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PROCEDE DE PREPARATION DUN COLLYRE DE CICLOSPORINE A
专利权人:
CHU Clermont-Ferrand
发明人:
CHENNELL, Philip,CHIAMBARETTA, Frédéric,DELABORDE, Lucie,JOUANNET, Mireille,SAUTOU, Valérie
申请号:
EP16788156.4
公开号:
EP3355906A1
申请日:
2016.09.29
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
The invention relates to a method for preparing eye drops of cyclosporin A in the form of an emulsion, microemulsion or lipophilic/hydrophilic micellar solution in which the lipophilic and thus oily phase contains the cyclosporin A, characterised in that it comprises at least the following steps of: a) eliminating at least 99 wt% of the ethanol contained in the oily solution of cyclosporin A, under a flow of nitrogen with a pressure of 0.5 bar, at a temperature of 2 °C to 45 °C and for a time of 0.25 h to 24 h b) diluting in an aqueous solution the concentrate obtained in step a) 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) and d) sterile packaging of the obtained eye drops in packages that are suited for ophthalmic use.
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