Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall.
Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall.
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SLI381 (ADDERALL XR) 的药代动力学，Adderall 的缓释制剂。
DOI：
10.1097/01.chi.0000046850.56865.cb
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发表时间：
2003
期刊：
影响因子：
--
通讯作者：
Swanson,JamesM
中科院分区：
文献类型：
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作者：
McGough,JamesJ;Biederman,Joseph;Greenhill,LaurenceL;McCracken,JamesT;Spencer,ThomasJ;Posner,Kelly;Wigal,Sharon;Gornbein,Jeffrey;Tulloch,Simon;Swanson,JamesM
目的评估每日单剂量Adderall®（混合安非他明盐）和缓释制剂SLI381 （Adderall XR™）治疗儿童注意缺陷/多动障碍（ADHD）的药代动力学（PK）特性。方法51例6-12岁ADHD患儿进行为期6周、7次就诊、药代动力学和药物动力学研究。在第1次访问和第7次访问时进行了PK采样。在就诊1时，受试者接受初始口服剂量SLI381, 20mg。在访问时，7名受试者完成了1周的药物治疗，随机分配为每日一次口服SLI381 10mg， 20mg或30mg；阿得拉10毫克；或安慰剂。结果spk参数表现出明显的主体间变异性（变异系数为28-56%）。与Adderall相比，SLI381达到最大浓度的时间（Tmax）显示右旋安非他明平均增加3.0小时（t =−2.35,p = 0.04, df = 8.6），左旋安非他明平均增加3.2小时（t =−2.39,p = 0.04, df = 9.2）。d-和l-异构体浓度高度相关，比例约为3:1。结论ssli381的tmax值较阿得拉有所延长，适合每日1次给药。受试者间的可变性强调了个体剂量滴定的必要性。
OBJECTIVETo assess the pharmacokinetic (PK) properties of a single daily dose of Adderall®(mixed amphetamine salts) and the extended-release formulation, SLI381 (ADDERALL XR™), in pediatric attention-deficit/hyperactivity disorder (ADHD).METHODFifty-one children (aged 6–12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo.RESULTSPK parameters evidenced substantial intersubject variability (coefficients of variation = 28–56%). Time to maximum concentration (Tmax) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine (t = −2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine (t = −2.39, p = .04, df = 9.2). The d- and l-isomer concentrations were highly correlated and approximated a 3:1 ratio.CONCLUSIONSSLI381 showed extended Tmaxvalues compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration.