scholarly journals Quality assessment of Diflucan® tablets distributed online: Diflucan® distributed online

2021 ◽  
Vol 5 ◽  
pp. 239920262110020
Author(s):  
Tomoko Sanada ◽  
Myu Ohnishi ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Hirohito Tsuboi
Keyword(s):  
Raman Scattering ◽  
Near Infrared ◽  
Health Hazard ◽  
Active Pharmaceutical Ingredient ◽  
Visual Observation ◽  
The Internet ◽  
Content Uniformity ◽  
Potential Health ◽  
Raman Scattering Spectroscopy ◽  
Falsified Medicines

Background: Falsified medical products have been reported worldwide. Falsified medicines with poor quality are a potential health hazard. Some Internet sites advertise fluconazole (Diflucan®), an antifungal medicine used to treat deep mycoses, as “female Viagra®.” Aim: The aim of this study was to investigate the authenticity and quality of Diflucan® tablets distributed on the Internet. Methods: We ordered Diflucan® tablets via the Internet and evaluated them by visual observation, authenticity investigation, quality evaluation (quantity of the active pharmaceutical ingredient, content uniformity, and dissolution), and near-infrared and Raman scattering spectroscopy. Results: We obtained 11 samples of Diflucan® tablets from all 11 Japanese Internet sites identified in our search. Of 11 sites, 7 advertised fluconazole as having effects on female sexual function. Ten of the Diflucan® samples were confirmed as genuine and one sample was falsified. The genuine Diflucan® samples met the specifications of all quality evaluations. The packaging, size, and color of the falsified Diflucan® sample obtained in this study differed from the authentic Diflucan® tablet. The falsified Diflucan® sample obtained in this study did not contain fluconazole and instead contained what appeared to be sildenafil citrate. The spectra of the falsified Diflucan® tablet obtained in this study differed from the authentic Diflucan® tablet in near-infrared and Raman scattering spectroscopy. Conclusion: We confirmed that one falsified Diflucan® tablet was distributed online. Thus, continued measures against falsified medicines are required.

scholarly journals Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer

Pharmacy ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 3
Author(s):  
Tomoko Sanada ◽  
Naoko Yoshida ◽  
Kazuko Kimura ◽  
Hirohito Tsuboi
Keyword(s):  
Raman Scattering ◽  
Raman Spectra ◽  
Principal Component ◽  
Detection Methods ◽  
Score Plot ◽  
Raman Scattering Spectroscopy ◽  
Standard Product ◽  
Destructive Analysis ◽  
Falsified Medicines ◽  
Non Destructive

Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory study, Raman spectroscopy was performed to evaluate the applicability of the ultra-compact Raman scattering spectrometer (C13560). Principal component analysis (PCA) was also performed on the Raman spectra. This study analyzed tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) tablets. We tested the standard product and products purchased from the internet (genuine or falsified). For Cialis and Levitra, all falsified tablets were identified by the Raman spectra and PCA score plot. For Viagra, the Raman spectra of some falsified tablets were almost comparable to the standard tablet. The PCA score plots of falsified tablets were dispersed, and some plots of falsified tablets were close to the standard tablet. In conclusion, C13560 was useful for the discrimination of falsified Cialis and Levitra tablets, whereas some falsified Viagra tablets had Raman spectra similar to that of the standard tablet. The development of detection methods that can be introduced in various settings may help prevent the spread of falsified products.

“Insight” into Drug Quality: Comparison of Simvastatin Tablets from the US and Canada Obtained via the Internet

2007 ◽  
Vol 41 (7-8) ◽  
pp. 1111-1115 ◽  
Author(s):  
Michael A Veronin ◽  
Eunah Lee ◽  
E Neil Lewis
Keyword(s):  
Near Infrared ◽  
Imaging Techniques ◽  
Active Pharmaceutical Ingredient ◽  
The Internet ◽  
Economic Implications ◽  
Innovator Product ◽  
Drug Products ◽  
Significant Difference ◽  
The Us ◽  
Blend Uniformity

Background: Recently, there has been much debate in the US concerning drug importation from Canadian Internet pharmacies. The Food and Drug Administration and US drug manufacturers assert that drugs obtained from international markets via the Internet present a health risk to consumers from substandard products. The public's perception is that drugs from Canada are as safe as those from the US. Objective: To determine whether simvastatin tablets obtained via the Internet from Canadian generic manufacturers are comparable in blend uniformity, a major attribute of tablet quality, with the US innovator product. Methods: Generic simvastatin tablets from 4 Canadian Internet pharmacy Web sites and the US innovator product were obtained for pharmaceutical analysis, Tablet samples were analyzed using near-infrared spectroscopic imaging techniques, which are designed to detect formulation defects of drug products during the manufacturing process. Digital images were created, revealing the tablets’ internal structures. Results: The blend uniformity of the active pharmaceutical ingredient in the tablet samples from Canada was determined and compared with that of the US innovator product. Results indicated that there is little significant difference in blend uniformity among US innovator and Canadian generic tablets. Conclusions: Results of this study suggest comparable quality assurance manufacturing standards for the US innovator product and the Canadian generic drug products tested. These findings have clinical, legal, and economic implications that should be addressed by policy makers to safeguard consumers who choose to purchase Canadian-manufactured drugs via the Internet.

