871 research outputs found

    A novel method for pair-matching using three-dimensional digital models of bone:mesh-to-mesh value comparison

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    The commingling of human remains often hinders forensic/physical anthropologists during the identification process, as there are limited methods to accurately sort these remains. This study investigates a new method for pair-matching, a common individualization technique, which uses digital three-dimensional models of bone: mesh-to-mesh value comparison (MVC). The MVC method digitally compares the entire three-dimensional geometry of two bones at once to produce a single value to indicate their similarity. Two different versions of this method, one manual and the other automated, were created and then tested for how well they accurately pair-matched humeri. Each version was assessed using sensitivity and specificity. The manual mesh-to-mesh value comparison method was 100 % sensitive and 100 % specific. The automated mesh-to-mesh value comparison method was 95 % sensitive and 60 % specific. Our results indicate that the mesh-to-mesh value comparison method overall is a powerful new tool for accurately pair-matching commingled skeletal elements, although the automated version still needs improvement. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00414-016-1334-3) contains supplementary material, which is available to authorized users

    Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe

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    Pharmaceutical preparations are medicines that the pharmacist makes for the special needs of the patients that the pharmaceutical industry cannot comply for economic and logistic reasons. Pharmacy compounding is still an important component of pharmacy practice and a valuable therapeutical service that is an integrant part of the modern health care system, but its legislation is not harmonized among European and US countries.In 2011 the Committee of Ministers of the Council of Europe has adopted a Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. Aim of this resolution is to harmonize quality assurance and standards for pharmacy-made medicinal products among European countries and to pass the gap in quality assurance and standards between preparation in pharmacies and medicines prepared by the pharmaceutical industry. This article will analyze the actual rules and technical norms that regulate compounding activity and the expectations resultants from the new European and US laws

    Emulsion versus nanoemulsion : how much is the formulative shift critical for a cosmetic product?

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    The use of nanoemulsions in cosmetic products has been enlarged in the last decades because of several formulative advantages (e.g., the improved self-life stability, better texture properties). In addition, nanoemulsions seemed to improve the penetration of active ingredients through the human skin, comparing to conventional emulsion. In this contest, the risk of a higher systemic exposure of consumer to active ingredients, due to the ability of nanoemulsion to enhance permeation, results a critical attribute that should be evaluated for assuring the consumer safety. The aim of this work was the evaluation of how an oil-in-water (O/W) nanoemulsion can influence the in vitro skin permeation profiles of two model active ingredients with different polarity (i.e., caffeine and ethyl ximenynate). Preliminarily, since both selected molecules influenced the physical stability of nanoemulsion, formulative studies were carried out to identify the most stable formulation to perform in vitro permeation studies. The overall results demonstrated that nanoemulsions could significantly influence the permeation profiles of molecules as a function of their physicochemical properties. In particular, O/W nanoemulsions significantly improved the permeation profiles of apolar active ingredients in comparison to conventional emulsions, whereas no differences were observable for polar molecules. Considering such findings, it is worth observing that there is room for reconsidering the risk assessment of nanoemulsion-based cosmetic products

    Design of pressure-sensitive adhesive suitable for the preparation of transdermal patches by hot-melt printing

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    This work aimed to design low-melting pressure sensitive adhesives and to demonstrate the feasibility of the preparation of (trans)dermal patches by hot-melt ram extrusion printing. This approach allows defining both the geometry of (trans)dermal patch and the drug strength easily according to patient needs. The preparation steps are the mixing of a poly-ammonium methacrylate polymer (i.e. Eudragit RL and RS) with a suitable amount of plasticizer (triacetin or tributyl citrate) and drug (ketoprofen or nicotine), the melting in the ram extruder, and the printing on the backing layer foil. The formulations were characterized in terms of rheological and adhesive properties, in vitro drug release and skin permeation profiles. The (trans)dermal patches made of Eudragit RL or Eudragit RS plasticized with the 40% triacetin could be printed at 90 \ub0C giving formulations with suitable adhesive properties and without cold flow after 1 month of storage at 40 \ub0C. Furthermore, the overall results showed that the performances of printed (trans)dermal patches overlapped those made by solvent casting, suggesting that the proposed solvent-free technology can be useful to treat cutaneous pathologies when the availability of (trans)dermal patches with size and shape that perfectly fit with the skin area affected by the disease improves the safety of the pharmacological treatment

    Mucoadhesive budesonide formulation for the treatment of eosinophilic esophagitis

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    Eosinophilic esophagitis (EE) is a chronic immune/antigen-mediated esophageal inflammatory disease for which off-label topical corticosteroids (e.g., budesonide) are widely used in clinic. In general, thickening excipients are mixed with industrial products to improve the residence time of the drug on the esophageal mucosa. The compounding procedures are empirical and the composition is not supported by real physicochemical and technological characterization. The current study aimed to propose a standardized budesonide oral formulation intended to improve the resistance time of the drug on the esophageal mucosa for EE treatment. Different placebo and drug-loaded (0.025% w/w) formulations were prepared by changing the percentage of xanthan gum alone or in ratio 1:1 with guar gum. Both excipients were added in the composition for their mucoadhesive properties. The formulative space was rationalized based on the drug physicochemical stability and the main critical quality attributes of the formulation, e.g., rheological properties, syringeability, mucoadhesiveness and in vitro penetration of budesonide in porcine esophageal tissue. The obtained results demonstrated that gums allowed a prolonged residence time. However, the concentration of the mucoadhesive polymer has to be rationalized appropriately to permit the syringeability of the formulation and, therefore, easy dosing by the patient/caregiver

