Background <p>The antidepressant vortioxetine is available as an immediate-release (IR) tablet formulation and as a bioequivalent oral drops solution (20&#xa0;mg/mL) to allow personalised titration.</p> Methods <p>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.</p> Results <p>All dosing regimens approached 10&#xa0;mg steady-state concentrations within 2 weeks. The time to reach full steady-state was 12 days when starting with a 10&#xa0;mg IR-tablet, 14 days when starting with 5&#xa0;mg drops and increasing to 10&#xa0;mg (1&#xa0;mg/day increments), 17 days when starting with a 5&#xa0;mg IR-tablet for 7 days before increasing to 10&#xa0;mg, and 18 days when starting with 1&#xa0;mg drops and increasing to 10&#xa0;mg (1&#xa0;mg/day increments).</p> Conclusions <p>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.</p>

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

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

摘要

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.