Atorvastatin, an HMG CoA reductase inhibitor, is widely used for the treatment of dyslipidemia and prevention of cardiovascular disease. It belongs to Class 2 of the Biopharmaceutics Classification System owing to its low solubility and high permeability. In vitro dissolution testing is an essential tool for the design of a dosage form. Appropriate selection of dissolution test conditions is es...

Introduction Dissolution testing has increased in value and significance over the last quarter century. It has been used extensively to guide formulation development and to monitor formulation development,formulation changes, and manufacturing of products for new drugs. It is also widely used as a quality control tool to monitor the batchto-batch consistency of drug release from a product. Ther...

This report details discussions held over three days, August 4–6, 2014, in Ann Arbor, MI, on current research on in vivo predictive dissolution (IPD) testing. Participants hailed from academia, industry, and governmental bodies, and focused their attention on the role of IPD in various drug products. Academia was well represented at this conference with speakers mainly from the University of Mi...

INTRODUCTION Dissolution testing is an in vitro technique of great importance in formulation and development of pharmaceutical dosage forms,as it can be used as a substitute for in vivo studies under strictly defined and specified conditions (1). For the comparison of in vitro dissolution data and for use of such data for in vivo bioequivalence testing and in vitro-in vivo correlations (IVIVC) ...

The aim of the present study was to design a new biorelevant dissolution test apparatus for evaluating floating drug delivery systems. The gastric fluid secretion rate, volume of gastric fluid present in the stomach, and gastric emptying from the pylorus opening were taken into consideration. The material of construction was borosilicate glass. In vitro dissolution testing of pharmaceutical dos...

The most common pharmaceutical formulations for antibiotics are the tablets and hard gelatin capsules. The typical shelflife of these dosage forms is five years. In the most countries of the world it is required by the law that the expired medications have to be disposed following the respective regulations. Furthermore, it is common sense not to use the expired medications. The present study w...

This study describes various complications related to sample preparation (filtration) during development of a dissolution method intended to discriminate among different fenofibrate immediate-release formulations. Several dissolution apparatus and sample preparation techniques were tested. The flow-through cell apparatus (USP 4) was found unfit for dissolution testing of fenofibrate MeltDose fo...

In vitro dissolution testing of drug-eluting stents (DES) poses a special challenge in terms of apparatus design due to the very specialized local treatment of the vessel wall in the immediate vicinity of the blood flowing through the vessel and the stent lumen. A vessel-simulating flow-through cell was designed to emulate the placement of a DES in vivo and the flow through the lumen in a simpl...