Intravenous Infusion Solutions Research Articles

Effects of Rhodiola rosea injection on intrapulmonary shunt and blood IL-6 and TNF-α levels during single lung ventilation in patients undergoing radical resection of esophageal cancer

To explore the effects of Rhodiola rosea injection on pulmonary shunt and serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels during single lung ventilation in patients undergoing radical resection of esophageal cancer. Forty-six patients undergoing radical operation for esophageal cancer were randomized equally into control group and Rhodiola rosea injection group. In the Rhodiola group, 10 mL of Rhodiola rosea injection was added into 250 mL of normal saline or 5% glucose solution for slow intravenous infusion, and normal saline of the same volume was used in the control group after the patients entered the operation room. At T0, T1 and T3, PaO2 of the patient was recorded and 2 mL of deep venous blood was collected for determination of serum TNF-α and IL-6 levels. The incidence of postoperative atelectasis of the patients was recorded. Compared with those in the control group, the patients receiving Rhodiola rosea injection had significantly higher PaO2 and Qs/Qt at T1 and T2 (P<0.05) and lower serum IL-6 and TNF-α levels at T3 (P<0.05). No significant difference in the incidence of postoperative atelectasis was observed between the two groups (P>0.05). Rhodiola rosea injection before anesthesia induction can reduce intrapulmonary shunt during single lung ventilation, improve oxygenation, reduce serum IL-6 and TNF-α levels, and alleviate intraoperative lung injury in patients undergoing radical resection of esophageal cancer.

Stability of nafamostat in intravenous infusion solutions, human whole blood and extracted plasma: implications for clinical effectiveness studies.

Aim: To describe the stability of nafamostat in infusion solutions, during blood sample collectionand in extracted plasma samples in the autosampler. Methods: Nafamostat infusion solutions were stored at room temperature in the light for 24h. For sample collection stability, fresh blood spiked with nafamostat was subjected to combinations of anticoagulants, added esterase inhibitor and temperature. Nafamostat was monitored in the extracted plasma samples in the autosampler. Results: Nafamostat was stable in infusion solutions. Nafamostat in whole blood was stable for 3h before centrifugation when collected in sodium fluoride/potassium oxalate tubes (4°C). Nafamostat in extracted plasma samples degraded at 4.7±0.7% per h. Conclusion: Viable samples can be obtained using blood collection tubes with sodium fluoride, chilling and processing promptly.

Silver triangular nanoplates – A multifunctional probe for development of a label-free colorimetric glucose biosensors. Application to glucose in foods and medical samples

We propose here a simple label-free enzymatic-based colorimetric glucose biosensor using silver triangular nanoplates (AgTNPs) as a multifunctional probe that acts as a signal capturer and an optical transducer. The developed colorimetric glucose biosensor can be applied to glucose monitoring in food or pharmaceutical samples. The detection principle of developed enzymatic-based colorimetric glucose biosensor is based on the reaction of glucose oxidase (GOx) with glucose in a sample to obtain gluconic acid and hydrogen peroxide (H2O2). The generated H2O2 will then be recognised by a standing AgTNP solution with a colour change from blue to purple or colourless. This approach allows for glucose detection in a linear concentration range from 0 to 1 mM at low concentrations and from 1 mM to 2 mM at high concentrations of glucose. The limit of detection (LoD) of the developed biosensor is 0.01 mM with high selectivity. The developed glucose sensor was used to determine glucose in drinking samples and in dextrose–5 wt.% glucose intravenous infusion solution as a pharmaceutical representative sample.

Application of information-intelligence technologies in pharmacy intravenous admixture services in a Chinese third-class a hospital

