The dissolution performance of a solid drug product is a critical quality attribute (CQA) as it defines the bioavailability of the drug in the human body. Hence, assessing the in-vitro dissolution performance is a mandatory task in the release procedure of solid drug products, which is inherently time-consuming and destructive. The real-time release testing (RTRT) guideline established by the European Medicines Agency (EMA) provides the basis to substitute this laborious step by establishing robust correlations between CQAs and product attributes which can be measured non-invasively. In the present study we used the tablet porosity as a predictor for dissolution performance. Porosity was measured via a non-destructive optical method relying on a combination of photon time of flight spectroscopy (pTOFS) and gas in scattering media absorption spectroscopy (GASMAS). The porosity values obtained via this measurement showed a strong correlation with the in-vitro dissolution performance indicating suitability for real-time-release testing.
Learning Objectives:
Upon completion, participant will be able to describe a novel porosity measurement method and it's promising real-time release testing application of predicting in-vitro dissolution performance non-invasively.
Upon completion, participant will be able to understand the connection between liquid to solid ratio of a granulation process and the dissolution performance of the tablet produced of these granules.
Upon completion, participant will be able to describe the interaction of liquid to solid ratio duriing granulation and the tablet porosity regarding dissolution performance of a tablet.
