Andrew Kay Yang

US Patent:

6528067, Mar 4, 2003

Filed:

Dec 7, 1999

Appl. No.:

09/457085

Inventors:

Shlomo Magdassi - Jerusalem, IL
Andrew Yang - Rosemead CA
Chunlin Tao - Beverly Hills CA
Neil P. Desai - Los Angeles CA
Zhiwen Yao - Culver City CA
Patrick Soon-Shiong - Los Angeles CA

Assignee:

American Bioscience, Inc. - Santa Monica CA

International Classification:

A61K 3902

US Classification:

424264, 424489, 521 65

Abstract:

In accordance with the present invention, there are provided stabilized total nutrient admixture (TNA) compositions which are useful for the in vivo parenteral delivery of pharmacologically acceptable lipids or fats, as well as methods for the preparation thereof. In particular, the pharmacologically acceptable lipid or fat is contained within a protein walled shell. In a particular embodiment of the invention, a TNA composition using human serum albumin (HSA) as a stabilizer has been prepared as a convenient three-in-one formulation (i. e. , containing a fat emulsion, dextrose, and amino acids plus electrolytes). This âthree-in-oneâ formulation can be prepared in liquid form or in dry form (comprising submicron-sized nanoparticles). The dried material is stable, even under long term storage, and is easily reconstituted immediately before use by simply adding sterile water (with or without vitamin supplementation) This serves to rehydrate the powder into a TNA suitable for injection. The long shelf life, ease of reconstitution, and single-component injectability of invention compositions provide significant cost savings, as such compositions can be reconstituted and administered safely, even in the home.

US Patent:

6749868, Jun 15, 2004

Filed:

May 21, 1999

Appl. No.:

09/316642

Inventors:

Neil P. Desai - Los Angeles CA
Chunlin Tao - Beverly Hills CA
Andrew Yang - Rosemead CA
Leslie Louie - Montebello CA
Zhiwen Yao - Culver City CA
Patrick Soon-Shiong - Los Angeles CA
Shlomo Magdassi - Jerusalem, IL

Assignee:

American BioScience, Inc. - Santa Monica CA

International Classification:

A61K 916

US Classification:

424491, 424489, 424490

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.

US Patent:

7771751, Aug 10, 2010

Filed:

Aug 30, 2006

Appl. No.:

11/514030

Inventors:

Neil P. Desai - Los Angeles CA, US
Raj Selvaraj - Lisle IL, US
Andrew Yang - Rosemead CA, US
Patrick Soon-Shiong - Los Angeles CA, US

Assignee:

Abraxis Bioscience, LLC - Los Angeles CA

International Classification:

A61K 9/50
A61K 9/14
A61K 9/00

US Classification:

424499, 977702, 977705, 977773, 977788, 424489, 424400

Abstract:

The present invention provides compositions comprising a poorly water soluble pharmaceutical agent, a carrier protein, and an antimicrobial agent, wherein significant microbial growth is inhibited in the composition. The amount of the antimicrobial agent in the composition may be below the level that induces a toxicological effect or at a level where a potential side effect can be controlled or tolerated. Also provided are compositions comprising a poorly water soluble pharmaceutical agent, a carrier protein, a sugar, and optionally an antimicrobial agent. Methods of using the compositions are also provided.

US Patent:

7981445, Jul 19, 2011

Filed:

Mar 11, 2009

Appl. No.:

12/402358

Inventors:

Tapas De - Los Angeles CA, US
Neil P. Desai - Los Angeles CA, US
Andrew Yang - Rosemead CA, US
Zachary Yim - Los Angeles CA, US
Patrick Soon-Shiong - Los Angeles CA, US

Assignee:

Abraxis Bioscience, LLC - Los Angeles CA

International Classification:

A61K 31/7072
A61K 31/337
A61K 31/282
A61K 9/14
A61K 33/24

US Classification:

424489, 514449, 514 49, 514492, 424649

Abstract:

The present invention provides stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions. The use of stabilizing agents provide extended stability of nanoparticle suspensions and other formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration.

US Patent:

8034765, Oct 11, 2011

Filed:

Aug 30, 2006

Appl. No.:

11/513756

Inventors:

Tapas De - Los Angeles CA, US
Neil P. Desai - Los Angeles CA, US
Andrew Yang - Rosemead CA, US
Zachary Yim - Los Angeles CA, US
Patrick Soon-Shiong - Los Angeles CA, US

Assignee:

Abraxis BioScience, LLC - Los Angeles CA

International Classification:

A61K 31/337
A61K 38/38

US Classification:

514 2, 514449, 977906

Abstract:

The present invention provides stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions. The use of stabilizing agents provide extended stability of nanoparticle suspensions and other formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration.

US Patent:

8137684, Mar 20, 2012

Filed:

Sep 12, 2006

Appl. No.:

11/520523

Inventors:

Neil P. Desai - Los Angeles CA, US
Chunlin Tao - Los Angeles CA, US
Andrew Yang - Rosemead CA, US
Leslie Louie - Montabello CA, US
Patrick Soon-Shiong - Los Angeles CA, US

Assignee:

Abraxis Bioscience, LLC - Los Angeles CA

International Classification:

A61K 31/337

US Classification:

424400, 514449

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 selection 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.

US Patent:

20070092563, Apr 26, 2007

Filed:

Sep 12, 2006

Appl. No.:

11/520546

Inventors:

Neil Desai - Los Angeles CA, US
Patrick Soon-Shiong - Los Angeles CA, US
Andrew Yang - Rosemead CA, US

Assignee:

Abraxis BioScience, Inc. - Los Angeles CA

International Classification:

A61K 31/337
A61K 9/20

US Classification:

424464000, 514449000

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 selection 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.

US Patent:

20080171687, Jul 17, 2008

Filed:

Sep 16, 2005

Appl. No.:

11/575031

Inventors:

Neil P. Desai - Los Angeles CA, US
Chunlin Tao - Los Angeles CA, US
Andrew Yang - Rosemead CA, US
Tapas De - Los Angeles CA, US
Patrick Soon-Shiong - Los Angeles CA, US

Assignee:

Abraxis Bioscience, Inc. - Los Angeles CA

International Classification:

A61K 38/02
A61K 31/351
A61K 31/222
A61K 31/427

US Classification:

514 2, 514459, 514365, 514551

Abstract:

Sterile, stable pharmaceutical formulations of poorly water-soluble drugs dissolved in dimethyl isosorbide, a water-miscible solvent, as well as methods for their preparation and administration.