Understanding the Mechanism of Indomethacin-Saccharin Co-crystal Formation Using In-line Monitoring System based on PVM and FBRM
- Authors
- Kim, Paul; Cho, Min-Yong; Choi, Guang J.
- Issue Date
- Apr-2017
- Publisher
- 한국화학공학회
- Keywords
- Indomethacin (IMC); Saccharin (SAC) Co-crystallization; Anti-solvent; In-line monitoring; FBRM; PVM
- Citation
- Korean Chemical Engineering Research(HWAHAK KONGHAK), v.55, no.2, pp 180 - 189
- Pages
- 10
- Journal Title
- Korean Chemical Engineering Research(HWAHAK KONGHAK)
- Volume
- 55
- Number
- 2
- Start Page
- 180
- End Page
- 189
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/7662
- DOI
- 10.9713/kcer.2017.55.2.180
- ISSN
- 0304-128X
2233-9558
- Abstract
- Pharmaceutical co-crystals primarily to improve the solubility as well as stability of insoluble drug are to be investigated more intensively for IMDs as US FDA has reclassified co-crystal as a special case of solvates in August this year. In this study, we proposed a mechanism of indomethacin-saccharin co-crystal formation and the creation of transient indomethacin meta-stable form using in-line monitoring tools with the addition rate of anti-solvent as a critical process parameter. Among various instruments, we combined PVM (particle vision measurement) and FBRM (focused beam reflectance measurement) for the in-line monitoring of anti-solvent co-crystallization process. The off-line characterization of resulting powders was carried out employing the PXRD (powder x-ray diffraction) and DSC (differential scanning calorimeter). It was observed that the pathway to the final IMC-SAC co-crystal was significantly dependent upon the anti-solvent addition rate. The process conditions to obtain high quality co-crystal powder effectively were established. Consequently, we concluded that in-line monitoring combing the PVM and FBRM should be useful for the in-line monitoring of pharmaceutical co-crystallization processes.
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Collections - College of Medical Sciences > Department of Pharmaceutical Engineering > 1. Journal Articles
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