OPHTHALMIC SEALANT COMPOSITION AND METHOD FOR USE
A polymeric hydrogel sealant specifically formulated to seal ophthalmic wounds is provided. The sealant is formed by mixing two aqueous solutions. The first aqueous solution comprises an oxidized dextran having a specific average molecular weight range and oxidation level and the second aqueous solution comprises a 4-arm polyethylene glycol having two primary amine groups at the end of substantially every arm. A kit and method for sealing an ophthalmic wound using the hydrogel sealant is also provided.
1 . A kit comprising:
a) a first aqueous solution comprising about 15 wt % to about 30 wt % of an oxidized dextran containing aldehyde groups, said oxidized dextran having a weight-average molecular weight of about 8,500 to about 11,500 Daltons and an equivalent weight per aldehyde group of about 130 to about 165 Daltons; and
b) a second aqueous solution comprising about 15 wt % to about 45 wt % of a 4-arm polyethylene glycol substantially each arm of which has two primary amine groups at its end, wherein said 4-arm polyethylene glycol has a number-average molecular weight of about 9,000 Daltons to about 11,000 Daltons.
2 . The kit according to claim 1 wherein the first aqueous solution comprises the oxidized dextran at about 20 wt % to about 25 wt %.
3 . The kit according to claim 1 wherein the second aqueous solution comprises the 4-arm polyethylene glycol at about 25 wt % to about 40 wt %.
4 . The kit according to claim 1 wherein the first aqueous solution comprises the oxidized dextran at about 25 wt % and the second aqueous solution comprises the 4-arm polyethylene glycol at about 30 wt %.
5 . The kit according to claim 1 wherein at least one of the first aqueous solution or the second aqueous solution further comprises a colorant.
6 . A composition comprising the reaction product of:
a) a first aqueous solution comprising about 15 wt % to about 30 wt % of an oxidized dextran containing aldehyde groups, said oxidized dextran having a weight-average molecular weight of about 8,500 to about 11,500 Daltons and an equivalent weight per aldehyde group of about 130 to about 165 Daltons; and
b) a second aqueous solution comprising about 15 wt % to about 45 wt % of a 4-arm polyethylene glycol substantially each arm of which has two primary amine groups at its end, wherein said 4-arm polyethylene glycol has a number-average molecular weight of about 9,000 Daltons to about 11,000 Daltons.
7 . The composition according to claim 6 wherein the first aqueous solution comprises the oxidized dextran at about 20 wt % to about 25 wt %.
8 . The composition according to claim 6 wherein the second aqueous solution comprises the 4-arm polyethylene glycol at about 25 wt % to about 40 wt %.
9 . The composition according to claim 6 wherein the first aqueous solution comprises the oxidized dextran at about 25 wt % and the second aqueous solution comprises the 4-arm polyethylene glycol at about 30 wt %.
10 . A method of sealing an ophthalmic wound comprising applying to the wound:
a) a first aqueous solution comprising about 15 wt % to about 30 wt % of an oxidized dextran containing aldehyde groups, said oxidized dextran having a weight-average molecular weight of about 8,500 to about 11,500 Daltons and an equivalent weight per aldehyde group of about 130 to about 165 Daltons; and
b) a second aqueous solution comprising about 15 wt % to about 45 wt % of a 4-arm polyethylene glycol substantially each arm of which has two primary amine groups at its end, wherein said 4-arm polyethylene glycol has a number-average molecular weight of about 9,000 Daltons to about 11,000 Daltons.
11 . The method according to claim 10 wherein the first aqueous solution comprises the oxidized dextran at about 20 wt % to about 25 wt %.
12 . The method according to claim 10 wherein the second aqueous solution comprises the 4-arm polyethylene glycol at about 25 wt % to about 40 wt %.
13 . The method according to claim 10 wherein the first aqueous solution comprises the oxidized dextran at about 25 wt % and the second aqueous solution comprises the 4-arm polyethylene glycol at about 30 wt %.
14 . The method according to claim 10 wherein at least one of the first aqueous solution or the second aqueous solution further comprises a colorant.
15 . The method of claim 10 , wherein solution a) and solution b) are applied in a ratio of solution a) to solution b) of 1:3, 1:2, 1:1.5, 1:1, 1.15:1, or 2:1.
16 . The method of claim 15 , wherein the applied ratio of solution a) to solution b) is 1:1.
17 . The method of claim 10 further comprising applying the first aqueous solution and the second aqueous solution to the wound simultaneously without premixing.
18 . The method of claim 10 further comprising combining solution a) and solution b) to form a mixture and applying the mixture to the wound.
19 . The method of claim 17 , wherein solution a) is combined with solution b) in a ratio of 1:3, 1:2, 1:1.5, 1:1, 1.15:1, or 2:1.