Parenteral Nutrient Solutions Research Articles

Calcium and Phosphate Solubility in Neonatal Parenteral Nutrient Solutions Containing Aminosyn-PF or TrophAmine

The maximum solubilities of calcium and phosphate in neonatal total parenteral nutrient (TPN) solutions compounded using Aminosyn-PF or TrophAmine amino acid injection were determined. Eight solutions were compounded from Sterile Water for Injection, USP, 50% dextrose injection, usual electrolytes and trace metals, and Aminosyn-PF 7% or TrophAmine 6% to obtain concentrations of amino acids 2.5% and dextrose 25% and amino acids 1% and dextrose 10%. Cysteine hydrochloride was added to half of the solutions at a concentration of 40 mg/g of protein. The pH of each solution was determined at various times during admixture preparation. The solutions were divided into 20-mL aliquots, and phosphate and calcium were added to each aliquot at concentrations of 2.5 to 50 meq/L of calcium and 5 to 50 mmol/L of phosphate. All solutions were inspected visually for signs of precipitation or crystallization after 18 hours of storage at room temperature and again after 30 minutes in a 37 +/- 1 degrees C water bath. Samples with no visible signs of precipitation were filtered, and the filter membrane was inspected under a microscope. Solubility curves were prepared by plotting the concentrations of calcium and phosphate at which either visual or microscopic precipitation occurred. Calcium and phosphate solubility was greater in the solutions with higher concentrations of amino acids and dextrose. In contrast to the results of some previous studies, no important differences in calcium and phosphate solubility were observed between Aminosyn-PF and TrophAmine in solutions containing amino acid concentrations of 2.5%, with or without added cysteine hydrochloride.(ABSTRACT TRUNCATED AT 250 WORDS)

Compatibility of Drugs with a Heparin-Containing Neonatal Total Parenteral Nutrient Solution

Compatibility of Drugs with a Heparin-Containing Neonatal Total Parenteral Nutrient Solution

Stability of penicillins in total parenteral nutrient solution

The stability of ticarcillin, mezlocillin, and piperacillin in total parenteral nutrient (TPN) solutions at concentrations commonly used in adults was determined. Each antibiotic was added separately to three different amino acids-dextrose TPN solutions in two concentrations: 10 and 20 mg/mL. Amino acids concentration ranged from 25 g/L to 50 g/L. Dextrose concentration ranged from 100 g/L to 350 g/L. Solutions were assayed for antibiotic concentration immediately after mixing (time 0) and at 4, 8, 24, and 48 hours by high-performance liquid chromatography. The effect of the added penicillins on the stability of amino acids and other TPN additives was not investigated. Mezlocillin and piperacillin 10 and 20 mg/mL exhibited stability in TPN solution at 24 hours. Ticarcillin was stable for 24 hours at a concentration of 10 mg/mL, but at 20 mg/mL it was unstable at all times tested. The three antibiotics demonstrated the same characteristic stability in all three TPN solutions, suggesting that the concentrations of dextrose and amino acids did not affect stability. Ticarcillin, mezlocillin, and piperacillin are stable for 24 hours in the TPN solutions studied.

Use of refractive index measurement for quality assurance of pediatric parenteral nutrient solutions

Use of refractive index measurements to assure accurate formulation of pediatric parenteral nutrient base solutions is described. The refractive indexes for various amino acid and dextrose concentrations were determined. An equation was derived to define the theoretical refractive index for combinations of amino acids and dextrose. Finally, a clinically acceptable range (deviation from theoretical) was determined. The actual refractive index for 300 pediatric parenteral nutrient solutions was compared with the calculated theoretical reading. The actual refractive index for all solutions was consistently predicted by the derived equation. Discussions with clinicians resulted in identification of an allowable range for these readings. All reading were within the identified range. The use of refractive index measurements is a valuable quality assurance tool for pediatric parenteral nutrient base formulations.

