Abstract

Objectives: This study was conducted to evaluate suitable methods of testing crush-resistant tablets composed largely of thermoplastic polymers. The objectives were, i) to evaluate the effect of thermal processes on crush resistance, ii) to develop test method(s) to indicate whether a crush-resistant tablet is susceptible to tampering by insufflation based on generated particle sizes, and iii) to find an appropriate analytical tool for discriminatory studies.

Methods: We investigated the crush-resistance properties of poly(ethylene oxide) (PEO) tablets using three manual and four electrical devices. PEO tablets were directly compressed or further heat-treated to mimic thermal manufacturing processes (i.e., hot-melt extrusion, sintering). Differential scanning calorimetry was also utilized to evaluate effect of thermal processes on polymer properties.

Results: Non-heat treated tablets were easily crushed by all methods. Heat-treated tablets were only susceptible to cryogenic grinding and high-powered domestic blender. Our results confirm that manual methods are not suitable for discriminatory study.

Conclusions: Testing methods for crush resistance may not be applicable to all products nor allow control over all process factors. Notwithstanding, the use of high-powered electrical devices may be an effective discriminatory tool for testing heat treated PEO-based ADFs.

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