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The era of fake medicines: Investigating counterfeit medicinal products for erectile dysfunction disguised as herbal supplements

DOI: 10.1016/j.ijpharm.2022.121592 DOI Help

Authors: Hei Ming Kenneth Ho (University College London) , Zhaoan Xiong (University College London) , Hui Ying Wong (University College London) , Asma Buanz (University College London)
Co-authored by industrial partner: No

Type: Journal Paper
Journal: International Journal Of Pharmaceutics , VOL 105

State: Published (Approved)
Published: February 2022
Diamond Proposal Number(s): 28460

Abstract: Sales of substandard and falsified medical products (SF) are rising rapidly everywhere around the globe. The wide and easy access to these products is an alarming issue to the global health systems and undermined the health of patients, especially with the thrive of online commerce. To tackle this threat to public health, new ways to access these products should be identified and detection technologies should be strengthened. The overarching aim of this study was to investigate if herbal supplements sold online claiming to be natural alternatives to Viagra® were amongst these SF medical products and how effective different analytical techniques are in providing information about these products. 3 products which claimed to be herbal supplements for men sexual performance were purchased from an e-commerce platform. Two products were received as unregistered generic sildenafil citrate tablets manufactured in India (and thus different to the products information on the website) while one product was received in the same packaging as shown on the website, claiming to be an herbal product. Nevertheless, all products were proven to contain sildenafil citrate, the active pharmaceutical ingredients in Viagra® after the comprehensive analytical tests. The results elucidated that the quality standards for the unregistered generic sildenafil citrate tablets were fulfilled according to the British Pharmacopeia, but the falsified product failed the quality tests and contained approximately 200 mg sildenafil citrate, which is equivalent to 2-fold of the daily maximum dose. Furthermore, physical characterisations, including powder x-ray diffraction and thermal analysis were performed and revealed that the polymorphic forms of sildenafil citrate were different, demonstrating the importance of employing thermal analysis in addition to the conventional analysis techniques for the substandard and falsified medical products. These techniques provided valuable insights into the physical form of the active ingredient in these products. What is more, the ease with which these SF products were obtained and confirmed to be misleading consumers emphasises the need for tighter regulation for e-commerce websites in line with those enforced on online pharmacies.

Journal Keywords: Substandard and counterfeit medicines; Sildenafil; Herbal supplements; DSC-Synchrotron XRD; Physical characterisation

Subject Areas: Medicine

Instruments: I12-JEEP: Joint Engineering, Environmental and Processing

Added On: 21/02/2022 10:13

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Life Sciences & Biotech

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