Reducing the deterioraton of wetted hydrophilic coatings subjected to sterilization by radiation

Patent metadata

Field	Value
Publication number	US-9610384-B2
Application number	US-201415037605-A
Country	US
Kind code	B2
Filing date	Nov 20, 2014
Priority date	Nov 20, 2013
Publication date	Apr 4, 2017
Grant date	Apr 4, 2017

Abstract

A method of reducing the deterioration of a wetted hydrophilic coating caused by sterilization by radiation is provided. The method comprises the step of incorporating a thiosulfate anion and a buffer into the wetting hydrophilic coating comprising water. Some embodiments of the invention relate to a wetted hydrophilic coating, a wetting agent, a package comprising a wetted hydrophilic coating, and a method of sterilizing a wetted hydrophilic coating.

First claim

The invention claimed is:

1. A method of sterilizing a packaged article comprising the step of sterilizing with radiation a gas impermeable package enclosing an article comprising a wetted hydrophilic coating, the wetted hydrophilic coating comprising a hydrophilic coating, a thiosulfate anion, water, and a buffer for maintaining the pH at 7 or above.

2. The method according to claim 1 , wherein the wetted hydrophilic coating comprises water in an amount of at least 70 wt %, based on the total weight of the wetted hydrophilic coating and the thiosulfate anion is present in an amount of from 0.05 to 3 wt %, based on the total weight of the wetted hydrophilic coating.

3. The method according to claim 1 , wherein the wetted hydrophilic coating comprises water in an amount of at least 90 wt %, based on the total weight of the wetted hydrophilic coating and the thiosulfate anion is present in an amount of from 0.3 to 2 wt %, based on the total weight of the wetted hydrophilic coating.

4. The method according to claim 1 , wherein the buffer maintains the pH at from 7 to 9.

5. The method according to claim 1 , wherein the pH of the wetted hydrophilic coating is from 7 to 9.

6. The method according to claim 5 , wherein the buffer comprises a water soluble base having a pKb of from 5 to 10.

7. The method according to claim 5 , wherein the buffer capacity is 5 mmol or greater at at least one starting pH of from 7 to 8.5.

8. The method according to claim 7 , wherein the buffer capacity is 5 mmol or greater at at least one starting pH of from 7 to 8.5.

9. The method according to claim 5 , wherein the buffer capacity is from 5 mmol to 300 mmol at at least one starting pH of from 7 to 8.5.

10. The method according to claim 5 , wherein the buffer is a phosphate buffer.

11. The method according to claim 5 , wherein the wetted hydrophilic coating further comprises from 1 wt % to 20 wt %, based on the total amount of wetted hydrophilic coating, of a component selected from the group consisting of glycerol, monoacetin, diacetin, diacetone alcohol, diethyleneglycol, triethyleneglycol, tetraethyleneglycol, propyleneglycol and dipropyleneglycol.

12. The method according to claim 5 , wherein the wetted hydrophilic coating further comprises a further radical scavenger.

13. The method according to claim 5 , wherein the wetted hydrophilic coating further comprises a preservative.

14. The method according to claim 5 , wherein the thiosulfate anion is present as sodium thiosulfate, ammonium thiosulfate, barium thiosulfate, calcium thiosulfate, magnesium thiosulfate, potassium thiosulfate, lithium thiosulfate, iron thiosulfate, zinc thiosulfate, tin thiosulfate, silver thiosulfate or hydrates thereof.

15. The method according to claim 5 , wherein the hydrophilic coating is formed by curing a hydrophilic coating composition, the hydrophilic coating composition comprising at least 80 wt % of hydrophilic polymer, based on the total dry weight of the hydrophilic coating composition.

16. The method according to claim 5 , wherein the gas impermeable package encloses an oxygen scavenging packaging component.

17. The method according to claim 5 , wherein the gas impermeable package comprises an atmosphere within the gas impermeable package and in contact with the wetted hydrophilic coating that has an amount of oxygen that is less than an amount of oxygen that would have been present if oxygen scavengers present in the wetted hydrophilic coating were alone acting on ambient air at the time of packaging within the gas impermeable package.

18. The method according to claim 5 , wherein the radiation is gamma rays or electon beam at a dosage of greater than 25 kGy.

19. A sterilized packaged article formed by the method of claim 6 .

20. A sterilized packaged article formed by the method of claim 15 .

Assignees

• Dsm Ip Assets Bv

Inventors

• Belt Johannes Wilhelmus
• Daenen Robin Elisabeth Maria Jacobus

Classifications

• A61L31/143

  Stabilizers · CPC title

• A61L29/14

  Materials characterised by their function or physical properties {, e.g. lubricating compositions} · CPC title

• A61L29/085 Primary

  Macromolecular materials · CPC title

• A61B50/30

  Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40) · CPC title

• A61L2420/06

  Coatings containing a mixture of two or more compounds · CPC title