Mehak Mehta received her Bachelor's of Pharmacy degree from University of Delhi, India in 2009 and joined Department of Pharmaceutics, University of Minnesota in 2010.
Freeze-drying, also known as lyophilization, is widely used in pharmaceuticals to help improve stability and storage of thermolabile drugs, like antibodies and other protein formulations. There are numerous reports of processing induced in-situ phase transformations during freeze-drying. For example, dehydration of pentamidine isethionate trihydrate during primary drying yields an amorphous anhydrate, which can have implications on both chemical and physical stability of the final lyophile. The overall objective of my research is to be able to control the physical form of the excipient or the active pharmaceutical ingredient (API) during freeze-drying from both a mechanistic point of view and by taking advantage of the processing parameters. We are trying to look at hydrate/anhydrate transition in the frozen state in different model systems.
We tried to develop a stable intravenous formulation of a poorly water-soluble drug by using various approaches to enhance the solubility of the API like use of co-solvents, complexation-using cyclodextrins.
One of the other projects involved investigating the effect of processing parameters during freeze drying on the nature of phase crystallizing out. We were able to simulate the freeze-drying cycle using the low temperature stage in X-Ray diffractometer. Other solid-state characterization techniques like differential scanning calorimetry; thermogravimetric analysis and karl fischer titration were used to characterize the final lyophile.
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