Medical Device Development for Children and Young People—Reviewing the Challenges and Opportunities

Development of specific medical devices (MDs) is required to meet the healthcare needs of children and young people (CYP). In this context, MD development should address changes in growth and psychosocial maturation, physiology, and pathophysiology, and avoid inappropriate repurposing of adult technologies. Underpinning the development of MD for CYP is the need to ensure MD safety and effectiveness through pediatric MD-specific regulations. Contrary to current perceptions of limited market potential, the global pediatric healthcare market is expected to generate around USD 15,984 million by 2025. There are 1.8 billion young people in the world today; 40% of the global population is under 24, creating significant future healthcare market opportunities. This review highlights a number of technology areas that have led to successful pediatric MD, including 3D printing, advanced materials, drug delivery, and diagnostic imaging. To ensure the targeted development of MD for CYP, collaboration across multiple professional disciplines is required, facilitated by a platform to foster collaboration and drive innovation. The European Pediatric Translational Research Infrastructure (EPTRI) will be established as the European platform to support collaboration, including the life sciences industrial sector, to identify unmet needs in child health and support the development, adoption, and commercialization of pediatric MDs

Laser-induced breakdown spectroscopy: theory and applications

This book deals with the Laser-Induced Breakdown Spectroscopy (LIBS), a widely used atomic emission spectroscopy technique for elemental analysis of materials. It is based on the use of a high-power, short pulse laser excitation. The book is divided into two main sections: the first one concerning theoretical aspects of the technique, the second one describing the state of the art in applications of the technique in different scientific/technological areas. Numerous examples of state of the art applications provide the readers an almost complete scenario of the LIBS technique. The LIBS theoretical aspects are reviewed. The book helps the readers who are less familiar with the technique to understand the basic principles. Numerous examples of state of the art applications give an almost complete scenario of the LIBS technique potentiality. These examples of applications may have a strong impact on future industrial utilization. The authors made important contributions to the development of this field

Alternatives When an Authorized Medicinal Product is Not Available

The industrialization of medicinal products has permitted us to reach important results in terms of quality, efficacy, safety, and availability of drugs; however, not all the legitimate expectations of patients are met. When an authorized medicinal product is not available on the market, the physician can prescribe other pharmacological treatments in the following scenario: off-label prescriptions, extemporaneous preparations, compassionate use of medicinal products, and medicinal products authorized in foreign countries. The best solution among these alternatives should be evaluated case-by-case on the basis of good scientific evidence, expert medical judgement, and published literature, also keeping an eye on the availability, the cost, and the regulatory requirements at a national level

Patient-managed digital medical devices: Do we need further regulation?

In the heterogenous category of digital healthcare technologies, software with a medical purpose - i.e. therapy, diagnosis, prevention of a disease or monitoring of adherence to treatment - is expected have a strong impact. Indeed, it conforms to models of development and market access which are typical of information technology and unusual for healthcare. Avoiding any regulatory uncertainty is crucial for companies and competent authorities. In the European Union (EU), software with a medical purpose qualifies as a medical device, for which a strong regulatory framework is already in place. However, for patient-managed digital medical devices (pDMDs), i.e. software with a medical purpose intended to be used directly by patients, some open issues are still on the ground. These issues arise both at the EU level, related to risk-based classification and clinical evaluation, and the national level, related to prescription and reimbursement policies. The aim of this article is to analyse the classification and regulation of pDMDs in the EU, exploring the need of additional definitions, legislation or guidance

Data on spray-drying processing to optimize the yield of materials sensitive to heat and moisture content

Full dataset used to evaluate the spray-drying process parameters on the preparation of a micronized powder made of maltodextrin (MDX) is herein reported. The process parameters (namely, feed flow rate (FFR); inlet temperature (Tin); nozzle pressure (PN); noozle diameter (DN) and difference of pressure between cyclone and chamber (ΔP)) were screened through a Central Composite Design (25−1; 2∗5; nC=2) using the following responses: product yield, powder size and size dispersity (span) and the outlet temperature of the exhausted air (Tout). Data indicate that, in the considered range, only the product yield and the powder median diameter were influenced by the process. The product yield progressively increased on increasing inlet temperature and decreasing the amount or the size of droplets to be dried. The powder median diameter was positively influenced only by the nozzle diameter. This data presented in this article completes a wider work related on “Maltodextrins as drying auxiliary agent for the preparation of easily resuspendable nanoparticles” (Magri et al., 2019). Keywords: Spray-drying, Maltodextrins, Process optimizatio

