Preparation and in vitro/in vivo evaluation of a pantoprazole sodium drug-resin liquid delayed release suspension.

Pak J Pharm Sci

College of Pharmacy, Anhui University of Chinese Medicine, Hefei, PR China/Yangtze Delta Drug Advanced Research Institute, Nantong, PR China/Jiangsu University, Zhenjiang, PR China/Jiangsu Haizhihong Biopharmaceutical Co., Ltd, Nantong, PR China.

Published: March 2024

A drug-resin liquid delayed-release suspension of pantoprazole sodium (PAZ-Na) was prepared to improve the effectiveness, convenience and safety of peptic ulcer treatment in children, the elderly and patients with dysphagia. Pantoprazole sodium drug-resin complexes (PAZ-Na-DRC) were prepared using the bath method. The fluidized bed coating method is used to coat it and then add excipients to make a dry suspension prepared before use. The parameters of the in vitro release experimental conditions were optimized and the drug release curve showed delayed release. Rats were given commercial PAZ-Na enteric-coated pellet capsules and the PAZ-Na delayed release suspension via intragastric administration. The results showed that the T of the PAZ-Na delayed release suspension was increased from 2h to 4h compared with the PAZ-Na enteric-coated pellet capsules. Similarly, the C was reduced from 6.162μg/mL to 3.244μg/mL with the concentration-time curve is very gentle compared with the commercial drug capsules. After oral administration, the relative bioavailability of PAZ-Na delayed release suspension (AUC of 19.578 μg•h•mL) compared with the commercial drug (AUC of 17.388 μg•h•mL) was 112.67%. The findings showed that the PAZ-Na delayed release suspension for oral administration was successfully formulated with highly improved pharmacokinetic indices.

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