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Henry Lujan,1 Wezley C Griffin,2,3 Joseph H Taube,2,4 Christie M Sayes1,41Department of Environmental Science, Baylor University, Waco, TX, USA; 2Department of Biology, Baylor University, Waco, TX, USA; 3Department of Chemistry and Biochemistry, Baylor University, Waco, TX, USA; 4Institute for Biomedical Sciences, Baylor University, Waco, TX, USAIntroduction: The use of liposomes as a drug delivery carrier (DDC) for the treatment of various diseases, especially cancer, is rapidly increasing, requiring more stringent synthesis, formulation, and preservation techniques to bolster safety and efficacy. Liposomes otherwise referred to as phospholipid vesicles are self-assembled colloidal particles. When formed in either the micrometer or nanometer size range, they are ideal candidates as DDC because of their biological availability, performance, activity, and compatibility. Defining and addressing the critical quality attributes (CQAs) along the pharmaceutical production scale will enable a higher level of quality control for reproducibility. More specifically, understanding the CQAs of nanoliposomes that dictate its homogeneity and stability has the potential to widen applications in biomedical science.Methods: To this end, we designed a study that aimed to define synthesis, characterization, formulation (encapsulation), preservation, and cargo delivery and trafficking as the major components within a target product profile for nanoliposomes. A series of synthetic schemes were employed to measure physicochemical properties relevant to nanomaterial drug product development, including concentration gradients, probe versus bath sonication, and storage temperature measured by microscopy (electron and light) and dynamic light scattering.Results: Concentration was found to be a vital CQA as reducing concentrations resulted in nanometer-sized liposomes of |
