| 摘要 |
The present disclosure relates to a method for producing a composition comprising a biologically active material with an improved dissolution profile, said method comprising the steps of: dry milling a solid biologically active material, a milling aid and a millable grinding matrix in a mill, for a time period sufficient to produce particles of the biologically active material dispersed in an at least partially milled grinding matrix, wherein the particles have an average particle size falling within the range of 1– 200 µm determined on a particle number basis, wherein the average particle size of the biologically active material is reduced by less than 70% during dry milling, wherein the dissolution of the biologically active material is improved such that a dissolution concentration of X is achieved in 10-30 minutes and X is the concentration equal to the dissolution concentration of the biologically active material prior to dry milling after 60 minutes, wherein the particle size of the millable grinding matrix is reduced by the dry milling, wherein the time period sufficient is a range selected between 5 minutes and 8 hours. Also disclosed is the composition and unit dosage made by the method. |
