What Are The Factors To Be Considered In The In Vitro Degradation Test Of Absorbable Hemostatic Products?


2022-11-29

During the in vitro degradation study of absorbable hemostatic products, it is recommended to simulate the in vivo conditions (e.g., 37°C environment, proteolysis, etc.) to study the time required for the product to be completely degraded and absorbed and all degradation products. And establish a reasonable in vitro degradation study method based on product characteristics and clinical application. And refer to existing standard methods and compare with similar marketed products. The recommended observation indicators for in vitro degradation study include: product solubility, degradation period, conditions required for degradation, and the relationship between degradation rate and degradation conditions, the main degradation products and their content, and morphological changes (disintegration process, whether there are fragments falling, swelling of fragments, etc.).