Characterization of enteric-coated erythromycin tablets by Raman mapping and its pharmaceutical evaluation

Frontiers in Chemistry

Chemistry

Wanhui Liu¹  Wenbo Zou²  Changqin Hu³ 

[1] Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), School of Pharmacy, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, China;Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), School of Pharmacy, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, China;National Institutes for Food and Drug Control, Beijing, China;National Institutes for Food and Drug Control, Beijing, China;

关键词: Raman mapping;    coating formulation;    coating thickness;    dissolution;    enteric coated tablets;   

DOI  :  10.3389/fchem.2023.1270737

 received in 2023-08-01, accepted in 2023-10-09,  发布年份 2023

来源: Frontiers

【 摘 要 】

Enteric tablet coating thickness is a critical quality attribute of the coating process that can affect dissolution behavior in vitro as well as release in vivo. Raman mapping offers unique advantages in analyzing the distribution of active pharmaceutical ingredients and excipients in formulations. In this study, Raman mapping was used to characterize the coating of enteric-coated erythromycin tablets coated by two different processes and compare the differences in their coating formulation, thickness, and uniformity. Furthermore, we aimed to select the appropriate pH of the dissolution medium at which the coating slowly cracks to release the drug and determine the dissolution profile. The differences in the coating thickness and uniformity of the two products resulted in differences in dissolution behavior. Although there are differences in the coating processes for the two types of enteric-coated erythromycin tablets, the thickness of the outer coating on the side is a critical quality attribute in both processes. The outer coating of product A is relatively thick, and the thickness of the outer coating on the side affects the dissolution amount. The outer coating of product B is relatively thin, resulting in a short cracking time and large variation and a significant difference in the initial dissolution amounts between tablets. Raman mapping can be used to analyze the differences in coating formulations and for process evaluation.

【 授权许可】

Unknown   
Copyright © 2023 Zou, Liu and Hu.