ジェネリック医薬品の品質評価（1）―イコサペント酸エチル製剤における官能試験および成分分析試験―

概要

論文の詳細を見る
The overall quality of generic drugs (GE) was assessed by sensory evaluation (questionnaire survey) taken by the patient side, a composition analysis by the pharmacist side, and a questionnaire by medical manufacturers, using an icosapentaenoic acid ethyl ester (EPA-E) product. In the sensory evaluation, the original product was superior to the two other GEs in terms of the ease of finding the wrappings cutting point and its opening and external cutting points. In addition, there were GE products with a peculiar odor, which had residual beads (grain) in several wrappings. According to an analysis of the capsules odors and surface cleaning solutions, the odor was attributed to the raw material itself adhering to the capsule surfaces during the manufacturing process, and/or by the deterioration of the capsules during the manufacturing period. The result of the stress test also supported this conclusion. The total dioxin content in the original product was extremely low compared to any other GE product. Questionnaires to manufacturers showed that all supplied product information for medical personnel and patients via various media, and were striving to innovate and improve the quality retention of the wrapping. It also emerged that GEs were not always superior to the original product, whereas it is expected that GE manufacturers will provide products that improve on the original drugs for the convenience of patients.
日本医療薬学会の論文