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Summary Background & aims Wernicke's encephalopathy is associated mainly with malnourishment in alcohol-dependent patients but can be caused also by cancer, Crohn's disease, gastrointestinal surgery or prolonged parenteral nutrition (PN) without adequate supplementation of vitamins. The disorder, with a significant mortality rate of up to 20%, is often associated with the underlying disease and intensifies after administration of non-supplemented PN. Thus, it seems justified to add thiamine to PN admixtures prepared for parenterally fed patients. Due to the lack of data on the stability of thiamine in PN admixtures at concentrations exceeding 60 mg/L, we decided to determine the possibility of adding a high dose of thiamine (800 mg per bag, 320 mg/L) to PN admixtures in order to treat Wernicke's encephalopathy in malnourished patients. Methods The study aimed to assess the stability of the physical properties of PN admixtures (pH, zeta potential, particle size) and to determine thiamine content using an HPLC method. Results Thiamine was found to degrade regardless of the PN admixture composition and storage conditions. The highest decrease in thiamine content was observed at room temperature without light protection whereas the lowest at a temperature of 4 ± 1 °C with light protection. Conclusions The treatment of Wernicke's encephalopathy in parenterally fed patients is possible with the use of high thiamine doses (800 mg) added to PN admixtures without a decrease in the drug content above 10% within the first 24 h. It should be emphasized that thiamine as a photosensitive drug must be stored and administered under conditions ensuring light protection.

Background Postoperative administration of parenteral nutrition has become routine management in patients with gastrointestinal cancer. Providing patient the complete parenteral nutrition containing not only the macronutrients and electrolytes but also adequate doses of vitamins is a significant issue of nutritional therapy. The aim of the study was to develop parenteral nutrition containing a high dose of vitamin C (500 mg) and evaluate their stability. Methods Five compositions of parenteral nutrition were developed and stored for seven days in three different conditions. Physical stability studies including visual examination and determination of pH, size of lipid droplets (using dynamic laser scattering method), and zeta potential (using laser Doppler electrophoresis method) were performed for all studied parenteral nutrition with and without vitamin C immediately after preparation and after storage. The content of vitamin C was determined using high-performance liquid chromatography (HPLC) method. Results The addition of vitamin C to parenteral nutrition did not affect its physical stability. Degradation of vitamin C in parenteral nutrition occurred according to first-order kinetics reaction. The content of vitamin C remained above 90% of zero-time content within the first 24 h for each studied parenteral nutrition compositions stored at 4°C and 25°C with light protection. Conclusions Vitamin C added to parenteral nutrition was unstable regardless of the storage conditions nor parenteral nutrition compositions. However, for the first 24 h, the content of vitamin C remained in the pharmacopoeial limit. Therefore, supplementation of parenteral nutrition admixtures with vitamin C in the dose of 500 mg is possible in the condition of administration to the patients within the first 24 h.

Objective The aim of the study was to determine the stability of two non-commercially produced solutions: 1.68% sodium bicarbonate in 5% glucose (BIC solution) and 1.6% calcium chloride in 0.9% sodium chloride (CAL solution), which can be used to treat tumor lysis syndrome. One of the ways to treat the tumor lysis syndrome is to irrigate patients, alkalinize the urine through the supply of BIC solution or continuous hemodialysis with regional citrate anticoagulation, using a CAL solution. Method The study took place in two independent hospital pharmacies. Fifty samples of each solution were prepared under aseptic conditions, then the concentration of sodium and calcium ions was determined and microbiological purity tests were carried out. The tests were performed on the day of sample preparation and after seven days of storage at 4 ± 1℃. Results The obtained results showed that applied preparation method was precise and accuracy. The average concentration of sodium ions in BIC solutions ranged from 187.7 to 185.26 mmol/L on 1st and 7th day, respectively. The average concentration of calcium ions in CAL solution ranged from 68.92 to 68.80 mmol/L on 1st and 7th day, respectively. None of the samples were microbiologically contaminated. Conclusion Studied solutions for infusion were characterized by good chemical and microbiological stability when prepared in a clean room and stored at 4 ± 1℃.

Intravenous drug incompatibilities are a common cause of medical errors, contributing to ineffective therapy and even life-threatening events. The co-administration of drugs must always be supported by studies confirming compatibility and thus guarantee the therapy’s safety. Particular attention should be paid to the possible incompatibilities or degradation of intravenous cephalosporins in different infusion regimens since the administration of drugs with inadequate quality may cause treatment failure. Therefore, an appropriate stability test should be performed. The study aimed to present various aspects of the stability and compatibility of five cephalosporins: cefepime (CFE), cefuroxime (CFU), ceftriaxone (CFX), ceftazidime (CFZ), and cefazoline (CFL). The degradation studies in parenteral infusion fluids and PN admixtures were conducted for CFE and CFU. The interactions between CFX or CFZ and PN admixtures, as well as the compatibility of CFL with five commercial parenteral nutrition (PN) admixtures, were investigated. The content of CFX and CFZ in PN admixture after 24 h was &gt, 90%. CFL administered simultaneously with PN admixture by the same infusion set using Y-site was compatible only with Nutriflex Lipid Special. CFE and CFU were stable in all tested infusion fluids for a minimum of 48 h and decomposed in PN admixtures during storage.

