ORAL CONTROLLED RELEASE ONE-LAYERED FORMULATION CONTAINING TIANEPTINE SODIUM AND A PREPARATION METHOD THEREOF

摘要

PURPOSE: A controlled release single layer formulation for oral administration containing tianeptine sodium and a method for manufacturing the same are provided to control release rate of a drug and to be administered once a day. CONSTITUTION: A controlled release single layer formulation for oral administration contains 100 parts by weight of tianeptine sodium as an active ingredient, and 10-100 parts by weight of a hydrophilic matrix. In a dissolution test by buffer transition method, the release rate of the formulation is 30-50 wt% and 80-100 wt% in 2 hours and 20 hours later, respectively. The formulation is a single layer. A method for manufacturing the formulation comprises the steps of mixing 100 parts by weight of tianeptine sodium and 10-100 parts by weight of the hydrophilic matrix and granulating; and tableting the granule and obtaining a tablet. [Reference numerals] (AA) Example 3; (BB) Comparative example 1 (stablon tablet)