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Introduction: Posterior canal benign paroxysmal positional vertigo (PC-BPPV) is considered the most common cause of peripheral vertigo in the emergency department (ED). Although the canalith repositioning maneuver (CRM) is the standard of care, the most effective method to deliver it in the ED has been poorly studied. Objective: To compare two protocols of the Epley maneuver for the treatment of PC-BPPV. Patients and methods: We prospectively recruited 101 patients with unilateral PC-BPPV on physical examination, randomizing them to either a single Epley maneuver (EM) (n = 46) or multiple maneuvers (n = 55) on the same visit. Measured outcomes included presence/absence of positional nystagmus, resolution of vertigo, and score on the dizziness handicap inventory (DHI) at follow-up evaluations. The DHI was stratified into mild (≤30) and moderate-severe (>30). Results: Normalization of the Dix-Hallpike maneuver at day 5 was observed in 38% of the single EM group and 44.4% in the multiple EM group (p = 0.62). The DHI showed reduction from 42.2 (SD 18.4) to 31.9 (SD 23.7) in the single EM group and from 43.7 (SD 22.9) to 33.5 (SD 21.5) in the multiple EM group (p = 0.06). A higher number of patients improved from moderate-severe to mild DHI (p = 0.03) in the single EM group compared to the multi-EM group (p = 0.23). Conclusion: There was no statistically significant difference between performing a single EM versus multiple EMs for treatment of PC-BPPV in the emergency department. The single EM approach is associated with shorter physical contact between patients and examiner, which is logically safer in a pandemic context.

The data presented in this article are an update of the dataset provided by Musazzi et al. [1] and are related to the research article entitled “Equivalence assessment of creams with quali-quantitative differences in light of the EMA and FDA regulatory framework” [2]. In vitro permeation study (IVPT) is typically conducted using the method of Franz's diffusion cell for assessing the biopharmaceutical performance of topically applied products. While the human epidermis is considered the benchmark, various animal models (for instance, pig ear) have been accepted as a permeation membrane. Nonetheless, it is crucial to evaluate the integrity of the membrane to ensure the quality of the experiments. The methods employed for this assessment vary, and the outcomes are heavily reliant on the operational conditions, and the model membrane. The article contributes to the existing dataset by providing data on the electrical resistance values of pig ear skin samples and their correlation with the in vitro permeability fluxes of caffeine and benzoic acid. This data is utilized to determine a suitable cut-off for verifying the skin integrity of such an animal model. This information could be beneficial for facilitating critical or comprehensive analyses, contributing to the creation of a standard method.

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.

Urinary tract infections (UTIs) are very common disorders that affect adult women. Indeed, 50% of all women suffer from UTIs at least one time in their lifetime; 20–40% of them experience recurrent episodes. The majority of UTIs seems to be due to uropathogenic Escherichia coli that invades urothelial cells and forms quiescent bacterial reservoirs. Recurrences of UTIs are often treated with non-prescribed antibiotics by the patients, with increased issues connected to antibiotics resistance. D-mannose, a monosaccharide that is absorbed but not metabolized by the human body, has been proposed as an alternative approach for managing UTIs since it can inhibit the bacterial adhesion to the urothelium. This manuscript discusses the mechanisms through which D-mannose acts to highlight the regulatory aspects relevant for determining the administrative category of healthcare products placed on the market. The existing literature permits to conclude that the anti-adhesive effect of D-mannose cannot be considered as a pharmacological effect and, therefore, D-mannose-based products should be classified as medical devices composed of substances.

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.

