Nifedipine Oral Disintegration Tablet: Design, Optimization, Invivo-pharmacokinetic and Stability Studies

Abstract

Nifedipine has a bioavailability of 45-56 percent and a 2-hour elimination half-life. It has a 50 percent kidney excretion rate and a 5-15 percent bile excretion rate. The intention of this research is to invent and evaluate Nifedipine loaded ODT and to prove the enhancement of bioavailability. The 2³ factorial optimization design exposed about the outcome of independent variable on dependent variable throughout the formulation of Nifedipine ODT. From the records, it was accomplished that there was a good correlation between Disintegration time, Dissolution rate and super disintegration concentration. The formulation F4 (Nifedipine ODT) has achieve the goal of ODT drug delivery with desired release characteristics, cost-effective, decreased dose, effective administration and hence improved patient compliance. The invivo pharmacokinetic studies reveals that increase in AUC_0-∞; decrease in Tmax; increase in Cmax in Nifedipine ODT shows better bioavailability and faster duration of therapeutic action than marketed Nifilat^® dosage form. Nifedipine ODT was stable at various temperature, humidity conditions and there was no drastic change in evaluation parameters. That it was concluded that Oral dispersible tablet (ODT) was a suitable dosage form to enhance the solubility at the same time the bioavailability of BCS class II drugs like Nifedipine.