Quality control of metoprolol extended-release formulations in the presence of ethanol.

Q4 Medicine
Pharmeuropa bio & scientific notes Pub Date : 2010-10-01
A Amini, A Dawood, A-M Hesselgren, H Thor, S Jönsson, T Arvidsson, G Ragnarsson, M Johansson
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引用次数: 0

Abstract

This paper presents in-vitro metoprolol release from four different extended-release (ER) formulations, i.e. Metoprolol GEA® Retard, Logimax® forte, Metoprolol Sandoz® and Seloken ZOC® in the presence of 10 to 40% (v/v%) ethanol at pH 1.2 and pH 6.8. The assay of metoprolol in the dissolution media was performed by reversed phase liquid chromatography (RP-LC) using a mixture of methanol and 100 mM phosphate buffer (pH 3.5) in 40:60 ratio as eluent. The dissolution data showed that the metoprolol contents of Metoprolol Sandoz® and Seloken ZOC® were released fast in the presence of 20% ethanol at the investigated conditions, while the other products demonstrated much more stability against ethanol. Unexpectedly it was discovered that the release of metoprolol from Metoprolol GEA® Retard and to some extent also from Logimax® forte decreased in the ethanol containing media.

乙醇存在下美托洛尔缓释制剂的质量控制。
本文研究了美托洛尔GEA®Retard、Logimax®forte、美托洛尔山德士®和Seloken ZOC®四种不同缓释制剂在pH 1.2和pH 6.8条件下,在10% ~ 40% (v/v%)乙醇存在下的体外释放。采用反相液相色谱法(RP-LC)测定溶出介质中美托洛尔的含量,以甲醇与100 mM磷酸盐缓冲液(pH 3.5)以40:60的比例混合为洗脱液。结果表明,在此条件下,美托洛尔山德士®和Seloken ZOC®的美托洛尔在20%乙醇的存在下释放速度较快,而其他产品对乙醇的释放稳定性较好。出乎意料的是,在含乙醇培养基中,metoprolol GEA®Retard和Logimax®forte的美托洛尔释放量在一定程度上有所下降。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pharmeuropa bio & scientific notes
Pharmeuropa bio & scientific notes Medicine-Medicine (all)
CiteScore
0.70
自引率
0.00%
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0
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