Physical Characterization of Pharmaceutical Formulations in Frozen and Freeze-Dried Solid States: Techniques and Applications in Freeze-Drying Development

摘要: Physical characterization of formulations in frozen and freeze-dried solid states provides indispensable information for rational development pharmaceutical products. This article an overview the physical characteristics states, which are essential to both formulation process development. Along with a brief description techniques often used freeze-drying development, applications recent improvements these discussed. While most conventionally pharmaceuticals, some were designed or modified specifically studies freeze-drying. These include microscopy, X-ray powder diffractometry cryoenvironmental scanning can be characterize properties under conditions similar real vial lyophilization process. Novel conventional techniques, such as microcalorimetry near infrared (NIR) spectroscopy, facilitated receive special attention. Research developmental needs area also addressed, particularly need better understanding quantitative correlation between molecular mobility storage stability (shelf life).