Screening and Determination of Synthetic PDE-5 Inhibitors in Adulterated Sexual Enhancement Supplements

Jairoun, Ammar Abdulrahman; Al‐Hemyari, Sabaa Saleh; Shahwan, Moyad; Zyoud, Sa’ed H.; Ibrahim, Baharudin; Zyoud, Samer H.

doi:10.3390/molecules27196737

Cited by 10 publications

(5 citation statements)

References 20 publications

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“…Moreover, besides the analytical testing efforts, tighter regulations that directly address the problem by defining how these products are registered, advertised, and sold are necessary. In order to improve public health and safety, there should be ongoing efforts to research, regulate, and educate the public about sexual enhancement dietary supplements [ 48 ].…”

Section: Discussionmentioning

confidence: 99%

Determination of Phosphodiesterase Type-5 Inhibitors (PDE-5) in Dietary Supplements

et al. 2023

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This study proposed a high-performance thin-layer chromatography (HPTLC) screening method to detect phosphodiesterase 5 (PDE-5) inhibitors as possible adulterant agents in various dietary supplements. Chromatographic analysis was performed on silica gel 60F254 plates using a mixture of ethyl acetate:toluene:methanol:ammonia in a volume ratio of 50:30:20:0.5 as a mobile phase. The system provided compact spots and symmetrical peaks of sildenafil and tadalafil with retardation factor values of 0.55 and 0.90, respectively. The analysis of products purchased from the internet or specialized stores demonstrated the presence of sildenafil, tadalafil, or both compounds in 73.3% of products, highlighting inadequacies and inconsistencies in the labeling, as all dietary supplements were declared to be natural. The results were confirmed using ultra-high-performance liquid chromatography coupled with a positive electrospray ionization high-resolution tandem mass spectrometry (UHPLC-HRMS-MS) method. Furthermore, in some samples, vardenafil and various analogs of PDE-5 inhibitors were detected using a non-target HRMS-MS approach. The results of the quantitative analysis revealed similar findings between the two methods, with adulterant quantities found to be similar to or higher than those in approved medicinal products. This study demonstrated that the HPTLC method is a suitable and economical method for screening PDE-5 inhibitors as adulterants in dietary supplements intended for sexual activity enhancement.

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Section: Discussionmentioning

confidence: 99%

Determination of Phosphodiesterase Type-5 Inhibitors (PDE-5) in Dietary Supplements

et al. 2023

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“…Several analytical methods, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectroscopy (MS), are used in the screening of PDE-5 inhibitors to assess the authenticity of honey. However, each method has its own advantages and disadvantages [24,[32][33][34][35][36][37][38]. GC-MS is suitable for the analysis of volatile compounds with high sensitivity.…”

Section: Introductionmentioning

confidence: 99%

Counterfeiting honey with phosphodiesterase inhibitors for sexual activity enhancement: detection using high-performance liquid chromatography coupled with a photodiode array detector (HPLC-PAD)

2024

JOMH

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Globally, there have been several reports of natural products contaminated with illegal adulterants that threaten consumer health because of their adverse pharmacological effects. To treat erectile dysfunction in men, herbal medicine is often adulterated with synthetic phosphodiesterase type 5 (PDE-5) inhibitors. Honey, which is popularly used for its health benefits, is subjected to adulteration with PDE-5 inhibitors. In this study, a rapid and reliable analytical method was proposed to determine the level of adulteration in honey samples. A total of 18 honey samples were tested for the presence of PDE-5 inhibitors (sildenafil, tadalafil and vardenafil) using a high-performance liquid chromatographic method coupled with a photodiode array detector (HPLC-PAD). Chromatography was performed using the Agilent ZORBAX SB-C18 column, with acetonitrile and buffer in the ratio of 1:4 as the mobile phase. Sildenafil, tadalafil and vardenafil reference standards were used for calibration. The retention times of the standards were 21.67, 18.15 and 21.30 min respectively. Of the total samples tested, 55% were positive for PDE-5 inhibitors. Six samples contained sildenafil, three samples contained tadalafil and one sample contained vardenafil. The findings from this study demonstrate that the HPLC-PAD method is suitable and economical for screening PDE-5 inhibitors as adulterants in honey samples marketed for use as sexual activity enhancers. Regular inspections of adulterated products are thus warranted to ensure the safety and health of consumers.

