Preparation of Diclofenac Lysine Sustained-release Tablets and Investigation of the Stability / 中国药房

ABSTRACT

AIM： On the basis of in vitro study， a preliminary survey of the stability of diclofenac lysine sustained-release tables(DLST) was carried out to identify the period of validity.METHODS： To observe the changes of DLST under high temperature， blaze， high humidity and room temperature(for long period) and to perform accelerating test for 3 months.RESULTS： The drug release was accelerated under high temperature， and the tablet was apt to absorb moisture because of its hydrophilic matrix and the drug release became faster at day 10 under blaze， and therefore DLST should be stored away from high temperature， high humidity and blaze.CONCLUSION： DLST is stable and the period of validity is tentatively fixed at 2 years.