GALLARATE, Marina,PEIRA, Elena,BATTAGLIA, Luigi Sebastiano
申请号:
EPEP2014/051812
公开号:
WO2015/007398A1
申请日:
2014.01.30
申请国别(地区):
WO
年份:
2015
代理人:
摘要:
A method for preparing solid lipid nanoparticles containing antibodies, comprising the steps of: (a) preparing a micellar solution comprising: from 0.02 mg/ml to 10 mg/ml of at least one anionic surfactant selected from the group consisting of alkylphosphates, alkylsulfates and alkylsulfonates from 0.1% to 30% by weight on the total weight of the micellar solution of at least one alkaline soap from 0.1% to 30% by weight on the total weight of the micellar solution of at least one non-ionic amphiphilic polymer selected from the group consisting of partially hydrolyzed polyvinyl acetate, polyoxyethylene/polyoxypropylene copolymers, polyacrylamides, polyvinylpyrrolidone and derivatives thereof, dextrane derivatives and agarose derivatives with various molecular weights, cellulose derivatives, non-ionic rubbers, cyclodextrins and derivatives thereof said micellar solution being prepared by means of the following steps: (i) solubilizing in water the at least one anionic surfactant (ii) adding the at least one alkaline soap, heating to a temperature comprised between 35°C and 90°C and (iii) adding the at least one non-ionic amphiphilic polymer (b) adding to the micellar solution prepared in step (a) a solution that contains at least one antibody of interest at a concentration comprised between 0.1 mg/ml and 10 mg/ml with respect to the final solution resulting from step (b) (c) adding to the solution obtained in step (b) at least one acid at a concentration comprised between 0.01M and 5M with respect to the final solution resulting from step (c) (d) cooling in an ice bath the suspension obtained in step (c) down to ambient temperature.Linvention concerne un procédé de préparation de nanoparticules lipidiques solides contenant des anticorps, qui comprend les étapes consistant à : (a) préparer une solution micellaire comprenant de 0,02 mg/ml à 10 mg/ml dau moins un tensioactif anionique, sélectionné dans le groupe constitué par des alkylphosphates, des alkylsulfates et des