BackgroundPharmacy intravenous admixture service (PIVAS) center has emerged as an important department of hospital as it can improve occupational protection and ensure the safety and effectiveness of intravenous infusions. However, medication errors were considered to be a significant challenge in PIVAS, so information-intelligence technologies were introduced to optimize the management of PIVAS. Our article summarized the application of information-intelligence technologies in PIVAS of a large third-class A hospital in China, and provided an example for PIVAS in other hospitals at home and abroad.MethodsPrescription-reviewing rules containing intravenous medications and infusion solution guideline were recorded in the database of prescription-cheking system. Drugs information were recorded in the PIVAS management system with special identification and warning labels to reduce intravenous infusion errors. Automatic labeling device was used to label the infusion bags, and the quality control program database of intelligent compounding robot for cytotoxic drugs was established ingeniously. Automatic sorting devices were applied for the third batch of finished infusion admixtures, and intelligent logistics robots were used to transport the infusion to the ward.ResultsAfter establishing and implementing of prescription-reviewing rules in the prescription-cheking system database, the number of prescriptions checked by pharmacists increased from 18 to 43 per minute. The success rate of intervention with irrational medical orders increased from 85.89% to 99.06% (P < 0.05). By introducing various intelligent devices, automatic labeling significantly enhanced work efficiency and reduced the error rate (P < 0.001). Furthermore, the use of intelligent intravenous compounding robots significantly reduced the risk of errors (P < 0.001).ConclusionsThe application of information-intelligence technologies in PIVAS can improve work efficiency and reduce error risk. However, some intelligent devices have failed to achieve the expected effect in practical use, and further improvements are needed to meet the demands of PIVAS in the future.

Use of a Hydrophobic Azo Dye for the Centrifuge-Less Cloud Point Extraction-Spectrophotometric Determination of Cobalt.

The hydrophobic azo dye 6-hexyl-4-(2-thiazolylazo)resorcinol (HTAR, H2L) was studied as part of a system for the centrifuge-less cloud point extraction (CL-CPE) and spectrophotometric determination of traces of cobalt. The extracted 1:2 (Co:HTAR) complex, [CoIII(HL−)(L2−)]0, shows an absorption maximum at 553 nm and contains HTAR in two different acid–base forms. Optimum conditions for its formation and CL-CPE were found as follows: 1 × 10−5 mol L−1 of HTAR, 1.64% of Triton X-114, pH of 7.8, incubation time of 20 min at ca. 50 °C, and cooling time of 30 min at ca. −20 °C. The linear range, limit of detection, and apparent molar absorptivity coefficient were 5.4–189 ng mL−1, 1.64 ng mL−1, and 2.63 × 105 L mol−1 cm−1, respectively. The developed procedure does not use any organic solvents and can be described as simple, cheap, sensitive, convenient, and environmentally friendly. It was successfully applied to the analysis of artificial mixtures and real samples, such as steel, dental alloy, rainwater, ampoules of vitamin B12, and saline solution for intravenous infusion.

In situ green analytical methods for the rapid and sensitive determination of a newly launched orphan anticancer drug; Tigecycline in infusion bags: comparative study

BackgroundTigecycline (TIG), an antimicrobial agent indicated for complex bacterial infections, is now approved by FDA as an orphan chemotherapeutic agent for the treatment of acute myeloid leukemia due to its inhibitory effects on pathways of activating, signaling and abnormal mitochondrial function in cancer cells. TIG is mainly administered as intravenous infusion through centralized unit of oncology centers. This necessitates the continuous analytical quality control of the prepared solution in order to identify and quantify TIG for safe intravenous administration to patients. Moreover, the clinical staff exposure risk to toxic drugs during daily handling must be considered. Such concerns require a fast, cost-effective and green analytical procedure for sensitive determination of TIG directly in infusion bags. In this work, we propose a simple, rapid and green capillary zone electrophoretic (CZE) method for the sensitive assay of TIG directly in infusion bags, in addition to three simple and green spectrophotometric methods.ResultsTIG solutions corresponding to clinical ranges were detected in 5%glucose. Validation of all the proposed methods was according to ICH guidelines. Greenness assessment was performed depending on Green Analytical Procedure Index (GAPI) and the Eco-scale approach which showed that the proposed methods are better eco-friendly methods than reported ones. It also revealed the superiority of our proposed methods in terms of simplicity and sensitivity for TIG determination in infusion bags. Quantification limits obtained were significantly lower than the administered range of TIG in infusion bags and lower than its maximum serum concentration (Cmax). This promotes the application of the proposed methods for the pharmacokinetics and bioavailability studies of TIG in various biological fluids.ConclusionsThis work reports, for the first time, CZE method for the direct and rapid determination of TIG and its separation from other components in intravenous infusion solution. The developed CZE method has several advantages over current chromatographic methods such as higher efficiency of separation within short analysis time, consumption of fewer quantities of chemicals and offering better resolution than HPLC. Moreover, three green spectrophotometric methods are also proposed for TIG determination that offer many advantages such as accuracy, precision, simplicity, specificity and facility of quantification and separation of the selected drug in infusion bags and pharmaceutical preparations without any techniques for extraction.

