Processes for making lactose utilizing pre-classification techniques and pharmaceutical formulations formed therefrom

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The Dmv-Fonterra Excipients Technology Gmbh, , Glaxo Group Limited patent solves the following problem:

In the field of inhalation therapy, it is generally desirable to use therapeutic molecules having a particle size (ie, diameter) in the range of 1 to 10 m. carrier molecule or excipients, such as lactose, canine therapeutic preparation also includes significantly larger diameter particles (for example, 100 to 150 m) which are not normally penetrate into the upper respiratory tract to the same degree as the active ingredient. In general, it is better to use a smaller particle size for the lactose or a lactose blend having a defined ratio of coarse and fine lactose.

Our analysis of this patent is as follows:

Dmv-Fonterra Excipients Technology Gmbh, , Glaxo Group Limited’s patent US 9365905 B2 deals with Processes for making lactose utilizing pre-classification techniques and pharmaceutical formulations formed therefrom.
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 with a number average the particle size of about 70 microns or less; stands the plurality of lactose particles to yield a plurality of milled lactose particles with an average particle size, (D50), from 50 micron to 100 micron; and classifying the plurality of milled lactose particles at least two pieces consisting of a fine particle and a coarse particle in which the fine particle has an average particle size, (D50), from 3 microns to 50 microns, and the coarse particle has an average particle size, (D50), from 40 micron to 250 micron.

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