INVESTIGATION OF CHEMICAL DIFFERENCES IN MEDICATIONS OBTAINED FROM DIVERSE SOURCES USING NOVEL SPECTROSCOPIC AND STATISTIC APPROACHES
Creators: name: Author, Unknown
Publisher: name: University of Lincoln
Year: 2023

description: Generic medications are those medicines manufactured by a pharmaceutical company withouta license from the company that has first invented and patented the same drug, when the relatedpatent and other exclusivity rights have expired. Only studies of bioequivalence are requestedas requirements to introduce a new generic medication in clinics, making easier and financiallyattractive for many pharmaceutical companies to participate in this typology of market.Organised criminality is strongly attracted by this market both for the high profitability, andfor the high similarity to the production and trafficking of illegal controlled substancesassociated to the extreme difficulties faced by the law enforcement authorities in effectivelyinvestigating the online market, because of its anonymity.A significant paradigm continuously frequented in pharmacology is the confliction betweenviews on generic medications that can be used interchangeably with the original medicines.Several clinical studies conducted in certain medical areas have shown as the genericmedications present an overlapping therapeutic equivalence to the original ones. On thecontrary, for certain other generics, both pharmacokinetics and pharmacodynamics issue havebeen 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 clinicalequivalence among generic and original medications, no study to the scientific community hasbeen presented on an analytical evaluation of the chemical composition of the different genericdrugs 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 qualitativeanalytical methodology to be able to discriminate differences in the chemical composition fromgeneric medicines that have been reported not presenting similar therapeutic equivalence inclinical comparison studies, obtained from authorised pharmacies and non-authorised onlinesellers.From the cardio-vascular area, digoxin (with the related cardiac glycosides digitoxin anddigoxigenin) and amlodipine (in its different salts maleate, mesylate and besylate used intherapies). 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 racemicand isomeric forms, equally for the same reasons as before, have been considered. As startinganalytical approaches, voltammetry, FT-IR, Raman spectroscopies and NMR have beenconsidered and a statistical data analysis approach of the analytical data obtained based on multivariate analysis such as principal component analysis, cross validation, correlation scatterplots and factor loadings has been implemented.This work has matched the aims initially set, generating novel methods of analysis toinvestigate differences in the chemical composition within different groups of genericmedications. This study has led to the creation and interpretation of new knowledge, through asystematic acquisition and understanding of a substantial body of scientific literature andthrough original research, and adjusting the project design in the light of unforeseen problems,conceptualizing, designing and implementing the research project for the generation of novelknowledge.