    Peripheral reductive capacity is associated with cognitive performance and survival in Alzheimer's disease

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    BACKGROUND: Oxidative stress is believed to be an early event and a key factor in Alzheimer's disease (AD) pathogenesis and progression. In spite of an intensive search for surrogate markers to monitor changes related to oxidative stress in the brain, there is as yet no consensus about which markers to use in clinical studies. The measurement of peripheral anti-oxidants is an alternative way of evaluating the involvement of oxidative stress in the course of the disease. Given the complexity of peripheral anti-oxidant defence, variations in the levels of individual anti-oxidant species may not fully reflect the overall capacity to fight oxidant conditions. We therefore chose to evaluate the total reductive capacity (herein defined as anti-oxidant capacity, AOC) in serum from control subjects and AD patients in order to study the association between peripheral anti-oxidant defence, cognitive impairment and patient survival. METHODS: We measured the levels of AOC in serum samples from 26 cognitively normal controls and 25 AD patients (12 post-mortem confirmed) who completed the Cambridge Cognitive Assessment. Cognitive decline was assessed in a subgroup of 19 patients who underwent a second cognitive assessment 2 years after the initial visit. RESULTS: Serum AOC levels were lower in AD patients than in controls and were correlated with their cognitive test scores, although AOC levels were unrelated to cognitive decline assessed two years later. On the other hand, AOC levels were predictive of the length of patients' survival, with higher levels giving longer survival. CONCLUSION: This study indicates that peripheral anti-oxidant defences are depleted in AD patients. The results suggest that serum AOC is a good index of the general health status and prognosis of patients but does not necessarily reflect the extent to which vulnerable neuronal populations are protected from oxidant processes. Further studies are required to establish whether peripheral AOC measurements may be useful in identifying asymptomatic individuals or those with early symptoms at high risk of developing significant cognitive impairment or dementia

    Attachment forerunners, dyadic sensitivity and development of the child in families with a preterm born baby

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    Objective: The aim of this study is to explore attachment forerunners and dyadic sensitivity in the family with preterm born child. Methods: 89 families, 35 with preterm born children ( 2500 gr.) were studied from 3 months to 1 year corrected age (267 total subjects). Mother-child and father-child couples were subjected to CARE-Index and both parents to DAS, CES-D and STAI Y-2. The child\u2019s psychomotor development was assessed by Bayley Scales. Results: The mothers of preterm children presented high risk interactive behaviors at CARE-Index (low scores at Dyadic Sensitivity Scale, p = .000), high anxiety (p = .003) and depression (p = .03). Preterm fathers presented low scores at Dyadic Sensitivity Scale (p = .000) and high anxiety (p = .024). In interaction, attachment forerunners suggest an insecure attachment in preterm mothers (p = .001) and fathers (p = .000) and in preterm children in the interaction with the mother (p = .028). These risk factors were correlated, in both parents, with low performance of the child at Bayley Scales (p =.04). Fathers of preterm children presented also a negative perception of the child and an unsatisfied perception of the hospital care. Conclusions: The results show in the preterm family that 40% of mothers and 75% of fathers are in high risk area suggested by CARE-Index. In these cases, insecure attachment forerunners, low dyadic sensitivity and psychological difficulties (couple conflicts, anxiety, depression) seem to influence the psychomotor development of the preterm child

    L’influenza dell’attaccamento e della sensibilità diadica genitorialesullo sviluppo psicomotorio del bambino nato pretermine

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    Lo scopo di questa ricerca è studiare i precursori dell’attaccamento e la sensibilità diadica genitoriale nelle famiglie con bambino nato pretermine. Sono state considerate 110 famiglie delle quali 55 con figli nati pretermine ( peso alla nascita < 1500 gr.) per un totale di 330 soggetti valutati durante i primi sei mesi di età corretta del bambino. Le diadi madre-bambino e padre-bambino sono state sottoposte al CARE-Index, una procedura videoregistrata per la valutazione dei precursori dell’attaccamento; ad entrambi i genitori sono stati somministrati CES-D, per la valutazione della depressione e STAI Y-2, per la valutazione dell’ansia di tratto. Lo sviluppo psicomotorio dei neonati è stato valutato tramite le scale Bayley. Rispetto ai controlli, nelle madri dei bambini pretermine sono stati evidenziati bassi punteggi di Sensibilità Diadica al CARE-Index (p=.025) ed elevati livelli di ansia (p=.026). Nei padri sono stati riscontrati bassi punteggi di Sensibilità Diadica (p=.004) e alti livelli di sintomi depressivi (p=.003). Nelle famiglie pretermine i precursori dell’attaccamento sono più frequentemente di tipo insicuro nelle madri (p=.000) e nei padri (p=.000), mentre nei neonati solo nell’interazione con la madre (p=012). Questi fattori sono risultati associati a minori punteggi alle scale Bayley (p=.000). Nelle madri dei neonati pretermine si riscontrano frequenti difficoltà con la famiglia di origine, nei padri una percezione negativa del proprio bambino e una maggiore insoddisfazione per l’assistenza ricevuta. Questi risultati evidenziano che il 40% delle madri e il 75% dei padri dei bambini nati pretermine rientra nella fascia ad alto rischio del CARE-Index (che richiede un trattamento psicologico e/o farmacologico). In tali casi, la scarsa sensibilità diadica, i precursori di attaccamento insicuro e le difficoltà psicologiche dei genitori sembrano influenzare lo sviluppo psicomotorio del bambino
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