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

P11-12

Studies on preformulation and efficient manufacturing process for continuous production of amiodarone tablets through AI formulation software 

  • Ju-Hyun Yoon1, Chae-Won Jeon1, 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 dosage form for continuous processing of amiodarone tablets, an antiarrhythmic drug used to treat and prevent arrhythmias. We predicted and performed a comparative evaluation of the essential preformulation results of amiodarone tablets through our self-produced AI formulation design software. In this study, transparent and equilibrium solubility tests were conducted in various solvents, and degradation was checked to confirm the compatibility between amiodarone and excipients. Additionally, flowability study was performed to predict the physical properties of API. As solubility test results, it is ‘poorly soluble’ in most solvents, but ‘soluble’ in methanol. And as a compatibility study, the interaction between API and 22 Excipients was confirmed under long-term storage conditions (25℃/60%RH) and accelerated storage conditions (40℃/75%RH) for up to 4 weeks. As a result, Sodium Stearyl Fumarate, Magnesium Carbonate, and Calcium Hydroxide were found to be incompatible excipients. As a result of the flowability study of API, Carr’s index was confirmed to be 30. When the artificial intelligence results and actual measurement results were confirmed, solubility was compared in 72% and formulation in 81%. The results of this study can be used in the development of amiodarone generic drugs, especially in designing the optimal formulation for continuous process application. It is expected that it will become basic data


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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