Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging

Roggo, Yves; Jent, Nadine; Edmond, A.; Chalus, Pascal; Ulmschneider, Michel

doi:10.1016/j.ejpb.2005.04.005

Cited by 114 publications

(56 citation statements)

References 19 publications

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“…Future innovations in CI equipment manufacture are likely to depress purchase costs and encourage more widespread utilisation of this emerging technology in the pharmaceutical sector. Compositional information [28], [29] Quality assessment [20], [30] Process related information [31], [32] Blend uniformity [33], [34] Coating thickness [35] Counterfeit drug detection [36], [37] Remote identification [38], [41] Staring imager High throughput analysis [38], [39] [22], [49] Tablet characterisation [17], [29], [50], [51], [52], [53], […”

Section: Discussionmentioning

confidence: 99%

“…PLS classification was used for the pre-tabletting blends with dissolution issues; cluster size of ingredients was measured to investigate the effect of compaction force on dissolution properties. In a similar study, the potential of NIR-CI for investigating the effects of processing on tablet dissolution was examined [32]. It was shown that NIR-CI could be used for the prediction of coating time and to understand batch differences due to different processing conditions.…”

Section: Process Related Informationmentioning

confidence: 99%

See 1 more Smart Citation

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

Gowen

O’Donnell

Cullen³

et al. 2008

European Journal of Pharmaceutics and Biopharmaceutics

243

147

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Section: Discussionmentioning

confidence: 99%

Section: Process Related Informationmentioning

confidence: 99%

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

Gowen

O’Donnell

Cullen³

et al. 2008

European Journal of Pharmaceutics and Biopharmaceutics

243

147

View full text Add to dashboard Cite

“…21,[34][35][36] Recently, many works have been published describing the use of near-infrared spectroscopy (NIR) in pharmaceutical industry for raw material testing, product quality control and process monitoring. [37][38][39][40] Doripenem reference standard and bulk were analyzed and the spectral bands were compared peak by peak. The major bands observed and their assignments for the molecule are shown in Table 1.…”

Section: Infrared Spectroscopymentioning

confidence: 99%

Characterization of the antibiotic doripenem using physicochemical methods: chromatography, spectrophotometry, spectroscopy and thermal analysis

et al. 2011

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Recebido em 1/11/10; aceito em 14/5/11; publicado na web em 22/7/11 Doripenem was characterized through physicochemical and spectroscopic techniques, as well as thermal analysis. TLC (Rf = 0.62) and HPLC (rt = 7.4 min) were found to be adequate to identify the drug. UV and infrared spectra showed similar profile between doripenem bulk and standard. The 1 H and 13 C NMR analysis revealed chemical shifts that allowed identifying the drug. Thermal analysis demonstrated three steps with mass loss, at 128, 178 and 276 o C. The work was successfully applied to qualitative analysis of doripenem, showing the reported methods can be used for physicochemical characterization of doripenem.

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“…Near infrared chemical imaging (NIR-CI) has also been used in the field of pharmaceutical technology [18][19][20][21]. More recently, NIR-CI has been used by Lopes et al to detect and classify counterfeit antiviral drugs [22] and to determine their chemical composition [23].…”

Section: Since Its Approval By the American Food And Drug Agency (Fdamentioning

confidence: 99%

Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis

Sacré

Deconinck

Saerens

et al. 2011

Journal of Pharmaceutical and Biomedical Analysis

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During the past years, pharmaceutical counterfeiting was mainly a problem of developing countries with weak enforcement and inspection programs. However, Europe and North America are more and more confronted with the counterfeiting problem. During this study, 26 counterfeits and imitations of Viagra ® tablets and 8 genuine tablets of Viagra ® were analysed by Raman microspectroscopy imaging.After unfolding the data, three maps are combined per sample and a first PCA is realised on these data. Then, the first principal components of each sample are assembled. The exploratory and classification analysis are performed on that matrix.PCA was applied as exploratory analysis tool on different spectral ranges to detect counterfeit medicines based on the full spectra (200-1800 cm After the exploratory analysis, three different classification algorithms were applied on the full spectra dataset: linear discriminant analysis, k-nearest neighbour and soft independent modelling of class analogy.PCA analysis of the 830-880cm -1 spectral region discriminated genuine samples while the multivariate analysis of the spectral region between 1200-1290 cm -1 returns no satisfactory results.A good discrimination of genuine samples was obtained with multivariate analysis of the full spectra region (200-1800 cm -1). Application of the k-NN and SIMCA algorithm returned 100% correct classification during both internal and external validation.

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Characterizing process effects on pharmaceutical solid forms using near-infrared spectroscopy and infrared imaging

Cited by 114 publications

References 19 publications

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

Recent applications of Chemical Imaging to pharmaceutical process monitoring and quality control

Characterization of the antibiotic doripenem using physicochemical methods: chromatography, spectrophotometry, spectroscopy and thermal analysis

Detection of counterfeit Viagra® by Raman microspectroscopy imaging and multivariate analysis

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