Category: Formulation and Quality
Purpose: According to Defelice's definition in 1995, nutraceutical is: “A food or parts of food that provide medical or health benefits, including the prevention and/or treatment of disease”. Nutraceuticals are now the most growing market with an estimated worth of USD 117 billion worldwide, in 2017. The purpose of this project is evaluation of Over-the-Counter (OTC) male enhancement nutraceuticals sold in online outlets like Amazon and ebay with respect to claim, pharmaceutical quality, and safety assessments.
Methods: Three different batches of each six-male-enhancement nutraceutical namely; AlphaMan XL®, MACA®, Prime Test®, Golden X®, Horny Goat Weed® and Leyene® were purchased from different online sellers on Amazon®. The tested products were analyzed via High-performance liquid chromatography (HPLC) and near infra-red (NIR) to detect any possible hidden adulterants. SeDeM analysis and pharmacopeial tests (content uniformity and weight variation tests), were conducted to evaluate the pharmaceutical quality and inter and intra batch variability of analyzed products.
Results: The results revealed that the analyzed male enhancement nutraceuticals were adulterated with sildenafil citrate. The HPLC analysis revealed that sildenafil citrate was found in heterogenous concentrations in AlphaMan XL® (10.67 mg on average in each tablet with SD of xx), MACA® (0.64 mg on average in each tablet with SD of xx), Prime Test® (3.20 mg on average in each tablet with SD of xx), Golden X®(49.60 mg on average in each tablet with SD of xx), Horny Goat Weed®(10.38 mg on average in each tablet with SD of xx) and Leyene® (24.33 mg on average in each tablet with SD of xx), as shown in figure 1.
All the analyzed products showed statistically significant differences in weight variability within and across different batches. The pharmacopeial tests showed the poor pharmaceutical quality of all tested nutraceuticals. Last, both of NIR and SeDeM analysis revealed the heterogenicity within and across the batches of AlphaMan XL®, MACA®, Prime Test®, Golden X®, Horny Goat Weed® and Leyene®.
Conclusion: Online male enhancement nutraceuticals contradicted label claims of being 100% natural and safe due to presence of undeclared sildenafil citrate. The majority of consumers heavily consumed the male enhancement herbal products with the misconception of their natural origin and safety. Unfortunately, most of the targeted consumers are suffered from heart or blood diseases, so sildenafil citrate is contraindicated in their cases. Hence, governmental organizations must pass restricted regulations on online marketing of nutraceuticals to protect consumer’s health and ban such products from the market.
Cindy Zheng– Hartford, Connecticut
Dina Mohamed– Alexandria, Al Iskandariyah, Egypt
Jessica Sweeney– Hartford, Connecticut
Mark Mikhail– Hartford, Connecticut
Nada Ahmed– Alexandria, Al Iskandariyah, Egypt
Nadine Amine– Hartford, Connecticut
Harshvir Kaur– Hartford, Connecticut
Doreen Szollosi– Hartford, Connecticut