Parenteral Nutrient Solutions Research Articles

Data Mining-Based Stability and Prescription Analysis of Neonatal Parenteral Nutrition Solution.

In order to evaluate the stability of neonatal parenteral nutrition solution, in this paper, the prescription of neonatal parenteral nutrition solution was investigated and analyzed. The formula of neonatal parenteral nutrition solution used, particularly the one utilized in this study, is commonly used in clinical practice. All the neonatal parenteral nutrition solution required for the test was prepared on the purification workbench in a sterile environment. The time points of stability of parenteral nutrient solution were 0, 12, and 24 hours, respectively, and three parallel samples were taken at each time point. Likewise, to investigate the stability of two kinds of fat milk injection in parenteral nutrition solution of neonates and provide a reference for subsequent experiments and to investigate the influence of electrolyte, amino acid, temperature, pH value, mixing sequence, and the final concentration of glucose on the stability of neonatal parenteral nutrition solution, the stability indexes of neonatal parenteral nutrition liquid mainly include appearance, pH, insoluble particles, fat milk particle size, and particle size distribution. Neonatal parenteral nutrition solution prescriptions from the First Affiliated Hospital of Jinan University, specifically from January to June 2019, were collected and statistically processed. The experimental data were processed by SPSS 19.0 software and data mining technology. The results were expressed as mean ± standard deviation and statistically processed by ANOVA. P < 0.05 was considered statistically significant. The results showed that the stability of neonatal parenteral nutrient solution was influenced by many factors. The formula of neonatal parenteral nutrition solution is generally reasonable, but there are unreasonable phenomena which are needed to be improved further if feasible.

Clinical observation of strictly control the infusion on the intervention of the premature infants' hard swelling and edema

Objective To explore the correlation between the infusion volume and infusion method with neonatal hard swelling, edema, looking for the best way to premature infusion. Methods A total of 62 cases of prematrue infants with gestational age ranged from 34 weeks to 36+ 5 weeks, and with weight equal or greater than 2kg were selected as the research objects.Compared different infusion method's efficacy through infusion speed control newborn room nurses on neonatal infusion volume. All the infants were randomly divided into A, B and C groups according to random number table method.Group A: the total volume was controlled, and infusion with conventional speed (5~6 drops a minute). Group B: the speed was controlled by trace injection pump infusion.Group C: the speed was controlled by 24 hours of continuous infusion pump, and then contrast in children with intravenous indwelling needle, the curative effect was observed.Three sets of liquid quantity control methods were for 1~3 days after the total amount (including milk, water and transfusion volume) for 50 ml/kg, 60 ml/kg, 80 ml/kg, 4~7 days 100 ml/kg, according to the daily intake of milk and water quantity adjusting infusion in children with quantity, infusion volume also includes parenteral nutrient solution: amino acids, fat milk, all consumption demand of reference to neonatal parenteral nutrition therapy concentration. Results Group C (in trace injection pump group 24 hours of continuous pumping) got best treatment effect, the degree of edema reduced, the swollen and complications of infusion reduced, the total cost reduced, the average hospitalization time of the child reduced(P<0.05). This method was better than that of Group A (the total control quantity, and speed of conventional infusion (5~6 drops/min) group) and Group B (control trace injection pump infusion speed, liquid input end of the day after the completion of treatment, do not need to 24 hours of continuous pumping group). It is worthy of clinical popularization and application. Conclusions Trace injection pump (in group C group 24 hours of continuous pumping) has best curative effect and the lightest edema and hard swollen complications. Key words: Strictly control the infusion; Intervention in the premature infant complications; Clinical observation

Physical compatibility of various drugs with neonatal total parenteral nutrient solution during simulated Y-site administration

The physical compatibility of various drugs with neonatal total parenteral nutrient (TPN) solution during simulated Y-site administration was evaluated. Study drugs were selected based on the lack of compatibility data with them and neonatal TPN solution and the frequency of use in a local neonatal unit. These drugs included amiodarone, caffeine citrate, clindamycin, enalaprilat, epinephrine, fluconazole, fosphenytoin sodium, hydrocortisone, metoclopramide, midazolam, pentobarbital, phenobarbital, and rifampin. Equal volumes of neonatal TPN solution or sterile water for injection were combined with study drugs or sterile water for injection at concentrations used clinically in neonates. Each test was performed in triplicate. The samples were examined via turbidimetric analysis and visually against light and dark backgrounds immediately after mixing and at 0.25, 0.5, 1, 2, and 3 hours after mixing. Analysis of variance was used to determine statistically significant differences between the test and control solutions. Many of the drugs studied exhibited no visual or turbidimetric evidence of incompatibility when combined with neonatal TPN solution for up to three hours in a simulated Y-site injection. Pentobarbital, phenobarbital, and rifampin formed visible precipitation immediately after mixing with the neonatal TPN solution. Caffeine citrate, clindamycin, enalaprilat, epinephrine, fluconazole, fosphenytoin sodium, hydrocortisone, metoclopramide, and midazolam exhibited no visual or turbidimetric evidence of incompatibility when combined with a neonatal TPN solution for up to three hours in a simulated Y-site injection. Amiodarone, pentobarbital, phenobarbital, and rifampin were not compatible with the neonatal TPN solution and should not be coadministered via Y-site injection.

