IntroductionIntroduction: there is a wide variety of enteral nutrition and infant formulas preparations. When there is a need to find infomation on a product, only the infomation from industy is ...available. Comparison amomg products becomes then ardous. Objective: to describe the development of NEmecum as the first website that allows a directed and independent search for enteral nutrition products and infant formulas, currently available in Spain, and to evaluate the initial use of NEmecum. Methods: the structure of a database that unifies the parameters of all formulas was developed, and the nutritional composition of all formulas was analyzed. Subsequently, the main search algorithms were selected and the digital tool was codified. Intensive dissemination was performed and the impact was evaluated. The profile of users and registered centers and the use of the tool were analyzed, and its usability was evaluated using the System Usability Scale (SUS) questionnaire. Results: a free-access responsive website (http://nemecum.com) that allows searches based on pre-established search filters was obtained. This tool allows for a detailed analysis avalaible formulas in Spain by observing a wide variety of formulas with similar characteristics. The dissemination campaign managed to increase its use exponentially, currently reaching 1,370 users and 79 registered centers. Usability was rated as excellent. Conclusion: the development of the NEmecum represents a valuable tool in the search and consultation of the characteristics of enteral nutrition formulas and infant preparations.
Therapeutic drug monitoring improves the benefit-risk balance of antipsychotic therapy. Ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) is considered the ...gold-standard method for measuring plasma drug concentrations; however, the Alinity C system has emerged as a promising alternative. This is the first study aimed at comparing UHPLC-MS/MS versus Alinity C in measuring plasma concentrations of aripiprazole and dehydroaripiprazole. A total of 86 plasma samples were analyzed. The active moiety of aripiprazole was measured in 60 samples using both systems and 26 samples were analyzed twice using Alinity C with an intermediate period of 6 months to assess its reproducibility. Spearman's correlation revealed a good association between the two assays (rs = 0.96) and no significance differences were found by McNemar's test when classifying samples between infra-, supra- and therapeutic ranges. Passing-Bablock regression showed a good correlation among methods (rs = 0.93) and a slope of 1.12 indicating a slight tendency of Alinity C to measure higher values than UHPLC-MS/MS. In addition, a good intra-method correlation across the two sequential analyses with Alinity C was obtained (rs = 0.99). Nonetheless, clinical decisions could be different in 15% of the cases depending on the chosen method. No differences were found in active moiety determination by Alinity C depending on the concentration of aripiprazole and dehydroaripiprazole of the samples.
Over the last two decades, pharmacogenetics and pharmacokinetics have been increasingly used in clinical practice in Psychiatry due to the high variability regarding response and side effects of ...antipsychotic drugs. Specifically, long-acting injectable (LAI) antipsychotics have different pharmacokinetic profile than oral formulations due to their sustained release characteristics. In addition, most of these drugs are metabolized by CYP2D6, whose interindividual genetic variability results in different metabolizer status and, consequently, into different plasma concentrations of the drugs. In this context, there is consistent evidence which supports the use of therapeutic drug monitoring (TDM) along with pharmacogenetic tests to improve safety and efficacy of antipsychotic pharmacotherapy. This comprehensive review aims to compile all the available pharmacokinetic and pharmacogenetic data regarding the three major LAI atypical antipsychotics: risperidone, paliperidone and aripiprazole. On the one hand, CYP2D6 metabolizer status influences the pharmacokinetics of LAI aripiprazole, but this relation remains a matter of debate for LAI risperidone and LAI paliperidone. On the other hand, developed population pharmacokinetic (popPK) models showed the influence of body weight or administration site on the pharmacokinetics of these LAI antipsychotics. The combination of pharmacogenetics and pharmacokinetics (including popPK models) leads to a personalized antipsychotic therapy. In this sense, the optimization of these treatments improves the benefit–risk balance and, consequently, patients’ quality of life.
