Anhdyrous lactose agglomerates and the preparation thereof

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The Campina Nederland Holding B.V. patent solves the following problem:

Lactose is widely used as a filler, filler, binder or diluent in tablets and capsules, and to a more limited extent on the lyophilized products, baby food formula, and as a carrier dry powder inhaler. Worldwide, whispered put the needs of their lactose monographs in the identity and purity of pharmaceutical grade lactose, thereby distinguishing between lactose monohydrate and anhydrous lactose. According to these medicines, anhydrous lactose must have a water content of at most 1 wt%, and for that reason particularly useful as excipient in moisture-sensitive applications.

Our analysis of this patent is as follows:

Campina Nederland Holding B.V.’s patent US 8173173 B2 deals with Anhdyrous lactose agglomerates and the preparation thereof.
The invention relates to a process for the preparation of anhydrous lactose agglomerates, said process comprising (i) subjecting essentially anhydrous lactose primary particles comprising at least 60 wt% lactose crystals in a granulator to a wet step granulation in a temperature range of 30-100 C. using a binder solution, which granulation mass subjected to dry for at least part of steps granulation, and (ii ) after dry granulation mass. The anhydrous lactose agglomerates comprising at least 50 wt% -lactose crystallites and a total water content in the range of 0-1.0 wt%, required by the standards laid down by the whispers anhydrous lactose excipients. These agglomerates combine with excellent compactibility and flowability properties and particularly useful as excipient in moisture-sensitive applications.

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