Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques

Westenberger, Benjamin J.; Ellison, Christopher D.; Fussner, Andrew S.; Jenney, Susan; Kolinski, Richard E.; Lipe, Terra G.; Lyon, Robbe C.; Moore, Terry W.; Revelle, Larry K.; Smith, Anjanette P.; Spencer, John; Story, Kimberly D.; Toler, Duckhee Y.; Wokovich, Anna M.; Buhse, Lucinda F.

doi:10.1016/j.ijpharm.2005.08.027

Cited by 72 publications

(46 citation statements)

References 5 publications

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“…NIR chemical imaging has been applied to understand blend inhomogeniety 23 and chemical analysis. 24 With the current study, it clearly demonstrates the potential use of the imaging tool in understanding physical variations in addition to chemical composition and hence the final product quality. The NIR spectra obtained from chemical imager was also transformed to second derivative (Fig.…”

Section: Nir Chemical Imagingsupporting

confidence: 51%

Process Analytical Technology: Chemometric Analysis of Raman and Near Infra-Red Spectroscopic Data for Predicting Physical Properties of Extended Release Matrix Tablets

Shah

Tawakkul

Khan

2007

Journal of Pharmaceutical Sciences

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Section: Nir Chemical Imagingsupporting

confidence: 51%

Process Analytical Technology: Chemometric Analysis of Raman and Near Infra-Red Spectroscopic Data for Predicting Physical Properties of Extended Release Matrix Tablets

Shah

Tawakkul

Khan

2007

Journal of Pharmaceutical Sciences

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“…However, the findings in this report support results with previously published work [Westenberger et al 2005;Veronin and Youan, 2004], and further studies are warranted to identify trends in accessibility and health risks for these types of drug products sold on the Internet.…”

Section: Limitations Of the Studysupporting

confidence: 89%

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

Veronin

Nutan

Dodla³

2014

Therapeutic Advances in Drug Safety

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Background: The accessibility of prescription drugs produced outside of the United States, most notably sildenafil citrate (innovator product, Viagra®), has been made much easier by the Internet. Of greatest concern to clinicians and policymakers is product quality and patient safety. The US Food and Drug Administration (FDA) has issued warnings to potential buyers that the safety of drugs purchased from the Internet cannot be guaranteed, and may present a health risk to consumers from substandard products. Objective: The objective of this study was to determine whether generic sildenafil citrate tablets from international markets obtained via the Internet are equivalent to the US innovator product regarding major aspects of pharmaceutical quality: potency, accuracy of labeling, and presence and level of impurities. This will help identify aspects of drug quality that may impact public health risks. Methods: A total of 15 sildenafil citrate tablets were obtained for pharmaceutical analysis: 14 generic samples from international Internet pharmacy websites and the US innovator product. According to US Pharmacopeial guidelines, tablet samples were tested using highperformance liquid chromatography for potency of active pharmaceutical ingredient (API) and levels of impurities (impurities A, B, C, and D). Impurity levels were compared with International Conference on Harmonisation (ICH) limits. Results: Among the 15 samples, 4 samples possessed higher impurity B levels than the ICH qualification threshold, 8 samples possessed higher impurity C levels than the ICH qualification threshold, and 4 samples possessed more than 1% impurity quantity of maximum daily dose (MDD). For API, 6 of the samples failed to fall within the 5% assay limit. Conclusions: Quality assurance tests are often used to detect formulation defects of drug products during the manufacturing and/or storage process. Results suggest that manufacturing standards for sildenafil citrate generic drug products compared with the US innovator product are not equivalent with regards to potency and levels of impurities. These findings have implications for safety and effectiveness that should be addressed by clinicians to safeguard consumers who choose to purchase sildenafil citrate and foreign-manufactured drugs, in general, via the Internet.

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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%

“…Westenberger et al [30] compared quality assessment of pharmaceutical products purchased via the internet using a variety of traditional (HPLC-based) and nontraditional (NIR, NIR-CI) techniques. A staring imager chemical imaging system was utilised to obtain Chemical Images of individual specimens at 121 wavelengths between 1050 -1700 nm.…”

Section: Quality Assessmentmentioning

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

242

147

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Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques

Cited by 72 publications

References 5 publications

Process Analytical Technology: Chemometric Analysis of Raman and Near Infra-Red Spectroscopic Data for Predicting Physical Properties of Extended Release Matrix Tablets

Process Analytical Technology: Chemometric Analysis of Raman and Near Infra-Red Spectroscopic Data for Predicting Physical Properties of Extended Release Matrix Tablets

Quantification of active pharmaceutical ingredient and impurities in sildenafil citrate obtained from the Internet

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

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