Preferred Route Research Articles

Impact of Spatial Orientation Ability on Air Traffic Conflict Detection in a Simulated Free Route Airspace Environment.

In the selection of job candidates who have the mental ability to become professional ATCOs, psychometric testing has been a ubiquitous activity in the ATM domain. To contribute to psychometric research in the ATM domain, we investigated the extent to which spatial orientation ability (SOA), as conceptualized in the spatial cognition and navigation literature, predicted air traffic conflict detection performance in a simulated free route airspace (FRA) environment. The implementation of free route airspace (FRA) over the past few years, notably in Europe, have facilitated air traffic services by giving greater flexibility to aviation operators in planning and choosing preferred air routes that can lead to quicker arrivals. FRA offers enhanced system safety and efficiency, but these benefits can be outweighed by the introduction of air traffic conflicts that are geometrically more complex. Such conflicts can arise from increased number and distribution of conflict points, as well as from elevated uncertainty in aircraft maneuvering (for instance, during heading changes). Overall, these issues will make conflict detection more challenging for air traffic controllers (ATCOs). Consequently, there is a need to select ATCOs with suitably high levels of spatial orientation ability (SOA) to ensure flight safety under FRA implementation. In this study, we tested 20 participants who are eligible for ATCO job application, and found that response time-based performance on a newly developed, open access, computerized spatial orientation test (SOT) predicted time to loss of minimum separation (tLMS) performance on an air traffic conflict detection task (AT-CDT) we designed. We found this predictive relationship to be significant to a moderately large extent under scenarios with high air traffic density (raw regression coefficient = 0.58). Moreover, we demonstrated our AT-CDT as a valid test in terms of eliciting well-known mental workload and spatial learning effects. We explained these findings in light of similar or overlapping mental processes that were most likely activated optimally under task conditions featuring approximately equal numbers of outcome-relevant stimuli. We conclude by discussing the further application of the SOT to the selection of prospective ATCOs who can demonstrate high levels of conflict detection performance in FRA during training simulations.

High pulse pressure predicts primary arteriovenous fistula failure within 1 year.

The arteriovenous fistula is the preferred access route for hemodialysis, although its high primary failure rate remains a clinical challenge. Multiple studies have attempted to determine the risk factors for primary arteriovenous fistula failure; however, none have identified pulse pressure as a potential predictive marker. High pulse pressure is a surrogate poor arterial compliance endpoint and leads to inferior cardiovascular outcomes. Our aim was to determine whether elevated pulse pressure indicates poor arteriovenous fistula maturation. We retrospectively reviewed 274 patients who underwent an arteriovenous fistula index operation between September 1, 2018 and May 31, 2019. Demographic, clinical data, and operative parameters were collected and analyzed. The maximum follow-up period was 365 days. Arteriovenous fistula failure was defined as the inability to achieve functional use during the follow-up period. We identified risk factors for arteriovenous fistula failure by performing a multivariate logistic regression analysis using backward elimination procedures. A total of 274 patients were included in the study. The patients' average age was 61.3 ± 14.0 years, approximately half of the patients (n = 161, 58.8%) were male, and the majority had hypertension. At the end of the follow-up period, 68 (24.8%) had arteriovenous fistula failure. The proportion of patients with pulse pressure values of >60 mmHg was significantly higher in the failure group than in the maturation group (66.0% vs 80.9%; p = 0.021). A PP value of >60 mmHg (odds ratio = 2.25; 95% confidence interval = 1.14-4.42; p = 0.019) and coronary artery disease or myocardial infarction (odds ratio = 1.97; 95% confidence interval = 1.01-3.84; p = 0.045) were found to be independent risk factors for primary arteriovenous fistula failure. High pulse pressure is an independent risk factor for primary arteriovenous fistula failure.

Telemedical Second Opinions in Germany: A Customer Survey of an Online Portal.

