Method for preparing an effervescent granulate comprising iron gluconate, granulate thus obtained and tablets containing the same

摘要

A method for preparing an effervescent granulate comprising ferrous gluconate as pharmacologically active ingredient, and citric acid and sodium bicarbonate as effervescent system, by means of wet granulation in a fluid-bed granulator, wherein the said method comprises the steps of I) feeding a mixture comprising ferrous gluconate, citric acid and sodium bicarbonate into the said granulator which is simultaneously fed with a flow of air heated to about 70 DEG C and having a moisture content of <1.0 g/kg; II) wetting the said mixture with nebulized water when this mixture has reached a temperature of about 35 DEG C; III) evaporating off the nebulizing water, while keeping the temperature of the said mixture substantially constant at 35 DEG C; IV) repeating steps II and III until a granulate with the desired features is obtained; and V) drying the said granulate with air heated to about 80 DEG C until its moisture content is