Prion free nanoparticle compositions and methods of making thereof

Patent metadata

Field	Value
Publication number	US-9446003-B2
Application number	US-201414191279-A
Country	US
Kind code	B2
Filing date	Feb 26, 2014
Priority date	Apr 15, 2009
Publication date	Sep 20, 2016
Grant date	Sep 20, 2016

Abstract

The present invention provides prion-free compositions comprising nanoparticles comprising albumin and substantially water insoluble drugs. Also provided are methods of making prion-free compositions and methods of removing prion proteins from the nanoparticle compositions. Methods of using the compositions, as well as kits useful for carrying out the methods are also provided.

First claim

What is claimed is:

1. A method of removing prion proteins from a composition comprising nanoparticles comprising a substantially water insoluble pharmacologically active agent coated with albumin, wherein said method comprises:
(a) providing a suspension of nanoparticles comprising a substantially water insoluble pharmacologically active agent coated with albumin; and
(b) treating said suspension of nanoparticles provided in step (a) by passing said suspension of nanoparticles through a chromatography column, wherein the column comprises a ligand capable of binding to a prion protein,
wherein there are no significant differences between the treated and untreated suspensions in terms of particle size and pH.

2. The method of claim 1 , wherein said ligand is a peptide.

3. The method of claim 1 , wherein the ligand is a triazine-based compound.

4. The method of claim 1 , wherein the water insoluble pharmacologically active agent is paclitaxel.

5. The method of claim 1 , wherein the nanoparticle suspension treated by step (b) does not show the presence of a prion protein based on the protein misfolding cyclic amplification assay.

6. The method of claim 1 , wherein the nanoparticle suspension treated by step (b) does not show the presence of a prion protein based on an immune-polymerase chain reaction assay used to detect prion proteins.

7. The method of claim 1 , wherein the nanoparticle suspension treated by step (b) is substantially free of cellular prion protein in the normal and abnormal isoforms.

8. The method of claim 1 , wherein said nanoparticles further comprise a negatively charged component.

9. The method of claim 8 , wherein said nanoparticles have a negative zeta potential.

10. The method of claim 8 , wherein the negatively charged component is selected from the group consisting of bile acids, glycocholic acid, cholic acid, chenodeoxycholic acid, autorcholic acid, glycochenodeoxycholic acid, taurodeoxycholic acid, lithocholic acid, ursodeoxycholic acid, dehydrocholic acid, sodium cholesteryl sulfate, and combinations thereof.

Assignees

• Abraxis Bioscience Llc

Inventors

• Desai Neil P
• Peykov Viktor
• Soon-Shiong Patrick

Classifications

• A61P31/12

  Antivirals · CPC title

• A61P35/00

  Antineoplastic agents · CPC title

• A61K9/1658

  Proteins, e.g. albumin, gelatin · CPC title

• A61K9/5169 Primary

  Proteins, e.g. albumin, gelatin · CPC title

• B82Y5/00

  Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery · CPC title