Current pharmacological therapies for the management of chronic articular diseases are far from being satisfactory, so new strategies need to be investigated. We tested the intra-articular pain relieving properties of a system of molecules from a characterized Centella asiatica extract (14G1862) in a rat model of osteoarthritis induced by monoiodoacetate (MIA). 14G1862 (0.2–2 mg mL⁻¹) was intra-articularly (i.a.) injected 7 days after MIA, behavioural and histological evaluations were performed 14, 30 and 60 days after treatments. Moreover, the effect of 14G1862 on nitrate production and iNOS expression in RAW 264.7 macrophages stimulated with LPS was assessed. In vitro, 14G1862 treatment attenuated LPS-induced NO production and iNOS expression in a comparable manner to celecoxib. In vivo, 14G1862 significantly reduced mechanical allodynia and hyperalgesia, spontaneous pain and motor alterations starting on day 14 up to day 60. The efficacy was higher or comparable to that evoked by triamcinolone acetonide (100 μg i.a.) used as reference drug. Histological evaluation highlighted the improvement of several morphological parameters in MIA + 14G1862-treated animals with particularly benefic effects on joint space and fibrin deposition. In conclusion, i.a. treatment with Centella asiatica is a candidate to be a novel effective approach for osteoarthritis therapy.

Abdominal pain is a frequent symptom of irritable bowel syndrome (IBS) and inflammatory bowel diseases (IBDs). Although the knowledge of these pathologies is progressing, new therapeutic strategies continue to be investigated. In the present study, the effect of a system of molecules of natural origin (a medical device according to EU Directive 93/42/EC, engineered starting from Boswellia serrata resins, Aloe vera polysaccharides and Matricaria chamomilla and Melissa officinalis polyphenols) was evaluated against the intestinal damage and visceral pain development in DNBS-induced colitis model in rats. The system (250 and 500 mg kg⁻¹) was orally administered once daily, starting three days before the injection of 2,4-dinitrobenzenesulfonic acid (DNBS) and for 14 days thereafter. The viscero-motor response (VMR) to colon-rectal balloon distension (CRD) was used as measure of visceral sensitivity. The product significantly reduced the VMR of DNBS-treated animals. Its effect on pain threshold was better than dexamethasone and mesalazine, and not lower than amitriptyline and otilonium bromide. At microscopic and macroscopic level, the tested system was more effective in protecting the intestinal mucosa than dexamethasone and mesalazine, promoting the healing of tissue lesions. Therefore, we suggest that the described system of molecules of natural origin may represent a therapeutic option to manage painful bowel diseases.

The approval of EU Regulation 2017/745 has created a regulatory framework capable of consolidating an entire category of therapeutic products, that of Substance-based Medical Devices. The Regulation creates the conditions required to promote innovation in therapeutics, both for the so-called “minor illnesses” as well as for important “unmet medical needs”. At the same time, it significantly raises the standards for evaluating their efficacy and safety. Among the different kinds of Substance-based Medical Devices, those made of natural complex substances offer a special opportunity. In this new regulatory context, natural substances can be made available to the patient within an “evidence-based” context, guided by the principles of Systems Biology and Systems Medicine, and under the control of the healthcare sector. Substance-based Medical Devices are already an important product in the European therapeutic market and will likely play an increasing role in the years to come.

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.

New technologies to improve the investigation of biodegradability and the environmental fate of pharmaceutical formulations.

Background: Hemorrhoidal disease (HD) is a common anorectal condition characterized by symptoms such as bleeding, pain, discomfort and itching. While often underdiagnosed due to patient reluctance to seek care, HD significantly impacts quality of life (QoL). Conservative treatments are preferred for low-grade HD, with increasing interest in natural substance-based therapies. Materials and Methods: A large-scale survey was conducted using a digital platform to collect real-world data (RWD) from patients, pharmacists and physicians. The research assessed perceived effectiveness, safety, tolerability, quality of life (QoL) and usage patterns of NeoFitoroid BioOintment. Quantitative analysis was also performed using a global score (GS) based on Likert scale ratings and their distribution. Results: A total of 2618 participants were included. A strong concordance across the three participating cohorts in the answers provided for all items of the questionnaire was observed. The descriptive analysis revealed high grades of effectiveness, safety and tolerability. Indeed, over 90% of respondents rated the product as “good” or “excellent” in terms of effectiveness and safety. Conclusions: These findings underscore the treatment’s effectiveness, safety, tolerability and positive influence on QoL in HD patients.