Overview of the compendial methods for quantitative determination of glucose in solutions for intravenous infusion

This paper provides a review of the pharmacopoeial methods for determination of the content of glucose in parenteral solutions (HPLC/RID method, polarimetry and volumetric titration) and evaluation of all critical aspects of the proposed methods, with a focus on accuracy, precision, time of analysis and resources for introducing, maintenance and conducting analysis. Comparative analysis of the results from assay (ten independent determinations) of Glucose 5% w/v solution for intravenous infusion, obtained using all three methods, was performed. The analysis confirmed that there is no statistical difference between the testing results obtained with each method, indicating that all three methods provide valid accurate and precise results. However, the availability of the equipment and trained personnel may be the crucial factor for small laboratories for selection of the method for assay of glucose in parenteral preparations. The obtained results and discussion on all critical aspects (accuracy, precision, time of analysis and resources for introducing, maintenance and conducting analysis) of the proposed methods, provide a valuable input to small laboratories on the suitability of these methods for quality control of Glucose 5% w/v solution for intravenous infusion. Keywords: Glucose, HPLC/RID, Polarimetry, Volumetry

Evaluating posaconazole, its pharmacology, efficacy and safety for the prophylaxis and treatment of fungal infections

ABSTRACT Introduction Invasive fungal diseases (IFDs) are a significant cause of morbidity and mortality among immunocompromised patients. Safe and effective antifungal medications used for prophylaxis and treatment are pivotal in their management. Posaconazole is a promising triazole antifungal agent. Areas covered The authors discuss the pharmacological properties of posaconazole, including pharmacokinetics/pharmacodynamics, safety and tolerability profile, together with efficacy data for prophylaxis and treatment as well as its use in special populations based on current literature. Expert opinion Posaconazole has a favorable safety and tolerability profile; however, caution is advised when co-administered with agents that are CYP3A4 inhibitors, because their concentration may significantly increase, and their levels should be closely monitored. It has an extended spectrum of activity against yeasts and filamentous fungi. It is successfully used as prophylaxis for patients with acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) and post-hematopoietic cell transplantation (HCT) with graft-versus-host disease (GVHD). It is the first line treatment for oropharyngeal candidiasis and is also used as a salvage treatment for refractory IFDs. Currently available formulations include the oral suspension, delayed-release tablets and solution for intravenous infusion, all with different PK/PD properties and indications. Its use in children and adolescents is currently being examined in Phase-II clinical trials.

Porushennia sertsevo-sudynnoi diialnosti ta endotelialnoi funktsii u vahitnykh iz nedyferentsiiovanoiu spoluchnotkanynnoiu dysplaziieiu; yikh korektsiia zavdiaky vkliuchenniu do protokolnoi prohramy likuvannia karnitynarhininovoho kompleksu

