Preparation and Stability of Levocetirizine Hydrochloride Chewable Tablets / 中国药房

ABSTRACT

OBJECTIVE:To prepare Levocetirizine hydrochloride chewable tablets,and to investigate the stability. METH-ODSLevocetirizine hydrochloride chewable tablets were prepared with wet granulation. Using accumulative dissolution rate within 45 min as index,the formulation of Levocetirizine hydrochloride chewable tablets was optimized by orthogonal design with the in-ternal and external ratio of MCC and carboxymethyl starch sodium,the amount of magnesium stearate as factors. The dissolution rate and content uniformity of optimized tablet were verified. The appearance,dissolution rate,related substance and content change of the tablet were investigated within 10 d under the condition of high temperature(60 ℃),high light(4 500 lx)and high moisture (92.5%). RESULTS:The optimized formulation of the tablet was as levocetirizine hydrochloride 5 mg,lactose 30 mg, microcrystalline cellulose 90 mg(internal-external ratio 4∶5),mannitol 60 mg,aspartame 10 mg,carboxymethyl starch sodium 12 mg(internal-external ratio 1∶1)and magnesium stearate 1.0%. The accumulative dissolution rates of 3 batches of optimized tablet were(97.23±1.21)%,(98.49±1.28)% and(98.15±1.94)%. The content uniformity were 2.30,2.34 and 2.60. Those indicators had no significant change except related substance increased slightly under high temperature on 10th day and high moisture on 5th day. CONCLUSIONS:Levocetirizine hydrochloride chewable tablets is prepared successfully with good stability.