ARTICLE | doi:10.20944/preprints202212.0162.v1
Subject: Medicine And Pharmacology, Pharmacology And Toxicology Keywords: Temocillin; Stability; Outpatient Parenteral Antimicrobial Therapy; Temperatures; Elastomeric devices; Infusion bags
Online: 8 December 2022 (14:32:52 CET)
Objective: To evaluate the physical and chemical stability of the antibiotic temocillin at the recommended dose for severe infections and contained in infusion bags or elastomeric devices at different temperatures for its use in Outpatient Parenteral Antimicrobial Therapy (OPAT) programs.Method: Solutions of temocillin 12 g/L diluted in 0.9% sodium chloride were stored at 4ºC ± 2ºC, 25°C ± 2°C, 32°C ± 2°C and 37°C ± 2°C for 72 h both in polypropylene infusion bags and in polyisoprene elastomeric pumps. Physical and chemical stability were evaluated at 12, 24, 30 48 and 72 h after manufacturing. The solutions were considered stable if color, clearness and pH remained unchanged and if the percentage of intact drug was ≥90%. Results: There were no observed changes in color or clarity in any of the refrigerated (4°C) samples or in the samples incubated at 25ºC and 32ºC. At 37ºC, an increase in intensity of yellow color was observed at 30, 48 and 72 h in both infusion bags and elastomeric pumps samples. All samples remained within the pH range 6.84–6.06. At 4ºC, 25ºC and 32°C ± 2°C, temocillin attained the stability criteria of ≥90% of the original concentration for the whole experiment in both devices. At 37ºC, temocillin was stable for 24 h but its concentration dropped below 90% from that time point both in the infusion bags and in the elastomeric pumps.Conclusions: According to the data provided in this stability study, temocillin administrated by continuous infusion would be an appropriate candidate for the treatment of patients that can be discharge to complete therapy in an OPAT program.