Scientific Evidence

Pharmaceutical products have contributed to improving the expectancy and quality of life of millions of patients and their role in our society is undisputed. However, many active pharmaceutical ingredients have been found in rivers, lakes, seas, drinking water and can cause damage to the environment and ecosystems. Environmental contamination is known to affect biodiversity and health. From a "One Health" perspective, human health is safeguarded by preserving the environment and ecosystems. Italy is at the forefront on the issue of protecting biodiversity, having included it among the fundamental principles of the Constitution. At the same time the European Commission launched the strategy to protect biodiversity by 2030. To map and limit the environmental effect of drugs, it has been proposed the topic of ecopharmacovigilance and eco-directed sustainable prescribing.

It's in this context that this work on the ready biodegradability of a drug-based on loperamide and a medical device made of complex natural matrix, Lenodiar-Pediatric®, was carried out for the first time. The products, indicated to treat diarrhoea, were found to be readily biodegradable. For Lenodiar-Pediatric® the biodegradation isn't surprising, while for the drug-based on loperamide it was due to the degradation of excipients. Indeed, the UHPLC-qToF investigation highlighted that loperamide was present at the end of the test and is therefore potentially persistent in the environment, confirming the most relevant literature.

In conclusion, therapeutic products made of natural complex matrix which efficacy and safety have been proven according to Evidence-Based Standards may play an important role in safeguarding biodiversity.

Diarrhea continues to be a global health problem as acute diarrhea carries the risk of dehydration, while both acute and chronic diarrhea can significantly affect patients’ quality of life and reduce productivity. The innovative medical device Actitan, which consists of a complex of natural molecules, could be an effective option for the treatment of diarrhea from various causes. The aim of this post-market cross-sectional study was to evaluate the perceived efficacy, safety and usage pattern of the two formulations for adults (Actitan-P) and children (Actitan-F) among patients/child caregivers, physicians and pharmacists. Participants completed online questionnaires with closed multiple-choice questions that were rated on a verbal 5-point Likert scale. These surveys were conducted via the online platform Real World Data, which provides digital questionnaires for patients, doctors and pharmacists. Two separate surveys were conducted for the two formulations, with a total of 2630 participants (1488 participants for Actitan-P and 1142 participants for Actitan-F). Overall, the results indicate a high level of efficacy and safety of the product. In the case of Actitan-F, more than 96% of caregivers rated safety as good or excellent, and over 92% rated efficacy as good or excellent. Actitan-P also received positive feedback: nearly 86% of patients reported good/excellent efficacy, and more than 93% rated safety as good or excellent. These positive evaluations were confirmed by physicians and pharmacists, who also did not report adverse effects. In summary, this study confirms the role of Actitan as a safe and effective option for the treatment of diarrhea of different causes and in different patient groups, including young children.

Suspect screening and untargeted analysis using UHPLC-qToF are two advanced analytical approaches now used to achieve an extensive chemical profile of samples, which are then typically confirmed through targeted analysis. These techniques can detect a large number of chemical features simultaneously and are currently being introduced into the study of contaminants of emerging concern (CECs) and into the study of the extent of human chemical exposure (the exposome). Here is described the use of these techniques to characterize chemical mixtures derived from the OECD 301F ready biodegradability test (RBT) of a chemical and natural formulation currently used to treat reflux disease and functional dyspepsia. Untargeted analysis clearly evidenced a different behavior between formulations containing only natural products with respect to that containing synthetic and non-naturally occurring substances. Suspect screening analysis improved the untargeted analysis of the omeprazole-based medicine, leading to the tentative identification of a number of omeprazole-derived transformation products, thereby enabling their preliminary quali-quantitative evaluation. Targeted analysis was then performed to confirm the preliminary data gained from the suspect screening approach. The validation of the analytical method for the quantitative determination of omeprazole and its major metabolite, omeprazole sulphide, has provided robust data to evaluate the behavior of omeprazole during the OECD 301F test. Using advanced analytical approaches, the RBT performed on the two products under investigation confirmed that omeprazole is not readily biodegradable, while the medical device made of natural substances has proven to be readily biodegradable.