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Details for Patent: 6,749,868

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Summary for Patent: 6,749,868

Title: Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof
Abstract:In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug paclitaxel) in which the pharmacologically active agent is delivered in the form of suspended particles coated with protein (which acts as a stabilizing agent). In particular, protein and pharmacologically active agent in a biocompatible dispersing medium are subjected to high shear, in the absence of any conventional surfactants, and also in the absence of any polymeric core material for the particles. The procedure yields particles with a diameter of less than about 1 micron. The use of specific composition and preparation conditions (e.g., addition of a polar solvent to the organic phase), and careful election of the proper organic phase and phase fraction, enables the reproducible production of unusually small nanoparticles of less than 200 nm diameter, which can be sterile-filtered. The particulate system produced according to the invention can be converted into a redispersible dry powder comprising nanoparticles of water-insoluble drug coated with a protein, and free protein to which molecules of the pharmacological agent are bound. This results in a unique delivery system, in which part of the pharmacologically active agent is readily bioavailable (in the form of molecules bound to the protein), and part of the agent is present within particles without any polymeric matrix therein.
Inventor(s): Desai; Neil P. (Los Angeles, CA), Tao; Chunlin (Beverly Hills, CA), Yang; Andrew (Rosemead, CA), Louie; Leslie (Montebello, CA), Yao; Zhiwen (Culver City, CA), Soon-Shiong; Patrick (Los Angeles, CA), Magdassi; Shlomo (Jerusalem, IL)
Assignee: American BioScience, Inc. (Santa Monica, CA)
Application Number:09/316,642
Patent Claim Types:
see list of patent claims
Delivery;
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International Patent Family for Patent: 6,749,868

Country Document Number Publication Date
WIPO (PCT)0071079Nov 30, 2000
WIPO (PCT)0189522Nov 29, 2001
WIPO (PCT)02087545Nov 07, 2002
WIPO (PCT)03096944Nov 27, 2003
WIPO (PCT)9418954Sep 01, 1994
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