Elaboración de un Comprimido de Carbamazepina con Matriz Hidrofilica Mediante Compresión Directa

Abstract

This research was based on developing a carbamazepine tablet with a hydrophilic matrix by direct compression, at the Pharmaceutical Technology Pilot Plant of the Central University of Ecuador. The experimental method used allows us to investigate through in vitro dissolution how efficient our formulation is in prolonging the release of the active ingredient. The materials used in this research are: Raw Materials (carbamazepine, diluents, binders, lubricants, disintegrants); Reagents (working standard carbamazepine, methanol, sodium lauryl sulfate, distilled water); Laboratory materials (volumetric flasks, volumetric pipette, spatula, beakers, test tubes, sieves, test tube, mortar and pestle); Equipment (SCIENTECH SA216 Analytical Balance, BRANSON 3200 Ultrasound, UV-VIS Unicam UV-500 S233 Series Spectrophotometer, Erweka Mixer, Piccola Tableting Machine, Destokes Durometer, Erweka Friabilizer, Erweka 6 Dissolver). As a result, we obtained an in vitro dissolution of seven hours with a release of the active ingredient in a sustained-type controlled release form represented in graphs of dissolution profiles. In conclusion, the study of the release matrix allowed us to demonstrate "in vitro" that its behavior is effective for the release of the active ingredient and does not represent an obstacle in the formulation, providing us with an average release of 94.09% of the active ingredient in 7 hours of dissolution. It is useful to recommend that the dissolution tests, when adjusted to the conditions posed by the USP32, should be defined if the pharmaceutical form is going to have the same behavior since the transit in the Gastrointestinal Tract is long, so I recommend that it be carried out a study of bioavailability of the tablet.