We conducted research to assess hospital pharmacists’ familiarity with/interpretation of data requirements for the different regulatory approval frameworks and the impact of this on their approach to substitution in the formulary. The online questionnaire included a small molecule (acetylsalicylic acid—follow-ons approved via the generic pathway), two biologic drugs (insulin glargine and etanercept—follow-ons approved via the biosimilar pathway), a non-biologic complex drug (NBCD; glatiramer acetate—follow-ons approved via the hybrid pathway) and a nanomedicine, ferric carboxymaltose (no follow-ons approved as yet). The study was conducted in two phases: an initial qualitative pilot study with 30 participants, followed by a quantitative stage involving 201 pharmacists from five European countries. Most expected negligible safety/efficacy differences between reference and follow-on products. Head-to-head clinical data showing therapeutic equivalence as a prerequisite for reference product/follow-on substitution was perceived to be needed most for biologics (47%), followed by NBCDs (44%)/nanomedicines (39%) and small molecules (23%). Overall, 28% did not know the data requirements for follow-on approval via the hybrid pathway; 16% were familiar with this pathway, compared with 50% and 55% for the generic and biosimilar pathways, respectively. Overall, 19% of respondents thought the European Medicines Agency (EMA) was responsible for defining the substitutability of follow-ons. Education is required to increase hospital pharmacist’s knowledge of regulatory approval frameworks and their relevance to substitution practices.

Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (

Cannabidiol (CBD) is a non-psychoactive cannabinoid isolated from Cannabis sativa which, given its claimed beneficial properties and therapeutic potential, has lately aroused considerable attention from the scientific community. Starting from the little literature evidence, the main purpose of this study was to investigate the topical administration of CBD, with particular focus on the influence of vehicle-related aspects on the skin permeation process. This could provide useful information for the design of suitable drug delivery systems which could be used in developing topical medicines and cosmetics. In vitro human skin permeation studies were conducted using modified Franz diffusion cells to compare the performance of four solutions and two semisolid formulations. The Hildebrand solubility parameter was used to better understand the thermodynamic aspects implied in the partitioning process of the cannabinoid compound into the skin. It was interestingly found that a hydrophilic gel, mostly consisting of propylene glycol (79%, w/w), can be an optimal choice for the topical administration of CBD. Moreover, the feasibility of the preparation of CBD-loaded (trans)dermal patches, made with new printing technology, was also demonstrated.

Upper gastrointestinal (GI) symptoms are usual complaints among patients presenting to Italian community pharmacies. However, information on treatment history of those patients is often lacking. This descriptive, cross-sectional study aims at exploring the medication history of individuals with upper GI tract symptoms visiting one of the 20 enrolled community pharmacies, over a period of 7 months, based on the administration of a questionnaire. Of 1,020 interviewees, 62.1% had asked for a medical consultation. The most frequent symptom was epigastric burning (31.8%), followed by acid regurgitation (14.6%) and post-prandial fullness (12.0%). Of the 1,609 therapies, proton pump inhibitors constituted the most represented therapeutic class (35.6%) followed by antacids (17.5%) and alginate-based products (17.2%). In treating symptoms, 38.1% of the patients do not seek medical advice, while 42.0% rely on non-prescription therapies. As findings suggest, support to patients with GI disorders in community pharmacies can be enhanced for a safer self-medication.

Abstract Late‐onset migration of pacing leads in the left hemithorax is a rare but potentially life‐threatening complication. Radiological examinations are required to detect any involvement of either left ventricle or lung parenchyma, prompting immediate surgical extraction in this setting. Identification of high‐risk patients is mandatory to prevent this complex iatrogenic complication.

The data presented in this article are related to the research article entitled “Design of in vitro skin permeation studies according to the EMA Guideline on quality of transdermal patches” (https://doi.org/10.1016/j.ejps.2018.09.014) (Cilurzo et al., 2018) [1].In vitro permeation studies are generally carried out by Franz’s diffusion cell method using human epidermis as a membrane (Franz, 1975) [2]. The evaluation of membrane integrity is mandatory to assure the quality of the experiments. However, the methods used for this determination are different and the results are strictly dependent on the operative conditions. The article reports the electrical resistance values of human epidermis samples and in vitro skin permeability data of caffeine and benzoic acid. The data are used to establish a cut-off suitable for checking the skin integrity. This information may be useful to enable critical or extended analyses in order to contribute to the development of a compendial method.

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 optimization

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.

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.