Dissolution Testing and Physical Testing

Dissolution tests are used in the pharma industry in order to characterize dissolution properties of the active drug, the active drug's release, as well as the dissolution from a dosage formulation. While standard tablets are typically tested using the paddle method (USP 2), swelling or floating dosage forms e.g. capsules, are tested according to the basket method (USP 1), whereas paddle-over-disk (USP 5) and rotating cylinder (USP 6) methods are utilized for transdermal dosage forms. The flow-through dissolution method (USP 4 / EP Flow-through cell) is a very interesting method that offers complete flexibility on media volumes and allows repeatable positioning of virtually all dosage forms: powders, suspensions, suppositories, APIs, lipophilic forms, liposomes, microspheres, semi-solids, implants, as well as medical devices including drug eluting stents. In addition to dissolution testing, solid dosage forms are tested to determine the compliance of physical characteristics: disintegration, friability, hardness, flowability, etc. All instruments for these tests can operate as stand alone units, but they are also ready for easy integration with data management software and reporting - in full compliance with requirement 21 CFR 11.