Sterility of filgrastim (G-CSF) in syringes.

OBJECTIVE: To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment. DESIGN: The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0, 24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity. SETTING: A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room. MAIN OUTCOME MEASURES: The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity. RESULTS: Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days. CONCLUSIONS: Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.

Intravenous histamine H2-receptor antagonists and parenteral nutrition: patterns of use.

Patterns of use of i.v. histamine h2-receptor antagonists (H2RAs) and parenteral nutrient solutions in patients receiving both given separately or as admixtures were studied. Consecutive adult patients at a university teaching hospital were placed in an "admixed group," consisting of all those who received an i.v. H2RA as a parenteral nutrient solution additive, or a "nonadmixed group," consisting of all those who received an i.v. H2RA and a parenteral nutrient solution as separate infusions. Data were collected for many variables, including interruptions in therapy, route and method of administration, indication for use, total daily dose of H2RA, patient demographic data, and any additional anti-ulcer drugs prescribed. A total of 128 patients received 158 regimens of therapy, 60 regimens in the admixed group and 98 in the nonadmixed group. There was at least one interruption in i.v. H2RA therapy for 32% of the admixed-group regimens and 33% of the nonadmixed-group regimens. When an interruption occurred, patients in the admixed group missed an average of 40% of their daily H2RA dose, compared with 53% for the nonadmixed group. No alternative anti-ulcer drug was given on 10 (23%) of the 42 days when intensive care patients had an interruption in H2RA therapy, versus 33 (55%) of the 60 days of H2RA interruption for non-intensive-care patients. Interruptions in i.v. H2RA therapy occurred more frequently when the H2RA was a component of the nutrient solution than when it was given as a separate infusion. Supplemental anti-ulcer therapy was typically not provided during interruptions in H2RA therapy, regardless of the method of administration.

Compatibility of cyclosporine with fat emulsion.

The compatibility of cyclosporine with fat emulsion was studied. Admixtures consisted of cyclosporine injection at final drug concentrations of 0.5 and 2.0 mg/mL in 10% and 20% fat emulsion. Fat emulsion stability was determined by visual inspection, pH testing, and particle-size measurements at 0, 24, and 48 hours. Cyclosporine stability was measured with high-performance liquid chromatography at the same intervals. The admixtures were stored in glass containers at 23-25 degrees C under fluorescent light. Mean particle diameters remained relatively constant in all the admixtures throughout the study period. No particles larger than 6 microns were observed. Cyclosporine retained more than 96% of its initial concentration in all the admixtures. There were no changes in color or consistency, and pH did not vary by more than 0.11 pH unit. Cyclosporine 0.5 or 2 mg/mL was compatible with 10% or 20% fat emulsion at room temperature in glass containers for up to 48 hours.

Stability of midazolam hydrochloride in parenteral nutrient solutions.

The compatibility and stability of midazolam hydrochloride in three parenteral nutrient (PN) solutions and the stability of 15 amino acids in the presence of midazolam hydrochloride were studied. Six combinations of three PN solutions with amino acid concentrations of 1.5%, 2.5%, and 5% and two midazolam concentrations (0.1 and 0.5 mg/mL) were prepared in triplicate and stored at room temperature under normal fluorescent lighting. Duplicate samples were visually inspected for color change, precipitation, or gas formation and tested for pH. The samples were evaluated for midazolam and amino acid content by high-performance liquid chromatography at zero, one, three, and five hours. Midazolam and amino acid concentrations did not change significantly during the study. There was no evidence of color change, precipitation, or gas formation with any midazolam-PN solution combination when the combinations were examined visually and under a microscope, and no substantial changes in pH occurred. Midazolam 0.1 and 0.5 mg/mL (as the hydrochloride salt) was stable in the three PN solutions studied; in addition, the amino acids present in the 1.5%, 2.5%, and 5% amino acid PN solutions were stable when combined with midazolam at concentrations of 0.1 and 0.5 mg/mL.