Method for producing biologically ingestible material and biologically ingestible material obtained therefrom

摘要

A production method is provided for obtaining a biologically ingestible material having an intended diameter with low energy as compared with conventional methods. The method includes mixing a fluid to be processed in a dispersed phase containing a pharmacologically active substance and a fluid to be processed in a continuous phase including at least a disperse solvent, while each of the fluids is retained in an independent state, in a thin film fluid formed between two processing surfaces arranged to be opposite to each other to be able to approach to and separate from each other, at least one of which rotates relative to the other, through independent pathways corresponding to the respective phases, whereby the components contained in the fluid to be processed in a dispersed phase are formed into microparticles having a desired diameter.

主权项

1. A method for producing a biologically ingestible material which is a microemulsion particle, wherein, a fluid to be processed in a dispersed phase including an oil phase component containing an oil-soluble pharmacologically active substance, and a fluid to be processed in a continuous phase comprising at least a liquid dispersing solvent are passed through independent pathways corresponding to the respective phases while respectively being kept in an independent state, and mixed in a thin film fluid formed between two processing surfaces arranged to be opposite to each other to be able to approach to and separate from each other, at least one of which rotates relative to the other, imparting pressure to one of the fluid to be processed in the dispersed phase and the fluid to be proceed in the continuous phase by a fluid pressure imparting mechanism to form a pressure-imparted fluid;
rotating at least two processing members of a first processing member and a second processing member relative to each other by a rotation drive mechanism, wherein said two processing surfaces including a first processing surface and a second processing surface provided by the first and second processing members are disposed opposite to each other, and a first processing member has the first processing surface and a second processing member has the second processing surface, the second processing member being capable of relatively approaching to and separating from the first processing member, and each of the processing surface constitutes part of the first flow path through which the pressure-imparted fluid is passed; providing at least the second processing member with a pressure-receiving surface, wherein at least part of the pressure-receiving surface is comprised of the second processing surface; receiving, by the pressure-receiving surface, pressure applied to the mixed fluid by the fluid pressure imparting mechanism, thereby generating the force to move in the direction of separating the second processing surface from the first processing surface; including the second flow path independent of the first flow path through which the pressure-imparted fluid is passed; providing at least one opening leading to the second flow path in at least either the first processing surface or the second processing surface; introducing the other of the fluid to be processed in the dispersed phase and the fluid to be proceed in the continuous phase that is other than the pressure-imparted fluid, into between the processing surfaces through the second flow path; mixing the fluid in the dispersed phase and the fluid in the continuous phase other than the fluid in the dispersed phase uniformly between the processing surfaces to form a mixed fluid, wherein the pressure-imparted mixed fluid is passed between the first and second processing surfaces being capable of approaching to and separating from each other and rotating relative to each other, whereby the mixed fluid forms a thin film fluid with thickness equal or smaller than the space between both the processing surfaces while passing between both the processing surfaces; whereby the components contained in the fluid to be processed in the dispersed phase are formed into microparticles having a desired particle diameter; and wherein the liquid dispersing solvent used in the fluid in the continuous phase is a pharmacologically acceptable liquid and wherein said independent pathways comprises a first flow path and a second flow path, and the second flow path, which is located further radially outward from a rotation center of said two processing surfaces than the first flow path, is inclined, with respect to the two processing surfaces, at an angle more than 0° and less than 90°.