Processes for making lactose utilizing pre-classification techniques and pharmaceutical formulations formed therefrom
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United States of America Patent
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Jun 14, 2016
Grant Date -
Feb 19, 2009
app pub date -
Feb 6, 2006
filing date -
Feb 10, 2005
priority date (Note) -
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Abstract
A process for forming lactose suitable for use in a pharmaceutical formulation comprises 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; 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; 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, (D50), ranging from about 3 microns to about 50 microns, and the coarse fraction has an average particle size, (D50), ranging from about 40 microns to about 250 microns.
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