Calcium and phosphate solubility in neonatal parenteral nutrient solutions containing Aminosyn PF

Factors affecting the solubility of calcium and phosphate in neonatal total parenteral nutrient (TPN) solutions containing a new amino acid formulation were studied. Six TPN solutions containing various concentrations of Aminosyn PF, an amino acid solution for infants and children, were prepared in 10% dextrose injection. Some of the solutions also contained cysteine hydrochloride 40 mg per gram of protein. Various concentrations of calcium gluconate and monobasic and dibasic potassium phosphate were added to 20-mL samples of the TPN solutions. A total of 27 samples of each TPN solution was prepared. Samples were visually inspected after 18 hours at 25 degrees C and again after 30 minutes in a water bath at 37 degrees C. Clear samples at this time were also examined microscopically. Solubility curves were prepared by plotting the concentrations at which either visual or microscopic precipitation occurred. Solubility curves for TPN formulations containing Aminosyn PF revealed a decrease in calcium solubility of 5 to 15 meq/L and a decrease in phosphate solubility of 5 to 15 mmol/L compared with previously published calcium-phosphate solubility curves for another similar amino acid solution, TrophAmine. Calcium and phosphate solubilities were also influenced by temperature and the time after solution preparation. In these TPN formulations containing Aminosyn PF as the amino acid source, the solubilities of calcium and phosphate were substantially less than reported in a previous study of solutions containing TrophAmine.

Use of a microcomputer in a pediatric hospital

The implementation and uses of a microcomputer in a 186-bed pediatric hospital are described. A Kaypro-10 portable microcomputer and an Epson Fx-80 printer were purchased in anticipation of increased workload generated by addition of beds to the hospital's neonatal intensive-care unit. Programs in C-BASIC language were developed for performing mathematical calculations, labeling of unit dose injections and oral liquids, and generating automatic-stop-order renewal notices. A master menu was designed to allow access to all programs. Work sheets to aid in the calculation of solution volumes required to deliver desired dosages of emergency drugs and for preparation of parenteral nutrient solutions are generated by the microcomputer, along with labels for these solutions. Other computer programs allow charging of floor stock items for i.v. admixtures, tracking of emergency-drug boxes, and generation of controlled-substances and anaphylaxis-dosing labels. A total of 510 hours was required to develop the microcomputer programs at a salary cost of $2600. Hospital pharmacies experiencing an expansion of patient services may be able to reduce the impact of the increased workload on manpower requirements by computerizing existing systems. Pharmacies with specialized needs can consider microcomputer implementation and inhouse software development as one alternative.

Computerized order calculation and label generation for neonatal parenteral nutrient solutions

Computerized order calculation and label generation for neonatal parenteral nutrient solutions

Bacterial and fungal growth after freezing or refrigerating parenteral nutrient solutions

Parenteral nutrient (PN) solutions were evaluated for growth of pathogenic organisms after refrigeration or freezing and then thawing. Sixteen bags of hypertonic dextrose and amino acid solutions were divided into two series (refrigerated and frozen), inoculated with Escherichia coli. Candida albicans, Staphylococcus aureus, or Streptococcus faecalis, and exposed to freezing or refrigeration. The inoculum concentration was greater than would likely occur with patient contamination of the solution. Microbial growth in the solutions was determined after warming to room temperature and at 17 or 18 hours after reaching room temperature. There was no increased growth of C. albicans in PN solutions that were frozen versus the refrigerated samples. Counts for all of the organisms in the frozen series, immediately after freezing and then thawing, decreased or stayed the same compared with baseline counts. Growth of E. coli, Staph. aureus, and Strep. faecalis increased in the frozen samples compared with the refrigerated samples after room-temperature storage, suggesting a possible increased risk of infectious complications if contaminated solutions are left at room temperature for extended periods. Since no increased risk of microbial growth is likely in frozen versus refrigerated PN solutions that are thawed and promptly infused, batch freezing may be an effective and convenient means of preparing PN solutions for home patients.