Introduction: Second medical opinions (SOs) can strengthen patients' certainty in decision making. In Germany, both personally delivered and telemedical SOs (often based on documents only) are provided. Our aim was to analyze the experiences of people who obtained telemedical SOs. We also investigated different routes of SO delivery (personally/by phone/documents only). Materials and Methods: German residents who obtained a telemedical SO via an online portal between January 2016 and February 2019 (n = 1,247) were contacted by post between August and November 2019 up to three times. The results were analyzed descriptively. Results: The 368 participants (response rate 30%) were 54% male, 95% statutory health insured, and 61 years old (median; interquartile range 51-72). Approximately 75% were (rather) satisfied with obtaining the SO via the online portal. The most preferred route of SO delivery was a personally delivered SO, which 80% would (rather) consider, followed by 70% (rather) considering SOs based on documents only and 48% (rather) considering SOs by phone. The most often mentioned advantage of telemedical SOs was independence of time and place, while the most important disadvantage was the standardized process resulting in a lack of direct and personal contact between the patient and the physician. Discussion: Although our results show that SOs (based on documents only) support patients and that patient satisfaction was high, personally delivered SOs were still preferred. Future research on the use of SOs based on documents only (in which patient population and in what situations) is needed.

The Nurse’s Role in Educating Pediatric Patients on Correct Inhaler Technique: An Interventional Study

The prevalence of pediatric respiratory diseases in Spain is 23%. Inhalation is the preferred route of administration but there are frequent errors in the performance of the inhalation technique leading a poor control of the disease. The aim of this research was to detect errors in the execution of the inhalation technique at a Pediatric Pulmonology Unit in a hospital of Aragón (Spain). In order to improve the administration of inhaled medication, an educational intervention for 1 year by nursing was conducted. This interventional study, including children aged 1 to 15 years with an inhalation therapy and who attended the Pediatric Pulmonology Unit, was conducted between September 2017 and September 2018. Logistic Regression models were conducted in SPSS. This study involved 393 children (61.1% boys). Before the intervention, 39.4% achieved a correct inhalation technique increasing up to 62.1% after the intervention. Those who had their first visit to the Unit, young children and girls had a higher risk of incorrect performance than those with subsequent visits, older children, and boys, respectively. The most common errors in the inhalation technique were not performing adequate apnoea after inhaling and not rinsing the mouth at the end of the procedure. The education given by nurses to pediatric patients improved the inhalation technique, achieving better control of the disease and use of the health system.

Two-Year Administration Data of an Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men

ABSTRACT Introduction An oral testosterone (T) replacement therapy (TRT) would be the preferred administration route for many hypogonadal men. Until recently, the only oral TRT approved in the US was methyl-T which has been associated with hepatotoxicity. Objective The safety of a novel oral T undecanoate (TU) formulation was evaluated in hypogonadal men with two-year follow up. Methods Two open-label, multicenter, dose-titration trials were conducted in hypogonadal men (serum T ≤ 300 ng/dL) age 18-75 years. Trial I was a randomized, active-controlled, 2-arm, 12-month study. Trial 2 was a long-term extension of those who completed Trial 1. Statistical analyses were only conducted with the subjects who completed Trial 1 and continued treatment in Trial 2, thus providing up to 2 full years of data. Safety was assessed by physical exam, AE reporting, and routine clinical laboratory measurements. Results Overall, 86 subjects participated in both studies. T concentration increased from 193.75 ± 9.44 ng/dL (Mean ± SEM) at baseline (BL) to 475.5 ± 49.7 ng/dL after 24 Mo of therapy with oral TU, and 84% of men achieved T in eugonadal range (300-1000 ng/dL) after 90 days of therapy. Mean T concentrations remained in the eugonadal range throughout Trial 2. There were no clinically significant changes in liver function tests – ALP (64.05 ± 1.95 to 53.74 U/L ± 1.86 U/L), ALT (27.8 ± 1.40 to 26.7 ± 1.6 U/L), AST (21.6 ± 0.76 to 22.0 ± 1.0 U/L), and bilirubin (0.58 ± 0.03 to 0.52 ± 0.03 mg/dL) throughout the two studies. At d270, one subject had an ALT level of 227 U/L, which was > 4x the ULN (ULN for ALT = 45 U/L). Despite continued use of oral TU, ALT was measured again on d290, and the level dropped to 87 U/L, < 2x ULN. This was the only instance of an LFT elevation. There was a modest initial increase in prostate-related growth endpoints (i.e. PSA and prostate volume) that stabilized over time. Although there was a slight increase in prostate-growth related endpoints, there were no significant changes in IPSS total score (-0.06 ± 3.9 vs BL). There were significant, yet modest, increases in mean HCT (44.3 ± 0.3 to 46.6 ± 0.5%, p < 0.001) and cuff systolic BP (127.1 ± 1.2 to 131.8 ± 1.67 mmHg vs BL, p = 0.006). The change in CV endpoints, including HDL-C, hematocrit, and BP, changed initially and stabilized throughout the 2 trials. For example, systolic BP varied 3 – 6 mm Hg from BL throughout the study. Conclusions This oral TU formulation is an option for hypogonadal men and has a safety profile consistent with other approved T products, such as a rise in hematocrit and a decrease in HDL-C. Notably, no evidence of liver toxicity was observed over 2 years. The long-term efficacy and safety profile of oral TU may provide a treatment option that avoids issues associated with other TRTs, such as injection site pain or transference to partners and children. Disclosure Yes, this is sponsored by industry/sponsor: Clarus Therapeutics Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Clarus Therapeutics

