Stability of temocillin in outpatient parenteral antimicrobial therapy: is it a real option?

Author:

Fernández-Rubio Beatriz1,Herrera-Hidalgo Laura12ORCID,López-Cortés Luis E345ORCID,Luque-Márquez Rafael23,De Alarcón Arístides23,Luque-Pardos Sonia367,Fernández-Polo Aurora8,Gutiérrez-Urbón José María9,Rodríguez-Baño Jesús345ORCID,Gil-Navarro María Victoria123,Gutiérrez-Valencia Alicia2ORCID

Affiliation:

1. Unidad de Gestión Clínica de Farmacia, Hospital Universitario Virgen del Rocío/Instituto de Biomedicina de Sevilla (IBiS) , Seville , Spain

2. Unidad de Gestión Clinica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen del Rocío/Instituto de Biomedicina de Sevilla (IBiS) , Seville , Spain

3. Centro de Investigación en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III , Madrid , Spain

4. Infectious Diseases and Microbiology Clinical Unit, University Hospital Virgen Macarena/Instituto de Biomedicina de Sevilla (IBiS) , Seville , Spain

5. Departament of Medicine, School of Medicine, University of Sevilla , Seville , Spain

6. Unidad de Gestión Clínica de Farmacia, Hospital del Mar , Barcelona , Spain

7. Infectious Pathology and Antimicrobials Research Group (IPAR), Institut Hospital del Mar d’Investigacions Mèdiques (IMIM) , Barcelona , Spain

8. Unidad de Gestión Clínica de Farmacia, Hospital Universitari Vall d’Hebron , Barcelona , Spain

9. Unidad de Gestión Clínica de Farmacia, Complexo Hospitalario Universitario de A Coruña , A Coruña , Spain

Abstract

Abstract Background Temocillin is an interesting alternative to carbapenems for susceptible Enterobacteriaceae. Although its use in outpatient parenteral antimicrobial therapy (OPAT) programmes has generated interest, this has been hampered by the lack of stability data. Objectives The purpose of the present study was to evaluate the physical and chemical stability of temocillin at the recommended dose for its use in OPAT programmes, contained in polypropylene infusion bags or polyisoprene elastomeric devices at different temperatures, and to describe a novel LC-MS/MS developed for the quantification of temocillin. Methods Temocillin daily dose (6 g) was diluted in 500 mL of 0.9% sodium chloride to obtain a final concentration of 12 g/L. This solution was stored at 4°C, 25°C, 32°C and 37°C for 72 h, both in polypropylene infusion bags and in polyisoprene elastomeric pumps. Physical and chemical stability were evaluated during 72 h after manufacturing. Solutions were considered stable if colour, clearness and pH remained unchanged and if the percentage of intact drug was ≥90%. Results Temocillin attained the chemical stability criterion of ≥90% of the original concentration for the whole experiment in both devices at 4°C, 25°C and 32°C. At 37°C, temocillin was stable for 24 h but its concentration dropped below 90% from that timepoint. No precipitation occurred and minor colour changes were observed. Conclusions Temocillin is stable under OPAT conditions and it would be an appropriate candidate for the treatment of patients who can be discharged to complete therapy in an OPAT programme. For this study, an LC-MS/MS method was developed.

Funder

Sociedad Española de Farmacia Hospitalaria

AFinf Working Group

Instituto de Salud Carlos III

European Development Regional Fund

Subprograma Miguel Servet

Subprograma Juan Rodés

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

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