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

Abstract

Abstract:Respiratory infections are often caused by bacteria, for this reason Clarithromycin was chosen because it fulfills their pharmacological properties as an antibiotic treatment. In the pharmaceutical market, Clarithromycin has experienced increasing use in the pediatric population, for this reason a formulation was developed in suspension form, since the oral administration is the most comfortable. Through the assays of preformulation were chosen the following suspending agents: Avicel CL-611, Avicel RC-591 and xanthan gum. We used a completely randomized design, also performed the analysis of variance (ANOVA) and the method LSD (least significant difference) to determine the suspending agent inside the formula. The concentration of flavoring was determined using the multiple comparison test of Duncan. The packing was chosen through experimental tests. The analytical method was performed with its respective validation for analysis of finished product. We performed the preparation of three pilot batches, which were subjected to quality control analysis to proceed to primary packaging. The extemporaneous suspension was subjected to an accelerated stability study, using the Arrhenius method which determined the lifetime of 2 years.