Clomipramine Hydrochloride Sustained Release Tablets

Clomipramine hydrochloride ( CH ) was a new-style oral tricycle antidepressant widely used in the management of inherent ,reactive, nerval and latent depressive illness or all kinds of depression state. It also could be used in reducing obsessive compulsive symptoms, panic attacks and associated anxiety. It took effect quickly and safely. For plain tablets, the usual administration was 25mg 3 times daily. Frequent administrations led to fluctuation in blood concentration and high incidence of adverse effects . Therefore it was necessary to prepare a kind of sustained release preparations. Combining with other filers , a sustained release tablet (SRT) of once daily administration was prepared by using hydroxypropyl methyl-cellulose as basic matrix material.According to the literature, UV spectrophotometry was developed for the investigation of physicochemical properties, content and drug release in vitro. High-performance liquid chromatography (HPLC) was applied in the determination of plasma concentration in dogs. The method was quick and accurate which could meet the requirement of the analysis.In the preformulation studies, the drug solubility in various media was determined. The influences of formulation, manufacture process and release condition on the accumulative percent of drug release in 12 hours were investigated .Basing on the results of single-factor tests, orthogonal design test was carried out to optimize the formulation and the optimal tablet administrated once a day was screened. Stability studies of...