Application of Flow-Through Dissolution Method for the Evaluation of Oral Formulations of Nifedipine

Autor: Gilles Caillé, I. J. McGilveray, V. Yu, S. A. Qureshi, R. Brien, G. Piccirilli
Rok vydání: 1994
Předmět:
Zdroj: Drug Development and Industrial Pharmacy. 20:1869-1882
ISSN: 1520-5762
0363-9045
DOI: 10.3109/03639049409050214
Popis: The drug release characteristics of three oral formulations (one conventional and 2 extended-release) of nifedipine were evaluated using a flow-through apparatus. The experiments were conducted for 4 to 24 hours using water or phosphate buffer (0.05 or 0.1 M; pH 7.4) with or without solubilizing agent, Tween, as a dissolution medium at a flow rate of 12.5 mL/min. The drug concentrations were determined using an HPLC method based on ratios of peak heights corresponding to UV absorbances at 254 nm for nifedipine and nitrendipine (internal standard). Dissolution characteristics in various media correspond to the nifedipine solubility in the medium. Peak nifedipine concentrations with 0.05 M phosphate buffer containing 0.5% Tween were significantly higher than those in the medium without Tween (21.5±1.0 vs 8.3±0.2 μg/mL, p c 0.001). Using a 0.05 M phosphate buffer with no Tween, the products tested showed distinct dissolution profiles representative of the respective formulation type. The conventional...
Databáze: OpenAIRE