Abstract: Numerous ready-to-use parenteral solutions are aseptically prepared in pharmacy-based aseptic preparation units. Microbiological stability of the preparations is influenced by the cleanroom environment, the complexity of the aseptic process, conditions during administration and the microbiological vulnerability of the products.: The aim of the study was to evaluate the ability of four different pathogens related to hospital infections to grow in ready-to-use, non-cytotoxic parenteral products aseptically prepared in hospital pharmacies.: In four consecutive series the antimicrobial activity of the following products was tested: caspofungin 35 mg or 70 mg in 250 mL 0.9 % NaCl solution (NS), micafungin 0.5 mg/mL in NS, vancomycin 5 mg/mL in G5/G10, heparin-sodium 1 IE/mL in NS, epinephrine 0.02 mg/mL in G5, norepinephrine 0.01 mg/mL in G5, phenylephrine 0.1 mg/mL, KCl solution 0.8 mmol/mL, trace elements 1:1 in G5/G10, midazolam 1 mg/mL injection solution, tranexamic acid 100 mg/mL injection solution, 50 % glucose solution, SMOFlipid 20 % lipid emulsion, 1 % propofol injection.Nine milliliter aliquots of each test solution were inoculated with 1 mL suspension of selected strains, i. e.: Most of the tested preparations induced no growth inhibition of the tested organisms. The selected strains lost viability in preparations containing vancomycin, phenylephrine or midazolam after a period of a few hours or days. Glucose 50 % w/v solution generated antimicrobial activity against: The lack of antimicrobial properties of ready-to-use, non-cytotoxic solutions should be considered while determining the shelf-life of the products. Ready-to-use preparations should be kept refrigerated whenever possible to inhibit the multiplication of any contaminating organism.

ObjectivesIrinotecan-loaded microspheres are used for simultaneous embolisation and chemotherapy of liver metastases of colorectal carcinoma. The aim of the study was to evaluate the compatibility of recently introduced DC BeadM1 (bead size 70–150 µm) loaded with irinotecan after admixture with different types and volumes of non-ionic contrast media over a maximum period of 24 h and storage at room temperature.MethodsTest suspensions were prepared by loading 2 mL DC BeadM1 with 100 mg irinotecan within 2 h. The loading efficiency was determined by measuring the concentrations of irinotecan in the excess solutions via a reversed phase high pressure liquid chromatography (RP-HPLC) assay with ultraviolet detection. The compatibility of irinotecan-loaded DC BeadM1 with different types and volumes of contrast media was studied by mixing 2 mL loaded bead slurry each with up to four different volumes (5, 10, 20, 30 mL) of seven different contrast media. Samples were withdrawn after 30 min, 1, 2, 4, 8 and 24 h. Admixtures were stored light protected at room temperature over the observation period. The concentrations of eluted irinotecan were measured in triplicate samples using the RP-HPLC assay.ResultsMixing of irinotecan loaded beads with non-ionic contrast media decreased the irinotecan loading efficiency between minimum 2.5% and maximum 17% over the observation period of 24 h. The rate and amount of irinotecan eluted from the beads varied relying on the type and volume of contrast medium admixed. However, no further elution or degradation was observed after the rapid release during the first 8 h.ConclusionsBecause of the rapid and extensive release of irinotecan, it is not recommendable to prepare admixtures of irinotecan-loaded DC BeadM1 with contrast media in centralised cytotoxic preparation units in advance. Admixture should be performed with the smallest possible amount by the radiologists immediately prior to the delivery procedure.

Compatibility of epirubicin-loaded DC bead™ with an equal volume of different contrast media in polypropylene syringes is given over a period of seven days. Due to a maximum elution of 0.1-0.5% of epirubicin from loaded DC bead™, admixtures with contrast media can be prepared in advance in centralized cytotoxic preparation units. Microbiological aspects have to be considered when determining the expiration date of the product.