The current United States Pharmacopeia (USP) test for the disintegration of drug tablets does not measure initial disintegration times and does not adequately describe tablet disintegration mechanisms. An Isothermal Mechanical Analysis (IsoTMA) method meeting USP specifications has been developed to measure the initial time and rate of drug disintegration. TMA monitors the physical dimension of the formulated drug tablet as a function of time, temperature, applied stress, and pH. TMA can be used to measure the swelling, shrinkage, or disintegration of a formulated tablet in a specified fluid. The focus of this study is to validate an efficient and precise IsoTMA method to measure dimensional stability of solid dose tablets. The precision of the method along with the effect of pH (1–10) and temperature (25–37 °C) on the rate of delivery was determined for nine drugs. Graphical representations of dimensional changes over time were created and compared. Drug delivery in a specific liquid medium was measured by UV analysis for the active pharmaceutical ingredient. An increase in temperature decreased the disintegration time and increased the disintegration rate (mm/min). For the drugs that are studied in this article, pH did not have an appreciable effect on the rate of disintegration.
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