CA2371912C - Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation - Google Patents

Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation Download PDF

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Publication number
CA2371912C
CA2371912C CA2371912A CA2371912A CA2371912C CA 2371912 C CA2371912 C CA 2371912C CA 2371912 A CA2371912 A CA 2371912A CA 2371912 A CA2371912 A CA 2371912A CA 2371912 C CA2371912 C CA 2371912C
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CA
Canada
Prior art keywords
paclitaxel
pharmacologically active
patients
abi
dose
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.)
Expired - Lifetime
Application number
CA2371912A
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English (en)
Other versions
CA2371912A1 (fr
Inventor
Neil P. Desai
Chunlin Tao
Andrew Yang
Leslie Louie
Zhiwen Yao
Patrick Soon-Shiong
Shlomo Magdassi
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.)
Abraxis Bioscience LLC
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Abraxis Bioscience LLC
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
Priority claimed from US09/316,642 external-priority patent/US6749868B1/en
Application filed by Abraxis Bioscience LLC filed Critical Abraxis Bioscience LLC
Priority to CA2684454A priority Critical patent/CA2684454A1/fr
Publication of CA2371912A1 publication Critical patent/CA2371912A1/fr
Application granted granted Critical
Publication of CA2371912C publication Critical patent/CA2371912C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5169—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne des compositions et des procédés convenant pour l'administration in vivo d'agents pharmacologiquement actifs essentiellement insolubles dans l'eau (tels que le médicament anticancéreux paclitaxel) dans lesquels un agent actif au plan pharmacologique est administré sous forme de particules en suspension enrobées d'une protéine (laquelle agit comme agent stabilisateur). En particulier, la protéine et l'agent pharmacologiquement actif présents dans un support dispersant biocompatible sont soumis à un cisaillement élevé en l'absence de tout tensioactif classique et en l'absence de matériau noyau polymère pour les particules. Le procédé selon l'invention permet d'obtenir des particules d'un diamètre inférieur au micron. L'utilisation d'une composition spécifique dans des conditions de préparation précises (adjonction d'un solvant polaire à la phase organique), et le choix raisonné de la phase organique appropriée et de la fraction de phase permet la production reproductible de nanoparticules exceptionnellement petites d'un diamètre inférieure à 200 nm qui peuvent être stérilisées par filtration. Le système de particules obtenu dans le cadre de l'invention peut être transformé en une poudre sèche redispersible comprenant des nanoparticules d'un médicament enrobé d'une protéine, insoluble dans l'eau, et d'une protéine libre à laquelle des molécules de l'agent pharmacologique sont liées. On obtient ainsi un système d'administration unique en son genre dans lequel un agent actif au plan pharmacologique est facilement biodisponible (sous forme de molécules liées à la protéine), et où une partie de l'agent est présente dans les particules sans aucune matrice polymère.
CA2371912A 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation Expired - Lifetime CA2371912C (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2684454A CA2684454A1 (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/316,642 US6749868B1 (en) 1993-02-22 1999-05-21 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
US09/316,642 1999-05-21
PCT/US2000/013954 WO2000071079A2 (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2684454A Division CA2684454A1 (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation

Publications (2)

Publication Number Publication Date
CA2371912A1 CA2371912A1 (fr) 2000-11-30
CA2371912C true CA2371912C (fr) 2010-02-16

Family

ID=23229970

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2684454A Abandoned CA2684454A1 (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation
CA2371912A Expired - Lifetime CA2371912C (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2684454A Abandoned CA2684454A1 (fr) 1999-05-21 2000-05-19 Agents a stabilisation proteinique actifs pharmacologiquement; procedes de fabrication et methodes d'utilisation

Country Status (5)

Country Link
EP (1) EP1178786A4 (fr)
AU (3) AU784416B2 (fr)
CA (2) CA2684454A1 (fr)
HK (1) HK1045646A1 (fr)
WO (1) WO2000071079A2 (fr)

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Also Published As

Publication number Publication date
AU2009217409A1 (en) 2009-10-08
AU2006202836B2 (en) 2009-10-08
AU5035900A (en) 2000-12-12
EP1178786A1 (fr) 2002-02-13
WO2000071079A3 (fr) 2008-03-27
EP1178786A4 (fr) 2006-03-01
HK1045646A1 (zh) 2002-12-06
CA2371912A1 (fr) 2000-11-30
AU2006202836A1 (en) 2006-07-27
AU784416B2 (en) 2006-03-30
CA2684454A1 (fr) 2000-11-18
WO2000071079A2 (fr) 2000-11-30

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Effective date: 20200519