A METHOD FOR PREPARING ORAL FORMULATION OF LOW DOSE ENTECAVIR

摘要

PURPOSE: A method for manufacturing an oral formulation of low dose entecavir is provided to ensure content uniformity by simple processes and to obtain the oral formulation which excellently treats HBV infection. CONSTITUTION: A method for manufacturing an oral formulation of entecavir comprises: a step of pulverizing entecavir in a particle size of 1-60 micrometer; a step of mixing 0.01-1 wt% of pulverized entecavir, 75-95 wt% of an excipient, 1-10 wt% of a binder, 1-10 wt% of a disintegrant, and 0.1-5 wt% of a lubricant and forming a pharmaceutical composition; and a step of molding the pharmaceutical composition by a direct compression method or a dry granule compression method.