(571j) Comparison of Tablet Dissolution Using USP Apparatus II and TIM-1 Gastrointestinal Compartment

The overall goal of pharmaceutical dosage forms is to deliver the proper therapeutic dosage of drug over the proper length of time. To characterize this release, the most common method used is dissolution in a USP II apparatus. Previous research has shown this technique to be quite lacking in terms of predicting actual drug release in vivo. Alternatively, the relatively new TIM apparatus provides a more sophisticated modeling of the human gastrointestinal system. Model pharmaceutical tablets were produced and dissolved in both systems and the resultant dissolution profiles compared. In addition, CFD models of the fluid flow in the TIM stomach compartment were compared to previously published CFD models of the USP II apparatus to determine the effects of fluid shear on dissolution. This was used in conjunction with a 3-D mechanistic model of tablet erosion and dissolution to determine the parametric differences between the two dissolution techniques and determine the effective correlation points between them.