Avaliação de impacto das alterações pós-registro na estabilidade de soluções de glicose injetável

Abstract

Drug stability refers to the ability of a product to maintain its characteristics within acceptable limits over time. To evaluate the stability of a medicine, factors that can influence it are examined, whether external, such as temperature, humidity and light, or internal, such as the physical-chemical properties of the active ingredient and excipients, the manufacturing method and the pharmaceutical form. This study aims to analyze the effects resulting from changes implemented after product registration, including changes in supplier, equipment and the sterilization process, in glucose solutions of different concentrations. The research was conducted through monitoring in an accelerated stability chamber, where critical parameters such as pH, 5-HMF (hydroxymethylfurfural) and glucose measurement were focused. The relevance of this study lies in understanding the impacts that post-registration changes can have on the stability and quality of injectable glucose solutions. This work aims to provide a comprehensive understanding of the implications of these changes, thus contributing to the safety and effectiveness of these products in the pharmaceutical market. Strict monitoring of the mentioned parameters was crucial to assess stability and ensure compliance with regulatory standards. As a result of the research, a tendency for pH to decrease over time was observed for all concentrations and types of changes addressed, in addition to variations in the levels of 5-HMF and related substances over time in glucose solutions at concentrations of 5%, 10% and 50%. Furthermore, there were variations in glucose dosage levels for different concentrations of solutions. The study carried out provided a thorough analysis of the effects of post registration changes in injectable glucose solutions, presenting crucial conclusions about their stability and quality. Therefore, given the results obtained, a more critical and proactive approach on the part of the pharmaceutical industry and regulatory agencies is essential.