PURPOSE: To obtain a high-quality and low-residue solid preparation useful as a medicine for esp. inflammatory enteropathy with its lesions inside the digestive tracts, by fluidized bed granulation of a composition containing active ingredients and a dextrin.
CONSTITUTION: A solution containing a dextrin as binder and, a 5-aminosalicylic acid compound and balsalazide compound as active ingredients, is sprayed with e.g. a spray gun and dried simultaneously into granules (fluidized bed granulation method). The granulated product is dried and sieved into the objective solid preparation. The weight ratio of the active ingredients to the dextrin is (95:5) to (70:30). In manufacturing a preparation of such a medicine for patients with lesions inside the digestive tracts, who need to suppress the use of an additive nonabsorbable to the digestive tracts to a minimum, the dextrin is only a usable additive among a number of additives because it is low in irritancy and antigen nature and has such characteristics as to be hard to left residues owing to its absorption inside the digestive tracts.
NOMURA SHIGEYUKI