RESUMO
The aim of the present study was to prepare and evaluate an osmotically controlled mucoadhesive cup-core (OCMC) containing aceclofenac. A special technique was used while preparing an OCMC. Stability of OCMC was determined in natural human saliva, and it was found that both pH and device are stable in human saliva. OCMC was evaluated by weight uniformity, thickness, hardness, friability, swelling, mucoadhesive strength and in vitro drug release. Swelling index was higher with formulations containing hydroxypropyl methylcellulose (HPMC) K4M alone, and it decreases with its decreasing concentration in the OCMC. The in vitro drug release studies showed a release with the composition of formulation up to 12 h. The mechanism of drug release was found to be zero order kinetics with diffusion controlled drug release. It has shown significant anti-inflammatory activity (P<0.001) and no hypersensitive reaction. It can be concluded that by changing the content of OCMC system, a desire effect is generated and it overcomes the drawback associated with the conventional buccal adhesive tablet.