Feeding Next‐Generation Nanomedicines to Europe: Regulatory and Quality Challenges

New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.Nanomedicines are revolutionizing the prognosis of many human diseases but their peculiar physicochemical properties are raising new challenges in regulatory approval. Current open issues regarding regulatory qualification and physicochemical characterization of nanosystems are critically discussed, considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued.imag

Caffeic Acid-PLGA Conjugate to Design Protein Drug Delivery Systems Stable to Irradiation

This work reports the feasibility of caffeic acid grafted PLGA (g-CA-PLGA) to design biodegradable sterile microspheres for the delivery of proteins. Ovalbumin (OVA) was selected as model compound because of its sensitiveness of γ-radiation. The adopted grafting procedure allowed us to obtain a material with good free radical scavenging properties, without a significant modification of Mw and Tg of the starting PLGA (Mw PLGA = 26.3 ± 1.3 kDa vs. Mw g-CA-PLGA = 22.8 ± 0.7 kDa; Tg PLGA = 47.7 ± 0.8 °C vs. Tg g-CA-PLGA = 47.4 ± 0.2 °C). By using a W1/O/W2 technique, g-CA-PLGA improved the encapsulation efficiency (EE), suggesting that the presence of caffeic residues improved the compatibility between components (EEPLGA = 35.0% ± 0.7% vs. EEg-CA-PLGA = 95.6% ± 2.7%). Microspheres particle size distribution ranged from 15 to 50 µm. The zeta-potential values of placebo and loaded microspheres were −25 mV and −15 mV, respectively. The irradiation of g-CA-PLGA at the dose of 25 kGy caused a less than 1% variation of Mw and the degradation patterns of the non-irradiated and irradiated microspheres were superimposable. The OVA content in g-CA-PLGA microspheres decreased to a lower extent with respect to PLGA microspheres. These results suggest that g-CA-PLGA is a promising biodegradable material to microencapsulate biological drugs

Do laws impact opioids consumption? A breakpoint analysis based on italian sales data

Purpose: In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors – such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies – on opioids sales to community pharmacies in Italy, focusing on the time period 2000–2010. Materials and methods: Five opioids were considered: codeine, tramadol, buprenorphine, morphine, and fentanyl. The analysis is based on sales data collected at wholesale distributors. For each one of the five drugs, time series of the number of Defined Daily Doses per thousand inhabitants per day in the period 2000–2010 were analyzed, and an estimation of breakpoints was performed using segmented linear regression. Results: Drug sales underwent a sharp increase in 2000–2010, although on different scales. Segmented regression analysis highlighted different potential breakpoints, corresponding to either a significant change in value and/or in slope. Sales of the five opioids were affected by at least one relevant event, often due to a synergy of regulatory, marketing, and technological factors. The effect of reimbursement changes has proved important. Conclusion: Between 2000 and 2010, regulatory, technological, and reimbursement changes significantly influenced opioid sales to community pharmacies in Italy. The sales of relatively new drug products seem to be less influenced by changes in reimbursement and regulatory policies than that of more established products, suggesting that physicians are more comfortable with “old” drugs, since their clinical use is supported by established clinical guidelines and protocols

Do laws impact opioids consumption? A breakpoint analysis based on Italian sales data

In Italy, where the adoption of opioid analgesics in pain management has been historically poor, an increase in opioids consumption occurred between 2000 and 2015. The aim of this study is to assess, through specific time series analyses for trend changes, the impact of different intervening factors \u2013 such as the availability of new drugs, the observance of clinical guidelines, changes in prescription regulations, and in reimbursement policies \u2013 on opioids sales to community pharmacies in Italy, focusing on the time period 2000\u20132010