US99550192A 1992-12-22 1992-12-22
US07/995,501 1992-12-22
PCT/US1993/011209 WO1994012031A1 (en) 1992-11-27 1993-11-18 Injectable composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA002308082A Division CA2308082A1 (en) 1992-11-27 1993-11-18 Injectable compostion

Publications (2)

Publication Number Publication Date
CA2149150A1 true CA2149150A1 (en) 1994-06-09
CA2149150C CA2149150C (en) 2000-08-01

Family

ID=25644377

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002308082A Abandoned CA2308082A1 (en) 1992-11-27 1993-11-18 Injectable compostion
CA002149150A Expired - Lifetime CA2149150C (en) 1992-11-27 1993-11-18 Injectable taxol composition with improved stability

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA002308082A Abandoned CA2308082A1 (en) 1992-11-27 1993-11-18 Injectable compostion

Country Status (12)

Country Link
US (7) US5733888A (en)
EP (4) EP0674510B1 (en)
JP (1) JP2880292B2 (en)
AT (2) ATE169216T1 (en)
AU (1) AU5612694A (en)
CA (2) CA2308082A1 (en)
DE (2) DE69320206T2 (en)
DK (2) DK0674510T3 (en)
ES (2) ES2119996T3 (en)
GR (1) GR3027724T3 (en)
PT (1) PT835657E (en)
WO (2) WO1994012031A1 (en)

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Also Published As

Publication number Publication date
EP0835657B1 (en) 2004-08-25
US5977164A (en) 1999-11-02
DK0835657T3 (en) 2005-01-10
EP1500393A1 (en) 2005-01-26
ES2224200T3 (en) 2005-03-01
AU5612694A (en) 1994-06-22
CA2308082A1 (en) 1994-06-09
WO1994012030A1 (en) 1994-06-09
EP0674510A1 (en) 1995-10-04
ATE274347T1 (en) 2004-09-15
DE69333605D1 (en) 2004-09-30
US6140359A (en) 2000-10-31
PT835657E (en) 2004-11-30
US20040204479A1 (en) 2004-10-14
US20030065022A1 (en) 2003-04-03
EP0835657A1 (en) 1998-04-15
US6770670B2 (en) 2004-08-03
ES2119996T3 (en) 1998-10-16
JP2880292B2 (en) 1999-04-05
ATE169216T1 (en) 1998-08-15
US6306894B1 (en) 2001-10-23
GR3027724T3 (en) 1998-11-30
DE69320206T2 (en) 1999-02-11
EP0674510A4 (en) 1995-08-12
US5733888A (en) 1998-03-31
DE69320206D1 (en) 1998-09-10
JPH08503945A (en) 1996-04-30
WO1994012031A1 (en) 1994-06-09
CA2149150C (en) 2000-08-01
EP0674510B1 (en) 1998-08-05
DE69333605T2 (en) 2005-02-03
EP1384474A1 (en) 2004-01-28
US5972992A (en) 1999-10-26
DK0674510T3 (en) 1999-05-10

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