Outpatient parenteral antimicrobial therapy (OPAT) with continuous infusion pumps is postulated as a very promising solution to treat complicated infections, such as endocarditis or osteomyelitis, ...that require patients to stay in hospital during extended periods of time, thus reducing their quality of life and increasing the risk of complications. However, stability studies of drugs in elastomeric devices are scarce, which limits their use in OPAT. Therefore, we evaluated the stability of ampicillin in sodium chloride 0.9% at two different concentrations, 50 and 15 mg/mL, in an elastomeric infusion pump when stored in the refrigerator and subsequently in real-life conditions at two different temperatures, 25 and 32 °C, with and without the use of a cooling device. The 15 mg/mL ampicillin is stable for up to 72 h under refrigeration, allowing subsequent dosing at 25 °C for 24 h with and without a cooling device, but at 32 °C its concentration drops below 90% after 8 h. In contrast, 50 mg/mL ampicillin only remains stable for the first 24 h under refrigeration, and subsequent administration at room temperature is not possible, even with the use of a cooling system. Our data support that 15 mg/mL AMP is suitable for use in OPAT if the volume and rate of infusion are tailored to the dosage needs of antimicrobial treatments.
Resumen Introducción: existe una amplia variedad de fórmulas o preparados de nutrición enteral y fórmulas o preparados infantiles. La consulta de información relacionada debe hacerse en las ...herramientas propias de cada laboratorio, lo que dificulta la visión crítica y la comparativa entre las mismas. Objetivo: describir el desarrollo de NEmecum como la primera web que permite realizar una búsqueda dirigida e independiente de fórmulas de nutrición o preparados infantiles, analizar el abanico nutricional actual en España y evaluar los datos de uso de la herramienta. Métodos: se desarrolló la estructura de una base de datos que unifica los parámetros de todas las fórmulas y se analizó el abanico nutricional español. Posteriormente, se seleccionaron los principales algoritmos de búsqueda dirigida y se codificó la herramienta digital. Se llevó a cabo una intensa difusión y se evaluó el impacto obtenido. Se analizaron el perfil de usuarios y centros registrados y los datos de uso de la herramienta y se evaluó su usabilidad mediante el cuestionario System Usability Scale (SUS). Resultados: se obtuvo una web responsive de acceso gratuito (http://nemecum.com) que permite realizar búsquedas dirigidas en base a unos filtros de búsqueda preestablecidos. La herramienta permitió analizar detalladamente el abanico nutricional en España, observándose la gran variedad de fórmulas disponibles de similares características. La campaña de difusión consiguió incrementar su uso de forma exponencial y cuenta actualmente con 1.370 usuarios y 79 centros registrados. La usabilidad fue valorada como excelente. Conclusión: el desarrollo de NEmecum supone una herramienta valiosa en la búsqueda y consulta de datos de fórmulas o preparados de nutrición enteral y fórmulas o preparados infantiles.
Current Situation and Challenges in Vitreous Substitutes Mondelo‐García, Cristina; Bandín‐Vilar, Enrique; García‐Quintanilla, Laura ...
Macromolecular bioscience,
August 2021, 2021-08-00, 20210801, Letnik:
21, Številka:
8
Journal Article
Recenzirano
Odprti dostop
Vitreo‐retinal disorders constitute a significant portion of treatable ocular diseases. These pathologies often require vitreo‐retinal surgery and, as a consequence, the use of vitreous substitutes. ...Nowadays, the vitreous substitutes that are used in clinical practice are mainly divided into gases (air, SF6, C2F6, C3F8) and liquids (perfluorocarbon liquids, silicone oils, and heavy silicone oils). There are specific advantages and drawbacks to each of these, which determine their clinical indications. However, developing the ideal biomaterial for vitreous substitution continues to be one of the most important challenges in ophthalmology, and a multidisciplinary approach is required. In this sense, recent research has focused on the development of biocompatible, biodegradable, and injectable hydrogels (natural, synthetic, and smart), which also act as medium and long‐term internal tamponade agents. This comprehensive review aims to cover the main characteristics and indications for use of the extensive range of vitreous substitutes that are currently used in clinical practice, before going on to describe the hydrogels that have been developed recently and which have emerged as promising biomaterials for vitreous substitution.
