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1. WO2002017853 - HYALURONAN-BASED ANTIADHESION COMPOSITIONS, THEIR PREPARATION AND USE

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[ EN ]

Claims

1. A solid material for preventing post-surgical adhesions comprising a compressed hyaluronan or hyaluronan derivatives based composition in the form of a film having a molecular weight of greater than 3xl05 and a thickness between 0.1 and 1.5 mm.

2. A material as claimed in claim 1 when the hyaluronan or hyaluronan derivatives based composition comprises a mixture of high and medium molecular weight hylan A fluids.

3. A material as claimed in claim 2 when the high molecular weight hylan A fluid has a molecular weight of greater than of about 5xl06 and the medium molecular weight hylan fluid has a molecular weight of below 2.0xl06.
4. A material as claimed in claim 3 when the weight ratio of high molecular weight hylan A to medium molecular weight hylan A is 2: 1.
5. A material as claimed in claim 1 wherein the HA is present in the form of an inorganic salt.
6. A material as claimed in claim 5 when the salt is in the form of an organic salt.
7. A material as claimed in Claim 1 wherein the hyaluronan derivatives are hylans.

8. A material as claimed in Claim 7 wherein the molecular weight is greater than 2xl06.

9. A material as claimed in Claim 1 wherein the material is a hyaluronan and the molecular weight is greater than 0.5 million.
10. A material as claimed in claim 1 and further comprising at least one other pharmacologically active substance incorporated therein to impart to the material the pharmacological properties of said substance.
11. A material as claimed in claim 10 when the pharmacologically active substance is a polysaccharide.
12. A material as claimed in Claim 11 wherein the polysaccharide is a glycosaminoglycan.

13. A material as claimed in claim 10 when the substance is poly lactic acid and it is present in an amount of about 0.1 to 10% by weight.
14. A material as claimed in claim 1 and further comprising a proteoglycan.

15. A material as claimed in claim 10 wherein the substance is an antineoplastic compound present in a therapeutically effective amount.
16. A material as claimed in Claim 10 wherein the pharmaceutically active substance is an antibiotic, an anti-inflammatory agent or human growth factor.
17. A material as claimed in claim 1 wherein the hyaluronan derivative is water insoluble hylan B gel or a slurry thereof.
18. A material as claimed in claim 1 in the form of a multilayered sandwich configured in alternating layers of hylan B gel and hylan A fluid.
19. A material as claimed in claim 1 and further comprising hyaluronan adhering protein molecules.
20. A process for preparing a compressed film of a hyaluronan or hyaluronan derivative for preventing post surgical adhesions, said process comprising preparing a homogeneous aqueous solution of 0.05 - 10% concentration by weight of the hyaluronan or hyaluronan derivative having a molecular weight of at least
lxlO6, placing the solution in a mold of a predetermined size, permitting the solution to stand to allow it to settle, and thereby remove any air bubbles, freeze drying the solution under vacuum to remove substantially all the water therefrom, removing the freeze dried solution from the mold and compressing it to a thickness of about 0.1 - 1.5 mm.
21. A process according to Claim 20 where the hyaluronan derivative is hylan A.
22. A process according to Claim 20 wherein where the hyaluronan derivative is hylan B.

23. A process according to Claim 20 wherein when the starting material is hylan A, the concentration is 0.05 - 3%; and when the starting material is hylan B, the concentration is 0.1 to 1 % .
24. A process according to Claim 20 wherein freeze drying is effected in stages, first at a starting temperature of about 15 °C for about 1-3 hours; second, by applying vacuum to reduce the pressure and the temperature to about 30°C for about 200 minutes; third, by raising the temperature initially to about 0°C for 180-220 minutes and then to about 25 °C for 400-600 minutes; and fourth, by reducing the vacuum for 120 minutes to remove any remaining interstitial water.

25. A process according to Claim 20 wherein compression is effected by subjecting the freeze dried material to a force of 10-450 lbs/in2 until the thickness of the material is about 0.1-1.5 mm.
26. A process according to Claim 20 wherein the solution further comprises a therapeutically effective amount of at least one additional substance having pharmacological properties.

27. A process according to Claim 26 wherein the additional substance is a glycosaminoglycan, an antineoplastic agent, polylactic acid, an antibiotic, an anti- inflammatory agent, a hormone, an anesthetic, an analgesic or a hyaluronan adhering protein or peptide.
28. A process for preparing a compressed film of a hyaluronan derivative for preventing post surgical adhesions, said process comprising preparing a homogeneous aqueous solution of 0.05 - 10% concentration by weight of the hyaluronan or hyaluronan derivative having a molecular weight of at least 1x10°, placing the solution in a mold of a predetermined size, permitting the solution to stand to allow it to settle, and thereby remove any air bubbles, drying the solution at a temperature of up to 65 °C to remove substantially all the water therefrom, removing the dried solution from the mold and compressing it to a thickness of about 0.1 - 1.5 mm.
29. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 1 before closing the surgical site.
30. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 10 before closing the surgical site.
31. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 12 before closing the surgical site.
32. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material -as claimed in Claim 13 before closing the surgical site.

33. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 15 before closing the
surgical site.
34. A method for preventing the formation of post surgical adhesions in an animal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 16 before closing the surgical site.
35. A method for preventing the formation of post surgical adhesions in a mammal undergoing surgery, said method comprising introducing to the surgical site an effective amount of a material as claimed in Claim 18 before closing the surgical site.