General considerations on the pharmaceutical research in the development of enteric coated generic formulations for proton pump inhibitors
At present,enteric coated preparations are increasingly used for drugs.Based on the past evaluation experience and reference to research literature,this article mainly focuses on the formulation process,quality research,stability,and other aspects of enteric coated preparations for proton pump inhibitors.We also propose general considerations for pharmaceutical research,and pay attention to the study of dose-elution,similarity of dissolution curves and in vitro comparative studies involving nasogastric tube administration.Based on the above discussions,we hope to provide a reference for the development and registration application of such generic drugs.
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