The Characterization of Fully Formulated Pharmaceuticals by Advanced Thermal Methods

摘要

Thermoanalytical methods have proven to be useful in all steps of the pharmaceutical development process and at quality control of product. These methods have become increasingly important in the solution of an assortment of scientific problems in the pharmaceutical industry. Careful attention must be paid to safety, quality, purity, and stability of a pharmaceutical formulation to ensure proper performance. Therefore, analysis of the folly formulated pharmaceutical tablet is critical in gaining an understanding of the pharmaceutical behavior. Nine Pharmaceuticals of various functionalities were evaluated using Differential Scanning Calorimetry (DSC) to characterize the "fingerprint" pattern and Oxidation Onset Temperature (OOT) of each pharmaceutical. In addition, the OOT method was evaluated with regard to effectiveness as a measure of relative pharmaceutical stability. Thermogravimetric Analysis (TGA) and Fourier Transform-Infrared Spectroscopy (FTIR) were used in conjunction with DSC results to characterize physical and chemical changes in the pharmaceutical sample as a function of temperature change.