Stability for 6 months and accuracy of a specific enteral caffeine base preparation for a multisite clinical trial.
Stability for 6 months and accuracy of a specific enteral caffeine base preparation for a multisite clinical trial.
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用于多中心临床试验的特定肠内咖啡因碱制剂的 6 个月稳定性和准确性。
DOI：
10.1111/bcp.15739
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发表时间：
2023
影响因子：
3.4
通讯作者：
Hunt,CarlE
中科院分区：
文献类型：
--
作者：
Erickson,Grant;McAnulty,Michael;Powers,Chelsea;Luong,Thu-Lan;Dobson,NicoleR;Hunt,CarlE
“早产儿间歇性缺氧和咖啡因（ICAF）”研究（NCT03321734）使用临时复合肠内咖啡因基础溶液作为其研究药物。本报告的主要目的是确定这种特定的肠内咖啡因基制剂储存长达6个月的稳定性，并评估最佳储存温度。为了分析稳定性，制备了咖啡因溶液，并在4°C和25°C（室温）下保存。使用高效液相色谱（HPLC）分析咖啡因浓度随时间的变化。为了确认复合咖啡因浓度的准确性，研究人员分析了来自三个研究药房的研究药物样本。稳定性结果表明，在室温下储存长达6个月时，咖啡因浓度在预期浓度的5%以内。我们的研究结果还表明，准确的咖啡因浓度是由多个研究药房实现的。
The ‘Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF)’ study (NCT03321734) uses an extemporaneously compounded enteral caffeine base solution for its study drug. The primary aim of this report is to determine the stability of this specific enteral caffeine base preparation stored for up to 6 months and assess optimal storage temperature. To analyse stability, caffeine solutions were prepared and stored at 4°C and 25°C (room temperature). The caffeine concentrations were analysed over time using high‐performance liquid chromatography (HPLC). To confirm the accuracy of compounded caffeine concentrations, study drug samples from three research pharmacies were analysed. Stability results showed that caffeine concentrations are within 5% of the expected concentration when stored for up to 6 months at room temperature. Our results also show that accurate caffeine concentrations were achieved by multiple research pharmacies.