Diseño y desarrollo de polvo para reconstituir una suspensión oral de claritromicina

Abstract

Abstract: Respiratory infections are frequently caused by bacteria, which is why Clarithromycin was chosen. In the pharmaceutical market, Clarithromycin has experienced increasing use in the pediatric population; For this reason, a formulation in the form of a suspension was developed, since the oral route is the most comfortable. Through a preformulation study, the viscosity agents were chosen: Avicel CL-611, Avicel RC-591 and Xanthan Gum. The completely randomized design was used, the analysis of variance (ANOVA) was performed and the LSD (least significant difference) method was also used to determine the viscosity agent within the formula. To determine the concentration of the flavoring agent, the DUNCAN multiple comparison test was used. The packaging was chosen through experimental tests. Three pilot batches were prepared, which were subjected to quality control analysis to proceed with packaging. The extemporaneous suspension was subjected to an accelerated stability study; using the Arrhenius method which determined the useful life of 2 years. In addition, all the requirements to obtain the Health Registration of the medicine were presented.