Lyophilization in Microgravity (Eli Lilly-Lyophilization)
Lyophilization in Microgravity (Eli Lilly-Lyophilization) seeks to understand the influence of gravity on the physical state and properties of lyophilized materials of interest in the pharmaceutical industry. Lyophilization (i.e., “freeze-drying”) is a common method for formulating pharmaceutical drug products with improved chemical and physical stability and is applicable to both small and large molecule pharmaceutical products. Lyophilized materials are reconstituted with an appropriate diluent prior to administration to patients, typically via an intravenous route. While lyophilization affords many advantages with respect to chemical stability, it introduces other elegance and patient-safety considerations such as clarity, reconstitution time, and particulate matter, some of which may be governed by the lyophilization process itself.
These studies are expected to drive an understanding of the fundamental properties that impact the physical characteristics of lyophilized materials and may result in improved processes for lyophilization in the pharmaceutical industry as well as other industries. When materials are lyophilized terrestrially, the freezing and subsequent drying process leads to a “layered” product in which material forms strata that are different in macroscopic form as seen by color and or structural differences as well as in microscopic form as seen in particle size and crystal form. The factors that contribute to these differences are hypothesized to be due, in part, to gravity and the settling effect as material comes out of solution. This experiment allows us to explore several aspects of the process that would otherwise not be possible, including answers to the following questions:
- Is the stratification the result of the freezing, or the dehydration process?
- How is the stratification related to the resulting crystal form and particle size?
- If there is no gravity, is there any stratification?
- If there is not stratification, are there differences in resulting crystal form and particle size? If no, then which form is favored?
Lyophilization-2 in Microgravity
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