Pharmaceutical Dissolution Testing

Pharmaceutical dissolution testing plays a key role in drug development and across the drug product lifecycle. In early phase development, dissolution helps to establish the dissolution mechanism, in later stages (stage II to III) dissolution testing helps to drive insight into key formulation or process parameters and also an in vitro-in vivo correlation. Supporting product registration and beyond, the focus is on identifying a quality control dissolution test method to verify process and product consistency.

Our scientists provide standard dissolution testing according to United States Pharmacopeia (USP) [General Chapter 〈711〉], European Pharmacopeia (EP) and US FDA guidelines for solid dose products. We are experienced in the development of specific dissolution approaches that are matched to the product’s specified release characteristics, in order to identify changes in critical quality attributes. This includes selection of the dissolution media, the dissolution apparatus and agitation rates.

For typical tablet solid dose forms such as tablets or floating capsules we provide standard USP Apparatus 1 (basket) and Apparatus 2 (paddle) instrumentation approaches. For immediate-release and extended release tablets we utilise the USP Apparatus 2. We also offer other dissolution techniques such as USP Apparatus 4 (flow-through-cell) which is useful for powders, suspensions, microspheres and medical devices such as drug eluting stents.

We use automation in dissolution testing to drive greater efficiency and productivity. UV/vis spectrophotometric determination of absorbance has been the traditional analytical method for dissolution testing and is the preferred method for efficiency and automation. Spectral deconvolution techniques allow the capability of handling multi-component analysis or analysis in UV absorbing matrices (e.g., excipients).