Development of Bio-adhesive Buccal Tablet of Nicorandil Using Factorial Approach

INTRODUCTION: In the present investigation, bio-adhesive buccal tablets were prepared using sustained-release polymer HPMC K100M, bio-adhesive polymer neem gum and an impervious backing layer of ethyl cellulose. Nicorandil is sensitive to first-pass metabolism effect; therefore, the formulation of buccal-adhesive dosage form can avoid this effect.
METHODS: We used the direct compression technique to prepare tablet formulation. A 32 Full Factorial Design was composed in which the amount of HPMCK100M (X1) and NEEM GUM (X2) were chosen as the independent variables and the dependent variables were being the percentage drug release at 6 h (Y1) and mucoadhesive strengths in grams (Y2). Various in vitro parameters viz. thickness, friability, hardness, weight variation, surface pH, moisture absorption ration, dissolution studies, and drug release kinetics and ex vivo parameters like mucoadhesive strengths and mucoadhesion time were performed for prepared tablets. We subjected the optimized batch to comparison with the marketed formulation and stability studies.
RESULTS: Formulation (F5) containing a 50: 50 ratio of neem gum and HPMC K100M was considered to be optimum. Zero-order release kinetics model best fitted the optimized batch release profile that suggested the system would release the drug at a constant rate.
DISCUSSION AND CONCLUSION: The optimized formulation releases the drug at a sustained rate along with bio-adhesive nature deduced that the buccal route can be an elective for the administration of Nicorandil.