Mansourian Mercedeh, Dijkers Eli, Silva Carolina C V, Polonini Hudson C
Fagron BV, 3065 WB Rotterdam, The Netherlands.
Pharmaceutics. 2023 Sep 26;15(10):2388. doi: 10.3390/pharmaceutics15102388.
The present study aimed to evaluate the stability of active pharmaceutical ingredients (APIs) from different pharmacological classes in a compounded oral suspending vehicle. Oral suspensions of amoxicillin trihydrate (50 mg/mL), clozapine (25 mg/mL), indomethacin (5.0 mg/mL), levodopa/carbidopa (10.0/2.5 mg/mL), levothyroxine sodium (T4, 25 µg/mL), lomustine (4.0 and 10.0 mg/mL), methyldopa (25 mg/mL) and procarbazine (10.0 mg/mL) were formulated in SyrSpend SF PH4 and the stability was monitored for up to 90 days, except for amoxicillin trihydrate, which was evaluated for 30 days only. The APIs' stability was determined by measuring percent recovery using stability-indicating high-performance liquid chromatography (HPLC or UHPLC) or titration (amoxicillin trihydrate only). The stability of amoxicillin trihydrate, clozapine, indomethacin and levodopa/carbidopa were studied at both refrigerated (2-8 °C) and room temperature (20-25 °C). Lomustine, procarbazine, and methyldopa were studied at refrigerated temperature only. Our data demonstrated promising stability for the compounded suspensions containing various APIs, investigated in SyrSpend SF PH4, as all APIs exhibited stability throughout the study duration and met content uniformity criteria. These findings lead to the conclusion that the tested compounded oral suspensions present a viable approach for creating personalized, age-appropriate formulations. The capacity to ensure dose consistency and stability using APIs from diverse pharmacological classes renders them suitable choices for both pediatric and geriatric patients.
本研究旨在评估不同药理类别的活性药物成分(API)在复方口服混悬剂中的稳定性。将三水合阿莫西林(50 mg/mL)、氯氮平(25 mg/mL)、吲哚美辛(5.0 mg/mL)、左旋多巴/卡比多巴(10.0/2.5 mg/mL)、左甲状腺素钠(T4,25 μg/mL)、洛莫司汀(4.0和10.0 mg/mL)、甲基多巴(25 mg/mL)和丙卡巴肼(10.0 mg/mL)的口服混悬剂用SyrSpend SF PH4配制,并监测其长达90天的稳定性,三水合阿莫西林除外,其仅评估30天。通过使用稳定性指示高效液相色谱法(HPLC或UHPLC)或滴定法(仅三水合阿莫西林)测量回收率来确定API的稳定性。在冷藏(2-8°C)和室温(20-25°C)下研究了三水合阿莫西林、氯氮平、吲哚美辛和左旋多巴/卡比多巴的稳定性。仅在冷藏温度下研究了洛莫司汀、丙卡巴肼和甲基多巴。我们的数据表明,在SyrSpend SF PH4中研究的含有各种API的复方混悬剂具有良好的稳定性,因为所有API在整个研究期间均表现出稳定性,并符合含量均匀度标准。这些发现得出结论,所测试的复方口服混悬剂是创建个性化、适合年龄的制剂的可行方法。使用来自不同药理类别的API确保剂量一致性和稳定性的能力使其成为儿科和老年患者的合适选择。