Ferreira Anderson O, Polonini Hudson C, Loures da Silva Sharlene, Cerqueira de Melo Victor Augusto, de Andrade Laura, Brandão Marcos Antônio Fernandes
Ortofarma-Quality Control Laboratories, Matias Barbosa, MG, Brazil. anderson@ortofarma.
Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.
Int J Pharm Compd. 2017 May-Jun;21(3):255-263.
The objective of this study was to evaluate the stability of 10 commonly used active pharmaceutical ingredients compounded in oral suspensions using an internationally used suspending vehicle (SyrSpend SF PH4): alprazolam 1.0 mg/mL, atropine sulfate 0.1 mg/mL, glutamine 250.0 mg/mL, levofloxacin 50.0 mg/mL, metoprolol tartrate 10.0 mg/mL, nitrofurantoin 2.0 mg/mL, ondansetron hydrochloride 0.8 mg/mL, oxandrolone 3.0 mg/mL, pregabaline 20.0 mg/mL, riboflavin 10.0 mg/mL. All suspensions were stored at both controlled refrigeration (2°C to 8°C) and controlled room temperature (20°C to 25°C). Stability was assessed by measuring the percent recovery at varying time points throughout a 90-day period. Active pharmaceutical ingredients quantification was performed by high-performance liquid chromatography via a stability-indicating method. Given the percentage of recovery of the active pharmaceutical ingredients within the suspensions, the beyond-use date of the final products (active pharmaceutical ingredients + vehicle) was at least 90 days for all suspensions with regard to both temperatures. This suggests that the vehicle is stable for compounding active pharmaceutical ingredients from different pharmacological classes.
本研究的目的是使用一种国际通用的助悬剂（SyrSpend SF PH4）评估10种常用活性药物成分在口服混悬液中的稳定性：阿普唑仑1.0 mg/mL、硫酸阿托品0.1 mg/mL、谷氨酰胺250.0 mg/mL、左氧氟沙星50.0 mg/mL、酒石酸美托洛尔10.0 mg/mL、呋喃妥因2.0 mg/mL、盐酸昂丹司琼0.8 mg/mL、氧雄龙3.0 mg/mL、普瑞巴林20.0 mg/mL、核黄素10.0 mg/mL。所有混悬液均在控制冷藏（2°C至8°C）和控制室温（20°C至25°C）下储存。通过在90天内不同时间点测量回收率来评估稳定性。活性药物成分的定量通过高效液相色谱法采用稳定性指示方法进行。鉴于混悬液中活性药物成分的回收率，所有混悬液在两种温度下最终产品（活性药物成分+助悬剂）的有效期至少为90天。这表明该助悬剂对于配制来自不同药理类别的活性药物成分是稳定的。
