Patent ID: 6495160
Filing Date: 2002-12-17
Classification: A61K

Abstract:
A process for the preparation of a biphasic multicomponent pharmaceutical composition consisting of an oil phase and a water phase wherein the composition comprises:one or more lipophilic or oil carrier; one or more hydrophilic or aqueous carrier; one or more ionic or nonionic surfactant; one or more cosurfactant; and one or more active principle for pharmaceutical use, wherein said composition further comprises a compound able to modify the partition of the active principle between said phases, selected from the group consisting of N-methyl pyrrolidone (NMP), &bgr;-cyclodextrin, hydroxypropyl &bgr;-cyclodextrin and dimethyl &bgr;-cyclodextrin, the preparation process comprising the following steps: a) maintaining a mixture consisting of the lipophilic or oil carrier, the cosurfactant and a fraction of the surfactant under mild stirring and temperature control; b) adding the hydrophilic or aqueous carrier to the mixture of step a) while maintaining the mild stirring and the temperature control; c) adding the compound able to modify the partition of the active principle to one of the two phases before the mixing, according to its miscibility with the aqueous or oil phase; d) adding the residual fraction of surfactant; e) adding the active principle, in dissolved and/or dispersed form, to the composition already constituted.