First dissolution-focused CRO launched
Sotax said that the new spin-off company, SPS Pharma Services, is the only outsourcing company dedicated to dissolution testing for formulation and Quality Assurance (QA). The effectiveness of oral dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract - or, for buccal dissolution, the mouth - prior to absorption into the system. Drug dissolution - the rate of release of a finished drug product - is therefore an important aspect in development, particularly with the introduction of controlled-release dosage forms and the increasing use of poorly water-soluble drugs.
When developing a new drug, it is important to demonstrate that the in vitro dissolution tests are predictive of the behaviour of the formulation in vivo - a process known as in vitro-in vivo correlation or IVIVC.
Dissolution testing is therefore a critical formulation tool in drug development, measuring the stability of the product, establishing its in vivo availability and ensuring uniformity between production lots. The method is used to formulate the drug dosage form and to develop quality control specifications for its manufacturing process.
But with the recent arrival on the market of a new generation of less soluble compounds, including drugs that target specific areas of the body, traditional tests have become obsolete.
For these new types of products more complex dissolution methods are needed, so the US Pharmacopoeia has developed various standards for apparatus use, and one of these, USP 4, covers the flow-through method, which is becoming more commonly used as it can handle a broad range of dosage forms, including not only tablets and capsules but also implants, stents, suppositories and powders or granules.
According to recent research, dissolution studies are the most frequently used tools in the development, characterisation and utilisation processes of controlled release formulations. And in particular the USP 4 method, which has been employed for many years in the testing of different dosage forms such as tablets and capsules, is the method of choice for extended release and poorly soluble products.
SPS Pharma Services, headquartered in Clermont-Ferrand, France, said it will specialise in the development of dissolution methods with a focus on the USP 4 techniques and will provide a wide range of services, including screening of available dissolution methods for new compounds, development of dissolution methods, evaluation of semi or full automation of dissolution methods and method transfer from manual dissolution systems to semi or fully automated dissolution systems.
