CINCO AÑOS DE ESTUDIO DE ESTABILIDAD EN CURSO DE LAS TABLETAS DE POLICOSANOL (5, 10 Y 20 MG) EN BLÍSTERES

Abstract

According to current international Good Manufacturing Practice guidelines, ongoing stability testing is required for the market-life of all medicinal licensed products, as part of the Annual Product Quality Review. Taking that into account, samples from one batch a year of the three Policosanol formulations (PPG 5, 10 and 20 mg), stored in Climatic Zone IV conditions, were continuously monitored since 2017, in order to demonstrate stability and quality over their 5-years shelf life. Results showed that these three formulations, packed in polyvinylchloride /aluminium thermo-sealed blisters, fulfilled the specified quality parameters during all the study. Until now, all the assayed batches maintained their values of fatty alcohol content, uniformity of content, disintegration time, color, and microbial content without significant changes with respect to the initial values in all samplings. No evidence of degradation product formation was determined by Gas Chromatography, which is consistent with the fact that no decrease in the fatty alcohol content was observed throughout the study. First included batches, produced in 2017 and stored for five years, showed no evidence of degradation and fulfilled all the specification limits defined in their registration documents. That is consistent with the approved labelled shelf life of these formulations, which had been previously determined by Research and Development studies, before their marketing approval.