Detection of trace crystallinity in an amorphous system using Raman microscopy and chemometric analysis
A novel analytical method to detect and characterize active pharmaceutical ingredient (API) trace crystallinity in an amorphous system using Raman microscopy and chemometric methods, namely band-target entropy minimization (BTEM) and target transformation factor analysis (TTFA) is developed. The met...
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| Published in | European journal of pharmaceutical sciences Vol. 42; no. 1; pp. 45 - 54 |
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| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Kindlington
Elsevier B.V
18.01.2011
Elsevier |
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| Online Access | Get full text |
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| Abstract | A novel analytical method to detect and characterize active pharmaceutical ingredient (API) trace crystallinity in an amorphous system using Raman microscopy and chemometric methods, namely band-target entropy minimization (BTEM) and target transformation factor analysis (TTFA) is developed. The method starts with Raman mapping measurements performed on some random areas of the amorphous system. This is followed by chemometric data analysis. In the case of a system without any a priori information, the BTEM algorithm is used to recover a set of pure component Raman spectral estimates followed by component and/or crystal structure identification. In the case of a system with some a priori information, TTFA is used to predict the presence or existence of a suspected component and/or crystal structure in the observed system.
Four different amorphous systems were used as models. It is demonstrated that combined Raman microscopy and chemometric methods (BTEM or TTFA) outperformed powder X-ray diffraction (PXRD) in detecting trace crystallinity in amorphous systems. The spatial distributions of drug and polymer can also be directly obtained in order to study the homogeneity of the APIs in the solid dispersions. The present methodology appears very general and applicable to many other types of systems. |
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| AbstractList | A novel analytical method to detect and characterize active pharmaceutical ingredient (API) trace crystallinity in an amorphous system using Raman microscopy and chemometric methods, namely band-target entropy minimization (BTEM) and target transformation factor analysis (TTFA) is developed. The method starts with Raman mapping measurements performed on some random areas of the amorphous system. This is followed by chemometric data analysis. In the case of a system without any a priori information, the BTEM algorithm is used to recover a set of pure component Raman spectral estimates followed by component and/or crystal structure identification. In the case of a system with some a priori information, TTFA is used to predict the presence or existence of a suspected component and/or crystal structure in the observed system. Four different amorphous systems were used as models. It is demonstrated that combined Raman microscopy and chemometric methods (BTEM or TTFA) outperformed powder X-ray diffraction (PXRD) in detecting trace crystallinity in amorphous systems. The spatial distributions of drug and polymer can also be directly obtained in order to study the homogeneity of the APIs in the solid dispersions. The present methodology appears very general and applicable to many other types of systems. A novel analytical method to detect and characterize active pharmaceutical ingredient (API) trace crystallinity in an amorphous system using Raman microscopy and chemometric methods, namely band-target entropy minimization (BTEM) and target transformation factor analysis (TTFA) is developed. The method starts with Raman mapping measurements performed on some random areas of the amorphous system. This is followed by chemometric data analysis. In the case of a system without any a priori information, the BTEM algorithm is used to recover a set of pure component Raman spectral estimates followed by component and/or crystal structure identification. In the case of a system with some a priori information, TTFA is used to predict the presence or existence of a suspected component and/or crystal structure in the observed system. Four different amorphous systems were used as models. It is demonstrated that combined Raman microscopy and chemometric methods (BTEM or TTFA) outperformed powder X-ray diffraction (PXRD) in detecting trace crystallinity in amorphous systems. The spatial distributions of drug and polymer can also be directly obtained in order to study the homogeneity of the APIs in the solid dispersions. The present methodology appears very general and applicable to many other types of systems. |
| Author | Widjaja, Effendi Lau, Grace Hanefeld, Andrea Tan, Reginald B.H. Garland, Marc Ng, Wai Kiong Fischbach, Matthias Kanaujia, Parijat Saal, Christoph Maio, Mario |
| Author_xml | – sequence: 1 givenname: Effendi surname: Widjaja fullname: Widjaja, Effendi email: effendi_widjaja@ices.a-star.edu.sg organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore – sequence: 2 givenname: Parijat surname: Kanaujia fullname: Kanaujia, Parijat organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore – sequence: 3 givenname: Grace surname: Lau fullname: Lau, Grace organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore – sequence: 4 givenname: Wai Kiong surname: Ng fullname: Ng, Wai Kiong organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore – sequence: 5 givenname: Marc surname: Garland fullname: Garland, Marc organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore – sequence: 6 givenname: Christoph surname: Saal fullname: Saal, Christoph organization: Merck KGaA Frankfurter Str. 250, D 64293 Darmstadt, Germany – sequence: 7 givenname: Andrea surname: Hanefeld fullname: Hanefeld, Andrea organization: Merck KGaA Frankfurter Str. 250, D 64293 Darmstadt, Germany – sequence: 8 givenname: Matthias surname: Fischbach fullname: Fischbach, Matthias organization: Merck KGaA Frankfurter Str. 250, D 64293 Darmstadt, Germany – sequence: 9 givenname: Mario surname: Maio fullname: Maio, Mario organization: Merck KGaA Frankfurter Str. 250, D 64293 Darmstadt, Germany – sequence: 10 givenname: Reginald B.H. surname: Tan fullname: Tan, Reginald B.H. email: reginald_tan@ices.a-star.edu.sg organization: Institute of Chemical and Engineering Sciences, 1 Pesek Road, Jurong Island, Singapore 627833, Singapore |
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| Copyright | 2010 Elsevier B.V. 2015 INIST-CNRS Copyright © 2010 Elsevier B.V. All rights reserved. |
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| Keywords | Trace crystallinity Target transformation factor analysis Amorphous Band-target entropy minimization Raman microscopy Formulation Hot melt extrusion Active pharmaceutical ingredients Polymorphism Hot melt Pharmaceutical technology Targeting Entropy Crystallinity Target Microscopy Extrusion Active ingredient Detection Chemometrics |
| Language | English |
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| SubjectTerms | Active pharmaceutical ingredients Algorithms Amorphous Band-target entropy minimization Biological and medical sciences Crystallization Drug Compounding Drug Stability Drug Storage Entropy Fenofibrate - chemistry Formulation General pharmacology Hot melt extrusion Medical sciences Microscopy - methods Microscopy, Electron, Scanning Pharmaceutical Preparations - chemistry Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Phase Transition Polymorphism Raman microscopy Spectrum Analysis, Raman - methods Surface Properties Target transformation factor analysis Trace crystallinity X-Ray Diffraction |
| Title | Detection of trace crystallinity in an amorphous system using Raman microscopy and chemometric analysis |
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