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Methods and compositions for delivering interleukin-1 receptor antagonist

Inactive Publication Date: 2016-01-07
BIOMET MFG CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent text describes a method for generating interleukin-1 receptor antagonist, which can help in reducing inflammation and treatment of chronic inflammatory conditions. The method involves contacting a liquid containing white blood cells with a solid extraction material and subjecting it to an electromagnetic field. This combination can increase the production of interleukin-1 receptor antagonist faster than either step alone. The resulting concentration of interleukin-1 receptor antagonist in the solution is greater than the concentration in the liquid before the contact. This method can be carried out using a pulsed or capacitively coupled electromagnetic field.

Problems solved by technology

However, many such methods and compositions are associated with issues regarding stability and half-life of IL-1ra as well as the amount and rate of IL-1ra provided.

Method used

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  • Methods and compositions for delivering interleukin-1 receptor antagonist
  • Methods and compositions for delivering interleukin-1 receptor antagonist
  • Methods and compositions for delivering interleukin-1 receptor antagonist

Examples

Experimental program
Comparison scheme
Effect test

example 1

Characterization of Solutions Rich in IL-1ra

[0123]A solution rich in interleukin-1 receptor antagonist was prepared from seven consented human providers. Blood (55 mL) was drawn into a 60 cc syringe with 5 mL of anticoagulant citrate dextrose solution A (ACD-A, Citra Anticoagulant, Inc., Braintree, Mass.). Platelet-rich plasma (PRP) was created using the GPS III platelet concentration system (800-1 003A, Biomet Biologics, Warsaw, Ind.) according to the instructions for use. The solution was generated by adding 6 mL of PRP to a modified Plasmax device containing 1 gram of polyacrylamide beads (Biomet Biologics, Warsaw, Ind.). The IL-1ra solution was removed from the Plasmax devices and was frozen at minus 50° C. for the assay. Cytokine content was assayed on a 16-plex ELISA (Searchlight Protein Array, Aushon Biosystems, Billerica, Mass.). The analytes included IL-4, IL-10, IL-11, IL-13, IL-1ra, IFN-Δ, sTNF-RI, sTNF-RII, IL-1α, IL-1β, TNF-α, IL-17, IL-18, bFGF, TBF-β1, and TBF-β2.

[012...

example 2

A Solution Rich in Interleukin-1 Receptor Antagonist Made from Equine Blood

[0125]A solution rich in interleukin-1 receptor antagonist was prepared from equine blood. Platelet-rich plasma (PRP) was created using the GPS 11I platelet concentration system (8001003A, Biomet Biologics, Warsaw, Ind.) according to the instructions for use. The solution was generated by adding 6 mL of PRP to a modified Plasmax device containing I gram of polyacrylamide beads (Biomet Biologics, Warsaw, Ind.). The IL-1ra solution was removed from the Plasmax devices and was frozen at minus 50° C. for an ELISA assay (Equine DuoSet ELISA kit, R&D Systems, Minneapolis, Minn.). Equine IL-1ra was measured in the baseline whole blood, PRP, and IL-1ra solution. The devices used were able to produce a solution rich in interleukin-1 receptor antagonist (FIG. 12).

example 3

Generation of IL-1ra from Platelet-Rich Plasma

[0126]An IL-1ra-rich solution is created as follows. Whole blood (70 mL) anticoagulated (10%) with ACD-A (Braintree, Mass., USA) is drawn from 5 healthy volunteers. A portion (10 mL) is reserved for a whole blood measurement. Platelet-rich plasma (PRP) (6 mL) is produced using the GPS® II System (Biomet Biologics, LLC, Warsaw, Ind., USA). Complete blood counts are collected for the whole blood and PRP samples following a validated procedure, as described in Woodell-May J E, Ridderman D N, Swift M J, Higgins J. “Producing Accurate Platelet Counts for Platelet Rich Plasma: Validation of a Hematology Analyzer and Preparation Techniques for Counting”J. Craniofac. Surg. (2005) September 16(5):749-56.

[0127]Following the PRP production, 5 mL of the PRP is added to a modified plasma concentration device (Plasmax™, Biomet Biologics LLC, Warsaw, Ind., USA) and incubated with polyacrylamide desiccating beads in the device for 24 hours at room tempe...

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Abstract

Methods, systems, and compositions related to generating and using a solution rich in interleukin-1 receptor antagonist are provided. Methods include contacting a liquid comprising white blood cells with a solid extraction material and stimulating with an electromagnetic field to activate production of interleukin-1 receptor antagonist. The interleukin-1 receptor antagonist can be separated from the solid extraction material. Methods for treating a site of inflammation in a patient include administering the solution rich in interleukin-1 receptor antagonist to the site of inflammation.

Description

INTRODUCTION[0001]The present technology relates to compositions comprising interleukin-1 receptor antagonist, and methods for generating, isolating, and administering such compositions.[0002]Interleukin-1 (IL-1) includes a family of cytokines that can stimulate lymphocytes and macrophages, activate phagocytes, increase prostaglandin production, contribute to degeneration of bone joints, increase bone marrow cell proliferation, and are involved in many chronic inflammatory conditions. IL-1 can be generated by macrophages, monocytes, and dendritic cells, and can be part of the inflammatory response against infection.[0003]The mode of action of IL-1 can be mediated by interleukin-1 receptor antagonist protein (IL-1ra; also known as “IRAP”). IL-1ra binds to the same receptor on the cell surf ace as IL-1, and thus prevents IL-1 from sending a signal to that cell. IL-1ra is secreted from white blood cells, including monocytes, macrophages, neutrophils, polymorphonuclear cells (PMNs), and...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K35/15A61K45/06
CPCA61K45/06A61K38/1793A61K35/15A61K38/177A61K38/2006A61P19/02A61P29/00A61P43/00A61K2300/00A61K38/17A61K38/20C07K1/14A61K38/1825A61K38/1841A61K38/191A61K38/2026A61K38/2066A61K38/2073A61K38/2086A61K38/217
Inventor HIGGINS, JOEL C.HOEPPNER, JACY C.WOODELL-MAY, JENNIFER E.
Owner BIOMET MFG CORP
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