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“…7 PDE5 inhibitor adulteration in sexual enhancement DS is a world-wide problem. [8][9][10][11][12][13] Ten out of 64 sexual enhancement DS samples collected from a Czech marketplace from 2009 to 2015 were found to have PDE5 inhibitor adulterants and 34 out of 62 DS for sexual enhancement were found to be adulterated with at least one PDE5 inhibitor from a Malaysian market from 2014 to 2016. 8,9 Other published studies also emphasize the global nature of this public health challenge.…”

Section: Introductionmentioning

confidence: 99%

“…8,9 Other published studies also emphasize the global nature of this public health challenge. [10][11][12][13] This cross-sectional survey study focuses on testing for the presence of prescription PDE5 inhibitors and/or 16 of their analogues in products marketed as DS for sexual enhancement, available at retail locations in the Sacramento area of California, with particular interest in some products that had received previous FDA warnings.…”

Section: Introductionmentioning

confidence: 99%

Cross-Sectional Survey of Adulterated Sexual Enhancement Products Sold in the Sacramento Area of California

Fischer,

Tucker,

et al. 2023

NDS

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The Food and Drug Administration (FDA) has warned against tainted products for sexual enhancement containing prescription phosphodiesterase-5 (PDE5) inhibitors marketed as dietary supplements. The California Department of Public Health (CDPH)'s Food and Drug Branch (FDB) initiated a study to assess the presence of such adulterated products, specifically to identify the presence of PDE5 inhibitors in dietary supplements marketed for sexual enhancement, sampled at local retail locations. Methods: A convenience sample of products marketed as sexual enhancement dietary supplements was purchased from retail stores, within a 15-mile radius of downtown Sacramento, California. Samples were submitted to the Food and Drug Laboratory Branch (FDLB) and screened for 19 different PDE5 inhibitors using liquid chromatography-mass spectrometry. Samples were collected and analyzed from 2016 to 2018. Results: One hundred and two different products were purchased from 28 different retail locations. Sixty-seven percent were found to be adulterated with at least one PDE5 inhibitor. Of the positive samples, 40% were found to contain one PDE5 inhibitor and 60% were found to contain two or more. Sildenafil was the most common PDE5 inhibitor identified (74%), followed by tadalafil (59%). Eighteen percent of the tested samples had been associated with previous FDA warnings listed in their Tainted Products Database. Of these warning-associated samples, 72% were found to contain PDE5 inhibitors and 46% of these contained at least one of the same adulterants reported by the FDA. Conclusion: FDA reports and warnings have focused on dietary supplements found online or through screenings of international mail shipments. FDB results add to FDA findings by demonstrating that such adulterated products marketed for sexual enhancement are also sold at retail locations in California. These products have the potential to cause severe adverse health effects and therefore, it is essential to raise awareness of this significant public health concern.

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Screening and Determination of Synthetic PDE-5 Inhibitors in Adulterated Sexual Enhancement Supplements

Cited by 10 publications

References 20 publications

Determination of Phosphodiesterase Type-5 Inhibitors (PDE-5) in Dietary Supplements

Determination of Phosphodiesterase Type-5 Inhibitors (PDE-5) in Dietary Supplements

Counterfeiting honey with phosphodiesterase inhibitors for sexual activity enhancement: detection using high-performance liquid chromatography coupled with a photodiode array detector (HPLC-PAD)

Cross-Sectional Survey of Adulterated Sexual Enhancement Products Sold in the Sacramento Area of California

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