Calculating the refractive index for pediatric parenteral nutrient solutions

The utility of refractometric analysis for calculating the refractive index (RI) of compounded parenteral nutrient solutions for pediatric patients was examined. An equation for calculating the RI of parenteral nutrient solutions was developed by chemical and linear regression analysis of 154 pediatric parenteral nutrient solutions. This equation was then validated by analyzing 1057 pediatric parenteral nutrition samples. The RI for the parenteral nutrient solutions could be calculated by summing the RI contribution for each ingredient and then adding the RI of water. The RI contribution for each ingredient was determined by multiplying the RI of the manufacturer's concentrate by the volume of the manufacturer's concentrate mixed into the parenteral nutrient solution divided by the total volume of the parenteral nutrient solution. The calculated RI was highly correlated with the measured RI (R(2) = 0.94, p < 0.0001). Using a range of two standard deviations (±0.0045), 99.8% of the samples fell into the comparative range. RIs of electrolytes, vitamins, and trace elements in the concentrations used did not affect the RI, similar to the findings of other studies. There was no statistical difference between the calculated RI and the measured RI in the final product of a pediatric parenteral nutrient solution. This method of quality control can be used by personnel compounding parenteral nutrient solutions to confirm the compounding accuracy of dextrose and amino acid concentrations in the final product, and a sample can be sent to the hospital laboratory for electrolyte verification.

Quality risk management for prepared sterile products in hospital pharmacy

BackgroundA hospital pharmacy (HP) prepares compounded sterile preparations (CSPs) following the current good manufacturing practice (cGMP) requirements. A quality risk management (QRM) is needed for the assessment, control, communication and...

Bacteremia outbreak tied to improper filtration by compounding pharmacy

An improper filtration process let Serratia marcescens in tap water pass into two batches of pharmacy-prepared amino acid solution and then into hospital patients, a joint federal–state investigation has determined. The amino acid solution, said Neil Gupta, an epidemic intelligence service officer with the Centers for Disease Control and Prevention (CDC), had been prepared from scratch by a compounding pharmacy that he identified only as “Pharmacy A.” He said this pharmacy “sterilized” 80- to 100-L batches of 15% amino acid solution because of a national shortage of the manufacturer-provided product. The pharmacy then incorporated its amino acid solution into adult parenteral nutrient solutions for distribution in Alabama. In all, according to the state department of public health, the 2011 outbreak of S. marcescens bacteremia involved 19 patients at six hospitals in central Alabama: Cooper Green Mercy Hospital, Medical West, Prattville Baptist Hospital, Princeton Baptist Medical Center, Select Specialty Hospital—Birmingham, and Shelby Baptist Medical Center.

IOM tells FDA to develop new regulatory pathway for medical devices

Under the current regulatory process for medical devices, smart infusion pumps appear on the U.S. market before FDA evaluates their safety. So do the automated compounders many pharmacies use to prepare parenteral nutrient solutions. Since 1976, section 510(k) of the Federal Food, Drug, and Cosmetic Act has allowed a person to market a medium-risk medical device so long as it is “as safe, as effective, and performs as well as or better than the legally marketed device” identified in the “premarket notification.” FDA, the law states, reviews the pre-market notification and then takes one of the following actions: declares the new device “to be substantially equivalent to a legally marketed predicate device,” declares the new device “not substantially equivalent,” requests more information, or says the notification was unnecessary. “The 510(k) clearance process,” according to a new report from the Institute of Medicine (IOM), “is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”

Application of a Self-Made Swivel Intravenous Transfusion Device in Constructing Allogenic Small Bowel Transplantation Rejection Model in Rats