Is nasojejunal feeding as effective as we think? An evaluation of nasojejunal feeding in the Intensive Care Unit

Early enteral feeding is important in maintaining the integrity of the gastrointestinal tract mucosal barrier and associated with less bacterial translocation and decreased stimulation of the systemic inflammatory response and subsequent improved outcomes in intensive care (ICU) patients. Enteral feeding by nasogastric (NG) tubes is the preferred route of nutritional support for most ICU patients. However, ICU patients with delayed gastric emptying and poor intestinal motility may not tolerate gastric feeding and may therefore benefit from post-pyloric feeding via nasojejunal (NJ) tubes1.

Nutrition-related problems, nutritional support practices and barriers to adherence to nutritional guidelines during intensive treatment for acute myeloid leukemia: Patients' and hematology nurses' perspectives and experiences.

The updated guidelines of the European Society for Clinical Nutrition and Metabolism (ESPEN) and for Blood and Marrow Transplantation (EBMT) on nutrition in intensively treated acute myeloid leukemia (AML) patients recommend enteral nutrition (EN) instead of parenteral nutrition (PN) as the first-choice medical nutrition therapy. Despite this, PN remains the preferred route of nutrition administration in daily practice. The aim of this qualitative study was to gain insight into the patients' and hematology nurses' experiences and perceptions regarding nutritional problems and nutritional support and the reasons for the low adherence to the ESPEN/EBMT guidelines. Semi-structured interviews were conducted in 23 patients from various Dutch hospitals who had completed intensive AML treatment. Interviews with 22 patients were audio-recorded and transcribed, one interview was summarized. The transcripts and summary were thematically analyzed using Atlas.ti. From each of the 22 Dutch hospitals providing intensive AML treatment, one hematology nurse participated in a telephone questionnaire survey. The results of this survey are presented in a descriptive way. Nutritional problems were a major source of distress in most participating patients. Nutritional support often led to peace of mind and less concerns, provided that there were no conflicting nutritional support practices among treating hospitals. Patients perceived PN and EN as a life-line and necessary for the prevention of or recovery from physical decline, but they also experienced loss of independence, limited mobility, fear of unwanted body weight gain and problems related to the feeding equipment. Both patients and hematology nurses regarded PN as an easy method of nutrition administration, while EN was often seen as a necessary evil or was even refused by patients, owing to tube-related physical discomfort and EN intolerance. Both patients' and hematology nurses' reluctance to administer EN proved to be barriers to the ESPEN/EBMT nutritional guideline adherence. Among the surveyed hematology nurses, barriers to adherence included personal factors related to their knowledge (lack of awareness) and attitudes (negative outcome expectancy and lack of agreement), guideline-related factors (lack of evidence) and external factors (lack of collaboration). Individualized nutritional support, including EN and PN, may reduce nutrition-related distress in intensively treated AML patients, provided that conflicting nutritional support practices among hospitals are avoided or explained. The barriers to adherence to the ESPEN/EBMT guidelines on EN and PN in this patient group may be reduced by enhancing hematology nurses' awareness and knowledge of the guidelines, incorporating the guidelines into multidisciplinary clinical pathways, improving outcome of EN by proper triage of patients eligible for EN and increasing the level of evidence of the guidelines.