Context. Undifferentiated connective tissue dysplasia (UCTD) has negative impact on myocardial contractility and endothelial microvascular dysfunction and their frequent combination with cardiac arrhythmias suggests an unfavorable course of pregnancy and childbirth due to the formation of uteroplacental dysfunction. Objective. To reduce the incidence of obstetric complications associated with cardiovascular disorders in women with UCTD by including carnitine-arginine complex in the treatment program. Materials and methods. 58 pregnant women with diagnosed signs of UCTD, including mitral valve prolaps (MVP) with and without frequent extrasystoles, and 14 pregnant women of control group were examined. Metabolic support with of 4.2 g of L-arginine and 2.0 g of L-carnitine in the form of a solution for intravenous infusion once a day for 5 days were used for prenatal care of pregnant women with UCTD and prevention of obstetric complications in the experimental group. Results. There are violations of morpho-functional parameters of the heart with the development of moderate systolic-diastolic myocardial dysfunction and endothelial microvascular dysfunction in the initial state of pregnant women with MVP and extrasystolic arrhythmia against the background of UCTD. They were significantly more often diagnosed with miscarriage, late preeclampsia, placental dysfunction, birth defects, birth trauma, postpartum hemorrhage, etc. Echostructural abnormalities of the heart acted as predictors of arrhythmias, the presence of which was associated with more pronounced disorders of intracardiac hemodynamics. The results of a comprehensive study of the clinical and functional status of pregnant women with phenotypic signs of UCTD, MVP and extrasystolic arrhythmia suggest that in most cases they occur with moderate heart remodeling and significant endothelial dysfunction of the microvascular circulation, that was accompanied by significant deterioration of the obstetric situation. The use of standard medication by pregnant women did not significantly restore the incidence of arrhythmias, inotropic capacity of the myocardium and endothelial function of microvessels. Supraventricular and ventricular arrhythmias remained resistant to standard treatment, which justified the use of additional antiarrhythmic drugs. At the same time, there was a significant reduction in the incidence of arrhythmias in the group of patients with MVP and frequent ventricular or mixed extrasystoles – by 90.6 and 77.8 % respectively under the influence of complex drug treatment with the inclusion of L-arginine and L-carnitine. In the group of pregnant women with supraventricular arrhythmias, the antiarrhythmic effect was observed in only 37.5 % of patients, which justified the additional use of nebivolol hydrochloride at a dose of 2.5 mg/day. At the same time, such a comprehensive treatment in pregnant women with MVP and arrhythmia on the background of UCTD contributed to the restoration of the studied indicators of endothelial function of microvessels. Conclusions. In pregnant women with MVP and extrasystolic arrhythmia against the background of UCTD in the initial state there are violations of morpho-functional parameters of the heart with the development of moderate systolic-diastolic myocardial dysfunction and endothelial microvascular dysfunction, which are triggers of complicated pregnancy and childbirth. The inclusion of L-arginine and L-carnitine led to a significant improvement in the parameters of central cardiohemodynamics and restoration of endothelial function of microvessels and accompanied by a significant reduction of the incidence of extrasystolic arrhythmia and pregnancy complications.

A centrifuge-less cloud point extraction-spectrophotometric determination of copper(II) using 6-hexyl-4-(2-thiazolylazo)resorcinol

A simple, cheap, and environmentally friendly centrifuge-less cloud point extraction procedure was developed for the preconcentration of traces of Cu(II) before its spectrophotometric determination. It is based on a complexation reaction with the hydrophobic azo reagent 6-hexyl-4-(2-thiazolylazo)resorcinol (HTAR), in which a complex with a stoichiometric ratio of 1:1 and an absorption maximum at 535 nm is formed. The experimental conditions for Cu(II) determination were found: HTAR concentration (8 × 10−6 mol mL−1), mass fraction of the surfactant Triton X-114 (2.2%), pH (5.9, ammonium acetate buffer), and incubation time (10 min at 60 °C). The linear range, limit of detection, molar absorption coefficient and preconcentration factor were calculated to be 4.5–254 ng mL−1, 1.34 ng mL−1, 2.54 × 105 L mol−1 cm−1, and 10, respectively. The effect of foreign ions was studied, and the proposed procedure was applied to the analysis of water samples and a saline solution for intravenous infusion.

Acetate Ringer\u2019s solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial

BackgroundPrevious study drew different conclusions on significant differences between saline and balanced crystalloid solution infused in critical illness but both showed a statistical difference in the sepsis subgroup. Thus, we will specifically focus on septic patients in this study to compare the effects of saline and balanced solution. We hypothesize that effects of saline on renal outcomes are related to the underline acute kidney injury (AKI) severity and total volumes of infusion.Methods/designThe investigators designed a pragmatic, multi-center parallel controlled trial recruiting 312 patients who are diagnosed with sepsis/septic shock in the intensive care unit (ICU) and will be assigned with either acetate Ringer’s solution or saline in the corresponding month. Patients with an end-stage renal disease (ESRD) or who need renal replacement therapy (RRT) prior to or at the time of enrolment are excluded. Enrolled patients will be regarded as with mild, moderate, or severe sepsis on the basis of the severity of their illness and will be divided into subgroups according to their initial renal function and various intravenous infusion volumes when being analyzed. The primary outcome is major adverse kidney events within 28 days (MAKE28), including the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction. Secondary outcomes include 28-day mortality, internal environment disturbance, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, duration of RRT, and ICU and hospital length of stay.Results and conclusionsTo our knowledge, this study will be the first to focus on septic patients and provide credible and evident data on the comparison of outcome between acetate Ringer’s solution and saline for intravenous infusion in adult septic patients on the basis of baseline renal function and infusion volumes taken into consideration.Trial registrationClinicalTrials.gov NCT03685214. Registered on August 15, 2018

Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy

The use of Raman spectroscopy for analytical quality control of anticancer drug preparations in clinical pharmaceutical dispensing units is increasing in popularity, notably supported by commercially available, purpose designed instruments. Although not legislatively compulsory, analytical methods are frequently used post-preparation to verify the accuracy of a preparation in terms of identity and quantity of the drug in solution. However, while the rapid, cost effective and label free analysis achieved with Raman spectroscopy is appealing, it is important to understand the molecular origin of the spectral contributions collected from the solution of actives and excipients, to evaluate the strength and limitation for the technique, which can be used to identify and quantify either the prescribed commercial formulation, and/or the active drug itself, in personalised solutions. In the current study, four commercial formulations, Erbitux®, Truxima®, Ontruzant® and Avastin® of monoclonal antibodies (mAbs), corresponding respectively to cetuximab, rituximab, trastuzumab and bevacizumab have been used to highlight the key role of excipients in discrimination and quantification of the formulations. It is demonstrated that protein based anticancer drugs such as mAbs have a relatively weak Raman response, while excipients such as glycine, trehalose or histidine contribute significantly to the spectra. Multivariate analysis (partial least square regression and partial least square discriminant analysis) further demonstrates that the signatures of the mAbs themselves are not prominent in mathematical models and that those of the excipients are solely responsible for the differentiation of formulation and accurate determination of concentrations. While Raman spectroscopy can successfully validate the conformity of mAbs intravenous infusion solutions, the basis for the analysis should be considered, and special caution should be given to excipient compositions in commercial formulations to ensure reliability and reproducibility of the analysis.

Use of locally prepared peritoneal dialysis (PD) fluid for acute PD in children and infants in Africa.

In less well-resourced countries, the high cost of commercially available peritoneal dialysis (PD) fluid limits its use. The major concerns regarding bedside-prepared PD fluid is peritonitis as well as electrolyte disorders. The aim of this study was to review our experience with the use of PD fluids prepared at the bedside using the intravenous infusion solution Balsol (Fresenius Kabi). This was a retrospective review of all patients who received PD for acute kidney injury (AKI) using a bedside-prepared PD solution adapted from the intravenous solution Balsol in our intensive care unit. In total, 49 cases of acute PD were performed. Of the 49 children, 21 (43%) were male. The ages of the patients ranged from newborn to 10.2 years (median 0.33 years). The weight of children ranged from 1.3 kg to 50 kg (median 4.1 kg). The type of PD catheters used: Cook catheters, 41 patients; Kimal peel-away, 10 patients; and surgical inserted Tenckhoff type of catheter, 2 patients. The duration of PD was 1-17 days (median 3 days) Complications included peritonitis in 2 of 49 patients and blocked catheter in 6 of 49 patients. There were no electrolyte disturbances as a result of the PD. Overall survival was 43% of patients. Locally prepared PD solutions at the bedside adapted from intravenous solutions can be used safely and effectively. This has important relevance for centres in less well-resourced countries, where commercially produced PD fluid is not available for the management of AKI.

Neurotoxic Effect of Paracetamol on Female Rats: Role of Antioxidant Treatment and Prevention

