Design and evaluation of oral formulation for apixaban

Chien Chiao Wang, Yu Li Chen, Ta Chien Lu, Catherine Lee, Yu Chia Chang, Yen Fan Chan, Philip Mathew, Xing Rong Lin, Wen Rung Hsieh, Ting Yun Huang, Hsin Lan Huang, Tsong Long Hwang*

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

3 Scopus citations

Abstract

Non-valvular atrial fibrillation (NVAF) is a common form of cardiac arrhythmia that affects 1–1.5% of adults and roughly 10% of elderly adults with dysphagia. Apixaban is an anticoagulant referred to as a factor Xa inhibitor, which has been shown to reduce the risk of stroke and systemic embolism in cases of NVAF. Our objective in the current study was to formulate an orally disintegrating film to facilitate the administration of apixaban to elderly patients who have difficulty swallowing. Researchers have used a wide variety of cellulose-based or non-cellulose-based polymers in a variety of combinations to achieve specific characteristics related to film formation, disintegration performance, drug content, in vitro drug release, and stability. One of the two formulations in this study was specify that bioequivalence criteria met with respect to Cmax of the reference drug (ELIQUIS®) in terms of pharmacokinetic profile. Further research will be required to assess the applicability of orodispersible films created using colloidal polymers of high and low molecular weights to other drugs with poor solubility in water.

Original languageEnglish
Article numbere18422
Pages (from-to)e18422
JournalHeliyon
Volume9
Issue number8
DOIs
StatePublished - 08 2023

Bibliographical note

© 2023 The Authors.

Keywords

  • Apixaban
  • Non-valvular atrial fibrillation (NVAF)
  • Oral disintegrating film
  • Pharmacokinetics

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