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

P11-11

Comparative dissolution studies of pitavastatin-fenofibrate FDC dual-layered tablets to evaluate drug release characteristics in the body

  • Se-Eun Lee1, Do-Hyub Kim1, 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

The purpose of this study is to predict through a comparative dissolution test whether pitavastatin-fenofibrate FDC dual-layer tablet (PF-T), which is being developed for the treatment of dyslipidemia, acts equally in vivo as the existing capsules dosage form. We attempted to develop a tablet with greater stability and ease of administration compared to the existing formulation and conducted an in vitro study to secure drug release characteristics to establish drug equivalence. Comparative dissolution studies of the reference drug and the test drug were conducted in 4 test solutions (Ministry of Food and Drug Safety Notification) with pH conditions similar to those in the gastrointestinal tract. Since the API is poorly soluble, sodium lauryl sulfate, an anionic surfactant, was added to the test solution. For the test drug, three prescriptions were prepared for each type of disintegrant, and the dissolution pattern was checked, and then the ratio was adjusted using the disintegrant prescription that had the most similar dissolution pattern to the reference drug. As a final result, a prescription was obtained that had similar drug release characteristics to the reference drug in the sink condition of the 4 dissolution test solutions, and was evaluated to meet the standards for pharmaceutical equivalence. We expect a synergistic effect between the two drugs in the PF-T under development, and we think it will be an excellent medicine that will be conveniently used for patients.


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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