The purpose of this study is to develop a generic amiodarone drug as an arrhythmia treatment that can be continuous manufacturing by applying design of experiments (DoE). Amiodarone, an orphan drug, is currently in short supply due to inconsistent production and supply due to cost issues, and is currently designated as a national essential public drug. We have conducted research on amiodarone formulations that could be continuous produced through the DoE technique. We have used minitab 21 version, a design of experiment(DoE) software, and used binder and hardness as factor factors as the input variable X value. At this time, three types of binders were designed: copovidone, povidone K25, and povidone K90, and the hardness was designed in three ranges of 4.0kp, 5.5kp, and 7.0kp. As CQAs, four response factors (Y) were selected: dissolution, disintegration, friability, and assay. Using the design space and reaction optimization tool, the 5.5kp (hardness) tablet using povidone K90 (binder) showed a similar dissolution rate as the reference drug at tween 80 1% pH 4.0 and the similarity factor value (f2) was over 71.6, ensuring equivalence. In addition, the friability result was less than 0.25%, meeting the quality standards for finished pharmaceuticals. Through the experimental design method, we were able to efficiently save cost and time by enabling multivariate testing, unlike the existing approach of studying a single variable.
2024 Spring Convention