Geiger Christine M, Sorenson Bridget, Whaley Paul
Int J Pharm Compd. 2015 Sep-Oct;19(5):420-7.
The stability of 10 active pharmaceutical ingredients was studied in SyrSpend SF PH4 or SyrSpend SF Alka at room and/or refrigerated temperature (2°C to 8°C). An oral suspension of each active pharmaceutical ingredient was compounded in low actinic plastic bottles at a specific concentration in SyrSpend SF PH4 or SyrSpend SF Alka. Samples were assessed for stability immediately after preparation (day 0) followed by storage at room temperature and/or at refrigerated temperature. At set time points, the samples were removed from storage and assayed using a high-performance liquid chromatographic stability- indicating method. The active pharmaceutical ingredient was considered stable if the suspension retained 90% to 110% of the initial concentration. Furosemide was stable for at least 14 days in SyrSpend SF Alka at refrigerated conditions. Prednisolone sodium phosphate in SyrSpend SF PH4 was stable for at least 30 days at room temperature and refrigerated conditions. Ranitidine hydrochloride suspensions in SyrSpend SF PH4 at room temperature and refrigerated conditions were stable for at least 30 days and 58 days, respectively. Hydrocortisone hemisuccinate and sodium phosphate retained greater than 90% for at least 60 days at both room temperature and refrigerated samples in SyrSpend SF PH4. Amiodarone hydrochloride and nifedipine suspensions at both room temperature and refrigerated conditions retained greater than 90% of the initial concentrations for at least 90 days in SyrSpend SF PH4. Refrigerated samples of simvastatin in SyrSpend SF PH4 were stable for at least 90 days. Spironolactone in SyrSpend SF PH4 at room temperature retained more than 90% of the initial concentration for at least 90 days. Phenobarbital in SyrSpend SF PH4 retained above 90% of initial concentration for at least 154 days at room temperature. This study demonstrated the stability of a wide range of frequently used active pharmaceutical ingredients, tested in SyrSpend SF PH4 and SyrSpend SF Alka at different storage conditions.
在室温及/或冷藏温度（2°C至8°C）下，研究了10种活性药物成分在SyrSpend SF PH4或SyrSpend SF Alka中的稳定性。每种活性药物成分的口服混悬液在低光化塑料瓶中以特定浓度配制于SyrSpend SF PH4或SyrSpend SF Alka中。制备后立即（第0天）对样品进行稳定性评估，随后在室温及/或冷藏温度下储存。在设定的时间点，从储存中取出样品，使用高效液相色谱稳定性指示方法进行测定。如果混悬液保留了初始浓度的90%至110%，则认为活性药物成分是稳定的。速尿在SyrSpend SF Alka中冷藏条件下至少稳定14天。SyrSpend SF PH4中的泼尼松龙磷酸钠在室温及冷藏条件下至少稳定30天。SyrSpend SF PH4中的盐酸雷尼替丁混悬液在室温及冷藏条件下分别至少稳定30天和58天。SyrSpend SF PH4中的氢化可的松半琥珀酸酯和磷酸钠在室温及冷藏样品中至少60天内保留率大于90%。SyrSpend SF PH4中的盐酸胺碘酮和硝苯地平混悬液在室温及冷藏条件下至少90天内保留了初始浓度的90%以上。SyrSpend SF PH4中辛伐他汀的冷藏样品至少稳定90天。SyrSpend SF PH4中的螺内酯在室温下至少90天内保留了初始浓度的90%以上。SyrSpend SF PH4中的苯巴比妥在室温下至少154天内保留了初始浓度的90%以上。本研究证明了多种常用活性药物成分在不同储存条件下于SyrSpend SF PH4和SyrSpend SF Alka中测试时的稳定性。
