130,586 research outputs found
Produzione di preparati a base di piante medicinali o salutari: normativa europea e proposte di regolamentazione
No full textThe European resilience to medicines’ shortages through the pandemic
No full textThe shortage of medicines has increased worldwide, reducing the ability of national healthcare systems to find solutions to ensure patients' access to pharmacological therapies. Shortages can be traced to supply-related causes (e.g., manufacturing issues, regulatory issues, distribution) and demand-related ones (e.g., parallel trade, price and reimbursement policies, tendering). Moreover, extraordinary natural or geopolitical events (e.g., COVID-19 outbreak, Brexit, 2021 Suez Canal obstruction) can stress the resilience of the pharmaceutical manufacturing and distribution chains worldwide [ ]. Even if globalized players control the research and manufacturing of raw materials and medicinal products, the activities of regulatory authorities are still based on national or supranational (i.e., European Union) frameworks. Moreover, the heterogenicity of the National healthcare systems and the fragmentation of the National regulatory frameworks can be itself a cause of medicine unavailability and/or can limit the development of proper problem-solving strategies. It is the case of market distortions caused by the different reimbursement and price policies among European member states.
In 2019, the EMA and the HMA released two guidelines on shortages definition, notification and communication to promote information sharing and cooperation among European pharmaceutical stakeholders, regulators and professionals [1]. Moreover, National and Industrial Single Points of Contact (SPOC) have been created to facilitate sharing of the information and the coordination of emergency plans among the EMA, the Competent National Authorities (CNAs), and pharmaceutical industries.
However, harmonized and practical shortage risk-assessment metrics are still needed to promote stronger cooperation among European Countries. Although several measures have been proposed by regulators and professional associations, most of them are designed to face specific shortages’ root causes and cannot be applied widely. In this context, the application of harmonized algorithms able to determine the shortage/unavailability impact on public health can be useful to identify the most critical medicinal products and to improve the cooperation at National and European levels, permitting CNAs, healthcare professionals (e.g., pharmacists) and other stakeholders to adopt the most appropriate problem-solving strategies [1].
[1] U.M. Musazzi, D. Di Giorgio, P. Minghetti. New regulatory strategies to manage medicines shortages in Europe.
Int. J. Pharm., 579, 2020, 119171, https://doi.org/10.1016/j.ijpharm.2020.119171
Extended-release calcifediol in stage 3-4 chronic kidney disease : a new therapy for the treatment of secondary hyperparathyroidism associated with hypovitaminosis D
No full textA high percentage of patients with chronic kidney disease have hypovitaminosis D, which is a driver of secondary hyperparathyroidism and an important factor in chronic kidney disease-mineral and bone disorder. Vitamin D deficiency (serum total 25-OH vitamin D levels < 30 ng/mL) occurs early in the course of chronic kidney disease and treatment guidelines recommend early intervention to restore 25-OH vitamin D levels as a first step to prevent/delay the onset/progression of secondary hyperparathyroidism. The vitamin D forms administered to replace 25-OH vitamin D include cholecalciferol, ergocalciferol, and immediate- or extended-release formulations of calcifediol. Most patients with intermediate-stage chronic kidney disease will develop secondary hyperparathyroidism before dialysis is required. Control of parathyroid hormone levels becomes a major focus of therapy in these patients. This article focuses on the position of extended-release calcifediol in the treatment of patients with stage 3-4 chronic kidney disease and secondary hyperparathyroidism with hypovitaminosis D. Several characteristics of extended-release calcifediol support its use in the intermediate stages of chronic kidney disease. The pharmacokinetics of extended-release calcifediol make it effective for replenishing 25-OH vitamin D levels, with minimal impact on vitamin D catabolism from fibroblast-growth factor-23 and CYP24A1 upregulation. Extended-release calcifediol increases circulating 25-OH vitamin D levels in a dose-dependent manner and lowers parathyroid hormone levels by a clinically relevant extent, comparable to what can be achieved by administering active vitamin D analogues, though with a lower risk of hypercalcaemia and hyperphosphataemia. Active vitamin D analogues are reserved for patients undergoing dialysis or pre-dialysis patients with severe progressive secondary hyperparathyroidism
Compounding of (Trans)Dermal Patches by Hot-Melt Ram Extrusion 3D Printing
No full text(Trans)dermal patches (TP) are well-known pharmaceutical preparations designed to provide prolonged drug delivery through the skin to achieve a local, regional or systemic effect. TPs are often preferred to other topically-applied dosage forms since they make it possible to predetermine the drug absorption kinetic and to define the treated area. Thus, TPs can reduce the side effects on healthy skin and due to an undesired systemic drug absorption when localized cutaneous diseases or injuries have to be treated. TPs are produced by a solvent casting technique, but they cannot be easily compounded since, after solvent evaporation, significant modifications of the adhesive matrix, and therefore, of the drug release and adhesive properties, can occur over an unknown period of time, ranging from some days to weeks. These alterations cannot be monitored in a pharmacy setting.
