The objective of this research is to develop a non-destructive technique based on microwatt batch calorimetry to study the degradation of drugs (solid-state and liquid formulations), biochemicals, and biomaterials (e.g., those used in artificial organs). As a research tool, the microwatt calorimeter is complementary to, and provides information unattainable by more specific methods (e.g., chromatography and spectrophotometry).
The aim of Phase I is to establish the feasibility of using a microwatt calorimeter to study the degradation of solid-state dosage forms of drugs and drug mixtures. The effect of alternative heat sink materials and simple chamber configurations on instrument equilibration, sensitivity, and accuracy will also be investigated. In Phase II, an instrument will be designed based on Phase I results. The new instrument will have sophisticated electronic control and will be used to study a wide range of drugs, biochemicals, and biomaterials. The successful completion of this investigation will provide researchers with a rapid, accurate, and reliable instrument to measure overall decomposition rates without applying a physical or chemical stress (e.g., dissolution, heating, changes in ionic strength, etc.). Thus, new insights into the degradation process will be achieved. Commercialization is anticipated in new product development and testing.
