Time to steady state with slow titration of vortioxetine drops versus oral tablets: a pharmacokinetic model

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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 (20mg/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 10mg steady-state concentrations within 2 weeks. The time to reach full steady-state was 12 days when starting with a 10mg IR-tablet, 14 days when starting with 5mg drops and increasing to 10mg (1mg/day increments), 17 days when starting with a 5mg IR-tablet for 7 days before increasing to 10mg, and 18 days when starting with 1mg drops and increasing to 10mg (1mg/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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