RESUMO
The aseptic filling of drug products is carried out in pharmaceutical isolators that have been sterilized. A commonly used method for achieving a high level of sterility assurance is vaporized hydrogen peroxide (VHP) sterilization, which is favorable to other methods, such as ethylene oxide sterilization, due to its low cycle times and nontoxic residuals. While VHP cycles are often employed to create a sterile environment within an isolator, they can leave residual levels of hydrogen peroxide behind that can enter the product during fill-finish operations. Due to the oxidizing potential of hydrogen peroxide and the multiple possible sources of uptake along filling lines, the extent of the potential impact on product quality needs to be understood during pharmaceutical development. Herein, different factors affecting hydrogen peroxide uptake, points of entry along the filling line, and possible impacts on product quality are reviewed.
Assuntos
Peróxido de Hidrogênio , Esterilização , Esterilização/métodosRESUMO
The number of polymer-based vectors for siRNA delivery in clinical trials lags behind other delivery strategies; however, the molecular architectures and chemical compositions available to polymers make them attractive candidates for further exploration. Polymer vectors are extensively investigated in academic laboratories worldwide with fundamental progress having recently been made in the areas of high-throughput screening, synthetic methods, cellular internalization, endosomal escape and computational prediction and analysis. This review assesses recent advances within the field and highlights relevant developments from within the complementary fields of nanotechnology and protein chemistry with the intent to propose future work that addresses key gaps within the current body of knowledge, potentially advancing the development of the next generation of polymeric vectors.