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See detailEvaluation of the residual solvent content of counterfeit tablets and capsules
Deconinck, Eric; Canfyn, Michael; Sacre, Pierre-Yves ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2013), 81-82

A group of counterfeit samples of Viagra® and Cialis® were screened for their residual solvent content and compared to the content of the genuine products. It was observed that all counterfeit samples had ... [more ▼]

A group of counterfeit samples of Viagra® and Cialis® were screened for their residual solvent content and compared to the content of the genuine products. It was observed that all counterfeit samples had higher residual solvent contents compared to the genuine products. A more diverse range of residual solvents was found as well as higher concentrations. In general these concentrations did not exceed the international imposed maximum limits. Only in a few samples the limits were exceeded. A Projection Pursuit analysis revealed clusters of samples with similar residual solvent content, possibly enabling some future perspectives in forensic research. [less ▲]

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See detailChromatography in the detection and characterisation of illegal pharmaceutical preparations
Deconinck, Eric; Sacre, Pierre-Yves ULg; Courselle, Patricia et al

in Journal of Chromatographic Science (2013), 51(8), 791-806

Counterfeit and illegal pharmaceutical products are an increasing worldwide problem and constitute a major challenge for analytical laboratories to detect and characterize them. Spectroscopic techniques ... [more ▼]

Counterfeit and illegal pharmaceutical products are an increasing worldwide problem and constitute a major challenge for analytical laboratories to detect and characterize them. Spectroscopic techniques as infrared spectroscopy and Raman spectroscopy were always the first methods of choice to detect counterfeits and illegal preparations, but due to the evolution in the products seized and the necessity of risk assessment, chromatographic methods are becoming more important in this domain. This review intends to give a general overview of the techniques described in literature to characterize counterfeit and illegal pharmaceutical preparations, focussing on the role of chromatographic techniques, with different detection tools. [less ▲]

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See detailA validated GC-MS method for the determination and quantification of residual solvents in counterfeit tablets and capsules
Deconinck, Eric; Canfyn, Michaël; Sacre, Pierre-Yves ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2012), 70

A fast headspace GC-MS method was developed and validated for the detection and quantification of residual solvents of all three ICH-classes in counterfeit tablets and capsules. The method was validated ... [more ▼]

A fast headspace GC-MS method was developed and validated for the detection and quantification of residual solvents of all three ICH-classes in counterfeit tablets and capsules. The method was validated for ten solvents, selected based on an initial screening of counterfeit medicinal products. The considered solvents were ethanol, 2-propanol, acetone, ethylacetate, chloroform, carbon tetrachloride, benzene, toluene, dichloromethane and ethylbenzene. The proposed method uses a Phenomenex 624 capillary column (60 m x 0.32 mm; 1.8 µm film thickness) (Phenomenex, Torrance, USA) with an oven temperature program from 60°C (held for 5 min) to 270°C at 25 °C/min. 270°C is held for 10 min. The total run time is 23.4 minutes. The obtained method was fully validated by applying the “total error” profile. Calibration lines for all components were linear within the studied ranges. The relative bias and the relative standard deviations for all components were smaller than 5%, the -expectation tolerance limits did not exceed the acceptance limits of 10% and the relative expanded uncertainties were acceptable for all of the considered components. A method was obtained for the screening and quantification of residual solvents in counterfeit tablets and capsules, which will allow a fast screening of these products for the presence of residual solvents. [less ▲]

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See detailChemometrics and chromatographic fingerprints to discriminate and classify counterfeit medicines containing PDE-5 inhibitors.
Deconinck, Eric; Sacre, Pierre-Yves ULg; Courselle, Patricia et al

in Talanta (2012), 100

Chromatographic fingerprints recorded for a set of genuine and counterfeit samples of Viagra® and Cialis® were evaluated for their use in the detection and classification of counterfeit samples of these ... [more ▼]

Chromatographic fingerprints recorded for a set of genuine and counterfeit samples of Viagra® and Cialis® were evaluated for their use in the detection and classification of counterfeit samples of these groups of medicines. Therefore several exploratory chemometric techniques were applied to reveal structures in the data sets as well as differences among the samples. The focus was on the differentiation between genuine and counterfeit samples and on the differences between the samples of the different classes of counterfeits as defined by the Dutch National Institute for Public Health and the Environment (RIVM). In a second part the revealed differences between the samples were modelled to obtain a predictive model for both the differentiation between genuine and counterfeit samples as well as the classification of the counterfeit samples. The exploratory analysis clearly revealed differences in the data for the genuine and the counterfeit samples and with projection pursuit and hierarchical clustering differences among the different groups of counterfeits could be revealed, especially for the Viagra® data set. For both data sets predictive models were obtained with 100% correct classification rates for the differentiation between genuine and counterfeit medicines and high correct classification rates for the classification in the different classes of counterfeit medicines. For both data sets the best performing models were obtained with Least Square-Support Vector Machines (LS-SVM) and Soft Independent Modelling by Class Analogy (SIMCA). [less ▲]

