Objective:To develop a novel type of levetiracetam(LEV)unidirectional release controlled-release tablet.Methods:Solid dispersion particles were prepared by solvent-melting layer method,and a double layer core was obtained.The top surface of the protective layer was pasted with a protective film,the core was coated using impregnation method,and the protective film was torn off to obtain the bottom and side-coated LEV unidirectional drug release controlled release tablets.Taking the cumulative release rate in vitro as the evaluation index,the prescription technology was investigated,and the in vitro drug release model was fitted.Results:The final formulation was as follows:Drug layer:LEV 250 mg,octadecanol 62.5 mg,magnesium stearate 6.25 mg,tablet hardness 6 kg;Protective layer:lactose 200 mg;Coating layer:the coating solution was 10%EC M70 ethanol solution,and the weight gain percentage of the coating is 10%.The cumulative release rate of LEV controlled-release tablets was more than 90%after 12 h in vitro,and the release behavior was in accordance with zero-order release model.Conclusion:The formulation and preparation process of LEV controlled-release tablets is simple and feasible,and the in vitro drug release is slow and stable,which accords with the ideal characteristics of controlled-release tablets.
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