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The Global Characterisation of a Drug-Dendrimer Conjugate - PEGylated poly-lysine Dendrimer. | LitMetric

AI Article Synopsis

  • The emergence of drug-dendrimer conjugates in pharmaceutical research presents significant analytical challenges due to their high molecular weight and structural complexity.
  • Understanding their characteristics, including intact conjugates, building blocks, and active pharmaceutical ingredients (APIs), is crucial for assessing their efficacy and safety.
  • A comprehensive characterization study on a specific drug-dendrimer conjugate (PEGylated poly-lysine dendrimer AZD0466) illustrates the need for various analytical techniques to gain insights into these complex molecules, aiding future dendrimer-based medicine development.

Article Abstract

The recent emergence of drug-dendrimer conjugates within pharmaceutical industry research and development introduces a range of challenges for analytical and measurement science. These molecules are very high molecular weight (100-200kDa) with a significant degree of structural complexity. The characteristics and quality attributes that require understanding and definition, and impact efficacy and safety, are diverse. They relate to the intact conjugate, the various building blocks of these complex systems and the level of the free and bound active pharmaceutical ingredient (API). From an analytical and measurement science perspective, this necessitates the measurement of the molecular weight, impurity characterisation, the quantitation of the number of conjugated versus free API molecules, the determination of the impurity profiles of the building blocks, primary structure and both particle size and morphology. Here we report the first example of a global characterisation of a drug-dendrimer conjugate - PEGylated poly-lysine dendrimer currently under development (AZD0466). The impact of the wide variety of analytical and measurement techniques on the overall understanding of this complex molecular entity is discussed, with the relative capabilities of the various approaches compared. The results of this study are an essential platform for the research and development of the future generations of related dendrimer-based medicines.

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Source
http://dx.doi.org/10.1016/j.xphs.2022.11.005DOI Listing

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