Estudio de bioequivalencia In Vitro de anticonvulsivantes en fármacos comerciales y genéricos con carbamazepina

Abstract

It was determined the percentage of the active ingredient carbamazepine of four drugs of 200 mg the commercial drug Tegretol (C), and the generic drugs NIFA (G1 ), La Santé (G2 ), Laboratories Chile (G3 ) at the Instrumental Analysis Laboratory, Faculty of Sciences, Polytechnic School of Chimborazo in order to establish the in vitro bioequivalence of these anticonvulsants which are used in the treatment and prevention of epileptic seizures and anticonvulsants. Three different lots of each of these drugs were analysed though physicochemical dissolution and disintegration test set by the regulation of the United States Pharmacopoeia (USP). Subsequently, the statistical treatment of the data was performed using analysis of variance, analysis between lots and between repetitions, identification of absorbance by means of the use of the UV – Visible spectrophotometer equipment for determining the percentage (%) of active ingredients calculated. Generics and commercial drugs show differences in the disintegration; C Lot 2 was the fastest with 0.35 seconds and G2 the slowest with 2 minutes 30 seconds, both drugs accomplish the disintegration time of 3 minutes set by the USP 35 standard. In the dissolution test, the data determine that the arithmetic average in C = 83.7%, G1 = 81.3 %, G2 = 75.72%, G3 = 86.39% accomplishes with the value of principle release (Q) set in the USP 35 Dissolution regulations. The Anova test pointed that generics versus commercial drugs do not present significant difference in values of Q. The response of this study proves that the commercial and generic drugs sold in Ecuador with carbamazepine are Bioequivalent which guarantee security and efficiency. In vivo studies will reinforce what is argued in this research work.