Development of a dissolution medium for nimodipine tablets based on bioavailability evaluation.
A marked difference in the dissolution rate between two brands of nimodipine tablets was observed using a newly developed dissolution medium of pH 4.5 acetate buffer containing 0.05% sodium dodecyl sulfate (SDS). However, when pH 4.5 acetate buffer containing 0.3% SDS was used as dissolution medium, which was specified in the edition, the dissolution results of the both brands conformed to the BP requirements and no significant difference in dissolution was observed. The dissolution data obtained for two commercial brands of nimodipine tablets indicate the superiority of the proposed system as a discriminatory dissolution medium for nimodipine tablets. The relative bioavailability of the two brands of nimodipine tablets was determined in healthy adult volunteers after a single dose in a randomized crossover study. Plasma concentrations were determined by a liquid chromatography-tandem mass spectrometry method. Statistical comparison of the AUC(0-T), AUC(0- infinity), C(max), and T(max) indicated a significant difference in the two brands of nimodipine tablets.
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China. hezhgui@mail.sy.ln.cn
Zhonggui
Z
He
Dafang
D
Zhong
Xiaoyan
X
Chen
Xiaohong
X
Liu
Xing
X
Tang
Limei
L
Zhao
D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D018592:Cross-Over Studies; D004353:Drug Evaluation, Preclinical / Q000379:methods; D006801:Humans; D008297:Male; D009553:Nimodipine / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics*; D012995:Solubility / Q000187:drug effects; D013607:Tablets
D013607:Tablets; D009553:Nimodipine