mucoadhesive granules containing chitosan nano and / or microspheres and process for obtaining mucoadhesive granules

摘要

MUCOADESIVE BEANS CONTAINING NANO AND / OR MICROSPHERES OF CHITOSANA AND PROCESS OF OBTAINING MUCOADESIVE BEADS. This invention discloses a product, functional heterogeneous granules containing a granulation excipient and chitosan micro and / or nanoparticles encapsulating a pH sensitive active compound, and their production process. These granules incorporate nano and / or chitosan microparticulate active compounds, which have mucoadhesion and sustained release properties of the incorporated active compound. These properties potentiate greater efficiency of in vivo action of drugs or active agents when administered through mucous membranes, reduction of side effects, preservation of activity of labile active compounds and reduction of concentration and frequency of doses. The production process can be operated on a semi-continuous or discontinuous basis, under sterile conditions, and allows to be scaled for application in the industrial sector. Initially, the active compound is encapsulated in chitosan micro or nanoparticles in aqueous dispersion. Then the particles are separated by centrifugation, and the aqueous medium removed. The wet particles are dried and the granulation excipients are added to the wet mass which is subjected to the extrusion-spheronization granulation process.