One of the objects of the invention relates to a pharmaceutical composition in the form of a granulate, wherein the granulates comprises an active pharmaceutical ingredient (API) having a poor water
solubility intimately associated with at least one pharmaceutically acceptable
sugar, and optionally or preferably at least one pharmaceutically acceptable
excipient other than the at least one pharmaceutically acceptable
sugar, wherein the active pharmaceutically ingredient has a water
solubility less than about 20 mg / ml. The at least one pharmaceutically acceptable
excipient other than the at least one pharmaceutically acceptable
sugar is selected from the group consisting of disintegrants,
wetting agents, diluents, binders, lubricants, glidants,
coloring agents and
flavoring agents. The at least one pharmaceutically acceptable sugar is preferably selected from pyranosyl pyranoses, such as
lactose. Another object of the invention relates to a process for preparing a pharmaceutical granulate, comprising (a) combining an API having poor water
solubility with a solution comprising at least one pharmaceutically acceptable sugar, for example a pyranosyl
pyranose such as
lactose, and a
solvent, and optionally at least one pharmaceutically acceptable
excipient other than the at least one pharmaceutically acceptable sugar to form a combined mixture; (b)
drying the combined mixture of step (a); and (c) comminuting the product of step (b) to obtain the granulate.