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

P11-9

Formulation study of pitavastatin and fenofibrate FDC dual-layered tablets using artificial intelligence drug formulation program

  • Do-Hyub Kim1, Se-Eun Lee1, Nam-Joo Kim1, 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

In this study, we developed a fixed-dose combination (FDC) tablet of pitavastatin and fenofibrate used to treat dyslipidemia using our own artificial intelligence (AI)-based formulation design program. The AI program was utilized to investigate the physicochemical properties of pitavastatin and determine the optimal ratio of disintegrants and binders that would shown a dissolution profile similar to the reference drug. The AI program predicted 12 physicochemical properties of pitavastatin (solubility, log P, pKa, M.W., etc.) based on the SMILES (simplified molecular input line entry system) of the API, with a comparison accuracy of 82.3%. The design space (DS) of the disintegrant and binder ratio was established for optimal formulation design, and the dissolution profile was confirmed to be equivalent to that of the reference drug through experiments. The predicted DS and the DS obtained through the experimental design method showed a 85% agreement. This study demonstrated the potential of AI programs to predict the physicochemical properties of drugs and identify the ratio of disintegrants and binders that result in a dissolution profile similar to the reference drug, which is crucial in the formulation design of FDC tablets. Furthermore, it was verified that the use of deep learning-based AI models can be an effective tool to accelerate and improve the formulation development process by 75%.


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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