著者

木村 康浩 柴田 ゆうか 小豆原 結佳 土井 穂波 木平 健治

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.32, no.7, pp.667-672, 2006-07-10 (Released:2007-11-09)

参考文献数

6

被引用文献数

9 11

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Very little information is available on the quality of generic products. In this regard, it has recently been reported that several adverse reactions, among them angialgia and phlebitis, occurred when generic versions of injectable ritodrine hydrochloride products were used in pregnant patients and that these adverse reactions subsided when the generic products were switched to the original product. This suggests that the generic products contained impurities that caused the adverse reactions. It is therefore essential to determine the constituents of generic products and compare them with those of the original product.On doing this for the original and generic ritodrine hydrochloride products using high performance liquid chromatography, we found that 4 out of the 8 generics examined contained significantly higher amounts of impurities than the original product. In addition, it seemed that the generics contained unidentified impurities that were not present in the original product. For the other four generics, there was no difference in the proportion of impurities between them and the original product. These results suggest that there can be a great difference in quality between the original product and some generics. We must therefore choose generics based on quality information to minimize unpredictable adverse reactions so that more cost effective therapy may be achieved.In the present study, we obtained information on the quality of a particular group of generic products, but we feel it is necessary to gather information on more generic products to ensure safety when using them.

著者

木村 康浩 大浜 修 土井 穂波 柴田 ゆうか 木平 健治

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.6, pp.573-577, 2008 (Released:2009-09-04)

参考文献数

6

被引用文献数

5 4

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Very little information is available on the quality of generic products and it has recently been reported that anaphylaxy shock occurred when a generic formulation of an injectable cefazolin sodium product was used in a patient before surgery.This suggests that the generic product contained impurities that caused such an adverse reaction.It is therefore important to determine the constituents of generic products and compare them with those of the original products.We analyzed the original cefazolin sodium product and 4 generics of it by means of high performance liquid chromatography in order to determine differences in quality between them.Three impurities were found in the original product and 4 in the generic products,respectively.However,the impurity content of all of the generic products was significantly higher than that of the original product and on analyzing synthetic samples of impurities which could possibly be contained in the cefazolin sodium products,the chromatographic peaks of three of them overlapped with the peaks observed in the chromatograms of the original and generic products.These results suggest that there can be great differences in quality between the original and generic products,and that the impurities might be cefazolin-related substances.We must therefore select generics based on an appraisal of the quality information available for them in order to minimize unexpected adverse reactions and achieve more cost effective and safe therapy.

著者

木村 康浩 大浜 修 土井 穂波 柴田 ゆうか 木平 健治

出版者

日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.34, no.6, pp.573-577, 2008-06-10

被引用文献数

4

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Very little information is available on the quality of generic products and it has recently been reported that anaphylaxy shock occurred when a generic formulation of an injectable cefazolin sodium product was used in a patient before surgery. This suggests that the generic product contained impurities that caused such an adverse reaction. It is therefore important to determine the constituents of generic products and compare them with those of the original products. We analyzed the original cefazolin sodium product and 4 generics of it by means of high performance liquid chromatography in order to determine differences in quality between them. Three impurities were found in the original product and 4 in the generic products, respectively. However, the impurity content of all of the generic products was significantly higher than that of the original product and on analyzing synthetic samples of impurities which could possibly be contained in the cefazolin sodium products, the chromatographic peaks of three of them overlapped with the peaks observed in the chromatograms of the original and generic products. These results suggest that there can be great differences in quality between the original and generic products, and that the impurities might be cefazolin-related substances. We must therefore select generics based on an appraisal of the quality information available for them in order to minimize unexpected adverse reactions and achieve more cost effective and safe therapy.