Optimization of Nisoldipine Buccal Adhesive Tablets Formulation by Orthogoral Design / 中国药房

ABSTRACT

OBJECTIVE:To optimize the formulation of nisoldipine buccal adhesive tablets. METHODS: The formulation was optimized by orthogonal design with the dosage ratio of carbopol to chitosan in drug-containing layer and protection layer, the content of lactose and the tabletting hardness as factors. The bioadhesiveness and in vitro drug release rate of the tablets was measured as well. RESULTS: The optimal formulation was as follows the ratio of carbopol to chitosan in drug-containing layer and protection layer were 22.5∶22.5 and 33.3∶16.7 mg, respectively; the dosage of lactose was 10 mg, and tabletting hardness was 5 kg. The averge bioadhesiveness of 3 bacthes of optimized preparations was 79.5 g?cm-2, and the average in vitro drug release rate of the tablets in 12 h was more than 95%. CONCLUSIONS: The optimized nisoldipine buccal adhesive tablets enjoy ideal bioadhesiveness and slow-release character.