Wetting agent formulation
A first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device includes 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 wetting liquid formulation, comprising:
a liquid comprising an aqueous or oil-based base solution, a lipid media, or a combination of both;
an antioxidant dissolved in the liquid, the antioxidant being an oxadiazole derivative of gallic acid, and further comprising a solution enhancer to increase dissolvability of the antioxidant; and
wherein wetting a medical device with the wetting liquid formulation reduces degradation of a functional coating on the medical device.
2. The wetting liquid formulation of claim 1 , wherein the oxadiazole derivative of gallic acid is present in an amount of 0.001% to 5% by weight based on a total weight of the composition.
3. The wetting liquid formulation of claim 1 , 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.
4. The wetting liquid formulation of claim 1 , 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.
5. The wetting liquid formulation of claim 1 , wherein the oxadiazole derivative of gallic acid is present as a suspension within and/or around the functional coating.
6. The wetting liquid formulation of claim 1 , further comprising a stabilizer and/or a buffer solution.
7. The wetting liquid formulation of claim 3 , wherein the solution enhancer is selected from ethylene glycol, diethylene glycol, propylene glycol, or glycerol, and is present in an amount of 0.1% to 49.8% by weight, based on the total weight of the composition.
8. The wetting liquid formulation of claim 6 , wherein the buffer solution has a pH of from 2.0 to 7.4 and wherein the buffer solution prevents the gallic acid derivatives from recrystallization.
9. The wetting liquid formulation of claim 1 , wherein the composition is free of polyvinyl alcohol.
10. The wetting liquid formulation of claim 1 , further comprising polyvinylpyrrolidone (PVP) in an amount of 0.1 to 40% by weight.