MUCOADHESIVE GRANULES CONTAINING CHITOSAN NANO- AND/OR MICROSPHERES AND THE PROCESS OF MANUFACTURE

摘要

This invention relates to a product, functional heterogeneous granules containing a granulation excipient, and micro- and/or nanoparticles encapsulating a pH-sensitive active compound, and to the production process thereof. These granules incorporate active compounds in chitosan nano- and/or microparticles, which have mucoadhesion properties and sustained release of the incorporated active compound. These properties provide a higher in vivo action efficiency of vehiculated drugs or active compounds when administered through mucosae, reduction of side effects, conservation of the activity of labile active compounds, and reduction of the concentration and frequency of dosages. The production process can be operated in a semicontinuous or discontinuous regimen, under sterile conditions, and can be scaled for application in the industrial sector.