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Methods of making a chitosan product having an ultra-low endotoxin concentration and the ultra-low endotoxin chitosan product derived therefrom and method of accurately determining inflammatory and anti-inflammatory cellular response to such materials

  • US 20080248508A1
  • Filed: 11/13/2007
  • Published: 10/09/2008
  • Est. Priority Date: 08/17/2006
  • Status: Abandoned Application
First Claim
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1. A process for making ultrapure, low-endotoxin chitosan comprising:

  • (a) utilizing sterile, pyrogen-free labware, reagents and materials in strict endotoxin-free, sterile environment;

    (b) swelling chitosan having endotoxins, for up to 24 hours;

    (c) dissolving ratios equivalent to 1 kg/25 L to 1.5 kg/25 L of said chitosan in 0.01M to 4.0 M of a hydroxide base, forming a chitosan base solution and continuously stirring said chitosan base solution(d) heating said base solution between 60°

    C. and 100°

    C. for 45 minutes to 4 hours and continuously stirring said heated base solution;

    (e) rinsing said chitosan solution with up to 10×

    volume of ultra-pure pyrogen-free water and removing endotoxin fragments and residual endotoxin;

    (f) neutralizing said solution to a pH between 6.8 and 7.5;

    (g) forming a ultra-pure low endotoxin chitosan slurry;

    (h) transferring said slurry to a endotoxin-free closed system;

    (i) removing excess water from said slurry and forming said ultra-pure, low-endotoxin chitosan having an endotoxin concentration between 100 EU/g and 20 EU/g;

    (j) retaining molecular weight integrity of said chitosan at 30 kDa or greater and between 75% and 90% of said chitosan having endotoxins; and

    (k) storing said chitosan in endotoxin-free storage containers in an endotoxin-free environment with sterile, endotoxin-free connects.

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