Patent ID: 9365905
Filing Date: 2016-06-14
CPC Classification: A61K,A61P,C07H,C13K

Claim Text:
1. A process for forming lactose composition suitable for use in a pharmaceutical formulation, said process comprising: providing a plurality of lactose particles containing no more than 10% w/w of lactose particles having a volume average particle size of about 70 microns or less, wherein said plurality of lactose particles are present as crystalline lactose; milling the plurality of lactose particles to yield a plurality of milled lactose particles with an average particle size, (D50), ranging from about 50 microns to about 100 microns; classifying said 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, (D50), ranging from 10 microns to 30 microns, and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns; and combining a portion of the coarse fraction with a portion of the fine fraction to form a lactose composition consisting of the fine fraction and the coarse fraction; wherein said step of providing a plurality of lactose particles containing no more than 10% w/w of lactose particles having a volume average particle size of about 70 microns or less comprises obtaining said plurality of lactose particles by classifying crystalline lactose into two fractions comprising: (i) a fine fraction and (ii) said plurality of lactose particles containing no more than 10% w/w of lactose particles having a volume average particle size of about 70 microns or less.