Development of Release Control Formulations of Dexlansoprazole and Pharmacokinetic Evaluation
Abstract
This study focused on enhancing dosage convenience and simplifying the manufacturing process by dosage form change from traditional pellets to tablets of Dexlansoprazole. The prepared formulations were systematically evaluated for efficacy through a compatibility test that selected stable excipients for use with amorphous dexlansoprazole. Formulations with varying release patterns were evaluated by changing excipient ratios. The delayed-release formulation, incorporating a sustained release agent, exhibited an inability to mimic the absorption profile observed in the control drug pellet formulations. In contrast, an immediate release formulation’s dissolution pattern manifested absorption levels comparable to those of the control drug. The pharmacokinetic evaluation in beagle dogs to assess equivalence to the conventional double delayed release pellet formulation showed that the AUCt of the immediate release formulation had a confidence interval of 0.7318 to 1.1511 and the Cmax had a confidence interval of 0.8117 to 1.4609, indicating that the lag time could be increased by increasing the enteric coating percentage, which could further delay the Tmax and slow the dissipation rate,
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