Consistency Evaluation Of Omeprazole Enteric-coated Capsules

The Omeprazole enteric-coated capsule is one of the 289 products in this consistency evaluation plan.In principle,it is necessary to complete the re-evaluation by the end of 2018.The previous research showed that there were significant differences in the quality between generic and reference products,and there were high-risk in the safety and effectiveness.In view of this,the marketed Prilosec^?capsule（20 mg;Astra Zeneca;USA;enteric-coated granules in capsule）was selected as a reference-listed-drug,to launch a quality and efficacy consistency evaluation for the generic product.The consistency evaluation of Omeprazole enteric-coated capsules in-cludes quality consistency and bioequivalence between the generic and the reference products.By the research of analytical method validation（such as related substances,assay and dissolution）,the intial quality of the reference product and dissolution method in various mediums in vitro,established a quality consistency evaluation method,which included critical quality attributes,impurity profiles,stability and dissolution profiles.This approach can guide pharmaceutical development of the generic product and evaluate pharmaceutical equivalence.Pharmacokinetic studies were conducted and key pharmacokinetic endpoints such as AUC and C_maxwere used to determin bioequivalence of two products in healthy volunteers under the fasting conditions.The results show that the generic product is pharmaceutically equiva-lent and bioequivalent to the reference product both in vitro and in vivo.Therefore,the consistency evaluation method established in this paper can be uesd as a technical means for the development of Omeprazole en-teric-coated capsules,to ensure that the quality and efficacy are consistent with the reference product.