Analytical methods for characterising the functional performance of tablet formulations

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This study investigates the functional performance of tablets composed of pure pharmaceutical polymers and multi-component formulations through a quantitative evaluation of their characteristics. The wetting of pure polymer tablets is analyzed via contact angle measurement. A novel experimental setup is developed for the simultaneous and time-resolved assessment of water uptake and swelling, which is validated and applied. The study examines the effects of various tablet formulation properties, including polymer type, particle size, and the presence of excipients like fillers, disintegrants, and lubricants, as well as tablet porosity and the pH of the test medium. An empirical model is introduced to represent the experimental findings of water uptake and swelling with four key parameters. Disintegration and dispersion are characterized using a new analytical method that measures disintegration time and conducts a time-resolved size analysis of disintegrated tablet fragments within a flow channel. The disintegration time is also evaluated using a conventional tester, and results from both methods are compared. By varying fluid velocity, the study explores the influence of hydrodynamic conditions on tablet disintegration and dispersion, discussing potential correlations with in vivo conditions. Additionally, the impact of different formulation properties, such as polymer type and tablet porosity, is further examined.