Introduction

Lithium carbonate is used in the treatment of bipolar affective disorder; however, it requires strict control of serum levels because it is one of the drugs for psychiatric use with a narrow therapeutic margin. Extended-release lithium carbonate formulations have the advantage of providing more consistent serum concentrations, leading to fewer adverse events and better adherence to treatment.

Aim

To manufacture and optimize through a factorial design of experiments a lithium carbonate matrix system with a low viscosity HPMC (Methocel® E15LV), to obtain tablets that meet the extended-release criteria of the Pharmacopoeia of the United Mexican States (FEUM).

Methods

The tablets were manufactured by wet granulation and characterized by pharmacopoeial tests including in vitro release studies.

Results

By means of a design 22 a final formulation was obtained that met the requirement of drug released (%) in the sampling times established by the FEUM. The properties of the selected hydrophilic polymer together with the studied variables of polymer proportion (%) and compressive force allowed the release profile to be adapted to the established levels.

Conclusions

Hydrophilic matrices were obtained, with a simple and economical formulation that can be used in the treatment with lithium carbonate by prolonged release.