Study on Rolling Granulation of Valsartan Tablets
10.3969/j.issn.1008-049X.2018.06.016
- VernacularTitle:缬沙坦片的辊压干法制粒工艺研究
- Author:
Chen YAO
1
;
Yan ZHANG
Author Information
1. 解放军第161医院药剂科 武汉430022
- Keywords:
Valsartan tablets;
Rolling granulation;
Plackett-Burman experimental design;
Box-Behnken experimental design
- From:
China Pharmacist
2018;21(6):1015-1019,1036
- CountryChina
- Language:Chinese
-
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.