Paracetamol (Acetaminophen) is the most common nonprescription analgesic and antipyretic drug used. It can be found in different pharmaceutical dosage forms such as syrup, capsule, suppositories and intravenous (I.V) infusion solution. The intake frequency and the dose of paracetamol usually varied during pregnancy with a tendency toward higher doses in the last trimester. The effect of Paracetamol overdose was extensively studied on hepatocyte and nephrocyte of laboratory animals. The aim of this study is to focus on the effect of paracetamol overdose on Neurotoxicity (within Hippocampus, Cerebellum, and Olfactory Bulbs) of Paracetamol in the last trimester of pregnant rats. And this will be done through studying oxidative stress markers, the biochemical and antioxidant tests that indicate the presence of Hepatotoxicity and Nephrotoxicity, along with the protective effect of Vitamin E as antioxidant in pre‐ and post‐single toxic dose administration. Twenty female pregnant Wistar rats (average weight 200 gm ± 10) at gestational day 18 (GD18) were used. The pregnant rats were divided into four groups; the first (control) group received a 0.5 ml p.o of corn oil. The second group (paracetamol) group received a 3000 mg/kg p.o paracetamol dissolved in corn oil. The third (E + paracetamol) group received a 3000 mg/kg paracetamol one hour after 300 mg/kg p.o vitamin E. The fourth (paracetamol + E) group received a 3000 mg/kg paracetamol one hour before 300 mg/kg p.o vitamin E dissolved in corn oil. Twenty‐four hours After Paracetamol administration the rats were anesthetized and the brain, the liver, the kidney, and the blood were collected. Various biochemical tests were performed to show the effect of paracetamol overdose on liver including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST). Additionally, the effect of paracetamol on Blood urea nitrogen (BUN) and Creatinine levels were determined to detect nephrotoxicity, and the results showed significant elevation within the paracetamol treated group and levels were restored to the normal levels with vitamin E treated groups. Uric acid (UA) and superoxide dismutase (SOD) were used to detect the oxidative stress within the Liver, the Kidney, the Hippocampus, the Cerebellum, and the Olfactory Bulbs.Support or Funding InformationThis research is supported form Al‐Zaytoonah University of Jordan

Interchangeability of Essential Phospholipid Products

A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products.

Efficacy and safety of amantadine for the treatment of L-DOPA-induced dyskinesia.

L-DOPA induced dyskinesias (LIDs) may affect up to 40% of Parkinson's disease (PD) and impact negatively health-related quality of life. Amantadine has demonstrated significant antidyskinetic effects in animal PD models and in randomized double-blind placebo-controlled trials (RCTs) in patients with PD. These effects are thought to be related to the blockade of NMDA receptors modulating cortico-striatal glutamatergic-dopaminergic interactions involved in the genesis of LIDs. There are three pharmaceutical forms of amantadine currently available in the market: an oral immediate-release (IR) formulation, which is widely available; an extended-release (ER) formulation (ADS-5102) which has been recently developed and approved by the FDA; and an intravenous infusion (IV) solution, which is not commonly used in clinical practice. RCTs with amantadine IR or ER, involving more than 650 patients have shown consistent and long-lasting reductions in LIDs. Interestingly, ADS-5102 not only reduced LIDs, but also reduced significantly at the same time the duration of daily OFF-time, a unique finding compared with other antiparkinsonian medications that usually reduce time spent OFF at the cost of worsening of LIDs. Amantadine IR might also have possible effects on other PD symptoms such as apathy or fatigue. The most common adverse reactions with amantadine are constipation, cardiovascular dysfunction including QT prolongation, orthostatic hypotension and edema, neuropsychiatric symptoms such as hallucinations, confusion and delirium, nausea and livedo reticularis. Corneal degeneration is rare but critical. In summary, amantadine immediate and extended-release are effective and safe for the treatment of LIDs.

Bactericidal effects of deep ultraviolet light-emitting diode for solutions during intravenous infusion.

Background: Ultraviolet irradiation is effectively used as a disinfection method for inactivating microorganisms.Methods: We investigated the bactericidal effects by irradiation with a deep-ultraviolet light-emitting diode (DUV-LED) on the causative microorganisms of catheter related blood stream infection contaminating the solution for intravenous infusion. For irradiation, prototype modules for water disinfection with a DUV-LED were used. Experiments were conducted on five kinds of microorganisms. We examined the dependence of bactericidal action on eleven solutions. Administration sets were carried out three types.Results: When the administration set JY-PB343L containing the infusion tube made of polybutadiene was used, the bactericidal action of the DUV-LED against all tested microorganisms in the physiological saline solutions was considered to be effective. We confirmed that the number of viable bacteria decreased in 5% glucose solution and electrolyte infusions with DUV-LED irradiation.Conclusions: These results indicate that the DUV-LED irradiation has bactericidal effects in glucose infusion and electrolyte infusions by irradiating via a plasticizer-free polybutadiene administration set. We consider DUV-LED irradiation to be clinically applicable.

Subcutaneous Rituximab for the Treatment of B-Cell Hematologic Malignancies: A Review of the Scientific Rationale and Clinical Development.