Pigeon leadership hierarchies are not dependent on environmental contexts or individual phenotypes

Remaining cohesive on the move can be beneficial for animal groups. As such, animal groups have evolved coordination mechanisms such as leadership to resolve navigational conflicts of interest. Consistent “leaders” may have an intrinsic advantage over “followers” which compromise on their preferred route to retain cohesion, which highlights the question of the inter-individual variation (phenotype) that can predict leadership. Studies in both birds and fish have revealed that intrinsically faster individuals can lead movements, and leading movements propagate from the front edge of the flock/shoal. However, these experiments are generally conducted in relatively “familiar” environments, where the degree of compromise between the “leaders” and “followers” is low. We suggested that inter-individual differences in route efficiency, while not explanatory of leadership from familiar locations, may emerge as predictors of leadership from unfamiliar locations. We tested this prediction – and the potential impact of multiple other behavioral, morphological and “in-flight” phenotypes on leadership – using two groups of homing pigeons (Columba livia) (N = 16), a classic model species of leadership. We recorded N = 966 unique GPS trajectories from birds in (i) solo and familiar, and (ii) solo and unfamiliar contexts to measure solo speed and solo route efficiency; and (iii) group and familiar, and (iv) group and unfamiliar contexts to assess group leadership. Pigeon leadership hierarchies were similar across environmental context (i.e., familiarity). However, we found that no covariates could consistently predict leadership score in either context.

Electrochemical conversion of carbon dioxide to ethylene: Plant design, evaluation and prospects for the future

In support of the energy and feedstock transition, new concepts of producing chemical building blocks are necessary. While currently ethylene is mainly produced from fossil feedstocks, this paper explores its production via the electrochemical conversion of CO2. Different process routes were reviewed and a most promising route was selected based on Faradaic efficiency, current density, overpotential, and material availability. In this preferred route, syngas is produced electrochemically from CO2, which is then converted into methanol before the final conversion into ethylene and other high-value chemicals. On this preferred route, a design has been made which includes process design, unit design and a techno-economic evaluation, with CAPEX and OPEX included. Also the CO2 emission is evaluated and it was found that a net consumption of 2.5 ton CO2 per ton high-value chemical can be achieved. As expected, the investment and operational costs are very high with the applied price sets. However, when the electricity price decreases due to developments in renewable energy and a tax is implemented on CO2 emissions, this process can become economically viable and can contribute to CO2 emission reduction in view of climate change.

Biosynthesis and bioactivities of metal nanoparticles mediated by Helichrysum aureonitens

Biosynthesis of nanoparticles is the preferred route for the fabrication of biocompatible and cheaper drugs. In this study, the extract and major secondary metabolite from Helichrysum aureonitens, 3,5-dihydroxy-6,7,8-trimethoxyflavone, were used to synthesize silver and zinc oxide nanoparticles. Spectroscopic and microscopic techniques confirmed the formation of the nanoparticles. The flavone alone showed higher DPPH radical scavenging ability (IC50 = 487.1 μg mL−1) relative to the control, butylated hydroxytoluene. In addition, silver nanoparticles synthesized using the flavone had higher ferric reducing potential (Fe3+ to Fe2+) compared to the other test samples. The cytotoxic activity of the plant extract, the flavone, and their biosynthesized nanoparticles was also investigated using the MTT assay against the cancerous MCF-7 (breast adenocarcinoma) and A549 (human lung adenocarcinoma)), and non-cancerous HEK293 (human embryonic kidney) cell lines. The plant extract decreased the cell viability of A549 (IC50 = 68.6 μg mL−1) without being cytotoxic against HEK293, even at high concentrations. Silver nanoparticles significantly decreased cell viability of A549 and moderately decreased cell viability of MCF-7 but induced cell death of HEK293 even at low concentrations. This study provides a green synthesis route for silver and zinc oxide nanoparticles and confirms the therapeutic effectiveness of H. aureonitens, thereby validating its use in ethnomedicine.

Review of Fast-dissolving Tablets - A New Era in Brand-new Drug Delivery Systems

Fast disintegrating tablets (FDTs) have received ever-increasing demand during the last decade, and the field has become a rapidly growing area in the pharmaceutical industry. Oral drug delivery remains the preferred route for administration of various drugs. Recent developments in the technology have prompted scientists to develop FDTs with improved patient compliance and convenience. Upon introduction into the mouth, these tablets dissolve or disintegrate in the mouth in the absence of additional water for easy administration of active pharmaceutical ingredients. The popularity and usefulness of the formulation resulted in development of several FDT technologies. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. FDTs, or orally disintegrating tablets, are highly helpful for children and old people who have trouble swallowing standard pills and capsules .This review focuses on lyophilization, moulding, sublimation, and compaction FDT methods, as well as efforts to enhancing FDT qualities, such as spray drying and the usage of disintegrants. Taste-masking technology, experimental disintegration time measurements, and dissolution are also addressed.

