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The dataset contains data about amoxicillin quantification in milk and blood collected from lactating sows and in piglets’ blood, obtained in the framework of the Horizon 2020 IMI funded project ConcePTION. The main goal of ConcePTION is to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network. Within such framework, task 3.3 of WP3 aims at developing and characterising a relevant in vivo model for drug passage from maternal blood to human breast milk. Based on a preliminary scan of existing literature, the chosen species to perform such non-clinical trial was the porcine one due to high anatomical and physiological similarities. In the initial trial, amoxicillin was chosen as the first molecule for a variety of reasons including alignment with other Work Packages (WPs) performing studies on human breastmilk. Additionally, since amoxicillin is commonly used in pigs, the choice of the route of administration, the administration interval and the doses were supported by reliable background data.

The dataset contains data about metformin, levocetirizine and venlafaxine (and its main metabolite O-desmethyl venlafaxine) quantification in milk and blood collected from lactating sows and in piglets’ blood, obtained in the framework of the Horizon 2020 IMI funded project ConcePTION (grant agreement 821520). The main goal of ConcePTION is to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. This will be achieved by generating, cataloguing, linking, collecting and analysing data from pharmacovigilance, modelling, routine healthcare, breastmilk samples through a large network. Task 3.3 of WP3 aims at developing and characterising a relevant in vivo model for drug passage from maternal blood to human breast milk. Based on a preliminary scan of existing literature, the chosen species to perform such non-clinical trial was the porcine one due to high anatomical and physiological similarities. After performing a pilot study using amoxicillin, 3 additional in vivo trials were scheduled using metofmin, levocetirizine and velnfaxine. The chosen medicines were in agreement with other tasks and work packages within the project.

The present review aims to summarize the main features of mammary gland anatomy, and the physiology of lactation and colostrum/milk in the most commonly used animal species for regulatory toxicity. The final goal is the selection of a preferred animal species to be enrolled in studies investigating the potential transfer of drugs and exogenous molecules through milk, within the Innovative Medicines Initiative (IMI) funded project ConcePTION. Reference data regarding humans were also collected and analyzed in order to highlight critical similarities and differences with the studied species. Additional practical considerations were also taken into account, such as ethical consideration regarding the chosen species which affects the group size, financial implications and technical feasibility of lactation trials (e.g., ease of sampling, volume of sampling, hus-bandry requirements and scientific recognition). In conclusion, the present analysis of the literature confirms the complexity of the decisional process behind the choice of an animal model for in vivo trials. For some of the evaluated species, data were either poor or missing, highlighting the necessity to generate more physiological background studies for species that are routinely used in laboratory settings. Overall, when taking into consideration ethical factors, feasible group size, milk volume and ease of milk collection, and physiological similarities with humans, minipigs seem to represent the most appropriate choice.

The actual scenario regarding antibiotic resistance is extremely worrying and the scientific community invest time and efforts in the search for solutions. Essential oils (EOs) are products of the secondary metabolism of aromatic plants and are complex mixtures of several compounds. EOs show a wide variety of biological activities, that may suggest interesting applications in the reproduction field, as cryo-preservatives or substitutes for antibiotics, but studies regarding their effects on spermatozoa are lacking. The present research aimed at evaluating the opportunity to use essential oils in refrigerated swine seminal doses as a potential alternative to antibiotics. The preliminary step was about the study of swine seminal parameters in farm setting using advanced statistical methods, to better predict in vivo fertility on the basis of semen morpho-functional evaluations. In the first step some specific EOs were selected and the cytotoxic effects on swine spermatozoa were evaluated to identify non-spermicidal concentrations. The lower concentrations of Rosmarinus officinalis and Melaleuca alternifolia EOs not impacted the semen morpho-functinal parameters. The last step was the evaluation of antibacterial effects of the previously tested concentrations on the liquid phase of swine refrigerated seminal doses. In order to obtain standardized results, an in vitro model with the addition of E. coli was set up. Analyses, performed at 24 and 120 hours, included optical density evaluation, bacterial DNA quantification by qPCR, and colony count. The results demonstrated that both EOs, at a concentration of 0.4 mg/ml, are capable of delivering similar effects to ampicillin. At the lower concentration, M. alternifolia EO seemed more effective when compared to R. officinalis. In conclusion, this project showed the potential of some EOs in the field of swine artificial insemination, but also highlighted how it is necessary, before claiming natural compounds as future “mirac

Roberta Salaroli,1 Domenico Ventrella,1 Chiara Bernardini,1 Alberto Elmi,1 Augusta Zannoni,1,2 Maria Laura Bacci,1,2 Monica Forni,1,2 Fiorella Calanni,3 Antonella Ferrieri,4 Fabio Baldi5 1Department of Veterinary Medical Science, University of Bologna, Ozzano Emilia, Bologna, Italy; 2Health Sciences and Technologies Interdepartmental Center for Industrial Research, University of Bologna, Bologna, Italy; 3Pre-Clinical Research Department, Alfasigma, Bologna, Italy; 4Division of Clinical Research, Department of Research and Development, Alfasigma, Bologna, Italy; 5Center for the Study of Diseases of the Esophagus, University of Bologna and Gruppo Villa Maria Care & Research, Ravenna, ItalyCorrespondence: Monica ForniDepartment of Veterinary Medical Science, University of Bologna, Via Tolara, 50, Ozzano Emilia 40064, Bologna, ItalyTel +39 051 20 9 7913Email monica.forni@unibo.itPurpose: AL2106 is a new medical device based on a mixture of chondroitin sulphate in a xyloglucan and glycerol solution made to maximize its bioadhesive capability to the esophageal mucosa. The aim of the present study was twofold to evaluate the AL2106 protective effect on the esophageal mucosa when exposed to an acidic solution mimicking gastric reflux and to assess the resilience of this effect to saline washing.Materials and Methods: A porcine ex vivo model was used and the effects of the new medical device were compared to a sodium alginate suspension (SAS) already present on the market which was assumed as reference. Mucosal damage was induced in 19 porcine esophagi by perfusion with an acidic solution added with pepsin, and Evans blue dye (EBD) tissue uptake was used as an indicator of mucosal permeability. The EBD penetration, expressed as EBD μg/g of dry tissue, was assessed in specimens of untreated damaged mucosa and in specimens treated with AL2106 or SAS. The same evaluation was carried out after washing with normal saline.Results: Both topical agents tested signific