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

P11-6

​ A formulation studies of optimizing Amiodarone by applying DoE approach

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

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.


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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