Design and evaluation of a new mucoadhesive bi-layered tablet containing nimesulide for buccal administration

The present study was intended to develop a bi-layered tablet consisting of a mucoadhesive layer containing the drug to ensure satisfactory drug relea se versus the buccal mucosa and of a protective layer to prevent drug loss in the oral cavity. The developed tablet was tested for drug permeation thr ough a procine mucosal membrane and for drug loss through the protective la yer at the same time using a modified Franz method. The developed tablet wa s also tested in order to evaluate the mucoadhesion behaviour and the comfo rt in vivo in ten volunteers over a period of 8 h. The developed protective layer allowed a low loss of nimesulide through the protective layer (of th e order of mug) and permeation through the mucosal membrane which did not d iffer statistically from the amount permeated from a nimesulide suspension. The in vivo evaluation of mucoadhesive tablets revealed adequate comfort, and non-irritancy during the period of study and it was well accepted by th e volunteers. In conclusion, a mucoadhesive bi-layered tablet for buccal ad ministration was developed and, given its characteristics, this formulation has potential clinical usefulness for the treatment of oral lesions.