Investigating structural attributes of drug encapsulated microspheres with quantitative X-ray imaging

Clark, Andrew G.; Wang, Ruifeng; Lomeo, Josh; Wang, Yan; Zhu, Aiden; Shen, Mike; Bao, Quanying; Burgess, Diane J.; Qin, Bin; Zhang, Shawn

doi:10.1016/j.jconrel.2023.05.019

Cited by 3 publications

(4 citation statements)

References 26 publications

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“…For XRM, spatial variations in sample density will affect the intensity of the X-ray signal, allowing different phases of microspheres, such as PLGA, drug and pores, to be observed (Figure 5). 21,30 As (c, f and i) were images of microspheres partly split. Some protuberances of acetaminophen crystals were observed on the microspheres surface as the red arrows indicated in (c); (d, g and j) were images of acetaminophen crystals extracted from microspheres).…”

Section: X-ray Microscopymentioning

confidence: 99%

“…Figure 4 (b-j) Reprinted from International Journal of Pharmaceutics, 499, Guo Z, Yin X, Liu C, et al, Microstructural investigation using synchrotron radiation X-ray microtomography reveals tastemasking mechanism of Acetaminophen microspheres, 47-57, Copyright 2016, with permission from Elsevier. 89 Clark et al 21 prepared eight batches of minocycline microspheres by adjusting the preparation parameters. Thousands of microspheres from each batch were analyzed by XRM, and AI was used to determine inter-and intra-batch homogeneity.…”

Section: X-ray Microscopymentioning

confidence: 99%

“…Many studies have also suggested that Q1/Q2/Q3 is necessary for bioequivalence. 15,[20][21][22] The numerous studies investigating the key factors impacting the microstructure and release behavior of LAI microspheres have primarily focused on formulation composition and preparation processes. [23][24][25] However, these researches have not made a substantial contribution to the development of generic LAI microspheres.…”

Section: Introductionmentioning

confidence: 99%

“…(d) 3D rendering of the imaged XRM volume showing all segmented microspheres. Reprinted from Journal of Controlled Release, 358, Clark AG, Wang R, Lomeo J, et al, Investigating structural attributes of drug encapsulated microspheres with quantitative X-ray imaging, 626-635, Copyright 2023, with permission from Elsevier 21.…”

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confidence: 99%

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Microstructure Formation and Characterization of Long-Acting Injectable Microspheres: The Gateway to Fully Controlled Drug Release Pattern

Wang,

Zhang

et al. 2024

IJN

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Long-acting injectable microspheres have been on the market for more than three decades, but if calculated on the brand name, only 12 products have been approved by the FDA due to numerous challenges in achieving a fully controllable drug release pattern. Recently, more and more researches on the critical factors that determine the release kinetics of microspheres shifted from evaluating the typical physicochemical properties to exploring the microstructure. The microstructure of microspheres mainly includes the spatial distribution and the dispersed state of drug, PLGA and pores, which has been considered as one of the most important characteristics of microspheres, especially when comparative characterization of the microstructure (Q3) has been recommended by the FDA for the bioequivalence assessment. This review extracted the main variables affecting the microstructure formation from microsphere formulation compositions and preparation processes and highlighted the latest advances in microstructure characterization techniques. The further understanding of the microsphere microstructure has significant reference value for the development of longacting injectable microspheres, particularly for the development of the generic microspheres.

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Section: X-ray Microscopymentioning

confidence: 99%

Section: X-ray Microscopymentioning

confidence: 99%