Dissolution Testing

Dissolution is a test used by the pharmaceutical industry to characterize the dissolution properties of the active drug, the active drug's release and the dissolution from a dosage formulation. Dissolution testing is used to formulate the drug dosage form and to develop quality control specifications for its manufacturing process. An in-vitro dissolution test is a critical test that has to correlate with in-vivo clinical studies and which could require specific method developments. Dissolution testing is described in many pharmacopeias, in EP, USP chapters and FDA guidelines.

USP nomenclature for compendial apparatus for dissolution testing includes USP 1 baskets, USP 2 paddles, USP 3 reciprocating cylinders, USP 4 flow through cell, USP 5 paddle over disk, USP 6 cylinders, USP 7 reciprocating holders. While tablets are usually tested in a classical dissolution bath with the USP 2 paddles method, floating capsules and tablets generally use the USP 1 baskets method. Novel dosage forms such as suspensions, implants, drug eluting stents, MR tablets, APIs, microspheres, soft gels and suppositories use the flow-through cell method USP 4. USP 5 (paddle-over-disk) and 6 (rotating cylinder) are used for transdermal patches. Dissolution testing can also require complementary equipment such as a media preparation station.

SOTAX design concepts allow for customization of the pharmaceutical testing systems for specific needs.

Xtend™ Dissolution Line for tablet testing

The ability to flexibly respond to permanent change in today’s fast-paced pharmaceutical environment can make the difference between success and failure. Fast time-to-market requirements, outsourcing, relocations, shift of manufacturing capacities and short return on investment considerations ask for equally flexible testing solutions in R&D and quality control laboratories. The new and fully modular and scalable Xtend™ concept is 100% based on this basic premise and allows lab scientists to tailor tablet dissolution testing to both their current and future needs – making their investment future-proof. This new concept consists of new individual and standardized Xtend™ modules which can be flexibly combined for different customer requirements.