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Development of flow-through cell dissolution method for in situ visualization of dissolution processes in solid dosage forms using X-ray μCT

Niloofar Moazami Goudarzi (UGent) , Aseel Samaro (UGent) , Chris Vervaet (UGent) and Matthieu Boone (UGent)
(2022) PHARMACEUTICS. 14(11).
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Abstract
Visualization of the dynamic behavior of pharmaceutical dosage forms during the dissolution process offers a better understanding of the drug release mechanism, enabling the design of customized dosage forms. In this study, an X-ray tomography-based approach is proposed to monitor and analyze the dynamics of the structure at the pore scale level during the dissolution process. A flow-through cell dissolution apparatus was developed, capable of mimicking the standard in vitro dissolution process, which can be easily positioned in an X-ray tomography setup. The method was utilized to study the dissolution of a Capa® (polycaprolactone)-based sustained-release 3D printed tablet. The impact of the flow rate on the active pharmaceutical ingredient (API) release rate was studied and 16 mL/min was selected as a suitable flow rate. Furthermore, cesium chloride (CsCl) was used as a contrast agent to increase the contrast between the sample and the dissolution medium. Data obtained with this novel technique were in a good agreement with the released drug rate acquired by the standard in vitro dissolution test (the similarity factor f(2) = 77%). Finally, the proposed approach allowed visualizing the internal structure of the sample, as well as real-time tracking of solution ingress into the product.
Keywords
dissolution, μCT, flow-through cell method, contrast agent, 3D printing, sustained release, mu CT, 3D printing, MAGNETIC-RESONANCE MICROSCOPY, CONTROLLED-RELEASE, DRUG DISSOLUTION, MORPHOLOGICAL-CHANGES, COMPUTED-TOMOGRAPHY, DENSITY VARIATIONS, TABLETS, MATRIX, QUANTIFICATION, SPECTROSCOPY

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MLA
Moazami Goudarzi, Niloofar, et al. “Development of Flow-through Cell Dissolution Method for in Situ Visualization of Dissolution Processes in Solid Dosage Forms Using X-Ray ΜCT.” PHARMACEUTICS, vol. 14, no. 11, 2022, doi:10.3390/pharmaceutics14112475.
APA
Moazami Goudarzi, N., Samaro, A., Vervaet, C., & Boone, M. (2022). Development of flow-through cell dissolution method for in situ visualization of dissolution processes in solid dosage forms using X-ray μCT. PHARMACEUTICS, 14(11). https://doi.org/10.3390/pharmaceutics14112475
Chicago author-date
Moazami Goudarzi, Niloofar, Aseel Samaro, Chris Vervaet, and Matthieu Boone. 2022. “Development of Flow-through Cell Dissolution Method for in Situ Visualization of Dissolution Processes in Solid Dosage Forms Using X-Ray ΜCT.” PHARMACEUTICS 14 (11). https://doi.org/10.3390/pharmaceutics14112475.
Chicago author-date (all authors)
Moazami Goudarzi, Niloofar, Aseel Samaro, Chris Vervaet, and Matthieu Boone. 2022. “Development of Flow-through Cell Dissolution Method for in Situ Visualization of Dissolution Processes in Solid Dosage Forms Using X-Ray ΜCT.” PHARMACEUTICS 14 (11). doi:10.3390/pharmaceutics14112475.
Vancouver
1.
Moazami Goudarzi N, Samaro A, Vervaet C, Boone M. Development of flow-through cell dissolution method for in situ visualization of dissolution processes in solid dosage forms using X-ray μCT. PHARMACEUTICS. 2022;14(11).
IEEE
[1]
N. Moazami Goudarzi, A. Samaro, C. Vervaet, and M. Boone, “Development of flow-through cell dissolution method for in situ visualization of dissolution processes in solid dosage forms using X-ray μCT,” PHARMACEUTICS, vol. 14, no. 11, 2022.
@article{01GS7KNJPP3ZS0FYWSQTZTCXGY,
  abstract     = {{Visualization of the dynamic behavior of pharmaceutical dosage forms during the dissolution process offers a better understanding of the drug release mechanism, enabling the design of customized dosage forms. In this study, an X-ray tomography-based approach is proposed to monitor and analyze the dynamics of the structure at the pore scale level during the dissolution process. A flow-through cell dissolution apparatus was developed, capable of mimicking the standard in vitro dissolution process, which can be easily positioned in an X-ray tomography setup. The method was utilized to study the dissolution of a Capa® (polycaprolactone)-based sustained-release 3D printed tablet. The impact of the flow rate on the active pharmaceutical ingredient (API) release rate was studied and 16 mL/min was selected as a suitable flow rate. Furthermore, cesium chloride (CsCl) was used as a contrast agent to increase the contrast between the sample and the dissolution medium. Data obtained with this novel technique were in a good agreement with the released drug rate acquired by the standard in vitro dissolution test (the similarity factor f(2) = 77%). Finally, the proposed approach allowed visualizing the internal structure of the sample, as well as real-time tracking of solution ingress into the product.}},
  articleno    = {{2475}},
  author       = {{Moazami Goudarzi, Niloofar and Samaro, Aseel and Vervaet, Chris and Boone, Matthieu}},
  issn         = {{1999-4923}},
  journal      = {{PHARMACEUTICS}},
  keywords     = {{dissolution,μCT,flow-through cell method,contrast agent,3D  printing,sustained release,mu CT,3D printing,MAGNETIC-RESONANCE MICROSCOPY,CONTROLLED-RELEASE,DRUG DISSOLUTION,MORPHOLOGICAL-CHANGES,COMPUTED-TOMOGRAPHY,DENSITY VARIATIONS,TABLETS,MATRIX,QUANTIFICATION,SPECTROSCOPY}},
  language     = {{eng}},
  number       = {{11}},
  pages        = {{16}},
  title        = {{Development of flow-through cell dissolution method for in situ visualization of dissolution processes in solid dosage forms using X-ray μCT}},
  url          = {{http://doi.org/10.3390/pharmaceutics14112475}},
  volume       = {{14}},
  year         = {{2022}},
}

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