Patent ID: 8501236

Claim:
A method for producing a crystalline tableting lactose additive, which method comprises: (a) providing a spray dried tableting additive in particulate form which particles at least partially consist of amorphous lactose and at least partially of crystalline lactose; and (b) converting the amorphous lactose into crystalline lactose by subjecting the particles for a time less than 10 minutes and under continuous agitation by a fluid bed device to a temperature T between 30° C. and 100° C. at a relative humidity between (i) a maximum of 60% and (ii) a minimum defined by the formula % relative humidity=218−47*Ln(T(° C.), or 25%, whichever is greater, wherein 5-20% of the total crystalline lactose obtained is in the form of β-lactose and wherein crystalline tableting lactose additive is substantially free of amorphous material.