Rituximab (MabThera®/Rituxan®), a chimeric murine/human monoclonal antibody that binds specifically to the transmembrane antigen CD20, was the first therapeutic antibody to enter clinical practice for the treatment of cancer. As monotherapy and in combination with chemotherapy, rituximab has been shown to prolong progression-free survival and, in some indications overall survival, in patients with various B-cell malignancies, while having a well-established and manageable safety profile and a wide therapeutic window. As a result, rituximab is considered to have revolutionized treatment practices for patients with B-cell malignancies. A subcutaneous (SC) formulation of rituximab has been developed, comprising the same monoclonal antibody as the originally marketed formulation [rituximab concentrate for solution for intravenous (IV) infusion], and has undergone a detailed, sequential clinical development program. This program demonstrated that, at fixed doses, rituximab SC achieves non-inferior serum trough concentrations in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia, with comparable efficacy and safety relative to the IV formulation. The added benefit of rituximab SC was demonstrated in dedicated studies showing that rituximab SC allows for simplified and shortened drug preparation and administration times resulting in a reduced treatment burden for patients as well as improved resource utilization (efficiency) at the treatment facility. The improved efficiency of delivering rituximab’s benefit to patients may broaden patient access to rituximab therapy in areas with low levels of healthcare resources, including IV-chair capacity constraints. This article is a companion paper to G. Salles, et al., which is also published in this issue. FundingF. Hoffmann-La Roche Ltd.

Effect of Intravenous Infusion Solutions on Bioelectrical Impedance Spectroscopy.

Bioelectrical impedance (BIA) is often used to measure body fluid spaces and thereby body composition. However, in acute animal studies, we found that impedance was driven by the saline content of intravenous (IV) fluids and not by the volume. The aim of the study was to investigate the effect of 3 different fluids acutely administered on the change in impedance, specifically resistance (R). Nine healthy adults participated in 3 treatment (0.9% saline, 5% dextrose, and a mixture of 0.3% saline + 3.3% dextrose) experiments on nonconsecutive days. They all received 1 L of one of the treatments intravenously over a 1-hour period. Repeated BIA measurements were performed prior to IV infusion and then every 5 minutes for the 1-hour infusion period, plus 3 more measurements up to 15 minutes after the completion of the infusion. The change in R in the 0.9% saline infusion experiment was significantly lower than that of the glucose and mixture treatment ( P < .001). Bioelectrical impedance spectroscopy and BIA measure salt rather than the volume changes over the infusion period. Hence, in patients receiving IV fluids, BIA of any kind (single frequency or multifrequency) cannot be used to measure body fluid spaces or body composition.

Post-reconstitution Stability of Telavancin with Commonly Used Diluents and Intravenous Infusion Solutions

ObjectiveThe post-reconstitution chemical stability and microbial challenge hold time of nonpreserved telavancin for injection was determined using common reconstitution diluents and intravenous (IV) infusion solutions stored at room temperature with light (ambient) or at 2°C to 8°C without light (refrigeration). MethodsTelavancin was reconstituted with 5% dextrose, 0.9% normal saline, or sterile water (15 mg/mL). Infusion solutions at 0.6 and 8.0 mg/mL were prepared in ViaFlex (polyvinyl chloride) IV bags (Baxter International Inc, Deerfield, Illinois) using 5% dextrose, 0.9% normal saline, or lactated Ringer’s solution. Chemical stability was evaluated for up to 14 days under refrigeration and for up to 3 days under ambient conditions. Telavancin concentration and degradant levels were determined using a stability-indicating HPLC method. Solutions were subjected to microbial-challenge testing for up to 48 hours (ambient) or for up to 6 days (refrigeration). ResultsAll reconstituted or infused telavancin solutions met the prespecified stability acceptance criteria after 2 days under ambient and minimum 7 days under refrigeration. Following inoculation with gram-positive and gram-negative microorganisms, telavancin infusion solutions stored under ambient conditions reduced or inhibited populations of all organisms up to 48 hours, except for Serratia marcescens, which exhibited growth of >0.5 log10 after 12 hours. All refrigerated samples inhibited or reduced bacterial populations up to 6 days. ConclusionsThese results are supportive of a total hold time for reconstituted telavancin in vials plus the time in IV infusion solutions in polyvinyl chloride bags to not exceed 12 hours under ambient conditions and 7 days under refrigeration.