Philip CHENNELL,Frédéric CHIAMBARETTA,Lucie DELABORDE,Mireille JOUANNET,Valérie SAUTOU
申请号:
US15762688
公开号:
US20180296633A1
申请日:
2016.09.29
申请国别(地区):
US
年份:
2018
代理人:
摘要:
A method for preparing eye drops of cyclosporin A in the form of an emulsion, a microemulsion, or a lipophilic/hydrophilic micellar solution whose lipophilic—and hence oily—phase contains cyclosporin A, characterized in that it comprises at least the following steps:a) eliminating at least 99 wt % of the ethanol contained in the oily solution of cyclosporin A, under a flow of nitrogen under a pressure of 0.5 bar, at a temperature of from 2° C. to 45° C. and for a period of from 0.25 h to 24 h,b) diluting the concentrate obtained in step a) in an aqueous solution,c) forming an emulsion, a microemulsion, or a micellar solution in which the aqueous phase makes up at least 75% of the final emulsion, microemulsion, or micellar solution, by stirring to mix the concentrated oily solution obtained in step a) with the diluted aqueous solution obtained in step b),d) sterile packaging of the obtained eye drops in packaging that is suitable for ophthalmic use.