Influence of Freezing Temperature on Product Parameters of Solid Dosage Forms Prepared via the Freeze‐Casting Technique

The freeze‐casting technique was used to formulate porous solid bodies containing theophylline as an active pharmaceutical ingredient, potato starch as a filler and citric acid or saccharose as binding agents. Aqueous suspensions of the ingredients were frozen at three different temperatures. The aim of this work was to investigate the influence of the freezing temperature on the ice crystal growth rate of the suspensions and the resulting porosity of the freeze‐casted samples. The impact of the freezing temperature on the solidification of the suspensions was analyzed via contact angle measurements. The rate of ice crystal growth was expressed as an overall linear growth rate. The porosity of the freeze‐casted bodies was determined by high‐pressure mercury porosimetry. A close correlation was found between the freezing temperature and the investigated product parameters. Lower cooling temperatures resulted in higher final porosities. The lowest temperature, at which final product properties could be regulated by varying the cooling regimes, was –30 °C. The influence of the freezing temperature and the impact of the additives were not remarkable at a freezing temperature lower than –30 °C. Therefore, it can be concluded that the optimum freezing temperature of the suspensions investigated in this study is in the temperature range between –20 °C and –30 °C.