abstract |
PROCESS FOR FORMING LACTOSIS SUITABLE FOR USE IN A PHARMACEUTICAL FORMULATION. A process for forming lactose suitable for use in a pharmaceutical formulation, comprising providing a plurality of lactose particles containing no more than 10% w / w lactose particles, having an average volumetric particle size of about 70 microns or less. ; milling the plurality of lactose particles to produce a plurality of milled lactose particles, with an average particle size, (D 50), ranging from about 50 microns to about 100 microns; and classifying the plurality of milled lactose particles into at least two fractions, comprising a fine fraction and a coarse fraction, wherein the fine fraction has an average particle size, (D 50), ranging from about 3 microns to about 60 microns. 50 microns and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns. |