The aim of this study was to develop and validate a dissolution test for the quality control of deflazacort (DEF) tablets, a drug mainly used for the prevention of organ transplantation rejection, labeled as containing 6 mg of active pharmaceutical ingredient (API), using an RP-HPLC method. After testing sink conditions and stability at 37°C, DEF was found to be unstable, and decomposed as a fu...

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 AAPS Workshop on Oral Bioperformance and 21st Century Testing was held in Chicago, Illinois, on October 13 and 14, 2012. The main objective of the workshop was to reevaluate and discuss the use of dissolution testing in a more biorelevant scenario. When dissolution testing was introduced in the early 1970s, there was a debate whether the test should be a development or a quality control too...

Drug dissolution (or release) testing is an analytical technique used to assess release profiles of drugs in pharmaceutical products,generally solid oral products such as tablets and capsules (1). This test gains its significance from the fact that if a drug from a product is to produce its effect, it must be released from the product and should generally be dissolved in the fluids of the gastr...

A recent report suggested that some folic acid preparations available in the United States failed to meet the specifications for dissolution specified by the US Pharmacopoeia (USP), of 70 per cent drug release in the first hour of testing. The Teratology Society recommends that women of childbearing age should take a daily supplement of 400 microg folic acid when they are trying to conceive, to...