Physical Properties Characterization
摘要
The quality and performance of pharmaceutical particles and powders are dependent on critical quality attributes that are identified in development. Powder characterization is a fundamental step for proper design and control of solid dosage form manufacturing processes. Properties like surface area, charge, crystal habit, and the presence of water and impurities are responsible for dramatic changes in the physical-chemical and biological behavior of pharmaceutical products. Therefore, accurate tuning of powder features is compulsory. In this regard, an arsenal of particle characterization techniques has today reached a high level of reliability and sensitivity, which allows insightful investigation of the complex crosstalk between particle properties and pharmaceutical processes. Novel technologies are now on the verge of breakthrough advances thanks to new methodologies and computer science.