Stability of vitamins in total parenteral nutrient solutions

Stability of vitamins in total parenteral nutrient solutions

Stability of tryptophan in total parenteral nutrient solutions

Stability of tryptophan in total parenteral nutrient solutions

Essential trace element provision to patients receiving home intravenous nutrition in the United Kingdom

The methods of provision of essential trace elements to patients receiving long-term home intravenous nutrition in the U.K. have been reviewed and their trace element status has been assessed. Over a 2 year period, 57 patients based on 15 hospitals throughout the country were studied. Although biochemical abnormalities of trace element status were frequent, related clinical complications were apparently rare. Zinc provision from commercial preparations generally required further supplementation. Copper requirements were variable. Manganese provision from trace element mixtures and chromium provision from contaminants of other parenteral nutrient solutions were excessive in many cases. Aluminium contamination is not significant in the nutrient solutions currently used in the U.K. The most common depletion state is for selenium which should probably be provided on a routine basis. The clinical consequences of long-term under- or over-provision of trace elements by the intravenous route requires further study.

Personnel costs and preparation time in a centralized intravenous admixture program

The amount of time and the cost of personnel time associated with the preparation of injectable products were determined. A time study consisting of 9041 observations during a seven-day period was conducted to determine the amount of time required of pharmacists and technicians for the preparation of total parenteral nutrient (TPN) solutions, large-volume injectables, antibiotic admixtures, antineoplastic admixtures, and investigational drugs. The established times were used to calculate relative value units for each product line and to determine the cost of pharmacist and technician time associated with the preparation of each product line. Preparation times ranged from 3.7 minutes for an antibiotic admixture to 49 minutes for a pediatric TPN solution. Total personnel costs ranged from $0.71 for an antibiotic admixture to $10.70 for a pediatric TPN solution. The calculated relative value units indicated that existing departmental time standards did not allow sufficient time for the preparation of some products. Establishing relative value units and calculating the cost of personnel time associated with the preparation of injectable products can be helpful for comparing the cost of purchasing ready-to-use products with the cost of preparing the same products.

Growth of bacteria and fungi in total nutrient admixtures

Total nutrient admixtures (TNAs) containing dextrose, amino acids, and fat emulsion were evaluated for their ability to support bacterial and fungal growth. The following solutions were tested: a standard adult total parenteral nutrient (TPN) solution with dextrose, amino acids, and electrolytes, a standard neonatal TPN solution with dextrose, amino acids, and electrolytes, a 10% fat emulsion, a 20% fat emulsion, a TNA with 40% of the total calories as fat, a TNA with 25% of the total calories as fat, a neonatal TNA with 25% of the total calories as fat, a control (fat emulsion was replaced with an equal amount of sterile water) for solution 5, and a control for solution 6. Serial dilutions of each solution were inoculated with 5 X 10(5) bacteria/mL or 5 X 10(3) fungi/mL, incubated, and visually rated on a scale of 0 (no growth) to 4 (maximal growth). Bacterial growth of Pseudomonas aeruginosa, Staphylococcus aureus, Staph. epidermidis, Streptococcus faecalis, and Group JK Corynebacterium was greater in the TNA solutions than in the control or standard TPN solutions. Escherichia coli, Candida tropicalis, and C. albicans grew in all solutions tested. Torulopsis glabrata grew better in solutions that did not contain fat emulsion. Growth characteristics did not differ significantly between the adult and neonatal (more dilute) solutions. The addition of fat emulsion to TPN solutions enhances the ability of these solutions to support bacterial growth; this possibility must be considered when evaluating patients for this type of total parenteral nutrition therapy.

