Study on the Formation Technology and Dissolution in vitro of Ibuprofen Dropping Pills / 中国药房

ABSTRACT

ABSTACT OBJECTIVE:To study the formation technology of Ibuprofen dropping pills and determine the dissolution in vitro. METHODS:Based on single factor test and with the spherical degree,drug-loading rate and pill weight variation as the evaluated indexes,response surface methodology was employed to screen the ratios of drug to matrix,drug solution temperatures and cryo-genic temperatures in the formation technology,and verification tests were conducted. The dissolution in vitro of the dropping pills prepared by the optimal technology was investigated and compared with that of the preparations sold in the market. RESULTS:The optimal formation technology of Ibuprofen dropping pills was as follows as the ratio of drug to matrix of 1∶6,drug solution temper-ature of 83 ℃ and cryogenic temperature of 7.3 ℃. In the verification tests,the self-made dropping pills demonstrated a spherical degree of 0.945 9,drug-loading rate of 99.82%,pill weight variation of 0.040 28 and drug-loading capacity of 30 mg/pill,with the actual comprehensive score of 0.972 5,deviating from the theoretical one (0.980 0) by 0.771 2%(RSD<1.5%,n=3). The dropping pills prepared had a dissolution rate of 25.36%at 5 min and an accumulated dissolution rate up to 90.12%at 30 min,sim-ilar with the Ibuprofen tablets sold in the market in drug release in vitro (f2=54.91),conforming to a first-order kinetic equation. CONCLUSIONS:The optimized formation technology is simple,stable,feasible and well reproducible,and the dropping pills which are prepared by such technology can release drug quickly.