Effect of composition on mechanical and physicochemical properties of mucoadhesive buccal films containing buprenorphine hydrochloride: From design of experiments to optimal formulation

Abstract

In this study, mucoadhesive buccal films containing Buprenorphine Hydrochloride were made. The parameters include polymers and plasticizers such as hydroxy propyl methyl cellulose, sodium alginate, sodium carboxy methyl cellulose, Carbopol, propylene glycol, glycerin, sorbitol, and sodium lauryl sulfate were selected as independent variables and their effects on folding endurance, tensile strength, young modulus, swelling index, and maximum swelling time were investigated. Analysis of variance shows that the best model to fit the correlations between variables and responses is quadratic. The three proposed optimal formulations containing buprenorphine hydrochloride by the software were prepared and characterized by mechanical and physicochemical analysis plus DSC and SEM tests. Mechanical and physicochemical properties were similar to software-predicted values. DSC showed compatibility between drug and film components in optimal formulations. The cross-sectional SEM images showed morphology including one upper porous layer and another lower dense layer. Drug release and swelling profiles were influenced by the morphology. In this system, the maximum release time varied between 1.5 and 2.5 h.