2025 Spring International Convention of
The Pharmaceutical Society of Korea

2025 Spring
International Convention of PSK

04.21(MON) - 04.22(TUE)
D+78

Abstracts

P11-5

Optimization of formulation and dissolution study of valsartan oral dosage forms with poor disintegration to ensure bioequivalence

  • Ho-Sik Woo1, Seongung Byeon1, 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 02707, Korea

This study aims to develop an optimized formulation for valsartan oral dosage form, a antihypertensive drug, and improve its low dissolution rate. A preformulation study was conducted to evaluate the solubility of valsartan and its compatibility with excipients. Based on the results, tablets were formulated using excipients that demonstrated compatibility. Dissolution profiles were assessed under standard test conditions as well as at pH 1.2, 4.0, and 6.8. The results revealed that the tablets did not disintegrate properly, leading to a low dissolution rate. To address this issue, the proportion of the pH modifier meglumine was reduced, and the proportion of disintegrants was increased. Additionally, various disintegrants were incorporated to optimize the formulation. Dissolution testing of the formulated tablets showed that the composition containing microcrystalline cellulose, croscarmellose sodium, meglumine, copovidone VA64, and magnesium stearate exhibited the most similar dissolution profile to the reference drug. The optimized formulation demonstrated comparable disintegration time and dissolution rates under standard test conditions and at pH 1.2, 4.0, and 6.8. This study successfully optimized the formulation of valsartan oral dosage form, ensuring bioequivalence with the reference product. The findings of this study are expected to serve as fundamental data for future bioequivalence studies and scale-up processes.


Q&A

작성하기
  • There are no registered questions
TODAY 2025. 07. 09

2025 Spring Convention

D+78

Conference infomation

Conference Schedule
Apr. 21(Mon) ~ 22(Tue), 2025
Conference Venue
Daegu Exhibition & Convention Center (EXCO) 10 Exco-ro, Buk-gu, Daegu, Republic of Korea
Location
Early Registration Period
Feb. 24(Mon) ~ Apr. 14(Mon), 2025
Abstract Submission Period
Feb. 24(Mon) ~ Apr. 3(Thu), 2025
Certificate of Attendance