Design, Formulation, and Evaluation of Risperidone Mucoadhesive Buccal Patches

Abstract

Objectives: To construct and optimize Risperidone (RIS) mucoadhesive buccal films for systemic distribution as an alternate route. To make buccal patches of Risperidone utilizing natural polymers such sodium alginate (SA), Hydroxypropyl methylcellulose (HPMC), Na CMC, and Carbopol 934 (CP 934). Method: Solvent casting created Risperidone buccal patches. The optimization study used a software-based response surface methodology approach with 23 factorial designs to evaluate 8 formulations of Risperidone mucoadhesive buccal patches to determine the significant effect of selected independent variables on the dependent variable. To assess patch appearance, thickness, weight homogeneity, folding durability, medication content, surface pH, swelling index, and FTIR. Invitro dissolution, ex-vivo permeation, residence time, and stability tests. Results: FTIR and DSC showed that Risperidone was entirely entrapped in polymer carrier bonds with no chemical interaction. Drug distribution was uniform in buccal patches at 90.14± 0.07 and 98.75± 0.80. Conclusion: Buccal patch medicine release and penetration depended on polymer type. Hydrophilic polymers boosted buccal patch drug release. F6 was the best of F1–F8. Formulation F6 had 82.03 ±0.82% in-vitro drug release and 75.21 ± 0.42% ex-vivo permeability after 7 hours. Stability tests did not modify appearance, surface pH, content homogeneity, in-vitro residence length, medication release, or ex-vivo penetration.