Role of an isomorphic desolvate in dissolution failures of an erythromycin tablet formulation

Abstract The investigation of dissolution failures for erythromycin dihydrate tablet formulation over a 12‐month period using a near‐infrared spectroscopy technique revealed the role of a desolvated dihydrate in the retardation of dissolution. Near infrared spectroscopy (NIR) indicated a dehydrated dihydrate of erythromycin is produced during formulation and gradually binds with Mg(OH) 2 . The binding delays the process of dissolution. NIR was used to successfully predict that humidifying the tablets would reverse the binding and increase the dissolution rate.