Campina Melkunie B.v.

Dmv Campina B.v.

Henricus A Van Den Biggelaar

Klaas Daniel Kussendrager

Michael M Meggelaars

Herman Vromans

A tableting excipient for making tablets by direct tableting in the form of a homogeneous mass consisting of a dried solution of lactose having a high .beta.-lactose content, to which solution 1-15 wt. % of a sugar alcohol, calculated on the solids of the solution to be dried, has been added prior to drying.

Tableting excipient

The invention relates to a spray dried lactose suitable for use as component of tablets and to a process for preparing same. The lactose is predominantly crystalline and contains at most 50% by weight of amorphous lactose. At least 50% by weight of the crystalline lactose consists of particles below 50 .mu.m. The preparation process comprises a step of suspending crystalline alpha-lactose hydrate at 0.degree.-90.degree. C. in a saturated lactose solution, and a spray drying step. The temperature of the suspension is kept substantially constant until the time of spray drying in order to minimize crystallization and dissolution events.

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Veghel, Netherlands

Henricus A Van Den Biggelaar