Calcium and phosphate solubility in neonatal parenteral nutrient solutions containing TrophAmine

Factors affecting solubilities of calcium and phosphate in neonatal total parenteral nutrient (TPN) solutions containing a new amino acid formulation were examined. Twelve TPN solutions containing various concentrations of TrophAmine, an amino acid formulation specific for infants and young children, were prepared in 10% dextrose injection. Some of the solutions also contained cysteine hydrochloride 40 mg/g of protein and either sodium bicarbonate or hydrochloric acid (lipid emulsion buffer) to buffer the solution pH to simulate that produced by simultaneously administering lipid emulsion through the i.v. line. Calcium gluconate and monobasic and dibasic potassium phosphate were added to 20-mL samples of the TPN solutions to achieve calcium concentrations of 10, 20, 30, 40, or 50 meq/L with phosphate concentrations of either 10, 20, 30, or 40 mmol/L; a total of 20 samples of each TPN solution was prepared. Samples were inspected visually for precipitation or crystallization after 18 hours at 25 degrees C and again after 30 minutes in a water bath at 37 degrees C. Clear samples at this time were also examined microscopically for evidence of microcrystallization. Solubility curves were prepared by plotting graphically the concentrations at which either visual or microscopic precipitation occurred. Temperature, amino acid concentration, and the addition of cysteine hydrochloride and lipid emulsion buffer each influenced the solubilities of calcium and phosphate in the TPN solutions. The use of TrophAmine as the amino acid source allowed slightly greater concentrations of phosphate to be solubilized as compared with older amino acid formulations.(ABSTRACT TRUNCATED AT 250 WORDS)

Determination of osmolality: A quality control method of parenteral nutrient solutions : [formula omitted], S Lefèvre, P. Chaumont, O. Corriol, M. Hamon. (Pharmacie, Hôpital des Enfants Malades, Paris, France)

Determination of osmolality: A quality control method of parenteral nutrient solutions : [formula omitted], S Lefèvre, P. Chaumont, O. Corriol, M. Hamon. (Pharmacie, Hôpital des Enfants Malades, Paris, France)

Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions

The stability of ranitidine hydrochloride in parenteral nutrient (PN) solutions and the effect of ranitidine hydrochloride on the amino acids in the PN solutions were studied. Six PN solutions (three each with amino acid contents of 2.125 and 4.25%) were prepared. Each PN solution also contained dextrose 25%, electrolytes, trace elements, vitamins, and heparin sodium. Ranitidine hydrochloride injection was added to four of the PN samples. Of the final samples, two contained no ranitidine, two contained ranitidine hydrochloride 50 micrograms/mL, and two contained ranitidine hydrochloride 100 micrograms/mL. Admixtures of ranitidine hydrochloride at the two concentrations in 0.9% sodium chloride injection were also prepared. Samples were observed for color change and tested for pH during storage at room temperature. Concentrations of amino acids were measured after 24 hours in samples without ranitidine and in samples containing ranitidine hydrochloride 100 micrograms/mL. Ranitidine hydrochloride content was determined by high-performance liquid chromatography at 12, 24, and 48 hours. No visual changes or pH changes occurred by 24 hours. All PN solutions became darker by 48 hours. The presence of ranitidine hydrochloride did not substantially affect amino acid concentrations. At 24 hours, at least 90% of the initial ranitidine concentrations remained in all samples. In three of the four PN samples at 48 hours, less than 90% of initial ranitidine concentrations remained. Ranitidine hydrochloride in concentrations of 50 and 100 micrograms/mL in parenteral nutrient solutions containing 4.25 and 2.125% crystalline amino acids is stable for 24 hours at room temperature. Under these conditions, concentrations of the amino acids contained in the PN solutions were not affected by the addition of ranitidine hydrochloride.

Amino acid stability and microbial growth in total parenteral nutrient solutions

The stability of amino acids in total parenteral nutrient (TPN) solutions stored for 30 days and the potential for stored TPN solutions to support growth of microbial contaminants were studied. Solutions of 3.5% crystalline amino acids and 25% dextrose with electrolytes were prepared either by using a commercially available amino acid solution with electrolytes or by adding electrolytes individually to a base TPN solution. Solutions were stored in polyvinyl chloride bags at refrigerated (4 degrees C) or room (25 degrees C) temperature for 30 days. Some bags were inoculated with Candida albicans or Pseudomonas maltophilia before storage to serve as positive controls for evaluation of microbial contamination. At appropriate intervals, bags of each type of solution under each storage condition were analyzed for amino acid content. Microbial growth was evaluated by filtering the contents of each bag and incubating the filter in brain-heart infusion broth. No microbial growth was detected in any of the study solutions, but all solutions inoculated with C. albicans and 2 of 16 solutions inoculated with Ps. maltophilia had evidence of growth. No significant decreases in the concentrations of any of the amino acids were noted for solutions stored at refrigerated temperature, but significant decreases in the concentrations of arginine and methionine were noted for solutions stored at room temperature. Total parenteral nutrient solutions can be stored for up to 30 days if they are kept at refrigerated temperatures and protected from light; however, quality assurance measures for these solutions should include end-product microbiologic testing.

