DIFLUPREDNATE EMULSION COMPOSITION CONTAINING ANTIMICROBIAL METAL
The present invention provides a difluprednate emulsion composition showing immediate effectiveness of preservative efficacy. The immediate effectiveness of preservative efficacy is achieved by adding an antimicrobial metal (excluding zinc). The present invention also provides a method of conferring immediate effectiveness of the preservative efficacy to an emulsion composition comprising difluprednate, the method includes preparing an emulsion composition comprising difluprednate and an antimicrobial metal (excluding zinc).
1 . An emulsion composition comprising difluprednate and an antimicrobial metal (excluding zinc).
2 . The emulsion composition according to claim 1 , wherein the antimicrobial metal (excluding zinc) is a salt or complex of an antimicrobial metal (excluding zinc).
3 . The emulsion composition according to claim 2 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a salt or complex of at least one antimicrobial metal selected from the group consisting of silver and copper.
4 . The emulsion composition according to claim 3 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a silver salt or silver complex.
5 . The emulsion composition according to claim 4 , wherein the silver salt or silver complex is at least one selected from the group consisting of silver nitrate, silver protein and phytic acid silver complex.
6 . The emulsion composition according to claim 4 , wherein the silver salt or silver complex has a silver ion concentration of not less than 0.00005 (w/v) % and not more than 0.6 (w/v) %.
7 . The emulsion composition according to claim 4 , wherein the silver salt or silver complex has a silver ion concentration of not less than 0.0005 (w/v) % and not more than 0.01 (w/v) %.
8 . The emulsion composition according to claim 3 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a copper salt or copper complex.
9 . The emulsion composition according to claim 8 , wherein the copper salt or copper complex is copper sulfate.
10 . The emulsion composition according to claim 8 , wherein the copper salt or copper complex has a copper ion concentration of higher than 0.0001 (w/v) % and not more than 0.5 (w/v) %.
11 . The emulsion composition according to claim 8 , wherein the copper salt or copper complex has a copper ion concentration of not less than 0.0005 (w/v) % and not more than 0.01 (w/v) %.
12 . (canceled)
13 . A method of conferring immediate effectiveness of preservative efficacy to an emulsion composition comprising difluprednate, the method comprising preparing an emulsion composition comprising difluprednate and an antimicrobial metal (excluding zinc).
14 . The method according to claim 13 , wherein the immediate effectiveness of preservative efficacy is a decrease in the viable cell count by 3 log or more within 24 hr after inoculation.
15 . The method according to claim 13 , wherein the immediate effectiveness of preservative efficacy is a decrease in the viable cell count by 3 log or more within 24 hr after inoculation and a decrease in the viable cell count by 2 log or more within 6 hr after inoculation.
16 . The method according to claim 13 , wherein the antimicrobial metal (excluding zinc) is a salt or complex of an antimicrobial metal (excluding zinc).
17 . The method according to claim 16 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a salt or complex of at least one antimicrobial metal selected from the group consisting silver and copper.
18 . The method according to claim 17 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a silver salt or silver complex.
19 . The method according to claim 18 , wherein the silver salt or silver complex is at least one selected from the group consisting of silver nitrate, silver protein and phytic acid silver complex.
20 .- 21 . (canceled)
22 . The method according to claim 17 , wherein the salt or complex of the antimicrobial metal (excluding zinc) is a copper salt or copper complex.
23 . The method according to claim 22 , wherein the copper salt or copper complex is copper sulfate.
24 .- 26 . (canceled)