Acta Pharm. 68 (2018) 441-455
Original research paper
Preparation and characterization of a
novel aqueous dispersion for enteric coating of pantoprazole
sodium pellets
MIN HAN, QIN YU, XUERONG LIU, FUQIANG HU and HONG YUAN
hufq@zju.edu.cn, yuanhong70@zju.edu.cn
1 College of
Pharmaceutical Sciences, Zhejiang University, 866 Yuhangtang
Road, Hangzhou 310058, China
2 Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd., Hangzhou 310011,
China
Accepted June 19, 2018
Published online July 16,
2018
The purpose of this work was to investigate a novel aqueous dispersion (Eudragit® L100-55) for enteric coating of drugs. Three different casting solutions, Eudragit® L100-55 aqueous dispersion, Eudragit® L100-55 organic solution, and Eudragit® L30D-55 aqueous dispersion, were used to prepare free films by the casting method. Drug-loaded pellets, prepared by the extrusion-spheronization method, were coated with one of these three coating solutions using the fluidized-bed spray coating technology. Properties of the free films were thoroughly investigated. Films formed by Eudragit® L100-55 aqueous dispersions showed similar properties to those formed by Eudragit® L100-55 organic solution regarding thermodynamic properties, moisture permeability, solubility and acid tolerance ability. Furthermore, the performance of the novel film was better than that formed by Eudragit® L30D-55 aqueous dispersion. Among the three enteric coating solutions, Eudragit® L100-55 aqueous dispersion will be a promising aqueous dispersion for enteric coating and can be used in the development of enteric-coated preparations.
Keywords: preparation of aqueous dispersion; Eudragit®L100-55;
Eudragit®L30D-55; free films; enteric-coated pellets; acid tolerance ability