Background

Cenobamate is a new, Food and Drug Administration (FDA)-approved oral antiepileptic drug for treatment of focal seizures in adults. This study examined recovery of cenobamate from suspensions administered through ex vivo enteral feeding tubes.

Methods

Suspensions containing 100 and 200 mg of cenobamate were prepared (five duplicates for each dose), passed through five vertically standing tubes, and collected into flasks. The flasks containing the suspensions were rinsed with deionized water, and this content was also injected into the tubes and collected in the flasks. Acetonitrile, isopropyl alcohol, and trifluoroacetic acid were added to the flasks, followed by deionized water to a concentration of 500 (100-mg cenobamate) and 400 (200-mg cenobamate) µg/mL. A 3-mL aliquot from each suspension was placed into a 10-mL flask, diluted to volume, and mixed, resulting in final concentrations of 150 and 120 µg/mL, respectively. All suspensions were analyzed by high-performance liquid chromatography (LC). The % LC recovery of cenobamate was calculated for each suspension, and mean % LC for duplicates.

Results

The % LC recovery of cenobamate from the 100-mg suspensions ranged from 96.2 to 99.1%, with mean % LC recovery between 96.3 and 98.3%. The % LC recovery of cenobamate from the 200-mg suspensions ranged from 97.1 to 102.6%, with mean % LC recovery between 98.5 and 101.7%.

Conclusion

The mean % LC recovery of cenobamate was within the predetermined acceptable range of 90.0–110.0%, suggesting no adhesion or adsorption of cenobamate to enteral feeding tubes. Delivery of cenobamate suspension via enteral feeding tubes may be a viable route of administration for patients who cannot swallow tablets.

中文翻译：

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通过肠管给药的 Cenobamate 的体外评价。

 背景

Cenobamate 是一种经美国食品和药物管理局 (FDA) 批准的新型口服抗癫痫药，用于治疗成人局灶性癫痫发作。本研究检查了通过离体肠饲管施用的悬浮液中新诺贝酯的回收率。

 方法

制备含有100和200mg新诺贝酯的悬浮液（每个剂量五份重复），通过五个垂直直立的管，并收集到烧瓶中。用去离子水冲洗含有悬浮液的烧瓶，并将该内容物也注入管中并收集在烧瓶中。将乙腈、异丙醇和三氟乙酸添加到烧瓶中，然后添加去离子水至浓度为 500（100 mg cenobamate）和 400（200 mg cenobamate）μg/mL。将每种悬浮液的 3 mL 等分试样放入 10 mL 烧瓶中，稀释至一定体积并混合，最终浓度分别为 150 µg/mL 和 120 µg/mL。所有悬浮液均通过高效液相色谱（LC）进行分析。计算每个悬浮液的cenobamate % LC 回收率，以及重复的平均% LC。

 结果

100 mg 悬浮液中新诺贝酯的 LC 回收率百分比范围为 96.2% 至 99.1%，平均 LC 回收率百分比范围为 96.3% 至 98.3%。 200 mg 悬浮液中新诺贝酯的 % LC 回收率范围为 97.1 至 102.6%，平均 % LC 回收率在 98.5 至 101.7% 之间。

 结论

Cenobamate 的平均 % LC 回收率在 90.0-110.0% 的预定可接受范围内，表明 Cenobamate 没有粘附或吸附到肠内饲管。对于无法吞咽药片的患者来说，通过肠饲管输送西诺贝酯混悬液可能是一种可行的给药途径。