Pharmaceutical dissolution testing for solid dosage forms including routine dissolution and advanced methods for immediate or controlled release systems
Pharmaceutical dissolution testing plays a key role in drug development and is used in all phases of development for quality control testing to assess batch-to-batch consistency, product release and stability testing programs.
In vitro dissolution testing for tablets, capsules or other solid oral dosage forms allows assessment of the availability of the active pharmaceutical ingredient (API) active drug materials in their formulation and gives an indication of the time required for release of the drug substance from the dosage form.
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.
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.
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 development process and support your crucial 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.
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