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

P11-10

Formulation and dissolution studies of newly tyrosine kinase inhibitor tablets for bioequivalence studies

  • Seong-June Gong1, In-Bin Kang1, Hyun-Su Park1, Ho-Sik Woo1, Joo-Eun Kim*2
  • 1 Department 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

Tyrosine kinase inhibitors (TKIs) play a crucial role in the treatment of various cancers. In particular, this drug is sold as a drug that inhibits abnormal proteins produced by the abnormal chromosome, the Philadelphia chromosome. In this study, we compared the formulation and release characteristics of a new TKI formulation with those of a reference drug. Preformulation studies indicated that the drug absorption site was the upper part of the stomach and small intestine. To optimize the formulation, we conducted dissolution tests on test drugs and the reference drug in pH 1.2 and pH 4.5 solutions. By analyzing the dissolution test results, we compared the release profiles of test drugs and the reference drug. Various formulations were manufactured by altering the disintegrant ratio and coating agent. As a result of In vitro studies revealed that the final formulation, coated with hydroxypropyl methylcellulose and using sodium croscarmellose as the disintegrant, exhibited comparable release profiles and bioavailability to the reference drug. Therefore, the new TKI formulation has been established as therapeutically equivalent to the reference drug, with similar efficacy and safety expectations.


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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