Texture profile analysis of bioadhesive polymeric semisolids: Mechanical characterization and investigation of interactions between formulation components

This study reports the use of texture profile analysis (TPA) to mechanically characterize polymeric, pharmaceutical semisolids containing at least one bioadhesive polymer and to determine interactions between formulation components. The hardness, adhesiveness, force per unit time required for compression (compressibility), and elasticity of polymeric, pharmaceutical semisolids containing polycarbophil (1 or 5% w/w), polyvinylpyrrolidone (3 or 5% w/w), and hydroxyethylcellulose (3, 5, or 10% w/w) in phosphate buffer (pH 6.8) were determined using a texture analyzer in the TPA mode (compression depth 15 mm, compression rate 8 mm s(-1) 15 s delay period). Increasing concentrations of polycarbophil, poly vinylpyrrolidone, and hydroxyethylcellulose significantly increased product hardness, adhesiveness, and compressibility but decreased product elasticity. Statistically, interactions between polymeric formulation components were observed within the experimental design and were probably due to relative differences in the physical states of polyvinylpyrrolidone and polycarbophil in the formulations, i.e., dispersed/dissolved and unswollen/swollen, respectively. Increased product hardness and compressibility were possibly due to the effects of hydroxyethylcellulose, polyvinylpyrrolidone, and polycarbophil on the viscosity of the formulations. Increased adhesiveness was related to the concentration and, more importantly, to the physical state of polycarbophil. Decreased product elasticity was due to the increased semisolid nature of the product. TPA is a rapid, straightforward analytical technique that may be applied to the mechanical characterization of polymeric, pharmaceutical semisolids. It provides a convenient means to rapidly identify physicochemical interactions between formulation components. (C) 1996 John Wiley & Sons, Inc.