Application of Novel Natural Sweetening Agent-Stevia in Formulation, Evaluation of Nicardipine Hydrochloride Orodispersable Tablets for Rapid Absorption

Abstract:

Objectives: The objective of this study was to develop a stable and effective form of an Orodispersible tablet containing Nicardipine Hydrochloride for the immediate treatment of high blood pressure and angina. The aim was to achieve this by using the natural sweetener stevia to improve taste. Background: Nicardipine Hydrochloride is used to treat high blood pressure and angina. However, currently available immediate release forms have limitations in terms of drug release and taste. Therefore, the goal was to develop an Orodispersible form of the drug that would enhance drug release and improve taste masking capabilities. Materials and Methods: We developed formulations of Nicardipine Hydrochloride Orodispersible tablets using the natural sweetener Stevia rebaudiana to enhance taste and reduce the caustic sensation. We confirmed the compatibility of the drug-excipient mixture using FTIR. Drug content and dissolution were determined through UV spectrophotometry. We also conducted organoleptic tests and other compendial specification tests. Precompression parameters were evaluated, and measures were taken to improve the flow behavior of the formulation blend by using excipients with excellent flow properties. Based on disintegration and dissolution time, we selected the F6 formulation as the optimized formula. We then subjected the developed trial to stability studies for three months, evaluating disintegration time, drug content, and dissolution. Results: The optimized formulation demonstrated a disintegration time of 46.25±0.85 sec and a dissolution rate of 100.50±2.50. Compendial tests remained stable without any significant fluctuations after the stability study. Also, the taste of the drug was pleasant after taste. Conclusion: Through the appropriate selection of excipients, we successfully developed a stable and effective form of Nicardipine Hydrochloride Orodispersible tablet with enhanced drug release (using the solid dispersion technique) and improved taste masking capabilities. The optimized formulation yielded favorable results in terms of disintegration and dissolution time, drug content, and stability.

Keywords: Orodispersable tablets, Stevia rebaudiana FTIR, UV spectrophotometry, Angina pectoris.