Moisture barrier prediction modelling

A calculation tool for the prediction of moisture uptake by pharmaceutical formulations, including desiccants and capsules at different storage conditions has been created in order to select appropriate packaging concept. In order to perform these calculations, the moisture permeability of the various bottles and blisters is essential to be known. In addition, a new tool to predict a quantitative understanding of moisture uptake of the product during in-use has been developed and it is necessary to verify by experiments the simulation. The moisture permeability of bottles is determined by using different desiccant, different mesh size and amount of desiccant, and the calculation is done with three different equations. The tool simulation in use was evaluated for tablets and desiccants by experimental measurements .The study of blister packaging uses finite element analysis compared with experimental measurements, in regards to the effects of the blister's material, form and size. The moisture uptake by the 75 ml HDPE bottles are not affected by using different types of desiccant, mesh size of the desiccant and by reducing the amount of desiccant by 50%. The drying process of desiccant has to be properly done in order to calculate the moisture permeability accurately. The linear regression method is recommended to evaluate permeability of different packaging. The tablet moisture content predictions with the PMC simulation, gravimetric and Loss on drying measurement give consistent result in 25ºC/60%RH and 40ºC/75%RH environment. However the PMC simulation is not able to calculate the moisture uptake for formulation with great absorption capacity. The last study on blister packaging show that the calculated Finite Element Method (FEM) permeability values of four different blister forms at either at 25ºC/60%RH or 40º/75%RH did not result in an overall good fit to the measured data.Validerat; 20101217 (root