Pharmacokinetics and Bioequivalence of Methylphenidate Hydrochloride 10 mg Immediate-Released Tablets in Healthy Thai Volunteers under Fasting Conditions

K. V
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Abstract

Methylphenidate is a central nervous system stimulant indicated for attention deficit hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate GPO ® had been developed as a generic alternative to Ritalin ® 10 for Thai people. The aims of this study were to characterize pharmacokinetics in Thai population, and to evaluate bioequivalence of Methylphenidate GPO ® to Ritalin ® 10 to support product registration. A comparative dissolution test was performed in four dissolution media, followed by an open-label, randomized, two-way crossover bioequivalence study under fasting conditions. A single dose of the test or reference product was administered in period I and switched over to another product in period II after 7-day washout period. Blood samples were collected at predefined time points over 24 hours after dosing. Plasma concentrations of methylphenidate were quantified using a validated liquid chromatography-mass spectrometry method. The pharmacokinetics was characterized from plasma concentration-time profile following administration of the test and reference formulations. The pharmacokinetic parameters were in agreement with the previously published data. The AUC 0-t , AUC 0−∞ and C max of two methylphenidate 10 mg tablet formulations were statistically compared in 23 healthy Thai volunteers. The analysis of variance (ANOVA) did not show any significant difference between the formulations. The ratios for geometric least-square means and 90% confidence intervals of log-transformed parameters were within the acceptance range of 80.00–125.00%. Both products were generally well tolerated by healthy Thai subjects. Methylphenidate GPO ® and Ritalin ® 10 were bioequivalent in terms of rate and extent of absorption, and could be used interchangeably.
盐酸哌甲酯10mg速释片在泰国健康志愿者禁食条件下的药代动力学和生物等效性
哌醋甲酯是一种中枢神经系统兴奋剂,用于治疗注意缺陷多动障碍(ADHD)和嗜睡症。哌甲酯GPO®已被开发为泰国人利他林®10的通用替代品。本研究的目的是表征泰国人群的药代动力学特征,并评估哌醋甲酯GPO®与利他林®10的生物等效性,以支持产品注册。在四种溶出介质中进行了比较溶出试验,然后在禁食条件下进行了开放标签、随机、双向交叉的生物等效性研究。在第一阶段使用单剂量的试验产品或参考产品,并在7天的洗脱期后在第二阶段切换到另一种产品。在给药后24小时内的预定时间点采集血样。使用有效的液相色谱-质谱法定量测定血浆中哌甲酯的浓度。通过给药试验制剂和参考制剂后的血浆浓度-时间曲线来表征药代动力学。药代动力学参数与先前发表的数据一致。比较两种哌醋甲酯10mg片剂在23名泰国健康志愿者体内的AUC 0-t、AUC 0−∞和cmax的差异。方差分析(ANOVA)未显示配方之间有显著差异。对数变换参数的几何最小二乘均值比值和90%置信区间均在80.00 ~ 125.00%的可接受范围内。这两种产品在健康的泰国受试者中普遍耐受良好。哌甲酯GPO®和利他林®10在吸收率和吸收率方面具有生物等效性,可以互换使用。
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