Personalized laparoscopic resection of colon cancer with the use of indocyanine green lymph node mapping: Technical and clinical outcomes.

To describe the experience of utilization of real time indocyanide green (ICG) fluorescent imaging for mapping out drainage lymph node and hence personalized lymphadenectomy in colorectal resection. Perioperative injection of ICG before or during colon cancer resection by either intraluminal submucosal injection or laparoscopic peritumoural injection. The drainage lymph nodes were mapped out, and hence lymphadenectomy was performed enbloc with the main tumor. The effectiveness of mapping of drainage lymphatics and the procedure performed were recorded. A total of 21 patients (M:F=14: 7) had perioperative ICG injection to map out the drainage lymphatics. The overall success rate was 86%. Seven patients (33%) had endoscopic submucosal injection, while 14 patients (67%) had intraoperative peritumoural injection. Three patients who had endoscopic submucosal injection had ICG extravasation, and hence failed lymph node mapping. Four patients (19%) had a change in extent of resection according to the lymph node mapping results. Personalized oncological colorectal resection and lymphadenectomy can be performed with the aid of ICG technology. Laparoscopic subserosal ICG injection may be the preferred route, as it minimize extravasation and aids to identify drainage lymph nodes without prolonging minimally invasive surgery. Further studies are required to determine the best route, strength, and timing of ICG injection and concordance with pathology to tailor the extent of resection for individual patients.

Thoracic endovascular aortic repair with a right thoracotomy approach

BackgroundThe common femoral artery is usually the preferred access route for thoracic endovascular aortic repair (TEVAR). However, if access from the common femoral artery is challenging, other routes must be considered. We report a case of TEVAR performed by approaching the descending thoracic aorta with a right thoracotomy and using the descending thoracic aorta as an access route.Case presentationA 70-year-old female was diagnosed with a descending thoracic aortic aneurysm (65 mm in diameter), a thoracoabdominal aneurysm (54 mm in diameter), and an abdominal aortic aneurysm (49 mm in diameter). Since the patient had severe chronic obstructive pulmonary disease, one-stage replacement of the thoracoabdominal aortic aneurysm was contraindicated and TEVAR on the descending aorta was selected. A strong tortuous section of the aorta—from the descending aorta to the abdominal aorta—hampered endovascular access to the site from the common femoral artery. A TEVAR approach from the abdominal aorta was also considered; however, an abdominal aortic aneurysm and a transverse colon loop stoma from an earlier surgery presented challenges to this technique. We chose to access the descending thoracic aorta with a thoracotomy from the right 6th intercostal space for TEVAR, because the access route that is not affected by the meandering of the aorta is considered to be the descending aorta with a right thoracotomy. The patient’s postoperative course was uneventful after the stent graft was placed. No complications were detected with postoperative contrast-enhanced computed tomography (CT).ConclusionsOur findings suggest that TEVAR can be performed by approaching the descending aorta from a right thoracotomy, if variations of vascular anatomy interfere with the more commonly used femoral artery approach.

Management of Hyperglycemia in Hospitalized Patients Receiving Parenteral Nutrition.

Almost half of inpatients on parenteral nutrition experience hyperglycemia, which increases the risk of complications and mortality. The blood glucose target for hospitalized patients on parenteral nutrition is 7.8 to 10.0 mmol/L (140 to 180 mg/dL). For patients with diabetes, the same parenteral nutrition formulae as for patients without diabetes can be used, as long as blood glucose levels can be adequately controlled using insulin. Insulin can be delivered via the subcutaneous or intravenous route or, alternatively, added to parenteral nutrition admixtures. Combining parenteral with enteral and oral nutrition can improve glycemic control in patients with sufficient endogenous insulin stores. Intravenous insulin infusion is the preferred route of insulin delivery in critical care as doses can be rapidly adjusted to altered requirements. For stable patients, insulin can be added directly to the parenteral nutrition bag. If parenteral nutrition is infused continuously over 24 hours, the subcutaneous injection of a long-acting insulin combined with correctional bolus insulin may be adequate. The aim of this review is to give an overview of the management of parenteral nutrition-associated hyperglycemia in inpatients with diabetes.

Modalities and preferred routes of geographic spread of cholera from endemic areas in eastern Democratic Republic of the Congo.

