Prediction of ice crystal size distribution during freezing of a pharmaceutical solution

In this work, a mathematical model is presented for the prediction of the crystal size distribution of ice over the entire height of products frozen in vials. Unlike previous approaches, which were all based on empirical observations, the present one makes use of principles of chemistry and physics. In particular, we focus on a simplified version of such model and show its applicability to typical pharmaceutical formulations. The model predictions have been validated analyzing with Scanning Electron Microscopy the pore dimension of freeze-dried products, which corresponds to the ice crystal dimension of frozen products.