著者

松浦 克彦 杉山 正 片桐 義博

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.31, no.10, pp.832-838, 2005-10-10 (Released:2011-03-04)

参考文献数

15

被引用文献数

3 4

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A pharmaceutical study was carried out to evaluate the quality of five Sodium Ozagrel (OZG) injection products. The quality of these products initially and after 12 weeks and 24 weeks of accelerated stability testing was evaluated based on characteristics such as pH, foreign insoluble matter, content and impurities. One brand name injection and four generic injections were evaluated. The brand name product and one generic product were in freeze-dried form and the other three generic injections were in liquid form.The pH of one generic injection was higher than that of the others. No foreign insoluble matter was observed in any product during the period of the study. The OZG content of the freeze-dried injections was approximately equal to that indicated on the labels but that of the liquid injections was appreciably higher, one of them having at least 15 % more than the indicated content. In the accelerated stability testing, the OZG content was still around 100% of the initial content after 24 weeks, showing that it was very stable. Quaternary salts were detected in the brand name injection but the concentration was only 0.02%. The cis form of OZG was detected in one generic injection but the concentration was only 0.03%. Accelerated stability testing did not increase the quantities of these impurities. Two unknown impurities were detected in one generic injection and one of them was detected in the other three generic injections.Our study showed that there was a difference in quality between the generic injections and the brand name OZG injections in terms of pH, content and impurities, suggesting that not only cost but also quality should be considered when deciding whether to use generics or not.

著者

松浦 克彦 林 秀樹 杉山 正 片桐 義博

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.4, pp.306-313, 2006-04-10 (Released:2007-11-09)

参考文献数

20

被引用文献数

5 5

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A comparative study was carried out to evaluate the quality of one brand name tablet (A) and five generic tablets (B∼F) containing 5 mg of enalapril maleate (ENA). Tablet quality was evaluated based on such characteristics as content, impurities, dissolution profile, hygroscopic properties, and stability. In the purity test, we measured the quantities of degradation products such as diacid compound (DA) and diketopiperazine compound (DKP) and in the hygroscopicity test, the weight and hardness of the tablets without blister packaging was measured initially and after 2 weeks and 4 weeks of storage at 0%, 43%, 75% and 93% relative humidity (RH). To test stability, we measured the quantities of ENA, DA, and DKP in tablets stored without blister packaging at 40°C and 75% RH for 12 weeks.The ENA content in all preparations was approximately equal to the indicated content. Initially, DA was not detected in any of the preparations. About 0.3% DKP was detected in preparation B and C. The dissolution profiles of all generic tablets were similar to those of the brand name tablet. For preparations A, B, and D, a marked increase in tablet weight and decrease in tablet hardness was observed with increasing RH. In the stability test, the remaining ENA content in preparations A, B, and D after 12 weeks was significantly lower than the initial content. The DA content in preparations A and D had increased markedly after 12 weeks and so had the DKP content in preparation B.Our study showed that the quality of the generic tablets C, E, and F was comparable to that of brand name tablet A with respect to stability and resistance to humidity. We conclude that if generic manufacturers continue to produce such high quality drugs, this will lead to greater confidence in their effectiveness and an increase in their use in the clinical setting.