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Pulsatile, Multiple Dose, Delivery system for Therapeutic Optimization

机译:脉动,多剂量,治疗优化输送系统

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While in many cases a steady, constant, plasma concentration level is desirable, in some instances rapid onset peaks accompanied by troughs are more therapeutically advantageous. However, this type of plasma profile generally requires the patient to take a dose of drug three to four times a day, depending on the half-life of the drug, to achieve therapeutic results. A single dosage unit delivering multiple doses of a drug as an immediate release or pulse profile at the required dosing intervals is desirable to improve patient compliance. In this study, a novel delivery system was evalauted to delivery a drug as an immediate release dose, with more than one dose per dosing unit, to minimize the total number of units required for the day. Two drugs were tested in this delivery system, metoprolol tartrate (MT) and methylphenidate hydrochloride (MPH). Both drugs are well absorbed from the gastrointestinal tract. MT was used as a surrogate for MPH for the early stage optimization of the delivery system, since it doesn't have the same regualtory control issues as MPH. Once the system was optimized, MPH was substituted for the MT.
机译:虽然在许多情况下是期望的稳定,常数,等离子体浓度水平,但在一些情况下,伴随着槽的快速发作峰是更加治疗上有利的。然而,这种类型的等离子体型材通常要求患者每天服用3至4次的剂量,这取决于药物的半衰期,以达到治疗结果。以所需给药间隔以立即释放或脉冲曲线递送多剂量药物的单个剂量单位是理想的,以改善患者的顺应性。在本研究中,新颖的递送系统被评估以将药物作为立即释放剂量递送,每剂量单位具有多于一个剂量,以最小化当天所需的单位总数。在该递送系统中测试了两种药物,美容托洛醇(MT)和盐酸甲基酚(MPH)。两种药物都从胃肠道吸收得很好。 MT被用作MPH的替代品,用于递送系统的早期优化,因为它没有与MPH相同的核心控制问题。一旦系统进行了优化,MPH就被替换为MT。

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