Time to efficacious steady state plasma concentrations with slow titration of Vortioxetine drops versus oral tablets: a Pharmacokinetic model.

IF 3.6 3区医学 Q1 PSYCHIATRY

Annals of General Psychiatry Pub Date : 2025-09-30 DOI:10.1186/s12991-025-00598-2

Andrea Fagiolini, Elin H Reines, Anja Farovik, Johan Areberg

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Abstract

Background: The antidepressant vortioxetine is available as an immediate-release (IR) tablet formulation and as a bioequivalent oral drops solution (20 mg/mL) to allow personalised titration.

Methods: This pharmacokinetic modelling analysis used data from a single-dose, crossover study to simulate the time taken to reach steady-state plasma concentrations using 'low and slow' titration approaches with drops compared with standard IR-tablet schedules.

Results: All dosing regimens approached 10 mg steady-state concentrations within 2 weeks. The time to reach full steady-state was 12 days when starting with a 10 mg IR-tablet, 14 days when starting with 5 mg drops and increasing to 10 mg (1 mg/day increments), 17 days when starting with a 5 mg IR-tablet for 7 days before increasing to 10 mg, and 18 days when starting with 1 mg drops and increasing to 10 mg (1 mg/day increments).

Conclusions: These data support the utility of vortioxetine drops in offering flexibility for personalised titration without relevant impact on the time taken to reach steady-state plasma concentrations.

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沃替西汀滴剂与口服片剂缓慢滴定达到有效稳定血浆浓度的时间：药代动力学模型。

背景：抗抑郁药沃替西汀可作为立即释放（IR）片剂制剂和生物等效口服滴剂溶液（20mg /mL），以允许个性化滴定。方法：本药代动力学建模分析使用单剂量交叉研究的数据来模拟与标准ir片方案相比，使用滴剂的“低速”滴定方法达到稳态血浆浓度所需的时间。结果：所有给药方案在2周内达到10mg的稳态浓度。达到完全稳定状态的时间为：从10mg ir片剂开始服用12天，从5mg开始滴药并增加到10mg （1mg /天递增）的时间为14天，从5mg开始滴药并增加到10mg的时间为17天，从1mg开始滴药并增加到10mg （1mg /天递增）的时间为18天。结论：这些数据支持vortioxetine滴剂在提供个性化滴定灵活性方面的效用，而不会对达到稳态血浆浓度所需的时间产生相关影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of General Psychiatry PSYCHIATRY-

CiteScore

6.60

自引率

2.70%

发文量

审稿时长

>12 weeks

期刊介绍： Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged. Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.