Design and Optimization of PEG 6000-Based Lovastatin Solid Dispersion and Development of Orodispersible Tablets for Enhanced Dissolution

Background: Lovastatin, a BCS Class II drug, exhibits poor aqueous solubility and dissolution-limited bioavailability, which may reduce therapeutic effectiveness. Solid dispersion using hydrophilic carriers is an effective approach to enhance solubility and dissolution. Orodispersible tablets (ODTs) further improve patient compliance and provide rapid drug release. Aim: The present study aimed to develop and optimize lovastatin solid dispersions using PEG 6000 and formulate the optimized dispersion into ODTs for improved dissolution and potential bioavailability. Method: Solid dispersions were prepared by fusion method and optimized using Central Composite Design by studying temperature, stirring speed, and drug addition rate on drug content, drug release, and dissolution efficiency. The optimized formulation was characterized using FTIR. The optimized solid dispersion was formulated into ODTs by direct compression and evaluated for physicochemical properties, dissolution, release kinetics, and stability. Results: The optimized formulation at 69.99°C and 499.38 rpm showed 99.23% drug content, 96.52% drug release, and 84.67% dissolution efficiency (desirability 0.904). FTIR confirmed absence of interaction, while DSC showed amorphous conversion. ODTs showed acceptable parameters with rapid disintegration (27 sec) and drug release (96.21% at 30 min). Drug release followed first-order kinetics with Fickian diffusion. Stability studies confirmed formulation stability. Conclusion: The developed ODTs significantly improved dissolution and may enhance oral bioavailability of lovastatin.