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Filters for infusion sets

A filter and infusion bag technology, which is applied in the field of protein therapy drug administration, can solve the problems of reducing the effective administration dose and the like

Inactive Publication Date: 2016-10-12
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Adsorption of proteins to the filter is undesirable because protein attached to the filter does not reach the patient, causing a reduction in the effective administered dose

Method used

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  • Filters for infusion sets
  • Filters for infusion sets
  • Filters for infusion sets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0010] The present invention provides a method of administering a positively charged protein therapeutic with a peripheral intravenous line comprising a 0.2 micron in-line intravenous filter, wherein the filter is a Baxter 0.2 micron high pressure extended life filter (e.g., 2C8671 and 2H5660), B. Braun Perifix (eg, 451550), Codan IVSTAR Plus 5 (eg, 76.3402), Pall Nanodyne ELD (eg, ELD96LLCE), Pall Posidyne ELD (eg, ELD96LL, ELD96LYL, and ELD96LLC), Rowe RoweFil 120 Nylon (eg, A-2356) and Terumo extension set TF-SW231H. The invention includes all code products of an infusion set having a filter identical to the disclosed filter, but other components of the infusion set (eg, tubing, valves, or needles) may differ.

[0011] The present invention provides a method of administering a positively charged protein therapeutic through a peripheral intravenous line comprising a 0.2 micron in-line intravenous filter, wherein the filter is a Baxter 0.2 micron high pressure extended life f...

example 1

[0051] Example 1: Analysis method

[0052] For the screens described in "Figure Legends", protein concentrations were determined by protein fluorescence analysis on a plate reader. In the following post-screening experiments, protein concentration was determined by Quantikine Human Relaxin-2 Immunoassay (R&D System Test Kit DRL200) (paragraphs 041, 043, and 044). Protein concentrations in the examples shown below were also determined by RP-HPLC measurements optimized by selection of suitable HPLC vials to achieve minimal adsorption loss of protein and by calibration experiments performed sequentially on samples with reference standards.

[0053] Biological activity is determined by a bioassay based on cell-based cAMP production.

[0054] The adsorption of H2 relaxin to infusion bags and infusion tubes filled with 5% dextrose or 0.9% saline was tested. Substantial absence of loss of H2 relaxin due to adsorption to infusion bags or threads was observed after 0, 1 or 30 hours o...

example 2

[0055] Example 2: Adsorption of Human Recombinant Relaxin 2 (Serelaxin) to Filters in 0.9% NaCl

[0056]

[0057]

[0058] 1 At a concentration of 5 μg / mL

[0059] 2 At a concentration of 30 μg / mL

[0060] Surprisingly, a positive charge on a filter did not predict whether it would adsorb positively charged proteins. Significant differences in adsorption were observed when different positively charged filters were tested. For example, little adsorption to neutral PES Baxter extension set 2C8671 and 2H5660 filters was observed and a flush volume of 20 mL was sufficient to achieve equilibrium. Partial adsorption to Pall Posidyne ELD ELD96LL was observed. The results are shown in Example 2 above.

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PUM

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Abstract

In an acute care setting, rapid onset of the therapeutic effects of medication is highly desirable. The invention provides in-line filters suitable for rapid delivery of a positively charged protein therapeutic via intravenous administration.

Description

technical field [0001] The present invention relates to filters for use in infusion sets and methods for their use in the administration of protein therapeutics. Background technique [0002] In-line filters are used in IV therapy to capture particulate matter and ensure the sterility of administered medications. A pore size of about 0.2 microns (eg, 0.22 μm) is standard for preventing microbial contamination. Positively charged filters (sometimes referred to as endotoxin filters) are chosen for infusion sets for the administration of positively charged protein therapeutics because the positive charges on the membrane repel the protein, making the protein resistant to filtration. The adsorption of the device pair is minimized. Adsorption of proteins to the filter is undesirable because protein attached to the filter does not reach the patient, causing a reduction in the effective administered dose. In acute care settings, the benefits of rapid delivery of effective intrav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): H04W48/20
CPCA61M5/14A61M2205/75A61M2205/7563A61M5/165A61K38/2221A61P5/24A61J1/10A61K9/0019A61K9/08
Inventor M·舒特T·霍布罗A·贝什尔M·比林顿
Owner NOVARTIS AG
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