Sosnowska Katarzyna, Winnicka Katarzyna, Czajkowska-Kośnik Anna
Department of Pharmaceutical Technology, Medical University of Białystok, Mickiewicza 2c, 15-222 Białystok, Poland.
Acta Pol Pharm. 2009 May-Jun;66(3):321-6.
In this paper, the stability of enalapril maleate in oral formulations prepared from commercially available tablets was investigated. Extemporaneously compounded, 0.1 mg/mL and 1.0 mg/mL, oral suspensions of enalapril maleate in sugar-containing and sugar-free vehicles were stored in the absence of light at 4 degrees and 25 degrees C for 30 days. Enalapril maleate stability was quantified after 7, 14, 21, and 30 days using HPLC method. Viscosities and pH of prepared suspensions were measured on each study day and no appreciable changes from the initial pH and initial viscosities occurred in any of the samples both at 25 degrees and 4 degrees C. It was shown that all the formulations retain minimum 98% of the initial enalapril maleate concentration after 30 days of storage at 25 degrees and 4 degrees C and they may provide an option in situations where the marketed suspension is unavailable.
本文研究了马来酸依那普利在由市售片剂制备的口服制剂中的稳定性。临时配制了含0.1 mg/mL和1.0 mg/mL马来酸依那普利的含糖和无糖载体的口服混悬液，在4℃和25℃避光条件下储存30天。使用高效液相色谱法在7天、14天、21天和30天后对马来酸依那普利的稳定性进行定量。在每个研究日测量所制备混悬液的粘度和pH值，在25℃和4℃下，任何样品的初始pH值和初始粘度均未发生明显变化。结果表明，所有制剂在25℃和4℃储存30天后，仍保留至少98%的初始马来酸依那普利浓度，并且在市售混悬液无法获得的情况下，它们可能提供一种选择。
