abstract |
A process for preparing a nanosuspension of a poorly soluble drug with an improved bioavailability, said method comprises: a) stirring the drug, which has been micronized, in an aqueous solution of polymeric excipient in the absence of surfactants; and b) passing the concentrate obtained in step a) through a high shear microfluidizer processor to obtain the nanosuspension c) diluting the concentrate obtained in step b) immediately before administration with a diluent comprising one or more agents surfactants, where the poorly soluble drug is cyclopropyl-N- {2 - [(1S) -1- (3-ethoxy-4-methoxyphenyl) -2- (methylsulfonyl) ethyl] -3-oxoisoindoline-4-yl} carboxamide or (+) - {2- [1- (3-Ethoxy-4-methoxyphenyl) -2-methylsulfonylethyl] -4-acetylaminoisoindoline-1,3-dione}, and wherein the aqueous polymeric excipient solution comprises HPMC E5. |