PURPOSE:To test the hypothesis that the pharmacokinetics of d-methylphenidate (d-MPH) would be altered by food ingested before administration of an immediate release formulation (dl-MPH- IR) but not when food is ingested before a slow release formulation (dl-MPH-SR).

METHODS:A randomized, four-phase, open label, crossover design was conducted in 24 healthy men who each received, on separate occasions, dl-MPH-IR and dl-MPH-SR taken after an overnight fast and 15 min after a standardized breakfast (20% protein, 21% fat, 59% carbohydrate). Plasma MPH levels were monitored by a validated, stereoselective. GLC-ECD method.

RESULTS:For plasma d-MPH, there were significant differences (ANOVA) between dl-MPH-IR and dl-MPH-SR in tmax, Cmax (peak exposure), and Cmax/AUC (sensitive to rate of absorption). Dl-MPH-SR on average delayed tmax from 2.3 to 3.7 h and lowered Cmax 34%. There was no significant difference between the formulations in AUC (extent of absorption). For dl-MPH-IR, food significantly increased Cmax (23%) and AUC (15%) and for dl-MPH-SR the corresponding increases were Cmax (17%) and AUC (14%). After dl-MPH-IR, food delayed average tmax from 2.0 to 2.5 but had no effect on tmax after dl-MPH-SR. There was no effect of food on Cmax/AUC (rate of absorption).

CONCLUSIONS:Food caused a significant increase in extent of absorption but had no effect on rate of absorption of d-MPH after either dl-MPHIR or dl-MPH-SR.

译文

目的:为了检验以下假设,即在服用速释制剂(dl-MPH-IR)之前摄入的食物会改变d-甲基哌醋甲酯(d-MPH)的药代动力学,但在食用时不会改变

方法:在24名健康男性中进行了随机,四阶段,开放标签,交叉设计,分别在隔夜禁食后和标准早餐(蛋白20%,脂肪21%,碳水化合物59%)15分钟后的15分钟内分别服用dl-MPH-IR和dl-MPH-SR。血浆MPH水平由经过验证的立体选择性监测。 GLC-ECD方法。

结果:对于血浆d-MPH,dl-MPH-IR和dl-MPH-SR在tmax,Cmax(峰值暴露)和Cmax / AUC(对吸收率敏感)。 D1-MPH-SR平均将tmax延迟从2.3到3.7 h,并将Cmax降低了34%。两种制剂的AUC(吸收程度)之间无显着差异。对于dl-MPH-IR,食物的Cmax(23%)和AUC(15%)显着增加,而对于dl-MPH-SR,食物的Cmax(17%)和AUC(14%)相应增加。 dl-MPH-IR后,食物将平均tmax从2.0推迟到2.5,但对dl-MPH-SR后的tmax没有影响。食物对Cmax / AUC(吸收率)没有影响。

结论:食物引起吸收程度的显着增加,但对d的吸收率没有影响dl-MPHIR或dl-MPH-SR之后的-MPH。

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