盐酸左米那普仑缓释胶囊剂的剂量倾泻研究

采用不同功能层处方及工艺参数制备盐酸左米那普仑缓释胶囊,通过对比其在40％乙醇介质中的释放曲线研究功能层处方及工艺因素对剂量倾泻的影响,并以自研制剂与参比制剂的释放曲线相似因子评价自研制剂发生剂量倾泻的风险.结果显示,随着包衣增重增大,剂量倾泻的程度降低;包衣液溶剂中乙醇浓度低于80％时,剂量倾泻加剧;随着雾化压力增大...

Dose dumping of levomilnacipran hydrochloride sustained-release capsules

In this study, different functional layer formulations and process parameters were used to prepare the levomilnacipran hydrochloride sustained-release capsules, the influence of functional layer formulation and process factors on dose dumping was studied by comparing their release curves in 40% ethanol; and the risk of dose dumping of the self-developed drug was evaluated by the similar factors of the release curve of the self-developed drug and the reference drug.The results showed that as the coating weight increased, the degree of dose dumping decreased; when the concentration of ethanol in the coating liquid solvent was less than 80%, the dose dumping increased; as the atomization pressure and maturation time increase, the dose dumping became more serious. In 0% ethanol (purified water), 5% ethanol, 20% ethanol and 40% ethanol media, the self-developed and reference preparations had the same degree of dose dumping within the specified time, and rotation speed had no significant effect on the release of metformin in vitro. In summary, formulation factors such as coating weight gain, ethanol concentration in the coating solution solvent, and process factors such as atomization pressure and curing time have a serious impact on the dose dumping of sustained-release capsules.Under the optimal functional layer formulation and process, special attention should be paid to the control of risk of self-developed dose dumping.