Haemostatic composition comprising hyaluronic acid
Inventors
MOELLER LENE, null • Møller, Lene • Devantier, Kristina • Wulff, Trine • Sabra, Mads Christian
Assignees
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Publication Number
US-8021684-B2
Publication Date
2011-09-20
Expiration Date
Abstract
The present invention relates to a haemostatic composition comprising a biologically absorbable material and hyaluronic acid or a derivative thereof, methods of producing such compositions and the use of these compositions. In particular the method of producing said haemostatic composition comprises treating it with dry heat at a temperature between 110-200° C.
Core Innovation
The invention relates to a sterile haemostatic composition comprising gelatin and hyaluronic acid (HA) or a salt thereof, wherein the gelatin and hyaluronic acid (HA) or a salt thereof is stabilized with dry heat at 110-200°C. The composition does not comprise a chemical cross-linking agent or residues thereof, and dry heat stabilization is used to support sterilisation and removal of endotoxins.
The invention further provides haemostatic compositions incorporating HA or a salt thereof with improved haemostatic performance compared with conventional gelatin sponges. The document describes reduced swelling and reduced adhesion, including evaluation against Surgifoam® and Spongostan®, and reports improved time to haemostasis and reduced bleeding intensity in a porcine spleen model.
The document also describes formulations and product forms in which gelatin and HA are provided together, including gelatin/HA mixtures treated with dry heat. HA-containing haemostatic materials are described as showing enhanced release of test substances from HA-containing sponges compared with matched controls, and example embodiments include powders/flakes, paste embodiments, sponge embodiments, and top sheet embodiments.
Claims Coverage
The independent claim covers a sterile haemostatic composition with two core inventive features: dry-heat stabilization of a gelatin/HA system at 110-200°C and the absence of chemical cross-linking agent or residues. Dependent claims refine product form and quantitative HA/gelatin content, and further specify additional HA characteristics and certain preparation/drying variants.
Sterile gelatin and hyaluronic acid stabilized with dry heat at 110-200°C
A sterile haemostatic composition comprising gelatin and hyaluronic acid (HA) or a salt thereof, wherein said gelatin and hyaluronic acid (HA) or a salt thereof is stabilized with dry heat at 110-200°C.
Exclusion of chemical cross-linking agent or residues
A sterile haemostatic composition wherein said haemostatic composition does not comprise a chemical cross-linking agent or residues thereof.
Form of sponge, powder, or flakes
The haemostatic composition is provided in the form of a sponge, powder, or flakes.
Gelatin content upper bound
The haemostatic composition includes at most 85% (w/w) of said gelatin.
Hyaluronic acid minimum content
The haemostatic composition includes hyaluronic acid (or a salt thereof) at a final content of at least 15% (w/w).
Haemostatic paste via pre-wetting powder or flakes with a liquid
A haemostatic paste made by pre-wetting a haemostatic composition that is a powder or flakes with a liquid to form a paste.
Freeze-drying as a drying variant
In the method, the drying step is performed by freeze-drying.
Overall, the claims focus on a sterile haemostatic gelatin/HA (or salt) composition stabilized with dry heat at 110-200°C without chemical cross-linking agents or residues, with dependent coverage for sponge, powder, flakes, and paste forms, quantitative gelatin/HA content constraints, and a freeze-drying drying variant.
Stated Advantages
Reduced swelling compared with conventional gelatin sponges (e.g., Surgifoam® and Spongostan®).
Improved time to haemostasis.
Reduced bleeding intensity in a porcine spleen model.
Reduced adhesion/anti-adhesive properties.
Enhanced release of test substances from HA-containing sponges.
Documented Applications
Haemostatic use in a porcine spleen model to improve haemostasis outcomes.
Local drug-delivery use where HA-containing haemostatic materials are described as delivering test substances including tobramycin sulphate and carboplatin.
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