Nowadays, there are many drawbacks associated with the different agents used in clinical practice for vitreous substitution. The development of the ideal biomaterial for vitreous substitution remains one of the most important challenges in ophthalmology. In this sense, recent research has focused on the development of biocompatible, biodegradable, and injectable biomaterials, which constitute a promising alternative for vitreous substitution.
•The high interindividual variability of once-monthly long-acting injectable aripiprazole makes it very difficult to predict its optimal dosing. In this context, population pharmacokinetic models ...constitute a valuable tool to characterize the pharmacokinetic properties of a drug and quantifying the sources of variability in drug exposure considering factors such as age, gender or genetics, among others. In addition, these models can also be used to optimize dosages in the clinical setting, since they contribute to guide decision-making and improve patient outcomes.•This is the first population pharmacokinetic model developed for LAI aripiprazole that includes aripiprazole and its main active metabolite, dehydroaripiprazole. It provides a personalized dosage recommendation that maximizes the probability of achieving optimal therapeutic concentrations and minimizes the difficulties associated with trial-and-error therapeutic strategies carried out in clinical practice.•Weight was the factor that most influenced aripiprazole absorption, which were inversely correlated. The CYP2D6 metabolizing phenotype and concomitant treatment with strong CYP2D6 inhibitors are the factors that most influence drug elimination and total drug exposure.
Population pharmacokinetic (popPK) models constitute a valuable tool for characterizing the pharmacokinetic properties of once-monthly long-acting injectable aripiprazole (LAI aripiprazole) and quantifying the sources of variability in drug exposure. Our aim is to develop a popPK model of both aripiprazole and its metabolite dehydro-aripiprazole in patients treated with LAI aripiprazole, and to personalize the dosing regimen of aripiprazole across different sub-groups of patients. This is a prospective study investigating the pharmacokinetics of LAI aripiprazole. A total of 93 patients were included, 21 for model development and 71 for external model evaluation. A one-compartment model with linear absorption and elimination adequately described both aripiprazole and dehydro-aripiprazole concentrations. The weight of the patients has been shown to be the factor that most influences the absorption. However, the metabolizing phenotype for CYP2D6 and the concomitant treatment with strong inhibitors of this cytochrome have been shown to be the covariates that most influence total drug exposure. This is the first popPK model developed for LAI aripiprazole that includes aripiprazole and its main active metabolite, dehydroaripiprazole. It provides a personalized dosage recommendation that maximizes the probability of achieving optimal therapeutic concentrations and minimizes the difficulties associated with trial-and-error therapeutic strategies carried out in clinical practice.
Inhaled administration of ethanol in the early stages of COVID-19 would favor its location on the initial replication sites, being able to reduce the progression of the disease and improving its ...prognosis. Before evaluating the efficacy and safety of this novel therapeutic strategy in humans, its characterization is required. The developed 65° ethanol formulation is stable at room temperature and protected from light for 15 days, maintaining its physicochemical and microbiological properties. Two oxygen flows have been tested for its administration (2 and 3 L/min) using an automated headspace gas chromatographic analysis technique (HS-GC-MS), with that of 2 L/min being the most appropriate one, ensuring the inhalation of an ethanol daily dose of 33.6 ± 3.6 mg/min and achieving more stable concentrations during the entire treatment (45 min). Under these conditions of administration, the formulation has proven to be safe, based on histological studies of the respiratory tracts and lungs of rats. On the other hand, these results are accompanied by the first preclinical molecular imaging study with radiolabeled ethanol administered by this route. The current ethanol formulation has received approval from the Spanish Agency of Medicines and Medical Devices for a phase II clinical trial for early-stage COVID-19 patients, which is currently in the recruitment phase (ALCOVID-19; EudraCT number: 2020-001760-29).
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