In vitro dissolution tests for solid oral dosage forms are extremely important to ensure the quality of these products. However, no dissolution test has been reported for finasteride (FNS) in immediate-release capsules. The aims of this work were to optimize a dissolution method for FNS capsules, validate the analytical method, and evaluate three different commercial products. The best in vitro...

Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and Drug Administration (FDA) has allowed the replacement of dissolution testing with disintegration ...

INTRODUCTION This study was designed to assess the effect of two bleaching agents on the disintegration tendency of three types of glass ionomers. MATERIALS AND METHODS A total of 90 specimens were prepared by using a split Teflon ring with an internal diameter of 5 mm and a thickness of 2 mm. The tested materials were applied and bleached according to manufacturer's instructions. Dissolution...

The establishment of biorelevant and discriminating dissolution procedure for drug products with limited water solubility is a useful technique for qualitative forecasting of the in vivo behavior of formulations. It also characterizes the drug product performance in pharmaceutical development. Lornoxicam, a BCS class-II drug is a nonsteroidal antiinflammatory drug of the oxicam class, has no of...

The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to both the pharmaceutical industry and the agencies that regulate them. These challenges include developing and validating the test methods, ensuring that methods are appropriately discriminatory, and addressing the potential for an in vivo–in vitro correlation (IVIVC). Di...

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 orally disintegrating tablet (ODT) is a novel dosage form that disintegrates in the oral cavity using saliva as the disintegrating medium and is swallowed as a fine dispersion. Due to rapid disintegration, the dissolution rate is controlled by the intrinsic solubility of the API; therefore, it is difficult to evaluate the effect of formulation and processing parameters on in vitro drug rele...

Bioavailabilities of seven tablets of ciprofloxacin were determined. The correlation between in-vivo bioavailability parameters and in-vitro dissolution rates were studied. Ciprofloxacin concentration from the blood was determined by microbiological assay technique. The release pattern of ciprofloxacin from tablets, which were determined by dissolution USP paddle method and spectrophotometric m...

With the increased reliance on in vitro dissolution testing as an indicator of in vivo drug behavior and the trend towards the in silico modeling of dosage form performance, the need for bioperformance dissolution methodology development has been enhanced. Determination of the in vivo drug delivery profile is essential for the bioperformance dissolution test development and in vitro/in vivo cor...

I. Introduction The US Food and Drug Administration sets performance limit on dissolution in terms of a specific percentage Q that the drug product is required to be dissolved at a specified time. Based on inferences from correlated bioavailability studies, these dissolution specifications were intended to assure that at least 80% of the labeled quantity of drug was available. When carried out ...