Opthalmic solutions
A method of preventing a lowering of concentration of a prostaglandin derivative, the prostaglandin derivative being 16-phenoxy-15-deoxy-15,15-difluoro-17,18,19,20-tetranorprostaglandin F2 α isopropyl ester, the prostaglandin derivative being contained in an ophthalmic solution as an active ingredient. The method including (i) adding to the ophthalmic solution a nonionic surfactant to inhibit the prostaglandin derivative from being adsorbed to a container which contains the ophthalmic solution, the container being made of a resin and (ii) adding to the ophthalmic solution an antioxidant to inhibit decomposition of the prostaglandin derivative.
1 . A method of preventing a lowering of concentration of a prostaglandin derivative, the prostaglandin derivative being 16-phenoxy-15-deoxy-15,15-difluoro-17,18,19,20-tetranorprostaglandin F2 α isopropyl ester, said prostaglandin derivative being contained in an ophthalmic solution as an active ingredient, comprising (i) adding to the ophthalmic solution a nonionic surfactant to inhibit the prostaglandin derivative from being adsorbed to a container which contains the ophthalmic solution, the container being made of a resin and (ii) adding to the ophthalmic solution an antioxidant to inhibit decomposition of the prostaglandin derivative.
2 . The method as claimed in claim 1 , wherein the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60.
3 . The method as claimed in claim 1 , wherein the antioxidant is ethylenediaminetetraacetic acid, a salt thereof or dibutylhydroxytoluene.
4 . The method as claimed in claim 1 , wherein the resinous container is made of a material which comprises polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
5 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %.
6 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; and the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative.
7 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; and the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.005 to 0.5 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00005 to 0.001 weight %.
8 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; and the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.05 to 0.1 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00005 to 0.0005 weight %.
9 . The method as claimed in claim 1 , wherein the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; and the antioxidant is ethylene diaminetetraacetic acid, a salt thereof or dibutylhydroxytoluene.
10 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.005 to 0.5 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.0005 to 0.001 weight %.
11 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.01 to 0.1 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00005 to 0.0005 weight %.
12 . The method as claimed in claim 1 , wherein the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
13 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
14 . The method as claimed in claim 1 , wherein the antioxidant is ethylenediaminetetraacetic acid, a salt thereof or dibutylhydroxytoluene; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
15 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.005 to 0.5 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00001 to 0.001 weight %; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
16 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.01 to 0.1 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00005 to 0.0005 weight %; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
17 . The method as claimed in claim 1 , wherein the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the antioxidant is ethylenediaminetetraacetic acid, a salt thereof or dibutylhydroxytoluene; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
18 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.005 to 0.5 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00001 to 0.001 weight %; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
19 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80 or polyoxyethylene hydrogenated castor oil 60; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.01 to 0.1 weight % or dibutylhydroxytoluene in a concentration in the ophthalmic solution of 0.00005 to 0.0005 weight %; and the resinous container is made of a material comprising polyethylene, polypropylene, polyethylene terephthalate or polyethylene naphthalate.
20 . The method as claimed in claim 1 , wherein the prostaglandin derivative is in a concentration in the ophthalmic solution of 0.00005 to 0.05 weight %; the nonionic surfactant is polysorbate 80; the nonionic surfactant is in a concentration in the ophthalmic solution of at least five times that of the prostaglandin derivative; the antioxidant is ethylenediaminetetraacetic acid or a salt thereof in a concentration in the ophthalmic solution of 0.01 to 0.1 weight %; and the resinous container is made of a material comprising polypropylene.
21 . The method as claimed in claim 1 , wherein the ophthalmic solution is an aqueous solution.
22 . The method as claimed in claim 21 , wherein the ophthalmic solution has a pH of 3 to 8.
23 . The method as claimed in claim 21 , wherein the ophthalmic solution has a pH of 4 to 7.