Enhancement of Solubility Profiles of Azelnidipine: Drug-Likeliness, Pastille Formulation, In-Vitro Drug Release Kinetics, and Evaluation Studies
Abstract
Introduction: This study aimed to enhance the solubility, a BCS class II drug with poor dissolution capacity, through pastillation methodology and a potetial startergy to imrprove its oral bioavailability. Methods: Azelnidipine pastilles were formulated using Gelucire 50/13 and Polyethylene glycol 6000 through the pastillation technique. Results: In-vitro drug release studies and stability testing were conducted.The optimized formulation (batch-VI) showed maximum drug content of 96.06%. DSC and XRD analyses confirmed the transformation of Azelnidipine from crystalline to amorphous form. The drug release profile demonstrated enhanced dissolution compared to marketed tablets. Stability studies conducted at 40°C±2°C/ 75%±5% RH for 90 days showed no significant changes in drug content and release profile. Conclusion: The pastillation method proved to be an effective approach for improving Azelnidipine’s dissolution rate and solubility. The formulation remained stable under accelerated conditions, indicating its potential as a viable oral drug delivery system.
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