Volume 4, Issue10
Formulation development and in-vitro evaluation of Nifedipine sublingual tablets using mesoporous silica
Author: Prathusha P, Bhargavi L, Belsen David J, Yogesh Choudhary, Upendra Reddy K, Ajith Patil, Fred Monsuur
Abstract: The objective of the study was to develop and optimize sublingual tablets of Nifedipine for the treatment of angina and hypertension. The solubility of Nifedipine was improved by solid dispersion. FTIR studies confirmed the absence of drug-excipients interactions. Eight formulations (F1-F8) of sublingual tablets were prepared by direct compression method using various concentrations of superdisintegrant and diluents. The formulated tablets were evaluated for hardness, thickness, weight variation, friability, wetting time; in-vitro dispersion time, water absorption ratio, drug content, disintegration time and the results were within USP limits. Formulation F8 showed shorter wetting time 22 sec, in-vitro dispersion time of 41 sec and disintegration time 1 min 45 sec and so it was selected as the optimized formulation. F8 showed 88 folds increase in solubility and in vitro-dissolution at 10 min compared to pure Nifedipine and 10 fold increase compared to marketed oral Nifedipine tablets. The drug releases from the sublingual tablets follow Higuchi release kinetics and diffusion was the main mechanism for drug release. Optimized formulation (F8) was found to be stable from stability studies.
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