Background Lacking a long-term continuous intravenous infusion device for experimental animals is the biggest obstacle to constructing an allogenic small bowel transplantation rejection model. Objective To establish a rat heterotopic small bowel transplantation model with the use of a swivel device for intravenous transfusion. Methods The randomized block design of controlled observations included 90 inbred male F344/NCrl BR rats as donors and 90 LEW/Crl rats as recipients. On the basis of body weight, the rats were divided into three groups each with 30 pairs of rats. Group 1, the control group, underwent small bowel transplantation. Group 2, the transfusion group, received small bowel transplantation and continuous infusion of parenteral nutrient solution. Group 3, the tacrolimus (FK506) treatment group, received small bowel transplantation, continuous infusion of parenteral nutrient solution, and intravenous injection of FK506. The general status and survival time of transplanted rats were observed for 5 weeks. Results The operative success rate was 100%. The survival rate was 83.3% (25/30) in the control group; and 96.7% (58/60) in groups 2 and 3 ( P = .039). The mean survival time of the FK506 group was 22.1 ± 13.4 days, which was significantly higher than that in the transfusion group (10.4 ± 2.9 days, P = .023). Conclusion The simple, practical swivel intravenous infusion device provided treatment for more than 30 days, a useful tool for heterotopic segmental small bowel transplantation.

Effect of addiivet selection on calculated aluminum content of parenteral nutrient solutions

The quantity of aluminum in common ingredients used to compound parenteral nutrient (PN) solutions was calculated to quantify the actual aluminum content, and opportunities to modify the aluminum content by changing the manufacturer of the ingredients were explored. A retrospective evaluation of a random sample of 10 neonatal, 10 pediatric, and 10 adult patients who received PN solutions was performed to quantify the aluminum content in these solutions on the basis of the ingredients used at the authors' institution. A recalculation was performed using the lowest aluminumcontaining ingredients to determine the potential for aluminum minimization in each PN solution. Various manufacturers produce each ingredient required to make PN solutions. Significant variation exists among manufacturers, vial size, and concentrations. Statistically significant differences in the mean aluminum content of PN solutions before and after aluminum minimization were found to exist within each sample of patients. Among the neonatal PN solutions, aluminum content was significantly reduced from a mean +/- S.D. of 84.16 +/- 47.61 to 33.6 +/- 16.69 mug/kg/day. The pediatric PN solutions had a significant decline in aluminum content from a mean +/- S.D. of 16.24 +/- 3.66 to 6.84 +/- 2.66 mug/kg/day. Aluminum content in the high-risk adult PN solutions significantly decreased from a mean +/- S.D. of 4.58 +/- 2.06 to 2.31 +/- 0.63 mug/kg/day. There is wide variability in the aluminum concentration of injectable products used in the compounding of PN solutions. Selecting products with low aluminum concentration may substantially reduce the amount of the element administered to patients.

Measured versus estimated aluminum content of parenteral nutrient solutions

A study was conducted to directly measure the aluminum concentration in a select number of parenteral nutrient (PN) solutions and to compare this value with the calculated dose using the concentrations reported by the manufacturer. Fifty 2.5-mL samples were prepared for analysis and were obtained from PN solutions prepared for adult and pediatric/neonatal patients. Intravenous large-volume parenterals were used as controls. Samples were sent to two different reference laboratories. Batch 1 included 26 samples, 22 from PN solutions, 1 control, and 3 paired (duplicate) samples selected from the 22 PN bags. Because 8 of the samples were lost to analysis, a second batch of samples was included. Batch 2 consisted of 24 samples from 4 PN solutions and 2 controls. Batch 2 was composed of four aliquots from each solution that were divided equally and sent to the two laboratories. Twenty-three values were used in the statistical analysis. The results showed that only two of the adult PN solutions equaled or exceeded the threshold set by the Food and Drug Administration (FDA) for measured aluminum exposure. The measured concentration of aluminum for all six of the pediatric and neonatal solutions met or exceeded the FDA threshold; however, this value was much lower than what had been estimated using the labeled aluminum concentration at expiry. In PN solutions expected to have a moderately high concentration of aluminum, the measured amount of aluminum was far less than the amount that would be estimated by calculation using the labeled concentrations of aluminum in each of the ingredients.

Should adding albumin to parenteral nutrient solutions be considered an unsafe practice?

