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Prion free nanoparticle compositions and methods of making thereof

a technology of nanoparticles and compositions, applied in the direction of drug compositions, macromolecular non-active ingredients, powder delivery, etc., can solve the problems of prion-free sources of blood derived products, permanent or transient infection of individuals, etc., and achieve high shear, high shear, high shear

Inactive Publication Date: 2010-11-25
ABRAXIS BIOSCI LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent provides various methods for making prion-free nanoparticle compositions that include albumin and a therapeutically effective amount of a pharmaceutical compound or other substance which needs to be delivered into cells. These methods involve either eliminating prions through use of specific techniques such as removal of prion proteins or exposure to high levels of heat/shear conditions, or ensuring that any remaining prions are unable to harm humans or animals. Additionally, these methods provide ways to make sure that the resulting nanoparticle compositions contain only minimal amounts of surfactants (which may affect their effectiveness). Overall, this technology allows for safer production of stable nanoparticle formulations suitable for delivery of drugs and other molecules across cell membranes.

Problems solved by technology

The technical problem addressed in this patent text relates to finding ways to prevent the transmission of prion diseases like mad cow disease through blood transfusions and organ transplants. While there has been much research on these issues, they remain challenges due to the difficulty in identifying silent carriers and the presence of prion proteins in various bodily fluids. The use of albumin-based nanoparticle technologies offer potential solutions for delivering therapeutic agents to specific targets while minimizing harmful side effects associated with traditional methods of administering medicines.

Method used

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  • Prion free nanoparticle compositions and methods of making thereof
  • Prion free nanoparticle compositions and methods of making thereof
  • Prion free nanoparticle compositions and methods of making thereof

Examples

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Effect test

example 1

Development of an Affinity Adsorbent for Removal of Prion Protein from Albumin Preparations

[0226]This study screened a four-resin panel of prion binding ligands by challenging the four-resin panel with two different commercially available albumin preparations (containing 20% w / v or 25% w / v albumin), spiked with scrapie hamster brain homogenate at two different concentrations (0.01% or 0.005%). The four-resin panel was previously identified by PRDT (Pathogen Removal and Diagnostic Technologies Inc; ProMetic Biosciences Ltd., Cambridge, UK) as good prion binders in the presence of 25% albumin Selection of an optimum resin can optimize the incorporation of a prion-reduction step in the production of albumin nanoparticles.

Methodology

[0227]Six Protein Isolation Kit for Sorbent Identification (PIKSI™, ProMetic Biosciences Ltd) kits were packed with twelve columns (at about 0.5 mL) of each of the four PRDT resins and the control resin (Toyopearl Amino AMN31). Each resin was challenged with...

example 2

Prion-Removal Feasibility Study of Formulated Suspensions Containing Paclitaxel and of Human Albumin Solution

[0238]Application of the prion-removal technology in the nanoparticle composition was evaluated using formulated suspensions containing paclitaxel (e.g., Abraxane™) and using human albumin solution containing various percentages of albumin (% w / v).

Experimental Conditions

Study Systems

[0239]Formulated Suspensions for Abraxane™ and sugar-paclitaxel formulation were evaluated. Formulated Suspension (FS) for Abraxane™ was formulated with post-evaporated suspension (PE) obtained from the production and human albumin solution (25%, Baxter, Deerfield, Ill.), containing approximately 7 mg / mL paclitaxel and 56 mg / mL human albumin Formulated Suspension (FS) for sugar-paclitaxel formulation was formulated with post-evaporated suspension (PE) obtained from the production, human albumin solution (25%, Baxter), sucrose, sodium chloride and edetate disodium dihydrate, containing approximatel...

example 3

TSE Removal by Prion Reduction Resins for 20% Albumin

[0247]In this study, potential TSE removal by prion reduction resins (PRDT column; ProMetic Biosciences, Ltd) in 20% (w / v) albumin (Grifols®) was evaluated. Starting material for the TSE removal process step was spiked with a model TSE agent. The process step was performed in the VirusSure laboratories (Virusure Forschung und Entwicklung GmbH, Vienna, Austria). Various fractions were collected during performance of the process step, and the TSE removal capacity of the process was calculated based on a determination of levels of TSE agent using a Western Blot assay for the detection of PrPsc.

[0248]This study followed and referenced the following guidelines, including 1) CPMP / BWP / 268 / 95 (revised in 1996), Note for Guidance on Virus Validation Studies: The Design, Contribution, and Interpretation of Studies Validating the Inactivation and Removal of Viruses; 2) CPMP / BWP / 5136 / 03 Guideline on the Investigation of Manufacturing Processe...

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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.

Description

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Claims

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Application Information

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Owner ABRAXIS BIOSCI LLC
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