Abstract

FRETES DE AQUINO, Sonia Lorena; VAZQUEZ MESA, Marta  and  LUGO RODRIGUEZ, Gladys Beatriz. Evaluation comparative between dissolution profiles of tablets 25mg Lamotrigine similar and innovative drug, traded in Paraguay. Mem. Inst. Investig. Cienc. Salud [online]. 2016, vol.14, n.2, pp.53-60. ISSN 1812-9528.  https://doi.org/10.18004/Mem.iics/1812-9528/2016.014(02)53-060.

Epilepsy is the most common neurologic disease in the world, this situation boosts the development of new anticonvulsant drugs (AEDs) as lamotrigine (LMT) having, the latter, a high economic cost for the population with seizures. The aim of the study was to compare the dissolution profiles of LMT tablets of 25 mg (Test) marketed in Paraguay and the Reference or innovator (Lamictal®). LMT 25mg tablets were chosen with the current health register sold in Paraguay and performing the quality controls according to general criteria of the official pharmacopoeia. Subsequently, the kinetics of dissolution of the Test and Reference products were determined in the three recommended dissolution media (pH 1,2 ; 4,5 and 6,8). The dissolution profiles of LMT products evaluated presented similar behavior at the three different pHs, releasing more than 85% within 15 minutes in the three dissolution media. No comparison with the f1 and f2 test was necessary. The kinetics of dissolution of the tablets of LMT 25 mg analyzed showed a similar in vitro behavior between the formulations. These results constitute only a guide for the implementation of bioequivalence studies between the Test and the Reference assayed in vitro. These tests carried out with LMT could emerge as an initial step in order to study the behavior of dissolution profiles of the Test product and the corresponding references in the Paraguayan market.

Keywords : Epilepsy; lamotrigine; in vitro dissolution tests.

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