난용성 약물의 용해도를 증가시키고 안정성을 향상하기 위한 제약 공결정은, 미국 FDA가 지난 2016년 8월에 공결정을 solvate의 특별한 경우라고 정의를 수정하면서, 개량신약의 개발에 더욱 박...
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https://www.riss.kr/link?id=A103118488
2017
Korean
KCI등재,SCOPUS,ESCI
학술저널
180-189(10쪽)
0
0
상세조회0
다운로드국문 초록 (Abstract)
난용성 약물의 용해도를 증가시키고 안정성을 향상하기 위한 제약 공결정은, 미국 FDA가 지난 2016년 8월에 공결정을 solvate의 특별한 경우라고 정의를 수정하면서, 개량신약의 개발에 더욱 박...
난용성 약물의 용해도를 증가시키고 안정성을 향상하기 위한 제약 공결정은, 미국 FDA가 지난 2016년 8월에 공결정을 solvate의 특별한 경우라고 정의를 수정하면서, 개량신약의 개발에 더욱 박차를 가할 것으로 추측된다. 본 연구에서는 모델 조합으로 잘 알려진 indomethacin-saccharin 공결정을 반용매 방법으로 제조할 때, 인라인 모니터링 기법을 적용하여, 반용매의 주입속도에 따른 indomethacin 준 안정상의 일시적인 생성 및 indomethacin-saccharin 공결정의 생성을 관찰하고 메커니즘을 제안하고자 하였다. 그간 인라인 모니터링을 위해서 매우 다양한 분석도구가 연구되어 왔는데, 본 연구에서는 PVM (particle vision measurement)와 FBRM (focused beam reflectance measurement)를 조합하여 공결정화 공정에서의 변화를 실시간으로 측정하였다. 공결정화 결과물의 오프라인 분석은 PXRD (powder x-ray diffraction)와 DSC (Differential scanning calorimeter)를 이용하여 수행하였다. 반용매의 주입 속도에 따라서 공결정이 생성되는 경로에 분명한 차이가 있음을 관찰하였으며, 이러한 상관 관계의 이해를 통해서 제약학적 특성이 더욱 일정하고 품질이 보증된 indomethacin-saccharin Co-crystal을 얻는 조건을 확립하였다. 본 연구결과, PVM과 FBRM을 조합한 인라인 모니터링은 제약 공결정 제조공정에서 활용성이 매우 높은 기술이라고 할 수 있다.
다국어 초록 (Multilingual 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 stu...
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.
참고문헌 (Reference)
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MSDS (Material Safety Data Sheet)를 위한 벤질알코올 연소특성치의 측정 및 예측
유적 합체기가 포함된 공기-물-기름 분리 공정에 대한 3상 Eulerian 전산유체역학
SNIPS 공정을 이용한 블록공중합체 분리막의 구조 형성에 관한 연구
학술지 이력
연월일 | 이력구분 | 이력상세 | 등재구분 |
---|---|---|---|
2023 | 평가예정 | 해외DB학술지평가 신청대상 (해외등재 학술지 평가) | |
2020-01-01 | 평가 | 등재학술지 유지 (해외등재 학술지 평가) | |
2013-01-01 | 평가 | 등재 1차 FAIL (등재유지) | |
2010-12-02 | 학술지명변경 | 한글명 : 화학공학 -> Korean Chemical Engineering Research(HWAHAK KONGHAK) | |
2010-01-01 | 평가 | 등재학술지 유지 (등재유지) | |
2009-08-25 | 학술지명변경 | 외국어명 : Korean Chem. Eng. Res. -> Korean Chemical Engineering Research | |
2008-01-01 | 평가 | 등재학술지 유지 (등재유지) | |
2007-09-27 | 학회명변경 | 영문명 : The Korean Institute Of Chemical Engineers -> The Korean Institute of Chemical Engineers | |
2006-01-01 | 평가 | 등재학술지 유지 (등재유지) | |
2004-01-01 | 평가 | 등재학술지 유지 (등재유지) | |
2001-07-01 | 평가 | 등재학술지 선정 (등재후보2차) | |
1999-01-01 | 평가 | 등재후보학술지 선정 (신규평가) |
학술지 인용정보
기준연도 | WOS-KCI 통합IF(2년) | KCIF(2년) | KCIF(3년) |
---|---|---|---|
2016 | 0.43 | 0.43 | 0.4 |
KCIF(4년) | KCIF(5년) | 중심성지수(3년) | 즉시성지수 |
0.37 | 0.35 | 0.496 | 0.11 |