CONCENTRATED AQUEOUS AND/OR ETHANOLIC SOLUTION OF 4-METHYLPYRAZOLE (FOMEPIZOLE)
A composition of matter comprising fomepizole and water wherein the content of water is about 3% to about 40% by weight, and methods of making fomepizole solutions effective to reduce the freezing point of pure fomepizole to less than about 18° C.
1 . A composition of matter comprising fomepizole and water wherein the content of water is about 3% to about 40% by weight.
2 . A composition of matter comprising fomepizole and ethanol wherein the amount of ethanol is about 4% or more by weight.
3 . A composition of matter comprising fomepizole, water, and ethanol, wherein the content of ethanol is about 0.1% by weight.
4 . The composition of claim 1 containing about 18% by weight water and about 82% by weight fomepizole.
5 . The composition of claim 1 wherein the water is present at an equimolar ratio to the fomepizole.
6 . The composition of claim 1 , wherein the amount of water is effective to reduce the freezing point of pure fomepizole to less than about 18° C.
7 . The composition of claim 2 , wherein the amount of ethanol in the mixture is effective to reduce the freezing point of pure fomepizole to less than about 18° C.
8 . The composition of claim 3 , wherein the combined amounts of water and ethanol are effective to reduce the freezing point of pure fomepizole to less than about 18° C.
9 . The composition of claim 3 wherein the water is present at an equimolar ratio to the fomepizole.
10 . The composition of claim 4 wherein the water is present at an equimolar ratio to the fomepizole.
11 . The composition of claim 6 , wherein the amount of water is effective to reduce the freezing point to less than about −6° C.
12 . A method for making an injectable solution of fomepizole, comprising the steps of (a) providing a concentrated solution comprising fomepizole and at least one of water or ethanol effective to reduce the freezing point of pure fomepizole to less than about 18° C., and (b) diluting the concentrated solution with water containing sodium chloride or dextrose effective to make an injectable solution.
13 . A method for making a concentrated solution of fomepizole having a reduce freezing point, comprising admixing fomepizole with ethanol, and at least 3% by weight of water, or a combination thereof.
14 . The method of claim 13 , wherein the freezing point is reduced to about 18° C.
15 . The method of claim 14 , wherein the freezing point is reduced to about 0° C.
16 . The method of claim 14 , wherein the freezing point is reduced to about −6° C.
17 . The method of claim 14 , wherein the freezing point is reduced to about −9° C.