Polonini H C, Silva S L, Cunha C N, Brandão M A F, Ferreira A O
Pharmazie. 2016 Apr;71(4):185-91.
A challenge with compounding oral liquid formulations is the limited availability of data to support the physical, chemical and microbiological stability of the formulation. This poses a patient safety concern and a risk for medication errors. The objective of this study was to evaluate the compatibility of the following active pharmaceutical ingredients (APIs) in 10 oral suspensions, using SyrSpend SF PH4 (liquid) as the suspending vehicle: cholecalciferol 50,000 IU/mL, haloperidol 0.5 mg/mL, imipramine hydrochloride 5.0 mg/mL, levodopa/carbidopa 5.0/1.25 mg/mL, lorazepam 1.0 mg/mL, minocycline hydrochloride 10.0 mg/mL, tacrolimus monohydrate 1.0 mg/mL, terbinafine 25.0 mg/mL, tramadol hydrochloride 10.0 mg/mL and valsartan 4.0 mg/mL. The suspensions were stored both refrigerated (2 - 8 degrees C) and at controlled room temperature (20 - 25 degrees C). This is the first stability study for these APIs in SyrSpend SF PH4 (liquid). Further, the stability of haloperidol,ilmipramine hydrochloride, minocycline, and valsartan in oral suspension has not been previously reported in the literature. Compatibility was assessed by measuring percent recovery at varying time points throughout a 90 days period. Quantification of the APIs was performed by high performance liquid chromatography (HPLC-UV). Given the percentage of recovery of the APIs within the suspensions, the beyond-use date of the final preparations was found to be at least 90 days for most suspensions both refrigerated and at room temperature. Exceptions were: Minocycline hydrochloride at both storage temperatures (60 days), levodopa/carbidopa at room temperature (30 days), and lorazepam at room temperature (60 days). This suggests that compounded suspensions of APIs from different pharmacological classes in SyrSpend SF PH4 (liquid) are stable.
配制口服液体制剂面临的一个挑战是，支持制剂物理、化学和微生物稳定性的数据有限。这引发了对患者安全的担忧以及用药错误的风险。本研究的目的是，使用SyrSpend SF PH4（液体）作为悬浮剂，评估10种口服混悬液中以下活性药物成分（API）的相容性：胆钙化醇50,000 IU/mL、氟哌啶醇0.5 mg/mL、盐酸丙咪嗪5.0 mg/mL、左旋多巴/卡比多巴5.0/1.25 mg/mL、劳拉西泮1.0 mg/mL、盐酸米诺环素10.0 mg/mL、一水合他克莫司1.0 mg/mL、特比萘芬25.0 mg/mL、盐酸曲马多10.0 mg/mL和缬沙坦4.0 mg/mL。混悬液分别在冷藏（2 - 8摄氏度）和控制室温（20 - 25摄氏度）下储存。这是这些API在SyrSpend SF PH4（液体）中的首次稳定性研究。此外，氟哌啶醇、盐酸丙咪嗪、米诺环素和缬沙坦在口服混悬液中的稳定性此前在文献中尚未有报道。通过在90天期间的不同时间点测量回收率来评估相容性。API的定量通过高效液相色谱法（HPLC - UV）进行。根据混悬液中API的回收率，大多数混悬液在冷藏和室温下最终制剂超过有效期的日期至少为90天。例外情况是：两种储存温度下的盐酸米诺环素（60天）、室温下的左旋多巴/卡比多巴（30天）和室温下的劳拉西泮（60天）。这表明在SyrSpend SF PH4（液体）中不同药理类别的API复方混悬液是稳定的。
