Method for the production of commercial nanoparticle and microparticle powders
A method for using dry milling to prepare nanoparticle and microparticle powders of a biologically active material are described. The nanoparticle and microparticle powders have desirable powder handling characteristics such as good content uniformity that make them suitable for commercial manufacture of drug products.
1 . A method for producing a blend containing nanoparticles and microparticles of biologically active material characterised by content uniformity, as measured by concentration of active material, after size segregation, varies from the average content by less than 4.0%, wherein the said method comprises the steps of: dry milling a solid biologically active material, sodium lauryl sulfate and a millable grinding matrix selected from the group consisting of lactose and mannitol in a mill comprising a plurality of milling bodies, for a time period sufficient to produce a blend characterised by content uniformity after size segregation, varies from the average content by less than 4.0% and comprising particles of the biologically active material having a median particle size, determined on a particle volume basis less than 1,000 nm dispersed in an at least partially milled grinding material.