Abstract
This investigation aimed to develop and assess gastro-retentive effervescent tablets containing Atorvastatin and Aspirin, utilizing the effervescent floating mechanism to enhance drug delivery within the stomach. The study encompassed pre-formulation investigations, tablet formulation, and comprehensive tablet evaluations. The drug evaluation phase confirmed the physical characteristics of Atorvastatin and Aspirin, establishing their suitability for pharmaceutical formulation. Identification tests through FTIR and UV-Visible spectroscopy provided critical data on these drugs' absorbance wavelengths and melting points. Moreover, solubility tests indicated the drugs' behavior in various solvents and buffer solutions, essential for formulation considerations. Pre-formulation studies focused on powder blend properties, revealing excellent flowability and compressibility. The angle of repose, bulk density, tapped density, Carr's index, and Hausner's ratio collectively demonstrated the powder blend's suitability for tablet manufacturing. Physio-chemical evaluations of the tablets demonstrated uniform weight, suitable hardness, and low friability, attesting to their robustness and ease of handling. Additionally, the tablets exhibited significant swelling in an acidic medium, a short floating lag time, and sustained buoyancy for over 8 hours, contributing to controlled drug release. In-vitro dissolution studies revealed sustained drug release profiles, following various kinetic models. The release mechanism involved both zero-order and Higuchi square root of time release rate constants, indicative of effective control over drug release for up to 12 hours. Stability studies on the optimized formulation, F8, showed no significant changes in drug content and percentage drug release over 180 days, confirming its long-term stability. In summary, this research successfully formulated gastro-retentive effervescent tablets of Atorvastatin and Aspirin, which exhibited favorable flow properties, physiochemical attributes, sustained drug release, and long-term stability. These findings hold great promise for improving drug delivery systems, enhancing bioavailability, and enabling targeted drug delivery within the gastric environment.