The technical issues surrounding the use of albumin in parenteral nutrient (PN) solutions are reviewed. Five criteria have been suggested to determine which compounds are optimal for addition to PN solutions: (1) stable dosage regimen over 24 hours, (2) pharmacokinetic profile supporting a 24-hour infusion, (3) stable PN solution infusion rate, (4) documented physical stability over at least 24 hours, and (5) documented chemical stability over at least 24 hours. Albumin is stable in solutions containing dextrose and electrolytes, but its stability in solutions containing dextrose and amino acids has not been evaluated. Signs of precipitation and flocculation have been reported when albumin and zinc chloride were added simultaneously to a two-in-one PN solution. Similar to hemoglobin, albumin is nonenzymatically glycosylated in vivo. One of the most common complications associated with the use of PN solutions is catheter-related bloodstream infection. Albumin 25 g/L in two-in-one PN solutions has been shown to clog 0.2-microm filters. Albumin products have historically contained a large amount of aluminum contamination; thus, the addition of albumin to PN solutions would further contribute to accumulated aluminum contaminants in patients receiving PN therapy, particularly neonates. Based on the available evidence, the addition of albumin to PN solutions cannot be recommended. The potential for complications due to infection and physical and chemical incompatibility and instability exists. Adding albumin to PN solutions can affect infusion flow rates and pump pressures, thereby compromising the appropriate delivery of PN solutions to patients. The theoretical risk of glycosylation and related complications outweigh potential benefits of albumin administration via PN solution.

Stability of roxatidine acetate in parenteral nutrient solutions containing different amino acid formulations

Roxatidine acetate hydrochloride is a histamine H2-receptor antagonist used in the treatment of peptic ulcers and hypersecretory conditions. The drug is thought to act by inhibiting gastric acid secretion.[1][1] The inhibitory effect is reported to be six times as potent as that of cimetidine.[2][2

Artificial Nutrition Support in Intestinal Failure: Principles and Practice of Parenteral Feeding

Patients with intestinal failure are at risk for malnutrition and its associated adverse consequences. In many of these patients it is not possible to feed via the gastrointestinal tract, and nutrients must be provided directly into the bloodstream. For some patients with irreversible intestinal failure, this is a lifelong requirement. Parenteral nutrient solutions may be tailored specifically to individual requirements and are usually administered directly into a central vein using an indwelling catheter. Serious complications related to both the indwelling catheter and metabolic consequences of the nutritional support may occur. A team approach to the provision and monitoring of parenteral nutrition in intestinal failure produces the best results.

Factors affecting the sterility of work areas in barrier isolators and a biological safety cabinet.

Factors affecting the sterility of the work area in barrier isolators and a biological safety cabinet (BSC) were studied. A study in a mother-and-child tertiary care teaching hospital in Canada examined the effects of a range of variables on the sterility of work areas in four barrier isolators and a standard BSC. The variables consisted of type of equipment (barrier isolator or BSC), day of the week (Monday through Thursday), time of day (0800-1000, 1000-1200, 1200-1400, and 1400-1600), sampling site (16 surfaces and 5 air sedimentation zones), type of product prepared (antimicrobial, total parenteral nutrient solution, etc.), cleaning procedure (before or after primary cleaning), and level of product preparation activity (none to intense). A total of 657 surface and air sedimentation samples, 327 plated onto Trypticase soy agar (TSA) and 330 onto Sabouraud dextrose agar (SAB-D), were taken during a 20-day period. Thirty-three (5%) of the samples yielded microbial growth when cultured (24 on TSA and 9 on SAB-D). A total of 74 isolates were identified, including Bacillus, Staphylococcus, Penicillium, Micrococcus, Corynebacterium, and Mucor species. Single-variable analysis showed that sampling site, sample type, the time of day samples were taken, and the types of equipment contributed significantly to microbial growth in the samples taken. Several variables were associated with microbial growth in samples from the work areas of barrier isolators and a BSC. More study is needed to compare BSCs and barrier isolators with respect to sterility.

Glutamine and the gastrointestinal tract.

The amino acid glutamine has become one of the most intensively studied nutrients in the field of nutrition and metabolic support. A variety of studies in cell culture systems, animal models of gut mucosal atrophy, injury/repair and adaptation and a limited number of clinical trials demonstrate trophic and cytoprotective effects of glutamine in small bowel and colonic mucosal cells. Although the routine clinical use of glutamine-enriched parenteral and enteral nutrient solutions remains controversial, available data demonstrate both the safety and metabolic and clinical efficacy of glutamine treatment in selected patient groups. Basic investigations are elucidating underlying mechanisms of glutamine action in intestinal cells. These will inform preclinical and clinical investigations designed to determine glutamine efficacy in selected gastrointestinal disorders. Emerging clinical trials will further define the utility of adjunctive glutamine supplementation as a component of specialized nutrition support in gastrointestinal disease.

Stability of Morphine Hydrochloride in a Total Parenteral Nutrient Solution.

The chemical stability of morphine hydrochloride in a total parenteral nutrient solution wasevaluated using a HPLC-ultraviolet detection system. This method is sensitive enough to measure morphine hydrochloride at concentrations as low as 0.2 nmol and produces highly reproducible results and requires 5.5 min per sample for separation and quantitation. Solutions of morphine hydrochloride in a total parenteral nutrient solution are chemically stable for 1 month when stored at 4°C and room temperature (20°C) with protection and no protection from environmental light. No loss of morphine hydrochloride due to adsorption in the polyethylene chloride (PEC) bags was found.