Pharmaceutical services in hospitals treating pediatric patients

A survey was conducted of pharmaceutical services in 120 of the 325 short-term hospitals associated with accredited pediatric residency training programs, 52 pediatric hospitals, and 68 adult hospitals with pediatric units or floors. The mail survey conducted in 1983 had a 70% response. Centralized pharmaceutical services were offered by the majority of the hospitals. Seventy-two percent of the respondents indicated that either a complete or partial unit dose drug-distribution system was used for most of their pediatric patients, while 25% indicated that they used either the traditional individual patient-fill system or some combination of drug-distribution systems. A total of 80% of the hospitals provided either complete or partial i.v. admixture services. The preparation of total parenteral nutrient solutions was the most common admixture service provided. Clinical services were provided, to some extent, by 63% of the respondents. Computers were used for multiple functions, such as generating patient profiles, organizing the formulary, and providing labels for unit dose and i.v. admixture services, by 33% of the respondents. Selection of therapeutic alternates was performed by pharmacists in 51% of the responding hospitals, and the majority of institutions had formulary systems. Modern drug-distribution systems and clinical services have been established in many hospitals treating pediatric patients.

Twenty-four-hour single-container system for parenteral nutrient admixtures

Development and implementation of a procedure for preparing parenteral nutrient (PN) solutions in 3-L containers at a 385-bed teaching hospital is described. After identifying problems in procedures for PN therapy, pharmacists collected time and cost data for preparing PN solutions using gravity flow and 1-L containers versus an automated compounding device and 3-L containers. They prepared a proposal for mixing a single daily solution in a 3-L container. A change in hospital policy to permit each PN solution to hang for 24 instead of 12 hours, a change in the pharmacy's schedule for preparing PN solutions, and a policy of hanging all fresh PN solutions between 1800 and 2400 were also proposed. After a one-month trial, the new procedures were adopted. To prepare an average of six PN solutions per day, time decreased from 5.32 to 2.33 hours. Inventory of PN supplies was reduced by 56%. Patients were charged approximately $25 less for three liters of PN solution. Standardized procedures improved efficiency of order filling. A standard procedure for preparing parenteral nutrient solutions in 3-L containers resulted in cost savings for the hospital and the patients and more efficient patient care.

Stability of morphine sulfate and meperidine hydrochloride in a parenteral nutrient formulation

The compatibility, stability, and availability of morphine sulfate and meperidine hydrochloride prepared in total parenteral nutrient (TPN) solution, 5% dextrose injection, and sterile water for injection in polyvinyl chloride (PVC) bags were evaluated. A 300-mg dose of each narcotic was mixed in 0.25-L bags of 5% dextrose injection and sterile water for injection, and in 3-L bags of TPN and sterile water for injection. Each solution was examined visually for precipitation, color change, turbidity, and the evolution of gas immediately after the addition of the drug to the bag and every 12 hours for a 36-hour period. Narcotic concentrations in each solution were determined by high-pressure liquid chromatography before and for 36 hours after the addition of the drugs to the bags. No loss of either drug because of adsorption to the PVC bags was found. Morphine sulfate and meperidine hydrochloride were chemically compatible and stable in TPN and 5% dextrose injection for 36 hours. Solutions of morphine sulfate or meperidine hydrochloride in PVC bags containing TPN or 5% dextrose injection are visually and chemically compatible, as well as stable and available for 36 hours when stored at 21.5 degrees C with no protection from environmental light.