Abstract

This study is focused on the development and optimization of the reservoir-type oral multiparticulate drug delivery systems loaded with galantamine hydrobromide. For this purpose, the process of applying of the drug onto sugar pellets through the medium of a hydroxypropyl methylcellulose-based suspension was investigated. A substantial part of the study was to refine the layering process in respect to the influence of critical process parameters on the formation of agglomerates between the pellets. This outcome is related to some critical coating factors, such as: spray rate, product temperature, airflow, concentration of hydroxypropyl methylcellulose in the coating suspension and spray pressure. In this study design of experiments was used as a statistical method for assessing the influence of critical process parameters on the agglomeration. For this purpose full factorial design of five factors at two levels was built. The effect of the main factors and their interaction on the response was evaluated using regression analysis, analysis of variance and graphical analysis of the experimental design. The results showed that the airflow and the concentration of hydroxypropyl methylcellulose in the coating suspension have the most significant effect on the formation of agglomerates during the drug layering process.