Amiodarone Tablet, as an orphan drug, has many problems with the supply of APIs and finished drugs due to price and quality competitiveness. To solve this problem, research for continuous production must be conducted to strengthen the unit cost competitiveness of finished pharmaceuticals. The purpose of research is to first conduct research to obtain the optimal equal dissolution pattern for continuous production during preliminary research during the development of a formulation capable of continuous production of the orphan drug amiodarone tablets. In study, we compared the dissolution pattern of Cordaron tablets, a reference drug, and found a similar dissolution pattern of more than 80% in 30 minutes. However, friability showed a high figure of 0.5%, exceeding the Maginot line. To supplement the friability, we conducted a dissolution test for the corresponding prescription at hardness levels of 4.0kp, 5.5kp, and 7.0kp. As a result, the friability was suitable when the hardness was 5.5kp and the dissolution pattern was most similar. In the stability study, a comparative evaluation of the stability of the tablets is being prepared under room temperature storage conditions (25±2℃/relative humidity 60±5%) and accelerated storage conditions (40±2℃/relative humidity 70±5%) for 6 months. This study is an important study for the treatment of arrhythmia and is expected to have great significance in the development of finished pharmaceuticals for continuous production.
2024 Spring Convention