Desarrollo de un comprimido de carbonato de litio de liberación prolongada mediante un diseño factorial.

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 pharmacopeial 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. [ABSTRACT FROM AUTHOR]