Dissolution
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Dissolution is a test used by the Pharmaceutical industry to characterise 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 testing 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 1, 2, 5, 6
Tablets are classically tested according to the USP 2 paddle method. Swelling or floating dosage forms such as capsules are tested according to USP 1 basket method. USP 5 (paddle-over-disk) and USP 6 (rotating cylinder) are used for transdermal dosage forms.
USP 4
To benefit from complete flexibility on media volumes and to reproducibly position dosage forms such as powders, APIs, lipophilic forms e.g. suppositories, suspensions, liposomes, microspheres, semi-solids, implants and medical devices e.g. drug eluting stents, the right method is the USP 4 flow-through cell.
