WETTING AGENT FORMULATION
A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device comprising an antioxidant selected from gallic acid or a derivative thereof. A second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes carboxymethyl cellulose or a derivative or salt thereof. The use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions, are also provided. The wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf-life of the wetted coated product.
1 . A composition for preventing or retarding degradation of a functional coating on a medical device, comprising:
carboxymethyl cellulose or a derivative or salt thereof.
2 . The composition of claim 1 , comprising a sodium salt of carboxymethyl cellulose.
3 . The composition of claim 1 , wherein carboxymethyl cellulose or a derivative or salt thereof is present in an amount of 0.1% to 10% by weight based on a total weight of the composition.
4 . The composition of claim 1 , further comprising an aqueous or oil based base solution or a lipid media or a combination thereof.
5 . The composition of claim 4 , wherein the aqueous base solution is selected from a group consisting of distilled water, deionized water, reverse osmosis water, filtered water and a saline solution.
6 . The composition of claim 4 , wherein the aqueous base solution is present in an amount of from 50% to 99.99% by weight, based on a total weight of the composition.
7 . The composition of claim , further comprising gallic acid or a derivative thereof selected from an ester, amide or oxadiazole derivative of gallic acid, preferably propyl gallate.
8 . The composition of claim 7 , wherein gallic acid or a derivative thereof is present in an amount of 0.001% to 1% by weight, based on the total weight of the composition.
9 . The composition of claim 1 , further comprising a stabilizer, a solution enhancer and/or a buffer solution.
10 . The composition of claim 9 , wherein the buffer solution has a pH of from 2.0 to 7.4.
11 . The composition of claim 9 , wherein the solution enhancer is selected from a group consisting of ethylene glycol, diethylene glycol, propylene glycol, and glycerol.
12 . The composition of claim 11 , wherein the solution enhancer is present in an amount of 0.1% to 49.8% by weight, based on the total weight of the composition.
13 . The composition of 1, comprising:
0.1% to 5% by weight of sodium carboxymethyl cellulose;
0% to 0.5% by weight of propyl gallate; and
1% to 10% by weight of propylene glycol.
14 . A method of preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation and/or from hydrolytic degradation by contacting at least a portion of the functional coating with the composition of claim 1 .