Male enhancement Nutraceuticals in the Middle East market: Claim, pharmaceutical quality and safety assessments

Int J Pharm. 2015 Aug 15;492(1-2):109-19. doi: 10.1016/j.ijpharm.2015.07.006. Epub 2015 Jul 9.

Abstract

The global market is invaded by male enhancement nutraceuticals claimed to be of natural origin sold with a major therapeutic claim. Most of these products have been reported by international systems like the Food and Drug Administration (FDA). We hypothesize that these products could represent a major threat to the health of the consumers. In this paper, pharmaceutical evaluation of some of these nutraceutical products sold in Egypt under the therapeutic claim of treating erectile dysfunction, are discussed along with pharmacological evaluation to investigate their safety and efficacy parameters. Samples were analyzed utterly using conventional methods, i.e.: HPLC, HPTLC, NIR, content uniformity and weight variation and friability. The SeDeM system was used for quality assessment. On the basis of the results of this research, the sampled products are adulterated and totally heterogeneous in their adulterant drug content and pharmaceutical quality. These products represent a major safety threat for the consumers in Egypt and the Middle East, especially; the target audience is mostly affected with heart and blood pressure problems seeking natural and safe alternatives to the well-established Phosphodiesterase 5 Inhibitors (PDE-5Is).

Keywords: Acetonitrile (CID: 6342); Adulteration; Ammonium formate (CID: 2723923); Clinical Study; Evaluation; Methanol (CID: 887); Middle East; Nutraceuticals; Phosphodiestrase inhibitors; SeDeM; Sildenafil; Sildenafil (CID:5212); Tadalafil (CID:110635); Tiger King; Vardenafil (CID:110634).

MeSH terms

  • Alanine Transaminase / blood
  • Animals
  • Aspartate Aminotransferases / blood
  • Creatinine / blood
  • Dietary Supplements* / analysis
  • Dietary Supplements* / toxicity
  • Drug Contamination*
  • Male
  • Middle East
  • Phosphodiesterase 5 Inhibitors* / analysis
  • Phosphodiesterase 5 Inhibitors* / pharmacokinetics
  • Phosphodiesterase 5 Inhibitors* / pharmacology
  • Phosphodiesterase 5 Inhibitors* / toxicity
  • Rats, Wistar
  • Sildenafil Citrate / analysis
  • Sildenafil Citrate / pharmacokinetics
  • Sildenafil Citrate / pharmacology
  • Sildenafil Citrate / toxicity
  • Tadalafil / analysis
  • Urea / blood
  • Vardenafil Dihydrochloride / analysis
  • gamma-Glutamyltransferase / metabolism

Substances

  • Phosphodiesterase 5 Inhibitors
  • Vardenafil Dihydrochloride
  • Tadalafil
  • Urea
  • Creatinine
  • Sildenafil Citrate
  • gamma-Glutamyltransferase
  • Aspartate Aminotransferases
  • Alanine Transaminase