Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Patent
1994-02-07
1997-05-20
Kishore, Gollamudi S.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
424422, 424423, 424424, 424425, 424426, 424443, 514 21, 514 54, A61K 900, A61K 908, A61K 3800
Patent
active
056310110
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a tissue treatment composition, especially a tissue adhesive having improved properties and to the use of such compositions as anti-adherence or would healing compositions, as slow-release drug formulations, for coating tissues or prosthetic materials, and as carriers for cell transplants.
The use of blood coagulating substances for stopping bleedings and for sealing wounds has been known for a long time. Thus, the hemostatic effect of fibrin powder was reported about 80 years ago, and attempts were made to employ fibrin or fibrin patches to stop bleeding in brain and general surgery.
Today such use of fibrin as a biologic adhesive has been widely accepted and found application in many fields of surgery. Generally fibrin sealants are based upon the two components fibrinogen and thrombin. As these components mix a fibrin coagulum is formed in that the fibrinogen molecule is cleaved through the action of thrombin to form fibrin monomers which spontaneously will polymerize to form a three-dimensional network of fibrin, largely kept together by hydrogen bonding. This corresponds to the last phase of the natural blood clotting cascade, the coagulation rate being dependent on the concentration of thrombin used.
In order to improve the tensile strength, covalent crosslinking between the fibrin chains is provided for by including Factor XIII in the sealant composition. The strength of the fibrin clot is further improved by the addition of fibronectin to the composition, the fibronectin being crosslinked and bound to the fibrin network formed.
To prevent a too early degradation of the fibrin clot by fibrinolys, the fibrin sealant composition may comprise a plasminogen activator inhibitor or a plasmin inhibitor, such as aprotinin. Such an inhibitor will also reduce the fibrinolytic activity resulting from any residual plasminogen in the fibrinogen composition.
Similarly, compositions according to the invention which include hyaluronic acid (or other polysaccharides), may also comprise a hyaluronidase inhibitor such as one or more flavonoids (or corresponding inhibitors for other polysaccharides) in order to prevent premature degradation (i.e. to prolong the duration) of the hyaluronic acid component by hyaluronidase which is always present in the surrounding tissues. The hyaluronic acid may, as mentioned above, be crosslinked, a commercially available example being Hylan.RTM. (trademark, available from Biomatrix, Ritchfield, N.Y., USA). The hyaluronic acid compositions may e.g. have the form of gels, solutions, etc.
The results obtainable by fibrin sealants are basically: the risk of serum, lymph and liquor leakage. The hemostatic effect may be enhanced if the fibrin sealant is combined with a biocompatible solid fiat material such as collagen. atraumatically connects tissues by forming a strong joint between them and adapts uneven wound surfaces. This glueing effect is increased by fibronectin being bound to exposed collagen. fibroblasts which in combination with efficient hemostasis and adhesion between the wound surfaces provides for an improved healing process. Wound healing promoted by fibrin sealants results in strong scar formation and does not prevent the formation of adhesions. The use of the compositions according to the invention as an anti-adherence/wound healing composition does, however, result in a normal (regenerative) tissue rather than scar tissue, i.e. optimal wound healing. Furthermore, such compositions also reduce the inflammatory response as appears from the test results reported in Table 4 below.
Fields of application include among others: ear, nose and throat surgery, general surgery, dentistry, neurosurgery, plastic surgery, thorax and vascular surgery, abdominal surgery, orthopaedics, accident surgery, gynaecology, urology, and opthalmology. Fibrin sealants have also been used for local application of drugs, such as antibiotics, growth factors and cytostatics. Commercial fibrin glues (prepared from human plasma) are available under the trade names Tissucol,
REFERENCES:
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patent: 5209776 (1993-05-01), Bass
patent: 5290552 (1994-03-01), Sierra
Dialog Information Services, File 434, Dialog Accession No. 05982181, Barton B et al.; "Fibrin Glue as a Biological Vascular Path-A Comparative Study"; J. Surg. Res.; May 1986, 40 (5) pp. 510-513.
Dialog Information Services, File 351, World Patent Index 81-91, Dialog Accession No. 007544894, Nippon Zeon KK: "Wound-Covering Material Preventing Exudation, Etc. - Comprises Fine-Pore Film Layer or Polyaminoacid and Core of Fibre or Metallic Net, Contg. Antibacterial and Bicompatible Materials".
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