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首页> 外文期刊>Journal of pharmaceutical sciences. >Effects of deaeration methods on dissolution testing in aqueous media: A study using a total dissolved gas pressure meter.
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Effects of deaeration methods on dissolution testing in aqueous media: A study using a total dissolved gas pressure meter.

机译:脱气方法对水性介质中溶出度测试的影响:使用总溶出气体压力计的研究。

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摘要

Dissolution testing is a critical method for the determination of pharmaceutical product quality and bioequivalence. For some products, dissolved gases in the dissolution medium affect dissolution results thus requiring degassing of the medium prior to use. In this study, we use a total dissolved gas and oxygen meter to measure both oxygen and total gases in dissolution media before and after application of a variety of deaeration methods. Dissolution testing results using a 10 mg Prednisone tablet (NCDA #2) are compared with the percent saturation of oxygen and total gases found in the medium. Reaeration of the medium during different stirring rates was also measured. This study confirms that measurement of total gases and not just oxygen in the medium is necessary to assess adequacy for dissolution testing. For those deaeration techniques that are performed at room temperature, the percent saturation of the total dissolved gases must be well below 100% to prevent outgassing once medium is brought to dissolution test method temperature, typically 37 degrees C. (c) 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95: 1606-1613, 2006.
机译:溶出度测试是确定药品质量和生物等效性的关键方法。对于某些产品,溶解介质中的溶解气体会影响溶解结果,因此需要在使用前对介质进行脱气。在这项研究中,我们在使用各种脱气方法之前和之后使用总溶解气体和氧气计来测量溶解介质中的氧气和总气体。将使用10 mg泼尼松片(NCDA#2)的溶出度测试结果与介质中发现的氧气和总气体的饱和百分比进行比较。还测量了在不同搅拌速率下的介质通气。这项研究证实,测量介质中的总气体而不只是氧气对于评估溶出度测试是否必要是必要的。对于在室温下进行的那些脱气技术,一旦将介质置于溶解度测试方法的温度(通常为37摄氏度)下,总溶解气体的饱和度百分比必须远低于100%,以防止脱气。(c)2006 Wiley-Liss ,Inc。和美国药剂师协会J Pharm Sci 95:1606-1613,2006。

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