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Investigations into the physical and chemical stability of concentrated co-trimoxazole intravenous infusions

Khaleel, I, Razi Zaidi, ST ORCID: 0000-0002-2031-1055, Shastri, MD ORCID: 0000-0002-1012-2779, Eapen, MS ORCID: 0000-0003-0570-7059, Ming, LC ORCID: 0000-0002-6971-1383, Wanandy, T ORCID: 0000-0003-4703-0488 and Patel, RP ORCID: 0000-0001-9344-1013 2017 , 'Investigations into the physical and chemical stability of concentrated co-trimoxazole intravenous infusions' , European Journal of Hospital Pharmacy , pp. 1-7 , doi: 10.1136/ejhpharm-2017-001225.

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Abstract

Objectives: High dose of intravenous sulfamethoxazoleand trimethoprim (co-trimoxazole) is often used inimmunocompromised patients for the treatment ofPneumocystis jiroveci pneumonia. Current manufacturer’sdilution recommendation for intravenous co-trimoxazole(1:25 v/v) requires the administration of 2 L of additionalfluid per day causing serious complications includingpulmonary oedema. Intravenous administration ofconcentrated solution of co-trimoxazole may minimisethe risk of fluid overload associated side effects.Therefore, the objective of the study was to investigatethe physicochemical stability of concentrated intravenousco-trimoxazole solutions.Methods: Four ampoules of intravenous co-trimoxazolewere injected into an infusion bag containing either 480(1:25 v/v), 380 (1:20 v/v), 280 (1:15 v/v) or 180 (1:10 v/v)mL of glucose 5% solution. Three bags for each dilution(total 12 bags) were prepared and stored at roomtemperature. An aliquot was withdrawn immediately(at 0 hour) and after 0.5, 1, 2 and 4 hours of storagefor high-performance liquid-chromatography (HPLC)analysis, and additional samples were withdrawn everyhalf an hour for microscopic examination. Each samplewas analysed for the concentration of trimethoprimand sulfamethoxazole using a stability indicating HPLCmethod. Samples were assessed for pH, change incolour (visually) and for particle content (microscopically)immediately after preparation and on each time ofanalysis.Results: Intravenous co-trimoxazole at 1:25, 1:20,1:15 and 1:10 v/v retained more than 98% of the initialconcentration of trimethoprim and sulfamethoxazole for4 hours. There was no major change in pH at time zeroand at various time points. Microscopically, no particleswere detected for at least 4 hours and 2 hours whenintravenous co-trimoxazole was diluted at 1:25 or 1:20and 1:15 v/v, respectively. More than 1200 particles/mL were detected after 2.5 hours of storage whenintravenous co-trimoxazole was diluted at 1:15 v/v.Conclusions: Intravenous co-trimoxazole is stable overa period of 4 hours when diluted with 380mL of glucose5% solution (1:20 v/v) and for 2 hours when diluted with280mL glucose 5% solution (1:15 v/v).

Item Type: Article
Authors/Creators:Khaleel, I and Razi Zaidi, ST and Shastri, MD and Eapen, MS and Ming, LC and Wanandy, T and Patel, RP
Keywords: Chromatography, stability, antibiotic, infusion, trimethoprim, sulfamethoxazole
Journal or Publication Title: European Journal of Hospital Pharmacy
Publisher: B M J Group
ISSN: 2047-9956
DOI / ID Number: 10.1136/ejhpharm-2017-001225
Copyright Information:

Copyright 2017 European Association of Hospital Pharmacists (unless otherwise stated in the text of the article)

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