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22 views1 page

Ahsiap

Siaap

Uploaded by

Adi Putra
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EV0063 Stability of amoxicillin/clavulanic acid and amoxicillin reconstituted in isotonic saline

Mieke Carlier1,2,3, Alain Verstraete1,2, Jan De Waele1,2,3 ,Veronique Stove1,2


1 Ghent University, Ghent, Belgium; 2 Ghent University Hospital, Ghent, Belgium;3 Research Foundation Flanders, Brussels, Belgium

Background Table 1 : method specifications


An increasing proportion of intensive care units use extended or continuous infusion when Transition Cone (V) Collision energy ( eV) Dwell time (s) Ionisation mode
administering broad spectrum beta-lactam antibiotics, in order to increase PK/PD target Amoxicillin 366.16  113.94 20 20 0.050 ESI +
attainment. Only 1 previous study assessed the stability of amoxicillin/clavulanic acid at room 366.16  349.00 10 0.050
temperature (RT) in a concentration of 20 g/L amoxicillin and 4 g/L clavulanic acid in Amoxicillin D4 370.22  113.90 20 20 0.050 ESI +
Clavulanic Acid 198.03  136.00 20 11 0.050 ESI -
polyolefin infusion bags. Amoxicillin/clavulanic acid was found to be stable for a maximum of
198.03  108.00 7 0.050
4h because of limited stability of clavulanic acid. One study tested the stability of amoxicillin
solution at RT and found this to be stable for 24h. However, interactions can occur between • Stability criterion : ≥ 90% intact molecule ≥ 90% (as specified by the European
drugs and containers, with the possible adsorption onto the surface of the container, leading to Pharmacopeia). The mean measured concentration was used.
loss of drug. Therefore, for each plastic material used and each drug, stability needs to be Results
confirmed. We hypothesized that stability may be improved by dilution. • Amoxicillin alone : Amoxicillin was found was stable until the maximal tested time of 12 h
Objectives storage at RT.
The aim of this study was to assess the stability of amoxicillin as a 10 g/L solution, and • Amoxicillin/clavulanic acid : The combination of amoxicillin and clavulanic acid was much
amoxicillin/clavulanic acid as a 10/2 g/L solution in isotonic saline in a polypropylene infusion less stable; the concentration of clavulanic acid fell below 90% after only 3 h
bag at RT (25°C).
Materials and methods
• Preparation :
• Amoxicillin 1000 mg (Clamoxyl®) and amoxicillin/clavulanic acid 1000 mg/200 mg
(Augmentin®) were obtained as the commercial powder preparation for injection from
GlaxoSmithKline (Wavre,Belgium)
• The powder was reconstituted in 20 mL of 0.9 % sodium chloride for injection and were
then mixed with 80 mL 0.9% sodium chloride solution in a polypropylene infusion bag (n=3 for
each antibiotic, all samples from each bag were analyzed in 5-fold)
• Storage : The infusion bags were stored at 25°C.
• Sampling : The amoxicillin solution was sampled immediately after preparation and at regular
intervals up to 12h later. The amoxicillin/clavulanic acid solution was sampled immediately
after preparation and up to 6h later.
• Analysis : Amoxicillin and clavulanic acid concentrations were determined using stability
indicating high performance liquid chromatography coupled to tandem mass spectrometry
• Sample preparation : The sample was diluted 200 times in water containing the internal Fig 1 Stability over time : mean % intact molecule in function of time. Error bars : ± 1 standard
standard amoxicillin D4 at a concentration of 2.5 mg/L deviation. Black line : limit of stability (90% intact molecule). ○ amoxicillin
(amoxicillin/clavulanic acid combination), □ clavulanic acid (amoxicillin/clavulanic acid
combination), × amoxicillin.

Conclusion
Acknowledgements Amoxicillin as a 10 g/L solution in NaCl 0.9% was stable for up to 12h at 25°C which may allow
Mieke Carlier is funded by a predoctoral mandate from the Research Foundation Flanders. Jan De Waele is a
administration as continuous infusion. When combined with clavulanic acid, stability was
senior clinical investigator from the Research Foundation Flanders.
insufficient to allow continuous infusion.

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