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Bioavailability and kinetics of maprotiline

D Alkalay, W E Wagner, S Carlsen

Clinical Pharmacology and Therapeutics

|May 1, 1980

Summary

Maprotiline hydrochloride tablets and trideuterated maprotiline hydrochloride solutions show comparable bioavailability in male subjects. This indicates similar absorption and pharmacokinetic profiles between the two formulations.

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Area of Science:

Pharmacokinetics
Drug bioavailability
Clinical pharmacology

Background:

Maprotiline hydrochloride is a tetracyclic antidepressant.
Understanding the comparative bioavailability of different formulations is crucial for therapeutic efficacy.

Purpose of the Study:

To compare the bioavailability of maprotiline hydrochloride administered as a tablet versus an aqueous solution.
To assess the pharmacokinetic equivalence of two maprotiline hydrochloride formulations.

Main Methods:

A single-dose, parallel-group study in six male subjects.
Simultaneous administration of a maprotiline hydrochloride tablet and a trideuterated maprotiline hydrochloride aqueous solution.
Analysis of blood levels of both unlabeled and isotope-labeled maprotiline over time.

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Main Results:

Blood levels of both formulations were superimposable, with no significant differences in peak levels, time to peak concentration, or area under the curve.
Biologic half-lives (beta-phase) were similar: 58 hr for unlabeled and 60.5 hr for labeled maprotiline.
Westlake confidence limits indicated less than 10% difference between formulations for key pharmacokinetic parameters.

Conclusions:

The maprotiline hydrochloride tablet and aqueous solution formulations are bioequivalent.
No significant differences in absorption, distribution, or elimination were observed between the two formulations.
This suggests interchangeable use of the tablet and solution forms of maprotiline hydrochloride.