Intravenous Suitability Studies of Commonly Used Oxacillin Sodium Solutions in the ACCUFUSER® Infusion Device


Our study compares two commonly used solutions of oxacillin sodium, 5.0 mg/mL in either 0.9% sodium chloride (NS) or 5% dextrose water (D5W), for their continued suitability for IV usage, and stability of active compound over time, when stored at two different controlled temperatures for six weeks. Both solutions were stored in an intravenous infusion device commercially available as Accufuser® and kept at a continuously maintained temperature of either 4 ± 2?C (CT) or 25 ± 2?C (RT). Suitability for IV administration was assessed by measuring changes in macrographical transparency and pH over time, and drug stability was assessed by measuring changes in oxacillin concentration over time using high-performance liquid chromatography (HPLC). After 6 weeks, concentrations of oxacillin were unchanged in the CT solutions, while both RT solutions showed significant decreases in the concentration of oxacillin after only two weeks. Final concentration compared to starting concentrations after 6 weeks at RT, were 36.57% in NS, while virtually no oxacillin was detectable in D5W. Also pH measurements showed a slight decrement at 2 weeks with RT, and at 6 weeks, there was a significant change in pH in both NS and D5W at RT. There was no significant change in color, transparency or appearance after 6 weeks in any of the oxacillin solutions stored in the Accufuser® infusion device. In summary, two commonly used IV solutions for oxacillin administration(5 mg/mL in NS or D5W) stored ready to use in the Accufuser® showed significant changes over time when maintained at RT, that would make the solutions inappropriate for therapeutic use. Both solutions when maintained in CT were not significantly altered and continued to be appropriate in pH and drug concentration for IV therapy. This suggests that ready-to-use solutions of oxacillin sodium in the Accufuser® infusion device can be kept at CT for up to 6 weeks safely but should not be stored at RT due to loss of potency and changes in pH.

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M. Kim, G. Lee, Y. Park, S. Kim, S. Kim, M. Kang, M. Kim and J. Kang, "Intravenous Suitability Studies of Commonly Used Oxacillin Sodium Solutions in the ACCUFUSER® Infusion Device," Pharmacology & Pharmacy, Vol. 2 No. 3, 2011, pp. 189-193. doi: 10.4236/pp.2011.23027.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] G. Y. Lee, M. J. Kim, M. Kang, Y. S. Park, S. H. Kim, S. Y. Kim, J. S. Kang, Stability of Commonly Used Antibi- otics Solutions in the Accufuser? Elastometric Infusion Device under Recommended Storage and Used Condi- tions. The Open Nutraceuticals Journal, Vol. 4, 2011, pp. 125-129.
[2] M. L. Stiles and L. V. Allen Jr, Stability of nafcillin so- dium, oxacillin sodium, penicillin G potassium, penicillin G sodium, and tobramycin sulfate in polyvinyl chloride drug reservoirs. American Journal of Health-System Pharmcy, Vol. 54, No. 9, 1997, pp.1068-1070.
[3] K. A. O’Bey, L. K. Jim, J. P. Gee and R. M. Johnson, Temperature dependence of the stability of tobramycin mixed with penicillins in human serum, American Jour- nal of Hospital Pharmacy, Vol. 39, No. 6, 1982, pp. 1005- 1008.
[4] Q. A. Xu, L. A. Trissel, C. A. Saenz, D. S. Ingram and K. Y. Williams, Stability of three cephalosporin antibiotics in AutoDose Infusion System bags. Journal of American Pharmaceutical Association (Washington D.C.; 1996), Vol. 42, No. 3, 2002, pp. 428-431.
[5] L. A. Trissel and Q. A. Xu, Stability of cefepime hydro- chloride in AutoDose Infusion System bags. The Annals of Pharmacotherapy, Vol. 37, No. 6, 2003, pp 804-807.
[6] J. H. Fischer JH, M. J. Cwik, M. S. Luer, C. B. Sibley and K. L. Deyo KL, Stability of fosphenytoin sodium with intravenous solutions in glass bottles, polyvinyl chloride bags, and polyethylene syringes. The Annals of Pharmacotherapy, Vol. 31, No. 5, 1997; pp 553-559.
[7] T. Dine, F. Khalfi, B. Gressier, M. Luyckx, C. Brunet, L. Ballester, F. Goudaliez, J. Kablan, M. Cazin and J. C. Cazin, Stability study for fotemustine in PVC infusion bags and sets under various conditions using a stabil- ity-indicating high-performance liquid chromatographic assay, Journal of Pharmaceutical Biomedical Analysis, Vol. 18, No. 3, 1998, pp. 373-381.
[8] B. Benaji, T. Dine, M. Luyckx, B. Gressier, C. Brunet, F. Goudaliez, M. Cazin M and J. C. Cazin, Stability and compatibility studies of zorubicin in intravenous fluids and PVC infusion bags, Journal of Pharmaceutical Bio- medical Analysis, Vol. 14, No. 6, 1996, pp. 695-705.
[9] Y. Zhang and L. A. Trissel, Physical and chemical stabil- ity of pemetrexed solutions in plastic syringes, The An- nals of Pharmacotherapy, Vol. 39, No. 12, 2005, pp. 2026-2028.
[10] V. Kumar, H. Bhutani and S. Singh, ICH guidance in practice: validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products. Journal of Pharmaceutical and Biomedical Analysis, Vol. 43, No. 2, 2007, pp. 769- 773.
[11] M. J. Akhtar, S. Khan and M. A. Khan, Determination of ampicillin in human plasma by high-performance liquid chromatography using ultraviolet detection, Journal of Pharmaceutical Biomedical Analalysis, Vol. 11, No. 4-5, 1993, pp. 375-378.
[12] J. Haginaka, J. Wakai, H. Yasuda, T. Uno, K. Takahashi and T. Katagi, High-performance liquid chromatographic determination of ampicillin and its metabolites in rat plasma, bile and urine by post-column degradation with sodium hydrochloride. Journal of Chromatography, Vol. 400, No. 6, 1987, pp. 101-111.
[13] V. F. Samanidou, E. N. Evaggelopoulou, I. N. Papadoy- annis, Development of a validated HPLC method for the determination of four penicillin antibiotics in pharmaceu- ticals and human biological fluids. Journal of Separation Science, Vol. 29, No. 11, 2006, pp. 1550-1560.

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