Counterfeit medicines and illicit health care products: analysis of active products and chemical profiling

During the PhD research, illicit medicines and fake food supplements have been studied, with particular attention in the analysis of active products and development of qualitative/quantitative analytical methods for screening and identification of active ingredients in drug formulation. This activity and the results generated during the 3 years research were useful to give precious information about the trend of illegal market and to complete investigations of AIFA (Italian Medicine Agency) and other Authority (Carabinieri NAS), which necessarily have to be supported by scientific data. Chemical analysis were carried out using high-performance liquid chromatography (HPLC-UV), gas chromatography/mass spectrometry (GC-MS), gas chromatography †" flame ionization detector (GC-FID) and more advanced laboratory techniques, such as ultra-performance liquid chromatography/time of flight mass spectrometry (UPLC/TOF-MS). The analytical methods developed and then validated, allowed to qualitatively and quantitatively determine the chemical composition of the drugs (active pharmaceutical ingredients (APIs) as well as other components). During the research, different classes of molecules, mainly present in the illicit market, have been analyzed, in particular the drugs used to treat erectile dysfunction ( ED) such as inhibitors of cGMP-specific phosphodiesterase type 5 (PDE-5), anabolic steroids used for doping as well as cosmetic creams containing corticosteroids and aminoglycosides antibiotics used as skin bleaching. Regarding investigation about illegal PDE-5 inhibitors, no. 21 samples were analyzed as a result of †œad hoc†� operations conducted by A.I.F.A related to the market of fake food supplements. Among these samples, no. 7 products were proved to contain sildenafil or tadalafil and in other two samples sildenafil derivatives were identified: thioaildenafil and hydroxythiohomosildenafil; the first of which found for the first time in the Italian market. Regarding cosmetic creams containing corticosteroids and anabolic steroids, active ingredients were monitored in more than 50 samples seized in all the country, providing useful information about trend of illicit market of medicines.