Design and in-vitro characterization of rosuvastatin calcium floating tablets by employing response surface method

Abstract

The present study aimed to design and characterize in-vitro floating tablets of Rosuvastatin Calcium using the Response Surface Method (RSM) to enhance the gastric residence time and improve bioavailability. Floating tablets were prepared using different concentrations of hydrophilic polymers and effervescent agents. The RSM was employed to optimize the formulation variables, namely the amount of hydrophilic polymer and effervescent agent, to achieve desired tablet buoyancy and drug release profile. The tablets were evaluated for physical parameters such as hardness, friability, floating lag time, total floating time, and in-vitro drug release. The drug release kinetics followed the Higuchi model, indicating diffusion-controlled release. Based on the evaluation of floating lag time and release characteristics, formula F6 was identified as the optimal formulation. F6 demonstrated a floating lag time of 171±0.81 seconds, a floatation time of 24 hours, and an impressive cumulative drug release of 99.87%. Notably, this formulation exhibited sustained release characteristics throughout the entire release period. The RSM effectively predicted the relationship between the independent variables and the responses, and the experimental values were in close agreement with the predicted values. The study successfully demonstrated the potential of designing Rosuvastatin Calcium floating tablets using RSM. The optimized formulation showed promising results in terms of buoyancy and drug release, suggesting its potential for once-daily administration and improved patient compliance.