4th Annual WML Academic Symposium

A coprocessed excipient is a combination of two or more compendial or non-compendial excipients designed to physically modify their properties without significant chemical change. The purpose of this research is physicochemical characterization of MicroceLac®100 powder and to determine the moisture uptake rate of its directly compressed tablets. After exposing the tablets to various relative humidity levels the absorbed moisture may induce a plasticizing effect (increasing the molecular mobility) leading to crystallization of amorphous content in the material. Both dynamic and static sorption isotherms will be used to determine square root of time dependent moisture uptake. A recrystallization inhibitor like HPMCAS (polymer) will be used to prevent this plasticizing effect of water depending on the chemical and physical association between water and polymer. The effect of moisture on solid state properties will be determined by means of differential scanning calorimetry, powder X-ray diffractometry and thermogravimetric analysis. Powder micromeritic properties will be determined to characterize the powder at the particulate level. Determining these moisture- induced changes could be useful in predicting the shelf life and understanding the behavior of MicroceLac®100 during storage and various steps of production of dosage forms.