This work demonstrated the feasibility of the extemporaneous preparation of (trans)dermal patches by hot-melt ram extrusion 3D printing [1]. This technology makes it possible to easily define both the patch geometry and the dose according to patient needs. The TP preparation consists of three simple technological operations: (i) the drug, the film-forming material (Eudragit (Eu) RL, RS or blends thereof) and the plasticizer (triacetin, TRI, or try-butyl citrate, TBC), which confers the adhesive properties [2], are mixed in a mortar; (ii) the mixture is fed in to the chamber of the ramextruder and heated to 90 °C; (iii) the melt mixture is printed with the desired geometry (thickness: 50 μm) on the backing layer and coupled with the release liner. The adhesive properties of printed
patches were investigated by shear and 180°-peel adhesion tests. The results showed that patches with suitable adhesive properties can be printed using 40% w/w of TRI or 50% w/w of TBC. The TRI containing patches showed higher shear adhesion values than TBC ones (p < 0.05). Since high values of shear adhesion are essential for the patch permanence onto the skin, TRI (40% w/w) was selected to print drug-loaded patches, using 2.34% w/w of ketoprofen (KP) and 3% of nicotine (NT) as model compounds. Neither drug affected the patch adhesive properties, even if a reduction of shear adhesion up to 8-folds was observed based on the drug type and the EuRL/EuRS ratio. Finally, the in vitro release studies showed that the EuRL/EuRS ratio impacted significantly on the release rate of both the tested drugs. According to the well-known characteristics of the two copolymers, the higher the concentration of EuRL in the matrix, the higher the release rate of both KP and NT.
References: [1] Musazzi, U.M.; Selmin, F.; Ortenzi, M.A.; Mohammed, G.K.; Franzé, S.; Minghetti, P.; Cilurzo, F. Personalized orodispersible films by hot melt ram extrusion 3d printing. Int. J. Pharm. 2018, 551, 52–59. [2] Quaroni, G.M.G.; Gennari, C.G.M.; Cilurzo, F.; Guylaine, D.; Creton, C.; Minghetti, P. Tuning the rheological properties of an ammonium methacrylate copolymer for the design of adhesives suitable for transdermal patches. Eur. J. Pharm. Sci. 2018, 111, 238–246
MeSH term explosion and author rank improve expert recommendations
No full textInformation overload is an often-cited phenomenon that reduces the productivity, efficiency and efficacy of scientists. One challenge for scientists is to find appropriate collaborators in their research. The literature describes various solutions to the problem of expertise location, but most current approaches do not appear to be very suitable for expert recommendations in biomedical research. In this study, we present the development and initial evaluation of a vector space model-based algorithm to calculate researcher similarity using four inputs: 1) MeSH terms of publications; 2) MeSH terms and author rank; 3) exploded MeSH terms; and 4) exploded MeSH terms and author rank. We developed and evaluated the algorithm using a data set of 17,525 authors and their 22,542 papers. On average, our algorithms correctly predicted 2.5 of the top 5/10 coauthors of individual scientists. Exploded MeSH and author rank outperformed all other algorithms in accuracy, followed closely by MeSH and author rank. Our results show that the accuracy of MeSH term-based matching can be enhanced with other metadata such as author rank
Regulatory framework of pharmaceutical compounding and actual developments of legislation in Europe
No full textPharmaceutical 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
DMM and ABC+D-AAI coding systems compared: a study on an Italian sample
No full textThe assessment of adult attachment is a complex process that could be influenced in its results by both the theoretical model and the method. The aim of this research is to compare two different
systems of AAI coding: the DMM (Crittenden, Landini, 2011) and the ABC+D model (Main, Goldwyn, Hesse 1982-2008).
Recent studies in high-risk and clinical samples (Crittenden, Claussen & Kozlowska, 2007; Crittenden & Spieker, 2009; Crittenden & Newman, 2010; Shah, Fonagy & Strathearn, 2010) have
suggested that the DMM may discriminate clinical population cases better than the ABC+D model. In particular, the ABC+D Disoriented/disorganised pattern (U/D), corresponds in the DMM to
different and specific organized high-risk patterns (A+, C+, A/C), which are complex, extreme patterns with indicators of rapid shifts in arousal, useful for clinical practice (Crittenden, 2015).
The aim of this study was to compare the DMM and the ABC+D model in the AAI coding process, and to explore their differences in discriminating low- and high-risk subjects. The results could be
a boon for the use of the AAI as a guide in the organization of a tailored and effective treatmen
Analisi delle decisioni della Commissione centrale per gli esercenti le professioni sanitarie relative ai farmacisti
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