PROCESS FOR PRODUCING DRUG GRANULES CONTAINING BRANCHED AMINO ACIDS

摘要

A granulation process whereby granules having a grain size falling in an appropriate range can be stably and highly efficiently produced in the granulation step for producing granules containing three branched amino acids, i.e., isoleucine, leucine and valine as the principal agents. This process is characterized in that the amount of water for kneading to be used in kneading in the extrusion granulation step is calculated in accordance with the following formula. Amount of water for kneading (% by weight based on powder) = (-0.25xD[50]+A) x (1.1-B/13.1). A: a numerical value of from 48 to 53; D[50]: the average grain size of branched amino acid materials expressed in the median diameter ( mu m) showing the accumulative 50% in logarithmic normal distribution of the grain size distribution on the volume basis; and B: the content of hydroxypropylcellulose (% based on branched amino acids), 0.5 ≤ B ≤ 5.