ABSTRACT:
The purpose of this study was to develop buccoadhesive tablets of Metoclopramide hydrochloride (MCP HCl) to release the drug for extended period of time and to bypass the presystemic metabolism of the drug. The buccal mucosa has been investigated for local and systemic delivery of therapeutic peptides and other drugs that are subjected to first-pass metabolism or are unstable within the rest of the gastrointestinal tract. MCP HCl is subjected to first-pass effect; therefore formulation of buccal adhesive dosage form can circumvent this effect. Extended release buccoadhesive hydrophilic matrices containing MCP HCl were prepared using a 32 full factorial design. Amounts of Carbopol 934P and Hydroxypropyl methylcellulose K4M were taken as the formulation variables. The objective of this work was to study the effect of mucoadhesive polymers on mucoadhesion and drug release characteristics of MCP HCl tablets. Statistical experimental design and data analysis using response surface methodology is also illustrated. Linear regression analysis and model fitting depicted that the formulations followed Higuchi (Matrix) model. The formulation variables were found to be significant for the release properties (P < 0.05), while Carbopol 934P loading was found to be significant for mucoadhesion.