2024 Spring International Convention of
The Pharmaceutical Society of Korea

2024 Spring
International Convention of PSK

04.17(WED) - 04.19(FRI)
D+28

Abstracts

P11-5

Preliminary research for continuous manufacturing to resolve supply shortage of orphan drug Amiodarone tablet

  • Chae-Won Jeon1, Ju-Hyun Yoon1, Ji-Yoon Lee1, Joo-Eun Kim*2
  • 1Department of Biopharmaceutical Chemistry, Kookmin University, Seoul, Republic of Korea. 02707
  • 2 Biopharmaceutical Chemistry Major, School of Applied Chemistry, Kookmin University, Seoul, Republic of Korea. 02707

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.


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TODAY 2024. 05. 17

2024 Spring Convention

D+28

Conference infomation

Conference Schedule
Apr. 17(Wed) ~ 19(Fri), 2024
Conference Venue
BPEX (Busan Port International Exhibition & Convention Center) Busan Metropolitan City, Republic of Korea
Location
Early Registration Period
Feb. 20(Tue) ~ Apr. 3(Wed), 2024
Abstract Submission Period
Feb. 20(Tue) ~ Apr. 3(Wed), 2024
Certificate of Attendance