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  • Antithrombogenic Products


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    Covalent heparin attachment – one step

    A) Proprietary commercial application Clotting times

    ID of a polysulfone tube was coated with a covalently bound water-based heparin coating. Modified Lee-White clotting time test from NAMSA on Steam-sterilized parts.

    Clotting time changes were significant. This information combined with un-coated data suggests that the Surface Solution samples did reduce clotting time.

    B) J.Strony PhD CWRU Thrombin times- human plasma – one step

    Two samples of coating resins were prepared. In one, heparin was bound covalently to the supporting resin through a linker and in the other the heparin was not bound. Films 3 mils thick were cast on PE sheets and removed. A control of benzalkonium heparin was prepared by casting the coating resin on PE and post-dipping in the ionic heparin solution. Films were soaked in saline for 24 hours and then removed and placed in fresh saline. Thrombin times for soak solutions, based on a pooled human plasma, yielded IU data shown below.

    Lost effectiveness was defined as <1 IU/24 Hour release. Benzalkonium control and unbound heparin were all ineffective at 24 hours or less. The bound heparin is sustained and released over atleast 14 days.

    C) Biocascade- Covalent attachment and sustained release measured by Anti Xa

    Two separate sections (~1-2 cm 2 each) of films (6-65D) were incubated in isotonic Anti-Xa buffer at 37 o C.   At various times (e.g. 1 hr, 24 hr, 48 hr, 1 wk, 2 wk,1,3 and 6 months), the incubation buffer was removed from the surface film and assayed for heparin Anti-Xa activity by the USP Anti-Xa method. Fresh buffer solution was then used to replace the removed buffer and the incubation continued until the next assay point, where the procedure was repeated. The film released heparin, at a relatively slow rate, resulting in about 20% of the theoretical heparin content being eluted as biologically active heparin in the first month.The film did not change physical shape during the incubation in buffer, but appeared to be hydrophilic and retain its original shape and texture.

    The remaining heparin is biologically active and accessible at the surface of the film as measured with the USP Anti-Xa method. This would appear to be an interesting, and stable anti-thrombotic film, as it appears that only small amounts of heparin are eluting from the film after one month, and that the remaining heparin is tightly bound and all heparin is biologically active.

    Research data and clinical studies

    Anti-Xa Activity of Heparin-containing Surface Films

    Summary:

    Two separate sections (~1-2 cm 2 each) of two distinct surface films (6-65B and 6-65D, respectively) were incubated in isotonic Anti-Xa buffer at 37 o C. At various times (e.g. 1 hr, 24 hr, 48 hr, 1 wk, 2 wk, etc.), the incubation buffer was removed from the surface film and assayed for heparin Anti-Xa activity by the USP Anti-Xa method. Fresh buffer solution was then used to replace the removed buffer and the incubation continued until the next assay point, where the procedure was repeated.

    The results with the two films were quite distinct. The 6-65B films appeared to be quite hydrophobic, with the film “scrolling” into a small tube in the incubation buffer. Also, within 1 week of extraction, over 2 mg (~450-500 Units) of heparin was extracted from each of the duplicate, 6-65B films. After two weeks, the 6-65B films had released a quantity of heparin equivalent to ~12-13% of the original film mass (see Table 1, attached). Film 6-65D, on the other hand, only eluted or released heparin at a relatively slow rate, resulting in about ~2-3% of the original film mass being eluted as biologically active heparin in the first two weeks (see Table 1). The 6-65D film also did not change physical shape during the incubation in buffer, but appeared to be hydrophilic and retain its original shape and texture.

    Experimental Design and Details

    • Cut 5-6 separate pieces of each of the 6-65 films and placed these in tared 12 X 75 mm Falcon tubes.
    • By weight, closely matched duplicate films for each of the two film types (4 samples total) were then treated with 1 ml each of USP Anti-Xa buffer for 1 hour at 37 o C.
    • The incubation buffer was removed to a separate tube, and then assayed for Anti-Xa activity, after appropriate serial dilution with additonal Anti-Xa buffer.
    • After removal of the first 1 ml of buffer from each film, the buffer was replaced in each tube with 5 mls of buffer for continued incubation. For all subsequent assays and incubations (beyond the 1 hour point), 5 mls of incubation buffer was used in each case.
    • Anti-Xa assay buffer consists of 0.05 M Tris, 0.0075 M EDTA, 0.175 M NaCl, and 0.1% PEG-8000, pH = 8.4
    • Anti-Xa assays were perfomed according to the USP Heparin Sodium monograph procedure on a STA Compact hemostasis instrument (Parsippany, NJ).

    Conclusions:

    Based upon the quantities of heparin released from each of the film types, the 6-65D appears to be retaining a significant portion of the starting heparin mass. If the remaining heparin is biologically active and accessible at the surface of the film, we will be able to measure this with the USP Anti-Xa method. This experiment is planned for the 1 month time period. If the latter experiment shows biologically active heparin on the film surface, this would appear to be an interesting, and stable anti-thrombotic film, as it appears that no further heparin is eluting from the 6-65D films at two weeks and that the remaining heparin is tightly bound.

    By contrast, the 6-65B films appear to have “released” all of the starting heparin within the the first two weeks, leaving little chance that there remains biologically active heparin at the film surface. My suggestion is to not assay or incubate the 6-65B films any further.

    Heparin release/retention in urethane 6-65D

    Time Ave eluted, mg Ave cum % Surface
    eluted Active
    0 Hr 0 0 by factor Xa
    1 Hr 0.0349 3.43
    1 Day 0.1609 17.415
    2 Day 0.0081 18.215
    3 Day 0.0063 18.835
    7 Day 0.0068 19.5
    14 Day 0.0004 19.58
    30 Day 0.0007 19.64 2.2mU/cm2
    60 Day 0.00005 20.66 2.5mU/cm2
    90 day below detection 1.5mU/cm2
    6 month below detection 2.0mU/cm2
    Film load,mg 1.02 100

    Test Facility: Biocascade

    Notes:

    The films were tested for bioavailable heparin via an antifactor Xa test. Surface heparin can bind AT III and inhibit anti Xa. Functional testing is more relevant than other styles of reporting heparin activity.

     

    C2G00017-A

    Antithrombogenic Heparin Patented Coatings

    The product is supplied as a kit with crosslinkers for improved strength and adhesion. See Instructions for use for mixing instructions.

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    Safety Data Sheets

    Coatings2Go, LLC is not responsible for the use of any of the information contained, or any product mentioned, in this document, and you must make your own determination of its suitability and completeness for your own use. You should conduct your own testing. All expressed and implied warranties, including any implied warranty of merchantability and warranty of fitness for a particular purpose and warranty arising out of the parties course of dealing are hereby disclaimed by C2G. The products are being sold "As Is". You are responsible for handling and disposal according to local, regional and federal regulations. C2G shall not be liable for any incidental or consequential damages. Nothing herein shall be construed as a license or sublicense to operate under any C2G or third party owned patent or as a warranty against infringement of any patent. By placing an order for any of these products and/or by accepting their delivery, the purchaser agrees to the above waivers.

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