VYXEOS® is the first FDA-approved dual-API liposomal formulation containing two different chemotherapeutics, daunorubicin and cytarabine at a 1:5 molar ratio. Analysis of bulk formulation does not provide insight to size-based distribution of APIs and excipients, therefore asymmetrical flow field-flow fractionation (AF4) was utilized for the size-based separation of VYXEOS® liposomes and collected size fractions were further analyzed for the concentrations of APIs, lipid excipients, and copper. Analysis results revealed a significant variation in API distribution across the size fractions, with the larger liposomes encapsulating a higher ratio of cytarabine to daunorubicin compared to the smaller liposomes, while lipid excipient composition was held constant across the size range. We attribute the size-based variation of API ratios to structural change during API loading and sequence of API loading. Cytarabine is first passively loaded into liposomes containing copper gluconate, and then daunorubicin is actively loaded using copper gradient where the daunorubicin is retained in the liposomes as a copper complex. This method can be extended to characterize various single and dual-API liposomal nanocarriers during drug product development and/or post market quality control.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.chroma.2024.465488 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Size-based separation of extracellular vesicles investigating the relationship between Tetraspanins and RNA.
Anal Chim Acta
January 2025
Department of Mechanical Engineering, Pohang University of Science and Technology, 77 Cheongam-Ro, Nam-Gu, Pohang, Gyeong-buk, 37673, Republic of Korea; School of Interdisciplinary Bioscience and Bioengineering, Pohang University of Science and Technology, 77 Cheongam-Ro, Nam-Gu, Pohang, Gyeong-buk, 37673, Republic of Korea. Electronic address:
Article Synopsis
- Extracellular vesicles (EVs) are tiny particles released by cells, which vary in size and make classification challenging; this study employs the coffee ring effect for better size-based separation of these particles.
- The method successfully differentiated EVs and virus-like particles (VLPs) based on size, revealing unique distribution patterns for tetraspanin markers and confirming these findings through advanced imaging techniques.
- Overall, the research offers deeper insights into EV heterogeneity and highlights how a cell's origin and development influence the properties of these particles.
NET guidelines for white patients may not fit Asian patients.
Am J Surg
December 2024
The Department of Surgery, University of Alabama at Birmingham, 1808 7th Avenue S, Birmingham, AL, 35233, USA. Electronic address:
Introduction: Pancreatic neuroendocrine tumors (pNETs) are slow growing, malignant tumors that show different survival outcomes by race. Current size-based guidelines were largely developed in White patients. Our aim was to investigate tumor size and incidence of lymph node metastasis (LNM) between White and Asian pNET patients to evaluate generalizability of established guidelines.
View Article and Find Full Text PDFTexture Analysis in Volumetric Imaging for Dentomaxillofacial Radiology: Transforming Diagnostic Approaches and Future Directions.
J Imaging
October 2024
Postgraduate Program in Dentistry, Cruzeiro do Sul University (UNICSUL), São Paulo 1506-000, SP, Brazil.
This narrative review explores texture analysis as a valuable technique in dentomaxillofacial diagnosis, providing an advanced method for quantification and characterization of different image modalities. The traditional imaging techniques rely primarily on visual assessment, which may overlook subtle variations in tissue structure. In contrast, texture analysis uses sophisticated algorithms to extract quantitative information from imaging data, thus offering deeper insights into the spatial distribution and relationships of pixel intensities.
View Article and Find Full Text PDFPoly(glycidyl methacrylate--ethylene glycol dimethacrylate) Monolith with Dual Porosity for Size Exclusion Chromatography.
Anal Chem
December 2024
Future Industries Institute, University of South Australia, Mawson Lakes Campus, Adelaide, South Australia 5095, Australia.
The use of polymeric monoliths as stationary phases for liquid chromatography has been limited, despite their ability to enhance the convection flow of the mobile phase with respect to particulate-based columns. This is due to a poor balance between the volume of flow through pores and the number of active sites within polymeric monoliths. In this paper, we present the obtainment of poly(glycidyl methacrylate--ethylene glycol dimethacrylate) (P(GMA--EDMA)) monoliths with dual pore size distributions (with pore sizes of 60 and 550 nm).
View Article and Find Full Text PDFEvaluation of size-based distribution of components in VYXEOS® liposomal formulation using asymmetric flow field-flow fractionation.
J Chromatogr A
December 2024
Arkansas Laboratory, Office of Regulatory Science, Office of Regulatory Affairs, U.S. Food and Drug Administration, Jefferson, AR 72079, United States. Electronic address:
VYXEOS® is the first FDA-approved dual-API liposomal formulation containing two different chemotherapeutics, daunorubicin and cytarabine at a 1:5 molar ratio. Analysis of bulk formulation does not provide insight to size-based distribution of APIs and excipients, therefore asymmetrical flow field-flow fractionation (AF4) was utilized for the size-based separation of VYXEOS® liposomes and collected size fractions were further analyzed for the concentrations of APIs, lipid excipients, and copper. Analysis results revealed a significant variation in API distribution across the size fractions, with the larger liposomes encapsulating a higher ratio of cytarabine to daunorubicin compared to the smaller liposomes, while lipid excipient composition was held constant across the size range.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!