Five lots of prednisone tablets that disintegrate within 5 min were collaboratively studied by 11 laboratories using USP Apparatus 2 under carefully controlled conditions. One lot gave complete dissolution. The reproducibility and repeatability of Apparatus 2 for the four lots still dissolving at the end of the test were 2.6 and 1.6 % of label claim, respectively, for the 11 laboratories. The U...

A dissolution test for telithromycin tablets was validated and developed. In order to choose the most discriminatory one, the conditions to carry out are 900 mL of sodium phosphate buffer at pH 7.5, paddles at 50 rpm stirring speed, time test set to 60 min and using USP apparatus 2 with paddles. The UV spectrophotometric method for determination of telithromycin released was developed and valid...

The objective of this study was to evaluate the effect of various hydrodynamic conditions on drug release from an eroding and gel forming matrix. For this purpose, dimenhydrinate was formulated with hydroxypropyl methyl cellulose and polyethylene oxide into matrix tablets and the drug release in deionized water was evaluated spectrophotometrically, using multiple dissolution methods, namely, co...

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...

The present study describes the development and validation of a dissolution method for carvedilol compression-coated tablets. Dissolution test was performed using a TDT-06T dissolution apparatus. Based on the physiological conditions of the body, 0.1N hydrochloric acid was used as dissolution medium and release was monitored for 2 hours to verify the immediate release pattern of the drug in aci...

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...

The aim of this study was to investigate if the changes made in the specifications of the disintegration procedure impact the performance of the disintegration test described in USP chapters <701> and <2040>. Different tablets and capsules were produced, and their disintegration times were determined. The following disintegration time parameters were analyzed: volume of the immersion fluid, typ...