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. 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.
Tablets are usually tested in a classical dissolution bath with the USP 2 paddles method. Floating capsules and tablets generally use USP 1 baskets method.USP 1,2,5,6 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. You can also visit the dissolution accessories and spare parts
SOTAX offers WinSOTAXplus Advanced Dissolution Software for a complete 21 CFR Part 11 Compliant testing environment. WinSOTAXplus has been installed and validated worldwide within the Pharmaceutical Industry. It has been developed under the TickIT quality system for software development and ISO 9001 accreditation.