Our staff members have contributed to a number of scientific publications before and during their association with Coriolis. This combined knowledge is the backbone of our scientific excellence. If you are interested in reprints of the publications, please feel free to contact us.
Our most recent publications are listed below by default. Please make use of the drop-down filter to explore all our papers by year of publication or highlight some award winning key publications.
J Pharm Sci. (2017)
Lyophilized Drug Product Cake Appearance: What Is Acceptable?
Patel SM , Nail SL , Pikal MJ , Geidobler R , Winter G , Hawe A , Davagnino J , Gupta SR
Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and efficacy). Striving for “uniform and elegant” cake appearance may continue to remain an important goal during the design and development of a lyophilized drug product. However, sometimes a non-ideal cake appearance has no impact on product quality and is an inherent characteristic of the product (either due to formulation, drug product presentation and/or freeze-drying process).
This commentary provides a summary of challenges related to visual appearance testing of freeze-dried products, particularly on how to judge the criticality of cake appearance. Furthermore, a harmonized nomenclature and description for variations in cake appearance from the ideal expectation of “uniform and elegant” is provided, including representative images. Finally, a science and risk based approach is discussed on establishing acceptance criteria for cake appearance.