Chromium and zinc contamination of parenteral nutrient solution components commonly used in infants and children.

Chromium and zinc contamination of components of parenteral nutrient (PN) solutions used in infants and children was studied. Solutions of amino acids, L-cysteine hydrochloride, dextrose, electrolytes, minerals, vitamins, multiple trace elements, and individual trace elements were obtained. A variety of manufacturers, lots, and expiration dates were represented when possible. The solutions were analyzed for chromium and zinc by flame atomic absorption spectrophotometry. In all amino acid products, chromium concentration was below the limit of detection and zinc concentration ranged from 0.06 to 4.97 mg/L. In the L-cysteine hydrochloride products, chromium was measurable in only two lots (0.11 and 0.23 mg/L); zinc was measurable in all lots (32-86 mg/L). Sodium and potassium salts of chloride and acetate had chromium concentrations of 0.02-0.23 mg/L and zinc concentrations of 0.35-0.56 mg/L. Phosphate salts contained chromium 0.39-0.44 mg/L and zinc 0.91-2.33 mg/L. In calcium gluconate, zinc concentration was 0.28-2.38 mg/L. In four lots of multiple trace elements, chromium was 92-104% and zinc was 100-113.5% of the labeled amount. A PN solution for a < 10-kg infant compounded from the components assayed would provide up to an additional 0.7 microgram of chromium per kilogram and 200 micrograms of zinc per kilogram. Zinc and chromium contaminants were detected in many of the products that are common components of PN solutions for infants and children; the contamination may be sufficient to result in the administration of zinc and chromium in amounts exceeding current recommendations.

Compatibility of parenteral nutrient solutions with selected drugs during simulated Y-site administration.

The compatibility of 102 drugs with parenteral nutrient (PN) solutions during simulated Y-site administration was studied. Five milliliters of each of four representative PN solutions was combined in duplicate in a 1:1 ratio with 5-mL samples of solutions of 102 drugs in 5% dextrose injection or 0.9% sodium chloride injection. Visual examinations were performed in fluorescent laboratory light and under high-intensity monodirectional light, and turbidity was measured. Particle sizing and counting were performed for selected solutions. All evaluations were performed at intervals up to four hours; storage was at 23 degrees C. Most of the drugs tested were compatible with the PN solutions. However, 20 drugs exhibited various incompatibilities with one or more of the PN solutions. During simulated Y-site administration, four PN solutions were compatible with 82 of 102 drugs for four hours at 23 degrees C. Twenty drugs were incompatible with one or more of the PN solutions.

Observational study of accuracy in compounding i.v. admixtures at five hospitals.

Rates of errors in i.v. admixture compounding at five U.S. hospital pharmacies were studied. Pharmacy staff members at five hospitals representing each U.S. geographic region were observed as they compounded sterile products in order to record the medication, dose, base solution, and other details. Intravenous admixtures, antineoplastic preparations, parenteral nutrient solutions, and ready-to-use products were included. Observations took place for five days at each pharmacy. The observers' notes were checked against the labels used to prepare the doses; any deviation was considered an error. The clinical importance of each error was assessed for its potential to affect a patient adversely. The mean error rate for the five hospitals combined was 9% (145 errors for 1679 doses), excluding ready-to-use products. Mean error rates for individual pharmacies ranged from 6% to 10%. Wrong-dose errors were the most common type of error. Parenteral nutrient solutions had the highest error rates-37% for manual preparation and 22% for preparation that was partly automated. Of every 100 errors, 2 were judged to be potentially clinically important. In five U.S. hospital pharmacies, the observed error rate for compounding i.v. admixtures was 9%.

Weight-based accuracy of parenteral nutrient solutions prepared with an automated compounder.

The accuracy of an automated compounder in preparing parenteral nutrient solutions was evaluated. A total of 480 1-, 2-, and 3--L solutions representing 68 different formulations, some containing electrolytes, were prepared with two Automix devices. The actual weight of the final product was compared with the calculated weight of all ingredients plus the weight of the empty final container. The weight of each ingredient was calculated by multiplying the specific gravity by the volume. A solution was considered acceptable if it weight 95% to 105% of the estimated weight. Only two bags were outside the acceptable range. The mean weight as a percentage of estimated weight for all bags was 100.07 +/- 1.26%. Of the 480 nutrient solutions prepared by an automated compounder, 478 were within 5% of their expected final weight.