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The absorption of sustained‐release methylphenidate formulations compared to an immediate‐release formulation

机译:缓释哌醋甲酯制剂与速释制剂相比的吸收率

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AbstractA crossover study in 18 subjects evaluated the plasma concentration–time profile of two different 20 mg sustained‐release (SR) methylphenidate (MPH) tablets administered before breakfast, compared to a 10 mg immediate‐release (IR) tablet administered before breakfast and again 5 h later, before lunch. Plasma MPH concentrations were determined using a sensitive and precise gas chromatography–mass spectrometry method, incorporating a deuterated internal standard. The mean peak MPH concentration was 6.4 ng ml−1for the IR product versus 4·6 ng ml−1and 4·8 ng ml−1for the two SR formulations. Peak concentrations occurred at 3·3 h after dosing with the SR products, compared to 1·5 h after the first dose of the IR product. The extent of absorption for the three products, as determined from areas under the plasma concentration‐time curves, were within 5 per cent of each other. There was no significant difference in rate or extent of absorption between the
机译:摘要一项针对 18 名受试者的交叉研究评估了早餐前给药的两种不同的 20 mg 缓释 (SR) 哌醋甲酯 (MPH) 片剂与早餐前和 5 小时后午餐前再次给药的 10 mg 速释 (IR) 片剂的血浆浓度-时间曲线。使用灵敏而精确的气相色谱-质谱法测定血浆 MPH 浓度,并结合氘代内标。IR产物的平均峰值MPH浓度为6.4 ng ml-1,而两种SR制剂的平均峰值MPH浓度为4.6 ng ml-1和4.8 ng ml-1。峰值浓度出现在 SR 产物给药后 3·3 小时,而 IR 产物首次给药后 1·5 小时。根据血浆浓度-时间曲线下的面积确定,这三种产物的吸收程度相差在5%以内。两者之间的吸收速率或程度没有显着差异

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