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Dissolution testing in the drug development process

Dissolution testing is used throughout the drug development process and is a requirement for all solid oral dosage forms for product release and stability testing. It is an essential analytical test used for detecting physical changes in an active pharmaceutical ingredient (API). Once a drug is formed, its dissolution properties have a direct effect on its absorption in the body. Therefore, the rate of dissolution of a tablet or capsule, for example, is critical to this process.

The dissolution and the drug release of tablets is controlled by various properties, including tablet material, morphological tablet structure, surface material, properties of the gel layer during dissolution, ph value of the environment during dissolution etc.NMR Microscopy is a technique that can be used in the dissolution of tablets. The dissolution process can be visualised by time resolved 2D and 3D images, observing the water protons.

Atomic Force Microscopy (AFM) has also been successfully utilised to study the dynamics of the dissolution process, and has added to the pharmaceutical industry’s overall understanding of this process at the molecular scale.

AFM has been used with great success to evaluate many of the steps in the drug fabrication process, including studies of drug interactions, gene delivery vehicles, crystal growth, and particle formation.