New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Fimognari, Carmela; Barrajón‐Catalán, Enrique; Luceri, Cristina; Turrini, Eleonora; Raschi, Emanuel; Bigagli, Elisabetta

doi:10.3389/fdsfr.2022.1001614

Cited by 2 publications

(2 citation statements)

References 44 publications

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“…As recently reviewed (Fimognari et al, 2022;Leone, 2022), MPs and SBMDs however differ in their mechanism of action: MPs have a demonstrated pharmacological mechanism of action while SBMDs must have "any mechanism, that is, not pharmacological". The definition of a "non pharmacological" mechanism of action for a therapeutic product represents a big challenge for preclinical and clinical research.…”

Section: Regulatory Agency Statementmentioning

confidence: 99%

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Rasi

Alessandro

2022

Front. Drug Saf. Regul.

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The recent European Union (EU) Regulations on clinical trial on medicinal products (MPs) (2014/536) and on medical devices (MD) (2017/745) represent potential improvement for the European health system and may offer advantages to the citizens. As Regulations, they are immediately applicable in Member States overruling national laws, being an advantage for stakeholders (e.g. sponsors and investigators) and Europe becomes de facto one homogeneous place for research and development of medicines and medical devices. This perspective commentary focuses on the most relevant methodological and regulatory aspects of the recent Regulation on clinical trials for drug development and how it may indirectly impact on substance-based medical devices (SBMD). The article highlights the innovations associated with the 2017/745 Regulation, especially to the area of SBMD, which represent a novelty among MDs. Since SBMDs share some aspects of medicines, they will increasingly undergo research in the future related to the performance and safety claims, via post-marketing surveillance. Importantly, SBMD’s Consumers are rapidly increasing due to their usage to treat some common symptoms, which not necessarily need conventional medicines. “Frontiers in Drug Safety and Regulation” created a section to reflect this rapidly-changing scenario and host reports on SBMD in a scientific environment. This initiative is also a reflection of the recent regulation on SBMDs. Thus, the improvement of clinical research through the new EU Regulation on clinical trials may become useful also to the new requirements for SBMD. A novel editorial initiative will further contribute to implement the EU Regulation providing adequate scientific dissemination.

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Section: Regulatory Agency Statementmentioning

confidence: 99%

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Rasi

Alessandro

2022

Front. Drug Saf. Regul.

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“…By definition, "substance-based medical devices are medical devices that are composed of substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body". Although they are herbal-like medicinal products in their presentation and pharmaceutical form, they achieve their principal intended effect via a physicochemical and/or physical mechanism of action (including mechanical action, a physical barrier such as a film, lubrication, hydration or dehydration, and pH modification) (Fimognari et al, 2022;Manellari et al, 2022). The ISO 10993 sets a series of standards and guidance for the biological evaluation of medical devices within a risk management process as part of the overall evaluation and development of the medical device (ISO, 2020).…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test

Bassetto¹,

Perin²,

Amadio³

et al. 2023

Front. Drug Saf. Regul.

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This study aims to develop an in vitro barrier effect test over biomimetic membrane, which is useful to establish the film forming ability of a substance-based medical device (SB-MD). The method contemplates a multiparametric approach including: i) the measurement of the transmembrane passage of a molecular-like marker over a lipid-impregnated biomimetic membrane (simulating the skin and gastro-intestinal and buccal tissues) by using a static diffusion cell apparatus (Franz cell); and ii) the evaluation of the integrity of the membrane (colorimetric test). In the first step, a series of lipid-impregnated biomimetic membranes (simulating gastro-intestinal, buccal, and skin tissues) were implemented and their permeability performance validated using model drugs (caffeine and acyclovir) by referring to literature data. As a result, the apparent permeability (Papp) of caffeine over the biomimetic gastro-intestinal membrane (Papp = 30.5E-6 cm/s) was roughly comparable to the literature values obtained with Caco-2 cell line membrane (Papp = 30.8E-6 cm/s) and with the Franz cell method (Papp = 36.2E-6 cm/s). Acyclovir was shown to be a poorly permeable substance both in the literature and experimental data. Following this step, the permeability study was extended to both biomimetic buccal and skin (STRAT-M®) membranes: for caffeine, biomimetic gastro-intestinal membrane was the most permeable (Papp = 30.5E-6 cm/s), followed by the buccal (Papp = 18.2E-6 cm/s) then the skin (Papp = 0.5E-6 cm/s) biomimetic membranes. In a second part of the work, the barrier effect test was developed following a similar permeability-like approach. The protocol was designed with the idea of assessing the capacity of a certain product to prevent the passage of caffeine across the biomimetic membrane with respect to a negative and positive control. The untreated membrane was the negative control, while membrane covered with a Vaseline film was the positive. As a last step, the developed barrier effect protocol was applied to an experimental gel-like SB-MD under development for the treatment of aphthae (Aphthae gel, an invented trade name), herein used as a case study. Regarding the results, Aphthae gel reduced the caffeine passage by 60.3%, thus highlighting its effectiveness to form a protective film. Overall, these results provide important knowledge and may pave the way for the use—including for industrial applications—of these simple but effective biomimetic membranes for carrying out high throughput screening necessary to design safe and effective SB-MDs before proceeding further with clinical trials, as requested by the regulations.

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New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Cited by 2 publications

References 44 publications

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Safety and efficacy of substance-based medical devices: Design of an in vitro barrier effect test

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