GB1036368A - Method for the manufacture of lactose-containing tablets - Google Patents

Abstract

Lactose, which contains at least 50% by weight beta-lactose, is prepared by drying or crystallizing a syrup or solution of lactose in water at a temperature above 200 DEG F. The preferred method comprises roll drying a syrup preprepared by dissolving in water lactose that has been recrystallized from whey concentrate, the syrup containing about 35 to 50% by weight of lactose. The syrup is fed into the bite of a double drum dryer, whose rollers are steam heated to 265 DEG to 340 DEG F., and thus dried to give a product containing about 0.3% of water, and about 75% of beta-lactose, the remainder being alpha-lactose.ALSO:Lactose-containing tablets, wherein the lactose comprises a major proportion of beta-lactose, and constitutes at least 25% by weight of the tablet, are prepared by forming a free-flowing mixture of an active ingredient and the lactose, and forming into tablets in the absence of added moisture. Suitable lactose, having a beta-lactose content of at least 50%, may be prepared by crystallising the lactose from aqueous solution, preferably a syrup, at a temperature above 200 DEG F. (e.g. by roll-drying on steam-heated rollers; see Division C2). The lactose may be colored by adding a water-soluble dye to the aqueous solution. An example is given for preparing tablets containing aspirin or soy-flour as the active ingredient, using a 75% by weight beta-lactose-containing roll-dried lactose. The tablets made from such lactose are said to be more resistant to capping and more readily water-soluble than those of the usual, mainly alpha, lactose.