Formulation Design of Amiodarone Hydrochloride Tablets Optimized for a Continuous Manufacturing Process

Background: Amiodarone hydrochloride is an antiarrhythmic agent, primarily classified as a Vaughan Williams Class III antiarrhythmic agent, used for the treatment and prevention of arrhythmia and designated as an essential national drug. Recently, the need to develop formulations suitable for continuous manufacturing, which is gaining significant attention in the pharmaceutical industry, has emerged. Objective: The objective of this study was to evaluate the formulation potential of amiodarone hydrochloride for the development of an oral tablet, with a specific focus on improving the initial dissolution rate to design a formulation optimized for continuous manufacturing. Methods: The primary physicochemical properties of amiodarone hydrochloride were predicted and subsequently validated through experimental characterization. Furthermore, the ratios of the binder and granulation liquid were optimized to facilitate robust and successful production via continuous manufacturing. Results: A new amiodarone hydrochloride tablet formulation, optimized for a continuous wet granulation process, was successfully developed by improving the initial dissolution rate through the optimization of the respective amounts of binder and granulation liquid. Conclusions: The optimal formulation design established in this research provides a critical foundation for enhancing the applicability of a continuous process in the manufacturing of amiodarone hydrochloride tablets.