Drug dissolution studies are commonly conducted using compendial methods employing USP Paddle and Basket apparatuses. In many cases, dissolution studies can be of limited benefit especially for product-dependent dissolution procedures like in extended release (ER) formulations. The high variability in dissolution testing, that is not productrelated, emphasizes the need for developing new method...

INTRODUCTION The release of the drug substance from a solid dosage form has a major impact on its rate and extent of absorption. In certain instances, as is the case with modified-release formulations, the rate-limiting step in the appearance of the drug in the systemic circulation is its release from the formulation. In the vast majority of cases, in vitro dissolution of an immediate-release p...

The aim of this study was the development of a dissolution test with IVIVC for extended-release bromopride (BPD) pellets using bioavailability data. BPD is a Biopharmaceutics Classification System Class 2 drug, and its absorption is primarily limited by its dissolution rate. Despite this, there are no reports describing a dissolution test for BPD dosage forms. The dissolution medium was selecte...

We demonstrate the use of modeling and simulation to investigate bioequivalence (BE) concerns raised about generic warfarin products. To test the hypothesis that the loss of isopropyl alcohol and slow dissolution in acidic pH has significant impact on the pharmacokinetics of warfarin sodium tablets, we conducted physiologically based pharmacokinetic absorption modeling and simulation using form...

This article discusses the dissolution of mineral fibers in simulated physiological fluids (SPF), and the parameters that affect the solubility measurement in a dynamic test where an SPF runs through a cell containing fibers (Scholze and Conradt test). Solutions simulate either the extracellular fluid (pH 7.6) or the intracellular fluid (pH 4.5). The fibers have various chemical compositions an...

A dissolution test for fesoterodine low dose extended-release tablets using liquid chromatographic (LC) method equipped with a C18 monolithic column was developed and validated. LC system was operated isocratically at controlled temperature (40 °C) using a mobile phase of acetonitrile:methanol:0.03 M ammonium acetate (pH 3.8) (30:15:55, v/v/v), run at a flow rate of 1.5 mL/min and detected at 2...