Evaluation of the Microcrystallinity of a Drug Substance, Indomethacin, in a Pharmaceutical Model Tablet by Chemometric FT-Raman Spectroscopy

Okumura, Tsuyoshi; Otsuka, Makoto

doi:10.1007/s11095-005-5281-9

Cited by 44 publications

(31 citation statements)

References 17 publications

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“…Wet granulation and subsequent drying Raman spectroscopy Paracetamol [140] Amorphisation and recrystallisation Melting and cooling API-polymer mixtures Micro FTIR spectroscopy Indometacin [141] Solid-solid amorphisation of crystalline indometacin to amorphous indometacin Solid-state conversion induced by pressure…”

Section: Discussionmentioning

confidence: 99%

“…A pressure-induced amorphisation of indometacin was observed in a study that aimed to establish a PLS method to determine the microcrystallinity of indometacin in model compacts of indometacin and mannitol based on Raman spectroscopy. [141] Crystalline indometacin was found to undergo a conversion to amorphous indometacin, which was more pronounced at higher compaction pressures. Furthermore, differences in microcrystallinity of indometacin at the surface and the interior of the compact could be described and showed the value of the Raman spectroscopic PLS model.…”

Section: Amorphous Formsmentioning

confidence: 95%

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Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

et al. 2009

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Objectives Solid-state transformations may occur during any stage of pharmaceutical processing and upon storage of a solid dosage form. Early detection and quantification of these transformations during the manufacture of solid dosage forms is important since the physical form of an active pharmaceutical ingredient can significantly influence its processing behaviour, including powder flow and compressibility, and biopharmaceutical properties such as solubility, dissolution rate and bioavailability. Key findings Vibrational spectroscopic techniques such as infrared, near-infrared, Raman and, most recently, terahertz pulsed spectroscopy have become popular for solidstate analysis since they are fast and non-destructive and allow solid-state changes to be probed at the molecular level. In particular, Raman and near-infrared spectroscopy, which require no sample preparation, are now commonly used coupled to fibreoptic probes and are able to characterise solid-state conversions in-line. Traditionally, uni-or bivariate approaches have been used to analyse spectroscopic data sets; however, recently the simultaneous detection of several solid-state forms has been increasingly performed using multivariate approaches where even overlapping spectral bands can be analysed. Summary This review discusses the applications of different vibrational spectroscopic techniques to detect and monitor solid-state transformations possible for crystalline polymorphs, hydrates and amorphous forms of pharmaceutical compounds. In this context, the theoretical basis of solid-state transformations and vibrational spectroscopy and common experimental approaches are described, including recent methods of data analysis.

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Section: Discussionmentioning

confidence: 99%

Section: Amorphous Formsmentioning

confidence: 95%

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

et al. 2009

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“…Owing to its ease and rapidity, IR spectroscopy was used to determine polymorph contamination during process development (Vogt et al, 2005). Some authors have reported the use of these techniques for the analysis of materials with different degrees of crystallinity (Okumura and Otsuka, 2005) and solid dispersions (Konno and Taylor, 2006). Raman spectroscopy was used to detect amorphous indomethacin at a level of 2% w/w using a calibration curve of indomethacin with various degrees of crystallinity.…”

Section: Vibrational Spectroscopymentioning

confidence: 99%

Physicochemical Characterization of Pharmaceutical Solids

Debnath

2011

Oral Bioavailability

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“…Raman spectroscopy is known as an excellent technique for the characterization of pharmaceutical products, especially for the study of solid-state medicaments, because it does not need manipulation or destruction of samples, can determine more than one component at the same time, and avoids the interference of water in the analyses. Raman technique has thus been widely applied to the pharmaceutical industry and the characterization of tablets, such as ecstasy [4], indomethacin [5] and ambroxol [6]. Applications of Raman spectroscopy in tablet analysis has extensively reported, such as solid-state evaluation, polymorphic forms analysis, investigation of coating characteristics, quantitative determination [7,8], and particularly in the identification of pharmaceutical drugs [9] and counterfeits [10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Classification and Quantitative Analysis of Azithromycin Tablets by Raman Spectroscopy and Chemometrics

Li¹,

Du²,

Cai³

et al. 2011

AJAC

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Raman spectroscopy has been proven a noninvasive technique with high potential in pharmaceutical industry. In this study, micro Raman technique and chemometric tools were used for identification of azithromycin (AZM) tablets by different manufacturers and quantitative analysis of the active pharmaceutical ingredient (API) in the samples. Support vector machine (SVM), Bayes classifier and K-nearest neighbour (KNN) were employed for identification, partial least squares (PLS) regression was used for quantitative determination, and interval partial least squares (iPLS) and Monte Carlo based uninformative variable elimination (MC-UVE) methods were used to select informative variables for improving the models. The results show that all the samples can be classified into groups by manufacturers with high accuracy, and the correlation coefficient between the predicted API concentrations and reference values is as high as 0.96. Therefore, micro Raman spectroscopy coupled with chemometrics may be a fast and powerful tool for identification and quantitative determination of pharmaceutical tablets.

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Evaluation of the Microcrystallinity of a Drug Substance, Indomethacin, in a Pharmaceutical Model Tablet by Chemometric FT-Raman Spectroscopy

Abstract: The established technique is ideally suited for precise quantification of microanalysis of drug substances and drug products, particularly at the surface and interior of the tablet.

Cited by 44 publications

References 17 publications

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Analysis of solid-state transformations of pharmaceutical compounds using vibrational spectroscopy

Physicochemical Characterization of Pharmaceutical Solids

Classification and Quantitative Analysis of Azithromycin Tablets by Raman Spectroscopy and Chemometrics

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