scholarly journals Quality and Authenticity of Metformin Tablets Circulating on Japanese Websites

2021 ◽  
Author(s):  
Shu Zhu ◽  
Naoko Yoshida ◽  
Hirohito Tsuboi ◽  
Ryo Matsushita ◽  
Kazuko Kimura
Keyword(s):  
Extended Release ◽  
The Internet ◽  
Content Uniformity ◽  
Substandard Medicines ◽  
Dissolution Tests ◽  
Two Samples ◽  
Sustained Release Tablets ◽  
Quality Testing ◽  
Falsified Medicines ◽  
States Pharmacopeia

Abstract Background Low-quality medicines and falsified medicines represent long-standing problems in developing countries. In Southeast Asia, the circulation of low-quality diabetes drugs (metformin) has been confirmed. It is possible that low-quality metformin has entered Japan via personal import through the Internet. This study evaluated the pharmaceutical quality and authenticity of metformin tablets obtained via the Internet in Japan. Methods In total, 33 samples of 500-mg metformin tablets and 7 samples of extended-release/sustained-release tablets (500, 750, and 1,000 mg) were purchased via personal import in January 2017. Confirmation of a prescription was never requested purchase. The obtained samples were subjected to visual observations and authenticity investigations. Additionally, quantitative analysis, content uniformity and dissolution tests were performed using HPLC–PDA. Results Our authenticity investigations revealed that seven samples were genuine products, whereas the authenticity of the remaining 33 samples was unclear. Referring to United States Pharmacopeia 2014 for validation, four samples failed quality testing, five samples failed content uniformity testing, and two samples failed dissolution testing. Conclusions Our findings illustrate that metformin tablets of poor-quantity and unregistered/unlicensed doses are available online and that it is important to increase consumer awareness about the presence of these medicines on the Internet to prevent the purchase of substandard medicines.

scholarly journals Laboratory evaluation of twelve portable devices for medicine quality screening

2021 ◽  
Vol 15 (9) ◽  
pp. e0009360
Author(s):  
Stephen C. Zambrzycki ◽  
Celine Caillet ◽  
Serena Vickers ◽  
Marcos Bouza ◽  
David V. Donndelinger ◽  
...  
Keyword(s):  
Near Infrared ◽  
Colorimetric Assay ◽  
Active Pharmaceutical Ingredient ◽  
Microfluidic System ◽  
Poor Quality ◽  
Laboratory Evaluation ◽  
Regulatory Function ◽  
Portable Devices ◽  
Liquid Chromatograph ◽  
Falsified Medicines

Background Post-market surveillance is a key regulatory function to prevent substandard and falsified (SF) medicines from being consumed by patients. Field deployable technologies offer the potential for rapid objective screening for SF medicines. Methods and findings We evaluated twelve devices: three near infrared spectrometers (MicroPHAZIR RX, NIR-S-G1, Neospectra 2.5), two Raman spectrometers (Progeny, TruScan RM), one mid-infrared spectrometer (4500a), one disposable colorimetric assay (Paper Analytical Devices, PAD), one disposable immunoassay (Rapid Diagnostic Test, RDT), one portable liquid chromatograph (C-Vue), one microfluidic system (PharmaChk), one mass spectrometer (QDa), and one thin layer chromatography kit (GPHF-Minilab). Each device was tested with a series of field collected medicines (FCM) along with simulated medicines (SIM) formulated in a laboratory. The FCM and SIM ranged from samples with good quality active pharmaceutical ingredient (API) concentrations, reduced concentrations of API (80% and 50% of the API), no API, and the wrong API. All the devices had high sensitivities (91.5 to 100.0%) detecting medicines with no API or the wrong API. However, the sensitivities of each device towards samples with 50% and 80% API varied greatly, from 0% to 100%. The infrared and Raman spectrometers had variable sensitivities for detecting samples with 50% and 80% API (from 5.6% to 50.0%). The devices with the ability to quantitate API (C-Vue, PharmaChk, QDa) had sensitivities ranging from 91.7% to 100% to detect all poor quality samples. The specificity was lower for the quantitative C-Vue, PharmaChk, & QDa (50.0% to 91.7%) than for all the other devices in this study (95.5% to 100%). Conclusions The twelve devices evaluated could detect medicines with the wrong or none of the APIs, consistent with falsified medicines, with high accuracy. However, API quantitation to detect formulations similar to those commonly found in substandards proved more difficult, requiring further technological innovation.

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