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See detailImpurity fingerprints for the identification of counterfeit medicines - a feasibility study
Sacré, Pierre-Yves ULg; Deconinck, Eric; Daszykowski, Michal et al

Poster (2011, September)

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See detailImpurity fingerprints for the identification of counterfeit medicines - a feasibility study
Sacré, Pierre-Yves ULg; deconinck, Eric; Daszykowski, Michal et al

Poster (2011, June 22)

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See detailDetection of counterfeit Viagra by Raman microspectroscopy imaging and multivariate analysis
Sacré, Pierre-Yves ULg; Deconinck, Eric; Saerens, Lien et al

Conference (2011, May 13)

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See detailDetection of counterfeit Viagra® by Raman Microspectroscopy imaging and multivariate analysis.
Sacré, Pierre-Yves ULg; Deconinck, Eric; Saerens, Lien et al

in Journal of Pharmaceutical & Biomedical Analysis (2011), 56

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See detailDevelopment and validation of a ultra-high-performance liquid chromatography-UV method for the detection and quantification of erectile dysfunction drugs and some of their analogues found in counterfeit medicines
Sacré, Pierre-Yves ULg; Deconinck, Eric; Chiap, Patrice ULg et al

in Journal of Chromatography. A (2011), 1218

Pharmaceutical counterfeiting is a permanently growing problem. Control laboratories are constantly analysing counterfeit medicines. In industrialised countries, one of the main counterfeited class of ... [more ▼]

Pharmaceutical counterfeiting is a permanently growing problem. Control laboratories are constantly analysing counterfeit medicines. In industrialised countries, one of the main counterfeited class of medicines are erectile dysfunction drugs. This paper describes the development and validation of a fast method to detect and quantify the three authorised phosphodiesterase type 5 inhibitors and five analogues. The method is based on the use of a sub-2 microns polar-embedded column with a gradient using acetonitrile as organic modifier and 10 mM ammonium formate buffer (pH 3.5) as aqueous component of the mobile phase. The separation was achieved in less than 4.5 min. The method has also been compared to the registered HPLC method for the assay of Viagra® which was considered as the reference method. The method is also compatible with on-line coupling mass spectrometry and will significantly reduce analysis times and solvent consumption. [less ▲]

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See detailImpurity fingerprints for the identification of counterfeit medicines - a feasibility study
Sacré, Pierre-Yves ULg; Deconinck, Eric; Daszykowski, Michal et al

in Analytica Chimica Acta (2011), 701

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See detailComparison and combination of spectroscopic techniques for the detection of counterfeit medicines
Sacré, Pierre-Yves ULg; Deconinck, Eric; De Beer, Thomas et al

Poster (2010, September 23)

During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra® and 39 ... [more ▼]

During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra® and 39 samples of counterfeit and imitations of Cialis®. The aim of the study was to investigate which of these techniques and associations of them were the best for discriminating genuine from counterfeit and imitation samples. Only the regions between 1800-400 cm-1 and 7000-4000 cm-1 were used for FT-IR and NIR spectroscopy respectively. Partial Least Square analysis has been used to allow the detection of counterfeit and imitation tablets. It is shown that for the Viagra® samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis® samples were provided by the combination of NIR and Raman spectroscopy (1400-1190 cm-1). These techniques permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities. [less ▲]

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See detailComparison and combination of spectroscopic techniques for the detection of counterfeit medicines
Sacré, Pierre-Yves ULg; Deconinck, Eric; De Beer, Thomas et al

in Journal of Pharmaceutical & Biomedical Analysis (2010), 53

During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra® and 39 ... [more ▼]

During this study, Fourier transform infrared spectroscopy (FT-IR), near infrared spectroscopy (NIR) and Raman spectroscopy were applied to 55 samples of counterfeit and imitations of Viagra® and 39 samples of counterfeit and imitations of Cialis®. The aim of the study was to investigate which of these techniques and associations of them were the best for discriminating genuine from counterfeit and imitation samples. Only the regions between 1800-400 cm-1 and 7000-4000 cm-1 were used for FT-IR and NIR spectroscopy respectively. Partial Least Square analysis has been used to allow the detection of counterfeit and imitation tablets. It is shown that for the Viagra® samples, the best results were provided by a combination of FT-IR and NIR spectroscopy. On the other hand, the best results for the Cialis® samples were provided by the combination of NIR and Raman spectroscopy (1400-1190 cm-1). These techniques permitted a clear discrimination between genuine and counterfeit or imitation samples but also the distinction of clusters among illegal samples. This might be interesting for forensic investigations by authorities. [less ▲]

Detailed reference viewed: 55 (14 ULg)