Acta Pharm. 67 (2017) 159-170

 

full paper

Original research paper

 

Development and evaluation of orally disintegrating tablet containing
mosapride resin complex

TONG WU, GUANHUA WANG, CAIHONG SHI, JINGHAN LI, NA ZHAO, ZIHAO DONG, WEISAN PAN and XIANGRONG ZHANG

zhangxr@vip.sina.com

1 School of Traditional Chinese Materia Medica, Shenyang Pharmaceutical University, Shenyang 110016, P.R. China

2 School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, Liaoning Province, P.R. China

3 State Key Laboratory of Medicinal Resources, Chemistry and Molecular Engineering, Guangxi Normal University, Gui Lin 541006, P.R. China

Accepted January 15, 2018

Published online February 6, 2018

 

The purpose of this study was to prepare a mosapride citrate-resin (Amberlite IRP 88) complex and orally fast-disintegrating tablets of the resin complex. The resinate complex of mosapride-Amberlite IRP 88, weight ratio 2:1, was prepared in an ethanol-water solution. The effects of alcohol concentration, temperature, and pH of the solution on complex formation were evaluated. The complex physicochemical properties were characterized by differential scanning calorimetry, X-ray diffraction and scanning electron microscopy. Orally disintegrating tablets were prepared by direct compression and were optimized using the response surface method. Optimized orally fast-disintegrating tablets disintegrated within 18 s. The pH dependence of mosapride release from the tablet decreased drug dissolution in simulated saliva, whereas it promptly released in the pH 1.0 solution. The data reported herein clearly demonstrate that tablets containing the mosapride- Amberlite IRP 88 complex for oral disintegration could be particularly useful for patients with swallowing difficulties.

 

Keywords: mosapride citrate, Amberlite IRP 88 resin, resin complex, orally disintegrating tablet, physicochemical characterization, dissolution