Elaboración y caracterización de microesferas de diclofenaco sódico a base de quitosano mediante el método de emulsión

Abstract

The purpose of this research study was to obtain chitosan microspheres loaded with diclofenac sodium with suitable physical-chemical characteristics to release the active ingredient in a prolonged way. To obtain the diclofenac sodium microspheres the emulsion method was used, followed by solvent evaporation making two formulations in order to standardize the production process. The best ones were selected under the best conditions. Three formulations were prepared and triplicated, varying on the amount of emulsifying agent. The microspheres were subsequently loaded with different concentrations of active ingredients to proceed with its physical-chemical analysis. The evaluation of the size and the morphology of the microspheres during optical microscopy, show that the formulations met the specification of being less than 1 millimeter in diameter. Therefore, the yield test was a maximum of 22% for formulation F1a. On the other hand, the microencapsulation efficiency test determine that the formula with the maximum yield was the F2b with a 28.84%. This one was subjected to the dissolution kinetics test complying with the acceptance criteria described in the USP39-NF34 for the release of diclofenac sodium prolonged with a release of 84.4% at 10 hours after being exposed to the dissolution process. The results allow us to conclude that the polymeric matrix F2b presents the adequate conditions to be loaded with the active ingredient and to be potentially a prolonged pharmaceutical release form, in this way reducing the adverse effects produced by pharmacotherapy with immediate-release for nonsteroidal anti-inflammatory drugs. It is suggested for further research to make changes on the production method and the variables in order to improve the capsulation efficiency of the active ingredient.