| 摘要 |
FIELD: medicine, pharmaceutics.SUBSTANCE: group of inventions refers to pharmaceutics. The first invention refers to a method for producing carrier particles of dry powder composition for inhalation. The above composition contains a fraction of simultaneously micronised particles made of a mix of alpha-lactose monohydrate and magnesium stearate; the above mix has a mass median diameter of less than 20 mcm, and also a fraction of coarse particles of alpha-lactose monohydrate having a mass diameter from 210 to 355 mcm. The above method involves the simultaneous micronisation of particles of alpha-lactose monohydrate and magnesium stearate. That is followed by mixing the above simultaneously micronised particles with the above coarse particles of alpha-lactose monohydrate for at least four hours for spheronising them. Before mixing as specified above, the simultaneously micronised particles are conditioned first at relative humidity 50-70%, temperature 22±2°C over a period of time making 48 hours. What is also described is another method for producing a dry powder composition for inhalation, additionally involving the stage of mixing the above carrier particles with one or more active ingredients.EFFECT: group of inventions provides decreasing electrostatic charge of the particles.6 cl, 2 dwg, 6 tbl, 6 ex |