A serious problem in everyday clinical practice is the co-administration of drugs using the same infusion line. Potential complications of co-administration of incompatible drugs include precipitation in the infusion line or central venous catheter leading to its occlusion. Administration of precipitate and large lipid droplets into the venous system may lead to the embolization of capillaries and local or systemic inflammatory reactions, with the consequences of venous thrombosis, chronic venous insufficiency, and even pulmonary embolism. The co-administration of drugs must always be confirmed and clearly defined. The study aimed to determine the interaction between colistin (COL) in the dose used during intermittent hemodialysis and five different ready-to-use PN admixtures (PN) (Kabiven, Smofkabiven, Olimel N9E, Nutriflex Lipid Special, and Nutriflex Omega Special). COL-PN compatibilities were tested by comparing physicochemical properties (pH, zeta potential, lipid emulsion particle size) of COL and PN at three time points: immediately after sample preparation, after ten minutes, and after four hours. No changes in the visual inspection were observed. Both PN without COL and COL-PN samples remained white, homogeneous oil-in-water emulsions with no signs of phase separation, precipitation, or color change. There were no significant changes in pH, and the mean droplet diameter remained below the acceptance limit of 500 nm. The zeta potential and osmolality of COL-PN samples ranged from &minus, 21.4 to &minus, 7.22 mV and from 567 to 1304 mOsm/kg, respectively. The COL does not influence the physical stability of studied PN admixtures. The co-infusion of COL with Kabiven, Nutriflex Lipid Special, Olimel N9E, Nutriflex Omega Special, and Smofkabiven is possible in the dose used during intermittent hemodialysis.

Background: Co-infusion of parenteral nutrition (PN) and other drugs increases the risk of the interaction between drug and PN admixtures that can cause embolization of small blood vessels, resulting in potentially fatal consequences, including pulmonary embolism, or liver and retina vascular damage. The present study aimed to determine the compatibility between ciprofloxacin (CF) and eighteen compounded PN admixtures in order to assess the possibility of their co-administration via Y-sites. Methods: CF and PN admixtures were mixed at two volume ratios (1:1 and 2:1) and potential interactions were examined using visual inspection, and measurements of pH, osmolality particle size, and zeta potential. The analyses were conducted immediately after sample preparation and after four hours of storage. Results: The compatibility tests showed that the addition of the CF to the PN admixtures did not cause any color change or sign of destabilization in the fat emulsion. However, precipitation was observed in formulations containing higher CF concentrations and, in the case of lower CF concentrations, in formulations containing magnesium and calcium ions at a molar ratio of 2:1. Conclusions: The administration of CF and PN admixtures via the Y-site should be avoided or performed only with PN admixtures for which compatibility has been confirmed and the CF concentration in samples is 1 mg/mL at a molar ratio of magnesium to calcium ions of 1:1.

Background: Ampicillin (AMP) is frequently administered parenterally in critically ill patients with meningitis or endocarditis. Many of them require parallel infusion of total parenteral nutrition (TPN) admixtures. The aim of the study was to determine the physicochemical stability of AMP in TPN admixtures. Methods: AMP was added to two formulations of TPN admixtures differing in the lipid emulsion (Lipofundin&reg, MCT/LCT 20% or LIPIDem&reg, ). Samples were stored at 4 &plusmn, 1 &deg, C with light protection, and at 25 &plusmn, C with and without light protection to assess the impact of temperature and light on formulation stability. Every 24 h the pH, zeta potential, mean droplet diameter (MDD) of a lipid emulsion, and AMP concentration using HPLC method were determined. The assessment of stability and compatibility of TPN admixtures with vitamins and trace elements was carried out immediately after preparation and after 24 h of storage. Results: The addition of AMP as well as vitamins and trace elements to the TPN admixtures did not affect their physical stability. An increase in the pH value of approx. 0.6 and reduction of zeta potential were observed. The MDD of the lipid emulsions was below the limit of 500 nm (dynamic light scattering (DLS) method) and no fat droplets greater than 525 nm were observed (light diffraction (LD) method). The content of AMP after the first 24 h was within the acceptable limit of 90% for TPN admixtures stored at 4 &plusmn, C and 25 &plusmn, C with light protection. Conclusions: The results showed that co-administration of AMP in the same bag with TPN admixture at the tested dose is possible when used ex tempore and with light protection.

