A framework for selecting analytical techniques in profiling authentic and counterfeit Viagra and Cialis

Anzanello, Michel J.; Ortiz, Rafael S.; Limberger, Renata Pereira; Mariotti, Kristiane de Cássia

doi:10.1016/j.forsciint.2013.12.005

Cited by 16 publications

(14 citation statements)

References 24 publications

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“…Although several studies based on infrared profiling [12,[14][15][16][17][18][19][20] have been published over this decade concerning identification of counterfeit samples of Viagra and Cialis, most of these works do not consider nor discuss the compositional characteristics of the samples, employing spectral profiling mostly as a data source for chemometrical analysis, an approach which, although very powerful and useful, is usually beyond practical use in most forensic laboratories. The present approach was based on more direct and comparative practical analyses of the spectral profiles of tablet cores, applied not only to identify the AI of each tablet, but also the major excipients/adjuvants present.…”

Section: Discussionmentioning

confidence: 99%

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market

Neto

Lisboa

2017

Science & Justice

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Section: Discussionmentioning

confidence: 99%

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market

Neto

Lisboa

2017

Science & Justice

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“…FTIR spectroscopy is a (rather) rapid technique and requires no or minimal sample pre‐treatment . Close attention is now being paid to the use of FTIR based methods for the identification of counterfeit medicines . For example, a handheld counterfeit device has been developed by the Food and Drug Administration (FDA) for the rapid screening of suspect pharmaceuticals .…”

Section: Analytical Technologies For the Detection Of Pharmaceutical mentioning

confidence: 99%

Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

et al. 2020

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The globalization of drug trade leads to the expansion of pharmaceutical counterfeiting. The immense threat of low quality drugs to millions of patients is considered to be an under‐addressed global health challenge. Analytical authentication technologies are the most effective methods to identify active pharmaceutical ingredients and impurities. However, most of these analytical testing techniques are expensive and need skilled personnel. To combat counterfeiting of drugs, the package of an increasing number of drugs is being protected through advanced package labeling technologies. Though, package labeling is only effective if the drugs are not repackaged. Therefore “in‐drug labeling,” instead of “drug package labeling,” may become powerful tools to protect drugs. This review aims to overview how advanced micro‐ and nanomaterials might become interesting markers for the labeling of tablets and capsules. Clearly, how well such identifiers can be integrated into “solid drugs” without compromising drug safety and efficacy remains a challenge. Also, incorporation of tags has so far only been reported for the protection of solid drug dosage forms. No doubts that in‐drug labeling technologies for “liquid drugs,” like injectables which contain expensive peptides, monoclonal antibodies, vaccines, dermal fillers, could help to protect them from counterfeiting as well.

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“…Counterfeiters are now also focusing on prescription medicines including 'lifesaving' medicines for cancer and heart disease [1][2][3]. For patients the use of counterfeit medicines can result in unexpected side effects, treatment failure or even death.…”

Section: Introductionmentioning

confidence: 99%

“…Counterfeit medicines are in fact a vast global problem impacting not only on the developing countries but also on the developed countries with effective regulatory systems and market control. In the last decade conservative estimates suggest that, taken globally, 10% of all medicines are counterfeit [3,4]. The World Health Organisation defines a counterfeit medicine as 'a medicine which is deliberately and fraudulently mislabelled with respect to its identity and/or source' and may include but not limited to: medicines containing no active ingredient, the wrong amount of active ingredient, the wrong active ingredient, high levels of contaminants and fake packaging.…”

Section: Introductionmentioning

confidence: 99%

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Counterfeit Tablet Investigations: Can ATR FT/IR Provide Rapid Targeted Quantitative Analyses?

Lawson¹

2014

J Anal Bioanal Tech

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Counterfeit medicines are now a global public health problem. In developed countries up to 1% of medicines are reported to be counterfeit whilst in developing countries the level is ~30-40%. In this research the potential of Attenuated Total Reflection (ATR) FT/IR techniques to provide rapid quantitative analyses of suspect tablet formulations is reported. Unlike conventional tablet analyses where several tablets are crushed and solvent extracted, ATR FT/IR methods require that only a single tablet be crushed prior to analysis. This provides a considerable time saving over the solvent extraction protocols cited in the British Pharmacopoeia. Reference ATR FT/IR spectra of the active pharmaceutical ingredient (API) and excipients, from crushed tablets, were recorded for identification purposes. Quantitative data was obtained from ATR FT/IR spectra of calibrated mixtures of the API in the excipients. Tablet samples from various countries, India, Africa, China, Belgium and the UK were examined. Initial results showed the API could be identified down to ca 5% w/w of the tablet. Quantification was linear with selected characteristic peak areas for each API/excipient mixture. The analysis of the tablet samples generally showed good agreement with expectation. This was confirmed by conventional extractive analyses followed by UV quantification. ATR FT/IR can therefore identify counterfeit tablets rapidly without the need for solvents. Whilst LC-MS/MS and NMR techniques may be the 'gold standards' of the analytical world they are of much reduced value in sub-Saharan African countries whereas a portable ATR FT/IR may prevent the use of counterfeit antimalarial tablets and contribute to improvements in patient health.

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A framework for selecting analytical techniques in profiling authentic and counterfeit Viagra and Cialis

Cited by 16 publications

References 24 publications

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market

ATR-FTIR characterization of generic brand-named and counterfeit sildenafil- and tadalafil-based tablets found on the Brazilian market

Materials and Technologies to Combat Counterfeiting of Pharmaceuticals: Current and Future Problem Tackling

Counterfeit Tablet Investigations: Can ATR FT/IR Provide Rapid Targeted Quantitative Analyses?

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