Cholera is endemic along the Great Lakes Region, in eastern Democratic Republic of the Congo (DRC). From these endemic areas, also under perpetual conflicts, outbreaks spread to other areas. However, the main routes of propagation remain unclear. This research aimed to explore the modalities and likely main routes of geographic spread of cholera from endemic areas in eastern DRC. We used historical reconstruction of major outbreak expansions of cholera since its introduction in eastern DRC, maps of distribution and spatiotemporal cluster detection analyses of cholera data from passive surveillance (2000-2017) to describe the spread dynamics of cholera from eastern DRC. Four modalities of geographic spread and their likely main routes from the source areas of epidemics to other areas were identified: in endemic eastern provinces, and in non-endemic provinces of eastern, central and western DRC. Using non-parametric statistics, we found that the higher the number of conflict events reported in eastern DRC, the greater the geographic spread of cholera across the country. The present study revealed that the dynamics of the spread of cholera follow a fairly well-defined spatial logic and can therefore be predicted.

Readiness of the Kenyan public health sector to provide pre-referral care for severe paediatric malaria.

ObjectiveTo assess readiness among primary public health facilities in Kenya to provide pre‐referral antimalarials for severe malaria.MethodsNine national surveys of randomly selected primary public health facilities undertaken bi‐annually between 2017 and 2021 were analysed. The outcomes included the availability of pre‐referral antimalarial drugs at the health facilities and health worker knowledge of recommended pre‐referral treatment for severe malaria.ResultsA total of 1540 health workers from 1355 health facilities were interviewed. Injectable artesunate was available at 46%, injectable quinine at 7%, and artemether at 3% of the health facilities. None of the facilities had rectal artesunate suppositories in stock. A total of 960 (62%) health workers were trained on the use of injectable artesunate. 73% of the health workers who had ever referred a child with severe malaria were aware that artesunate was the recommended treatment, 49% said that intramuscular injection was the preferred route of administration, and 60% stated the correct dose. The overall knowledge level of the treatment policy was low at 21% and only slightly higher among trained than untrained health workers (24% vs 14%; p < 0.001) and those with access to guidelines versus those without access (29% vs 17%; p < 0.001).ConclusionsThe readiness of primary health facilities and health workers to deliver appropriate pre‐referral care to children with complicated malaria in Kenya is inadequate. Further investments are required to ensure (a) availability of nationally recommended pre‐referral antimalarials; (b) appropriate training and supervision in their administration, and (c) monitoring of the entire referral process.

Synthesis and bioactivity of readily hydrolysable novel cationic lipids for potential lung delivery application of mRNAs

Lipid nanoparticles (LNPs) mediated mRNA delivery has gained prominence due to the success of mRNA vaccines against Covid-19, without which it would not have been possible. However, there is little clinical validation of this technology for other mRNA-based therapeutic approaches. Systemic administration of LNPs predominantly targets the liver, but delivery to other organs remains a challenge. Local approaches remain a viable option for some disease indications, such as Cystic Fibrosis, where aerosolized delivery to airway epithelium is the preferred route of administration. With this in mind, novel cationic lipids (L1-L4) have been designed, synthesized and co-formulated with a proprietary ionizable lipid. These LNPs were further nebulized, along with baseline control DOTAP-based LNP (DOTAP+), and tested in vitro for mRNA integrity and encapsulation efficiency, as well as transfection efficiency and cytotoxicity in cell cultures. Improved biodegradability and potentially superior elimination profiles of L1-L4, in part due to physicochemical characteristics of putative metabolites, are thought to be advantageous for prospective therapeutic lung delivery applications using these lipids.

Tratamiento antibiótico

Knowing antibiotics’ mechanism of action is of interest because with it, we can deduce important characteristics of each group of antibiotics and apply this knowledge to clinical practice. In this manner, we can better know the antibiotic spectrum, the preferred route of administration, the need to adjust according to kidney or liver function, or know if the antibiotic reaches sufficient levels at the site of infection. Antibiotics can have a bacteriostatic or bactericidal effect. The difference in activity tends to be related to the antimicrobial's mechanism of action, but also with the concentration of the antibiotic reached at the place of action. Bacterial cultures by means of an antibiogram allow us to determine the bacterial sensitivity of different antibiotics and predict the in vivo clinical outcome. Sensitivity or resistance is established through determination of the minimal inhibitory concentration (IMC). The relationship of some pharmacokinetic and pharmacodynamic parameters such as the maximum concentration, the area under the curve, and the IMC are decisive for decision-making regarding an antibiotic indication and dosage and thus for optimizing use and avoiding selecting for resistance.

