Study on Rolling Granulation of Valsartan Tablets / 中国药师

ABSTRACT

Objective: To prepare valsartan tablets and optimize the parameters of rolling granulation process. Methods: The par-ticle size (D50, Y1/μm), tablet hardness (Y2/N), and 30-min drug dissolution (Y3/%) as the evaluation indices, the critical process variables were studied by Plackett-Burman experiment design firstly, and then Box-Behnken response surface method was used to optimize the parameters of rolling granulation process. Results: Plackett-Burman experimental design showed that the rolling pressure and mesh size had significant effect on the granule size (P<0. 05). The rolling pressure, rolling nip and mesh size had significant effect on the tablet hardness (P<0. 05). The optimum rolling parameters based on Box-Behnken response surface method were as fol-lows the rolling pressure was 30 bar, the rolling nip was 3. 0 mm and the mesh size was 2. 0 mm. Valsartan tablets had good compres-sibility and high drug dissolution, which was similar to the in vitro dissolution profile of commercial reference preparations. Conclu-sion The experimental designs to optimize the rolling granulation process of valsartan tablets can improve the controllability of the prod-uct quality.