| abstract |
A new spray-dried paracetamol granulate contains 0.5-3 (pref. 1-2) wt.% polyvinylpyrrolidone and 0.3 (pref. 0.5-0.2) wt.% water. It is produced by spray-drying an aq. 40-60% paracetamol suspension contg. 0.5-3 wt.% polyvinylpyrrolidone at a solvent temp. of 10-70 degrees C in a conventional atomiser. Particle size is pref. 80-200 mu. The granulate is for the prodn. of paracetamol-contg. dosage forms, e.g. tablets. The granulate has excellent tabletting properties, and has good abrasion-resistance, freedom from dust, content uniformity, mixing stability and bioavailability. Despite the absence of preservatives and humectants, the granulate shows good stability; this stability is dependent on the moisture content being below 0.3 wt.%. |