FAST DISINTEGRATING TABLETS - A NEW ERA IN NOVEL DRUG DELIVERY SYSTEM

Among all dosage forms, fast-Disintegrating tablets are one of the most commonly used dosage forms, especially in children, because their nervous system and muscular system are not well developed compared to them in adults. and in adult patients with Parkinsons disease or hand tremors. Some fixed dosage forms, such as capsules and tablets, now have difficulty swallowing (dysphagia), which results in many cases of non-compliance and renders therapy ineffective. The most preferred routes of administration for various drugs are oral dosage forms and the oral route with specific limitations such as first-pass metabolism by the liver, psychiatric patients, at-risk patients, and non-cooperators. FDTs dissolve easily in saliva without the need for water. Fast- Disintegrating tablets dissolve in saliva in a minimum of less than 60 seconds., And these are really fast-digesting tablets. FDT formulations contain super disintegrants to increase the rate of tablet degradation in the buccal cavity. FDTs have advantages because they are easy to manufacture, have the right dosage, good chemical and physical strength, and are an ideal alternative for children and adult patients. FDTs have a faster rate of degradation, faster absorption, so that in vitro drug release time increases and this property of the drug (dosage form) increases bioavailability. FDT formulations have specific advantages in both conventional tablet and liquid dosage forms. There are many technologies for spray drying, cotton candy process, sublimation, melt granulation, direct freeze pressing / lyophilization, phase transition process, mass extrusion, etc. This overview provides brief information on FDT, including the definition, benefits, needs or requirements of FDT, key characteristics FDT, limitations, various challenges in the development of FDT, marketed tablet formulations that cause rapid digestion and so on.

P376 Switching from intravenous to subcutaneous vedolizumab maintenance treatment; feasibility, safety and clinical outcome

Abstract Background Vedolizumab (VDZ) has until recently been available only as intravenous (i.v.) formulation, but the drug is now available also as subcutaneous (s.c.) formulation. In the present study, we aimed to assess the feasibility, safety and clinical outcome when switching a real world cohort of patients with inflammatory bowel disease (IBD) from i.v. to s.c. VDZ treatment. Methods All IBD-patients receiving i.v. VDZ at the department were identified using the medical records. Patients in the induction period or with planned change of medical treatment or surgery within, 3 months were not routinely switched. The dosage of s.c. VDZ was calculated based on current i.v. dose and interval. Patients were assessed at first and fourth injection and after, 3 months. The primary endpoint was percentage of patients still on s.c. treatment after, 3 months. Secondary endpoints were adverse events, clinical disease activity scores (Harvey Bradshaw index and Partial Mayo Score), C-reactive protein (CRP), fecal calprotectin (FC), VDZ treatment interval, plasma-VDZ, and patients’ preferred route of administration. Results In total, 108 patients were switched, 51 with ulcerative colitis (UC) and, 57 with Crohn’s disease (CD). After, 3 months, 95.3% (103/108) remained on s.c. treatment. Four patients had switched back to i.v. and one changed treatment to ustekinumab. Nineteen patients (17.6%) experienced injection site reactions (ISR), and twelve of these (63.2%) had repeated reactions. In three cases, patients were switched back to i.v. treatment due to ISR. No serious adverse events related to the switch were observed. The median interval between injections was, 12 (IQR:, 7–18) days. The median p-VDZ at three months was, 44.4 (IQR:, 28.9–64.7) mg/L. In the UC and CD patients, 92% (47/51) and, 72% (41/57) were in clinical remission at first injection, whereas the corresponding numbers after three months were, 88% (p=0.18) and, 83% (p=0.11), respectively. No significant change in CRP and FC was observed. Before switching, 25% of the patients reported that they would prefer i.v. treatment, 28% s.c. treatment and, 47% were indifferent. Three months after switching, the corresponding numbers were, 18%, 53% and, 29%, respectively (p&amp;lt;0.001). Conclusion Switching from i.v. to s.c. VDZ was feasible and safe. Approximately one out of six experienced an ISR but only, 3% were switched back to i.v. administration. At, 3 months follow-up there was no change in clinical remission rates, CRP and FC. Furthermore, patients’ attitude towards route of administration changed after switching. The present real world data demonstrate that s.c. maintenance VDZ treatment represents an attractive alternative to i.v. treatment.