Abstract

Generic medications are those medicines manufactured by a pharmaceutical company without
a license from the company that has first invented and patented the same drug, when the related
patent and other exclusivity rights have expired. Only studies of bioequivalence are requested
as requirements to introduce a new generic medication in clinics, making easier and financially
attractive for many pharmaceutical companies to participate in this typology of market.
Organised criminality is strongly attracted by this market both for the high profitability, and
for the high similarity to the production and trafficking of illegal controlled substances
associated to the extreme difficulties faced by the law enforcement authorities in effectively
investigating the online market, because of its anonymity.

A significant paradigm continuously frequented in pharmacology is the confliction between
views on generic medications that can be used interchangeably with the original medicines.
Several clinical studies conducted in certain medical areas have shown as the generic
medications present an overlapping therapeutic equivalence to the original ones. On the
contrary, for certain other generics, both pharmacokinetics and pharmacodynamics issue have
been reported. Also, in some cases issues on the stability of generics have been raised.
Despite the numerous research articles and reviews published on the matter of clinical
equivalence among generic and original medications, no study to the scientific community has
been presented on an analytical evaluation of the chemical composition of the different generic
drugs that could shed some lights on the reason of the different clinical performances reported.
The main aim of this research was to develop a non-destructive quick qualitative
analytical methodology to be able to discriminate differences in the chemical composition from
generic medicines that have been reported not presenting similar therapeutic equivalence in
clinical comparison studies, obtained from authorised pharmacies and non-authorised online
sellers.

From the cardio-vascular area, digoxin (with the related cardiac glycosides digitoxin and
digoxigenin) and amlodipine (in its different salts maleate, mesylate and besylate used in
therapies). In the gastroenterology area, omeprazole both in its racemic and isomeric forms,
have been selected as samples to be analysed. In the antihistamine area, cetirizine, in its racemic
and isomeric forms, equally for the same reasons as before, have been considered. As starting
analytical approaches, voltammetry, FT-IR, Raman spectroscopies and NMR have been
considered and a statistical data analysis approach of the analytical data obtained based on
multivariate analysis such as principal component analysis, cross validation, correlation scatter
plots and factor loadings has been implemented.

This work has matched the aims initially set, generating novel methods of analysis to
investigate differences in the chemical composition within different groups of generic
medications. This study has led to the creation and interpretation of new knowledge, through a
systematic acquisition and understanding of a substantial body of scientific literature and
through original research, and adjusting the project design in the light of unforeseen problems,
conceptualizing, designing and implementing the research project for the generation of novel
knowledge.