Objectives Supplementation of parenteral nutrition (PN) admixtures with other parenteral drugs may be desired especially in the case of polypharmacy and limited vascular access. Metronidazole (MTZ) is administered in surgical and critically ill patients often requiring concomitant nutritional therapy in the form of parenteral nutrition. The aim of the study was to evaluate the possibility of the concomitant administration of MTZ with PN admixtures from one container. Methods MTZ (1500 mg) was combined with six different PN admixtures and stored for 7 days before the simulation of administration. The mean droplet size (MDS) of the lipid emulsion, zeta potential, color, and pH of the tested samples were determined every 24 h. The content of MTZ was determined by the high-performance liquid chromatography method within the same time frames. Results PN admixtures supplemented with MTZ were characterized by a pH range from 6.19 to 6.38 and zeta potential range from –21.6 mV to –8.8 mV. For all samples the pharmacopeial criteria for intravenously administered emulsions were met: The visual inspection showed no sign of emulsion destabilization or precipitation, and the MDS was 90% of the initial value throughout the whole study period. Conclusions Results showed the physicochemical compatibility and stability of PN admixtures supplemented with MTZ at the dose of 1500 mg. Such formulations can be stored at a temperature of 5°C for up to 7 d before administration to the patient.

Simultaneous administration of parenteral nutrition (PN) admixtures with intravenous antibiotics is a common clinical problem. Coadministration of drugs incompatible with PN admixture may affect its stability, especially in the context of lipid droplet size, which is a crucial parameter for patient safety. In the present study, we investigate the in vitro compatibility of meropenem (Meropenem 1000, MPM) with five commercial PN admixtures used worldwide: Kabiven, Olimel N9E, Nutriflex Lipid Special, Nutriflex Omega Special, and SmofKabiven. The appropriate volumetric ratios, reflecting their clinical practice ratios, were used to prepare the MPM–PN admixture samples. Physicochemical properties of MPM–PN admixtures samples were determined upon preparation and after four hours of storage. The pH changes for all MPM–PN admixtures samples did not exceed the assumed level of acceptability and ranged from 6.41 to 7.42. After four hours of storage, the osmolarity changes were ±3%, except MPM–Olimel N9E samples, for which differences from 7% to 11% were observed. The adopted level of acceptability of changes in zeta potential after four hours of storage (±3 mV) was met for MPM–Kabiven, MPM–Nutriflex Lipid Special, and MPM–Nutriflex Omega Special. The mean droplet diameter for all samples was below 500 nm. However, only in the case of Nutriflex Lipid Special and Nutriflex Omega Special, the addition of MPM did not cause the formation of the second fraction of lipid droplets. The coadministration of MPM via Y-site with Kabiven, Olimel N9E, and Smofkabiven should be avoided due to osmolarity fluctuations (MPM–Olimel), significant differences in zeta potential (MPM–Olimel, MPM–Smofkabiven), and the presence of the second fraction of lipid droplets &gt, 1000 nm (MPM–Kabiven, MPM–Olimel, and MPM–Smofkabiven). The assumed acceptance criteria for MPM compatibility of MPM with PN admixtures were met only for Nutriflex Lipid Special and Nutriflex Omega Special in 1:1, 2:1, and 4:1 volume ratios.

Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated. Methods: An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 &micro, m) with a C18 pre-column (LiChrospher 100, 4 mm, 5 &micro, m). The flow rate was 1.0 mL min&minus, 1 and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up. Results: The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures. Conclusions: The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t0.5 varied from 142.44 h to 300.45 h).

The group of patients most frequently in need of nutritional support are intensive care patients. This year (i.e., 2019), new European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines of clinical nutrition in intensive care were published, updating and gathering current knowledge on the subject of this group of patients. Planning the right nutritional intervention is often a challenging task involving the necessity of the choice of the enteral nutrition (EN) or parenteral nutrition (PN) route of administration, time of initiation, energy demand, amino acid content and demand as well as the use of immunomodulatory nutrition. The aim of this study was to specify and discuss the basic aspects of the clinical nutrition of critically ill patients recommended by ESPEN guidelines. Clinical nutrition in intensive care seems to be the best-studied type of nutritional intervention. However, meta-analyses and clinical studies comparing EN and PN and their impact on the prognosis of the intensive care patients showed ambiguous results. The nutritional interventions, starting with EN, should be initiated within 24–48 h whereas PN, if recommended, should be implemented within 3–7 days. The recommended method of calculation of the energy demand is indirect calorimetry, however, there are also validated equations used worldwide in everyday practice. The recommended protein intake in this group of patients and the results of insufficient or too high supply was addressed. In light of the concept of immunomodulatory nutrition, the use of appropriate amino acid solutions and lipid emulsion that can bring a positive effect on the modulation of the immune response was discussed.