Pharmaceutical Characterization And Drug Studies Of Proton Pump Inhibitors: Dexlansoprazole Vs. Omeprazole
Abstract
Proton pump inhibitors (PPIs) such as Dexlansoprazole and Omeprazole are widely used for the management of gastroesophageal reflux disease (GERD) and peptic ulcer disorder. However, their acid-labile nature demands rational preformulation strategies to ensure stability, bioavailability, and product performance. The present study focuses on the comparative pharmaceutical characterization and drug–excipient compatibility assessment of Dexlansoprazole and Omeprazole to support the development of optimized gastro-resistant oral dosage forms. Physicochemical profiling including organoleptic evaluation, melting point, pKa, solubility, and partition coefficient was performed. Solid-state characterization using FTIR spectroscopy and UV–visible spectral analysis was carried out to establish structural integrity. The results demonstrated differential physicochemical behavior between both PPIs, with Dexlansoprazole showing improved stability and solubility in alkaline media, while Omeprazole exhibited greater sensitivity to environmental stressors. Compatibility studies revealed selective excipient suitability for preserving drug integrity. The findings provide critical preformulation insights that can aid in the rational design of stable, effective, and patient-compliant gastro-resistant PPI formulations.
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