A Study of the Value of Thermal Mechanical Analysis in Assessing Disintegrants in Pharmaceutical Tablets

摘要

The method of evaluating the disintegration properties of various pharmaceutical tabletsrnis presented in the United States Pharmacopeia(USP). This is an in-vitro test for determining therntime it takes a given tablet to break up and thus release the active drug ingredient. This test, inrnfact, evaluates the effectiveness of the disintegrating agent. The guidelines for disintegration, asrnoutlined by the USP, are an indication of the maximum time for total disintegration of thernvarious tablets. This test does not require knowledge of the initial disintegration time and rate.rnIn this study the rate and extent of disintegration for various tablets was studied using a ThermalrnMechanical Analyzer. A protocol based on Thermal Mechanical Analysis (TMA) wasrndeveloped with good repeatability (CV = 0.19 to 11%). A good correlation was observed whenrnthe results of the TMA tests were compared with the standard USP method for enteric-coatedrntablets but not for uncoated or film-coated tablets. This new novel Thermal MechanicalrnAnalysis Method has been developed to measure the disintegration rate and time of variousrnformulations. The TMA method, coupled with current dissolution testing of active ingredient inrnsolution, will lead to a better understanding of drug delivery. The TMA method is also proposedrnas a valuable tool for quality control testing to evaluate tablet uniformity between productionrnbatches.