Assessing microstructural critical quality attributes in PLGA microspheres by FIB-SEM analytics

Clark, Andrew G.; Wang, Ruifeng; Qin, Yuri; Wang, Yan; Zhu, Aiden; Lomeo, Joshua; Bao, Quanying; Burgess, Diane J.; Chen, Jacie; Qin, Bin; Zou, Yuan; Zhang, Shawn

doi:10.1016/j.jconrel.2022.06.066

Cited by 7 publications

(7 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…An effective combination of formulation composition, preparation process and microsphere microstructure facilitates the development, quality control and regulatory review of LAI microsphere products. 8 Effects of Formulation Composition on the Microstructure Drug LAI microspheres have successfully delivered drug types ranging from hydrophilic (such as protein and peptide) to hydrophobic (such as naltrexone and risperidone) drugs. [50][51][52] The type of encapsulated drug largely determines the encapsulation efficiency and release performance of microspheres.…”

Section: Factors Contributing To the Microstructure Of Microspheresmentioning

confidence: 99%

“…29,85 Compared with mechanically-cut microspheres, FIB can provide higher accuracy and precision, thus obtaining a clean and artifact-free cross section for high-resolution SEM imaging. 8,98 For subsequent SEM imaging, the beam emitted by the electron gun passes through a pair of objective lens and aperture to form an extremely narrow high-energy electron beam, which is further focused on the sample surface through objective lens. Various signals are excited through the interaction between the beam and the sample, and each of those signals could be collected, amplified and re-imaged by a specific detector to achieve the purpose of characterization of the material microstructure.…”

Section: Focused Ion Beam Scanning Electron Microscopymentioning

confidence: 99%

“…7 The microstructure of microspheres mainly includes the spatial distribution and the dispersed state of drug, PLGA, and pores. 8 Its complexity mainly derives from the multi-attribute formulation compositions and multi-step manufacturing processes. [9][10][11] The properties and interactions of the drug, PLGA, and solvent, usually collectively dictate the impact of formulation composition on microstructure.…”

Section: Introductionmentioning

confidence: 99%

“…14,15 The significant impact of microstructure on LAI microsphere product release behavior has been emphasized in numerous studies. 8,[16][17][18][19] The FDA also recommended Q3, the similarity of microstructure, as part of the bioequivalence assessment. Many studies have also suggested that Q1/Q2/Q3 is necessary for bioequivalence.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Wang,

Zhang

et al. 2024

IJN

View full text Add to dashboard Cite

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.

show abstract

Section: Factors Contributing To the Microstructure Of Microspheresmentioning

confidence: 99%

Section: Focused Ion Beam Scanning Electron Microscopymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Wang,

Zhang

et al. 2024

IJN

View full text Add to dashboard Cite

show abstract

“…To this end, numerous formulation methods with different substrate materials such as lipid nanoparticles, [3] nanocrystals, [4] and microspheres [5] have been exploited to advance drug delivery systems. In particular, nanoscale formulations are believed to create enhanced permeability and retention effect (EPR) of solid tumors, enabling passive accumulation of preparations in the tumor environment and overcoming P‐glycoprotein‐mediated efflux [6] .…”

Section: Introductionmentioning

confidence: 99%

DNA Nanobarrel‐Based Drug Delivery for Paclitaxel and Doxorubicin

Wang

Zhang

et al. 2023

ChemBioChem

View full text Add to dashboard Cite

Co‐delivery of anticancer drugs and target agents by endogenous materials is an inevitable approach towards targeted and synergistic therapy. Employing DNA base pair complementarities, DNA nanotechnology exploits a unique nanostructuring method and has demonstrated its capacity for nanoscale positioning and templated assembly. Moreover, the water solubility, biocompatibility, and modifiability render DNA structure suitable candidate for drug delivery applications. We here report single‐stranded DNA tail conjugated antitumor drug paclitaxel (PTX), and the co‐delivery of PTX, doxorubicin and targeting agent mucin 1 (MUC‐1) aptamer on a DNA nanobarrel carrier. We investigated the effect of tail lengths on drug release efficiencies and dual drug codelivery‐enabled cytotoxicity. Owing to the rapidly developing field of structural DNA nanotechnology, functional DNA‐based drug delivery is promising to achieve clinical therapeutic applications.

show abstract

Effect of PLGA raw materials on in vitro and in vivo performance of drug-loaded microspheres

Liang,

Walker,

Schwendeman

et al. 2024

Drug Deliv. and Transl. Res.

View full text Add to dashboard Cite

Assessing microstructural critical quality attributes in PLGA microspheres by FIB-SEM analytics

Cited by 7 publications

References 27 publications

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

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

DNA Nanobarrel‐Based Drug Delivery for Paclitaxel and Doxorubicin

Effect of PLGA raw materials on in vitro and in vivo performance of drug-loaded microspheres

Contact Info

Product

Resources

About