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) ...

Purpose: To evaluate the usefulness of the flow-through cell apparatus for testing commercial vaginal tablets containing poorly water-soluble clotrimazole. Methods: The effect of experimental conditions (type of dissolution medium, flow rate and positioning of the tablet) on the dissolution profile of clotrimazole were examined and optimal parameters for conducting the experiments were determin...

OBJECTIVES The purpose of the present study was to use the solid dispersion (SD) technique to improve the dissolution rates of indomethacin (IMC). MATERIALS AND METHODS IMC solid dispersions in PVP K30 and isomalt (GALEN IQ 990) were prepared using the solvent evaporation technique and a hot melt method in weight ratios of 2, 10 and 30% (IMC:PVP). Solid dispersions and physical mixtures were ...

In vitro release kinetics of three commercially available sustained release tablets (SR) diltiazem hydrochloride were studied at pH 1.1 for 2 h and for another 6 h at pH 6.8 using the USP dissolution apparatus with the paddle assemble. The kinetics of the dissolution process was studied by analyzing the dissolution data using five kinetic equations: the zero-order equation, the first-order equa...

The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE resu...

This study explored the application of 400-DS dissolution apparatus 7 for individual pellet dissolution methodology by a design of experiment approach and compared its capability with that of the USP dissolution apparatus 1 and 2 for differentiating the coat quality of sustained release pellets. Drug loaded pellets were prepared by extrusion-spheronization from powder blends comprising 50%, w/w...

Lead-free selective soldering can result in extended times at high temperatures, which in turn can result in excessive dissolution of exposed copper, such as plated through holes. This phenomenon is more severe with lead-free, since the alloys have higher melting points, hence requiring longer times for the PTH to reach the higher temperatures, and the alloys typically have a greater capacity t...

Dissolution testing measures the rate of drug substance release into solution, impacting the extent of drug absorption. Drug manufacturers and regulatory agencies use dissolution testing to identify drug products that do not meet the desired clinical performance. Formulation composition and manufacturing processes can impact the material attributes of a drug product, which directly affect the d...

A multivariate test of size a for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed by using the approach for the common mean problem in a multivariate setup due to Halperin (1961). The performance of the proposed method is compared with Intersection Union Test as well as f2 criterion recommended by the FDA through a simulation study. All t...

The effect of formulation parameters on the in vitro release profile of a poorly soluble drug was investigated using rimonabant as model drug. A dissolution test was developed to evaluate the release profile of rimonabant from both 20mg film-coated tablet and capsule dosage forms. The test was applied to compare dissolution profiles of different dosage forms and to evaluate the effect of formul...