Background: Lercanidipine hydrochloride (HCl) is a poorly soluble calcium channel blocker limiting its oral bioavailability and therapeutic efficacy. Increasing its dissolution rate through appropriate formulation methods is essential for improved clinical outcomes.
Methodology: Solid dispersions of lercanidipine HCl were developed using hydrophilic carriers poloxamer 188, polyethylene glycol 6000, and polyvinylpyrrolidone K30 by solvent evaporation and fusion techniques at different drug-to-carrier ratios. Dispersible tablets were formulated from these solid dispersions, and optimization was performed using a 23 factorial design under Quality by Design principles. Characterization was conducted using FTIR, DSC, XRD, and dissolution studies, along with evaluation of tablet physical parameters such as content uniformity, hardness, friability, and disintegration time.
Results: Solid state analyses confirmed successful drug incorporation into carriers without significant interaction or loss of stability. Among formulations, poloxamer 188 (1:1 ratio) yielded the highest drug dissolution rate. The optimized tablet exhibited 99.98 % drug release within 45 min, fast disintegration (1-2 min), and satisfactory mechanical strength. Statistical analysis (ANOVA, p = 0.0113) indicated sodium starch glycolate and sodium lauryl sulfate as key variables influencing outcomes.
Conclusions: Solid dispersion strategies and factorial design optimization markedly improved the dissolution and disintegration properties of lercanidipine HCl tablets. These findings suggest practical approaches for formulation of fast-dissolving oral lercanidipine preparations that can enhance patient benefit and pharmaceutical quality.
Keywords: Solid dispersion; solubility; PEG 6000; poloxamer 188; polyvinyl pyrolidone (PVP K30); lercanidipine HCl; Design of Experiment.
How to cite this article: Swain S, Mahapatra AK, Sahu A, Panigrahi R; Integrated Solubility Enhancement and Tablet Formulation of Lercanidipine Hydrochloride Using Design of Experiments. Int J Drug Deliv Technol. 2026;16(1): 337-344. DOI: 10.25258/ijddt.16.1.36