AbstractBackgroundIn the University Medical Centre Mainz, standard concentrations are defined for medicinal products to be administered by continuous injection with syringe pumps in adult intensive care patients. The objective of this study was to evaluate the physicochemical stability of ready-to-use and ready-to-administer preparations containing Epinephrine (E) and Norepinephrine (NE) in standardized concentrations and prepared batch wise in the pharmacy department as basis for assigning shelf-lives.MethodsE 20 µg/mL and NE 10 µg/mL in disposable syringes and NE 40, 100, 200, 400 µg/ml in 50 ml amber type I glass vials were prepared batch wise and the concentrations were analyzed by stability-indicating, validated reversed-phase HPLC-PDA assays. Test solutions for long-term stability studies were stored under refrigeration (2–8 °C) for 6–12 months or at elevated temperatures (21–27 °C) light protected for up to 6 months or without light protection for up to one month. Osmolality and pH were measured on predefined intervals.ResultsThe concentrations of E in 50 mL syringes and NE in 10 mL syringes remained unchanged over a period of 6 months when stored at 2–8 °C. NE preparations of different concentrations prepared in amber glass vials remained stable over a study period of 12 months. At RT the shelf-life decreased to about 6 months and the exposure to mixed daylight at RT caused loss of stability in only few days.ConclusionsBatch wise preparation of ready-to-administer (RTA) preparations containing 20 µg/mL E or 10 µg/mL NE in disposable syringes as well as ready-to-use (RTU) preparations containing 40, 100, 200 and 400 µg/mL NE was successfully implemented in a pharmacy department. Storage of the preparations at refrigerated temperatures is required to obtain acceptable shelf-lives of 6–12 months. Elevated temperatures and especially exposure to mixed daylight significantly decreased the shelf life.

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.

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AbstractBackgroundProfound knowledge about the physicochemical stability is necessary in order to determine the “beyond-use-dates” of ready-to-administer preparations after reconstitution and dilution. This is especially true for unstable azanucleoside drugs like decitabine. The aim of this study was to determine the physicochemical stability of decitabine after reconstitution and dilution of DacogenMethodsTo determine the stability of frozen DacogenTo determine the stability of reconstituted DacogenDiluted DacogenDecitabine concentrations were determined at 0, 5, 8, 12, 24 and 48 hours after preparation. The pH-values were determined at 0, 8, 24 and 48 hours. Each sample was assayed by a validated stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) assay with photodiode array detection.ResultsWhen test solutions of reconstituted DacogenIn reconstituted test solutions in glass vials and in diluted test solutions in infusion bags stored under refrigeration decitabine concentrations remained above 90 % of the initial concentration for 12 hours and 24 hours, respectively. Several peaks of degradation products were observed which explicitly increased over time.In all test solutions the pH-values amounted to pH 7 and remained unchanged. No particulate matter and no colour changes were observed over the test period.ConclusionsReconstituted decitabine solution (Dacogen

Introduction: Medication adherence was only studied in a limited number of potential organ recipients. So far medication adherence was not evaluated by utilizing electronic monitoring systems in dialysis and liver cirrhosis patients. The main objective of the present study was to measure the medication adherence of patients suffering from end stage kidney or liver disease by an objectified method. Methods:Adult liver cirrhosis patients taking propranolol and dialysis patients taking phosphate binders, each medication 3 times daily, were eligible to be enrolled in the study protocol. Medication adherence was measured electronically with MEMS TM -containers over a period of 6 months in each patient.Results: 34 patients suffering from liver cirrhosis and 36 dialysis patients participated in the study and were analysed per protocol. The Dosing Adherence (DA) rate differed significantly (p<0.023) between the two patient groups (mean DA rate of liver cirrhosis patients vs. dialysis patients: 61% vs. 43%). Conclusion:Low medication adherence rates observed in liver cirrhosis patients and dialysis patients ask for better patient education. Pharmaceutical care programs enhancing adherence should be implemented in both patient groups before transplantation and continued after transplantation.