Abstract
Current plastic containers for solution type medicine have a problem in assessing the stability because of a decrease in water during strage, due to the moisture permeability of plastics. A lower humidity condition is selected in both the accelerated stability test and long-term storage stability test for the registration stability data. Thus, it is necessary to predict the water loss from the plastic containers in high accuracy in the development of primary plastic containers in the lower humidity condition. This study indicated that an application of material transfer dynamics using first order reaction equation is useful for the prediction of the water loss from the plastic containers in various storage conditions. When the ratio of apparent diffusion coefficient of water through the plastic container in the different two temperature conditions is available and data in one temperature/humidity condition is available, it is possible to calculate the water loss in the various storage conditions for the prediction. This prediction method may help the assurance level of the quality of development technology as well as container itself and stability evaluation of liquid type pharmaceuticals in plastic containers.
