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
Affiliations
Chien-Chiao Wang
Graduate Institute of Biomedical Sciences, College of Medicine, Chang Gung University, Taoyuan City, 333, Taiwan; TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Yu-Li Chen
Research Center for Chinese Herbal Medicine, Graduate Institute of Healthy Industry Technology, College of Human Ecology, Chang Gung University of Science and Technology, Taoyuan City, 333, Taiwan
Ta-Chien Lu
TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Catherine Lee
TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Yu-Chia Chang
Research Center for Chinese Herbal Medicine, Graduate Institute of Healthy Industry Technology, College of Human Ecology, Chang Gung University of Science and Technology, Taoyuan City, 333, Taiwan
Yen-Fan Chan
Research Center for Chinese Herbal Medicine, Graduate Institute of Healthy Industry Technology, College of Human Ecology, Chang Gung University of Science and Technology, Taoyuan City, 333, Taiwan
Philip Mathew
Novum Pharmaceutical Research Inc. Toronto, ON, M1L 4S4, Canada
Xing-Rong Lin
TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Wen-Rung Hsieh
TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Ting-Yun Huang
TAHO Pharmaceuticals Ltd. Neihu Dist., Taipei City, 114, Taiwan
Hsin-Lan Huang
Research Center for Chinese Herbal Medicine, Graduate Institute of Healthy Industry Technology, College of Human Ecology, Chang Gung University of Science and Technology, Taoyuan City, 333, Taiwan
Tsong-Long Hwang
Graduate Institute of Biomedical Sciences, College of Medicine, Chang Gung University, Taoyuan City, 333, Taiwan; Research Center for Chinese Herbal Medicine, Graduate Institute of Healthy Industry Technology, College of Human Ecology, Chang Gung University of Science and Technology, Taoyuan City, 333, Taiwan; Graduate Institute of Natural Products, College of Medicine, Chang Gung University, Taoyuan City, 333, Taiwan; Department of Anesthesiology, Chang Gung Memorial Hospital, Taoyuan City, 333, Taiwan; Department of Chemical Engineering, Ming Chi University of Technology, New Taipei City, 243, Taiwan; Corresponding author. Graduate Institute of Natural Products, College of Medicine, Chang Gung University, Taoyuan, 33302, Taiwan.
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.
