Foreword for the JPP special issue 'Recent Innovations in Dissolution Testing'

摘要

Traditionally, dissolution testing has been one of the most effective and relied upon tools for quality control of dosage forms, both directly after manufacture and during the shelf life of the formulation. The reason that it is such a powerful tool for these purposes is that it is a global indicator of the dosage form's ability to release the active pharmaceutical ingredient(s) (API) and enable it to become therapeutically effective. Other tools, such as content uniformity, friability, hardness or disintegration, only address certain attributes of the dosage form. For example, while the content uniformity reports whether the dosage form reliably contains the labelled amount, it is silent about whether the API can actually be released from the dosage form in the body.