A critical stage in the manufacture of a heat-labile parenteral drug is the sterilizing filtration step prior to filling of the drug product into the final dosage container or delivery system. Increasingly, biocompatible nanosuspensions are being considered and implemented in formulations to encapsulate drug molecules. They can be used to overcome solubility challenges, allowing for extended release and improved targeting of molecules at their intended sites of action. The liposomal delivery method can be costly and presents filtration challenges, and consequently this presents opportunities to better understand the effects of filtering liposomes, including what test conditions, such as filtration pressure and temperature, will influence overall filtration behaviour. To evaluate the effect of the above conditions on filtration behaviour, an investigation was performed where multiple sterilizing grade filters were challenged with fluorescent dye-encapsulated liposome solution. Confocal microscopy was used to measure the impact of each test and filter morphology on liposome filterability. This was a key technique in this investigation, providing a method to track and differentiate between fluorescent particles and a method to analyse each challenged membrane for adsorption and penetration of liposome. This type of analysis can be used to provide useful insights when identifying a suitable filter for the sterilization of final drug product using liposomes.

Using confocal microscopy to assess the effects of sterilizing grade filter morphology and experimental conditions on the filtration capacity of fluorescently tagged liposome, and in turn optimize filter selection for final drug manufacture

2019 Spring National Meeting

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