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).

Disintegration Testing
Our physico-chemical property team also provide disintegration tests which may be used to substitute for dissolution (ICH Q6A), for example, when immediate release solid oral drug products, made from highly water soluble drug substances, have been demonstrated to have consistently rapid drug release characteristics.

Friability Testing
We also perform friability testing form compress, uncoated tablets, using the analytical procedures described in the official pharmacopoeial texts, Ph. Eur. 2.9.7. Friability of Uncoated Tablets and USP Tablet Friability. Friability is the measurement of the propensity of a tablet break-up or crumble following compression during handling or subsequent storage and allows assessment of the tablet processing, design, formulation or moisture content. 

Controlled Release Studies
In combination with these dissolution approaches, we also offer imaging and spectroscopy techniques to support research such as confocal Raman fast mapping which allows mapping of the distribution of active ingredients and excipients in solid dosage systems and characterisation of controlled-release systems. Microscopy techniques can also be used to identify and quantify key quality attributes such as coating uniformity, thickness and surface features.

Through delivery of rugged and reproducible dissolution testing from our network of GMP compliant facilities in the USA and the UK, we can help you to identify any significant changes in product performance. Our expertise in dissolution testing will allow you to accelerate your drug development and support your quality control or release testing programs. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.