OBJECTIVE(S) The aim of this work was to investigate the effect of the natural and the chemically modified form of cyclodextrins namely; β-cyclodextrin (β-CD) and hydroxypropyl-β-cyclodextrin (HP-β-CD) respectively on the solubility and dissolution rate of aripiprazole; an antipsychotic medication showing poor aqueous solubility. MATERIALS AND METHODS Phase solubility of aripiprazole with the...

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 ...

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...

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...

PURPOSE: For poorly soluble, highly permeable (Class II) drugs, such as indomethacin, the rate of oral absorption is often controlled by the dissolution rate in the gastrointestinal tract. Therefore together with the permeability, the solubility and dissolution behaviour of a drug are key determinants of its oral bioavailability. The object of the present study is to increase dissolution rate o...

The purpose of the present study was to investigate the effect of polyethylene glycol (PEG) molecular weights (6000, 12000 and 20000) as solid dispersion (SD) carriers on the dissolution behavior of simvastatin. SDs with various drug : carrier ratios were prepared by solvent method and evaluated for dissolution rate. Differential scanning calorimetry (DSC), X-ray diffraction (XRD), infrared spe...

The objective of the present investigation was to study the influence of polyethylene glycol 4000 (PEG) and polyvinylpyrrolidone K30 (PVP) on in vitro dissolution of etoricoxib from solid dispersions. Preliminary studies were carried out using a physical mixture of the drug and carriers. Solid dispersions were prepared using the solvent evaporation method. A 32 factorial design was adopted in t...

In the present study, an attempt was made to increase the in vitro dissolution rate of carvedilol (antihypertensive) by cogrinding technique using various carriers, namely lactose, corn starch, treated agar, microcrystalline cellulose. The coground mixtures were prepared using the above excipients in four drug-carrier ratios, viz., 1:1, 1:3, 1:4 and 1:9. The prepared coground mixtures were eval...

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...

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing t...