Stability of Nafcillin Sodium Solutions in the Accufuser^® Elastomeric Infusion Device

Min-A Kang, Ju-Seop Kang

Department of Nursing, College of Nursing, Yonsei University, Seoul, South Korea.
Department of Pharmacology & Clinical Pharmacology Lab, College of Medicine and Division of Molecular Therapeutics Development, Hanyang Biomedical Research Institute, Hanyang University, Seoul, South Korea.

DOI: 10.4236/pp.2013.41008                

Abstract

The aim of this study was to investigate the stabilities of two kinds of solutions of nafcillin sodium (2.5 mg/mL) in 0.9% sodium chloride solution (NS, normal saline) and in injectable 5% dextrose water (D₅W) in the intravenous elastomeric infusion device (Accufuser®) based on recommended solutions and storage periods. The injectable nafcillin solutions (NS- and D₅W-nafcillin) in the Accufuser® device were stored and evaluated at controlled temperatures (room temperature, RT, 5℃ ± 2℃ and cold temperature, CT, 4℃ ± 2℃) during 6 weeks. Effects of the periods of storage (from 0 to 6 weeks) and the temperatures of storage (RT and CT) on the physicochemical appearances and concentrations of active compounds were determined. The visual clarity, pH, and concentrations of nafcillin sodium were determined by stability-indicating high-performance liquid chromatography (HPLC)-ultraviolet (UV) detection. The results showed that in NS and D₅W solutions, the amount of nafcillin slightly changed and remained 92.66% and 97.30% of their initial amounts at CT during 6 weeks, respectively. On the other hand, in NS and D₅W solutions at RT, the amount significantly decreased with time and reached 27.66% and 31.97% of their initial amounts during 4 weeks, respectively. Slight decrement of pH was observed in CT storage while significant change was observed in the RT storage. Moreover, in CT, no significant changes in physical appearances and colors of the solutions were observed during the study. However, the solutions changed into yellowish color and some particles were detected in both kinds of nafcillin solutions (NS and D₅W) after 1.5 weeks in RT conditions. To sum up, under CT two kinds of nafcillin sodium solutions (NS and D₅W) were stable with time in Accufuser® without any significant physical changes and retained almost all of the initial concentrations up to 6 weeks. However, the solutions were not stable in RT storage. We suggest that nafcillin sodium solutions in an Accufuser® should be preferentially diluted in NS and D₅W while storing in CT condition.

Keywords

Stability; Nafcillin Sodium; Intravenous Elastomeric Infusion Device (Accufuser^®)

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	M. A. Kang and J. S. Kang, “Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC-UV Method,” Pharmacology & Pharmacy, Vol. 3, No. 4, 2012, pp. 462-467.
[2]	G. A. Lee, M. J. Kim, M. Kang, et al., “Stability of Commonly Used Antibiotics Solutions in the Accufuser® Elastometric Infusion Device under Recommended Storage and Used Conditions,” The Open Nutraceuticals Journal, Vol. 4, 2011, pp. 125-129. doi:10.2174/1876396001104010125
[3]	L. V. Allen Jr., M. L. Stiles, S. J. Prince and J. Smeeding, “Stability of 14 Drugs in the Latex Reservoir of an Elastomeric Infusion Device,” American Journal of Health-System Pharmacy, Vol. 53, No. 22, 1996, pp. 2740-2743.
[4]	M. L. Stiles and L. V. Allen Jr., “Stability of Nafcillin Sodium, Oxacillin Sodium, Penicillin G Potassium, Pencillin G Sodium, and Tobramycin Sulfate in Polyvinyl Chloride Drug Reservoirs,” American Journal of Health- System Pharmacy, Vol. 54, 1997, pp. 1068-1070.
[5]	Y. Zhang and L. A. Trissel, “Physical Instability of Frozen Pemetrexed Solutions in PVC Bags,” Annals of Pharmacotherapy, Vol. 40, No. 7-8, 2006, pp. 1289-1292.
[6]	L. A. Trissel and Y. Zhang, “Stability of Methylprednisolone Sodium Succinate in Autodose Infusion System Bags,” Journal of American Pharmacists Association, Vol. 42, No. 6, 2002, pp. 868-870.
[7]	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.
[8]	Research Committees of Boston University Research Copmliance, “Conditional Use of Expired Medical Materials,” 2012. http://www.bu.edu/orccommittees/iacuc/policies-and-guidelines/conditional-use-of-expired-medical-materials/
[9]	A. Antoniskis, B. C. Anderson, E. J. van Volkinburg, J. M. Jackson and D. N. Gilbert, “Feasibility of Outpatient Self-Administration of Parenteral Antibiotics,” The Western Journal of Medicine, Vol. 128, 1978, pp. 203-206.
[10]	D. M. Poretz, D. Rich, J. O. Morales, L. V. Behren, et al., “Outpatietns Use of Intravenous Antibiotics,” American Journal of Medicine, Vol. 97, Suppl. 2A, 1994, pp. 1-55. doi:10.1016/0002-9343(94)90280-1
[11]	A. J. J. Wood, “Out-patient Parenteral Antimicrobial-Drug Therapy,” New England Journal of Medicine, Vol. 337, No. 12, 1997, pp. 829-838. doi:10.1056/NEJM199709183371207
[12]	E. Boven, M. M. Nauta, F. P. Schulper, et al., “Secondary Screening of Platinum Compounds in Human Ovarian Cancer Xenografts in Nude Mice,” European Journal of Cancer and Clinical Oncology, Vol. 25, 1995, pp. 276- 283.
[13]	J. P. Fee and G. H. Thompson, “Comparative Tolerability of Profiles of the Inhaled Anesthetics,” Drug Safety, Vol. 16, No. 3, 1997, pp. 157-170.
[14]	D. F. Driscoll, “Stability and Compatibility Assessment Techniques for Total Parental Nutrition Admixtures: Setting the Bar According to Pharmacopeial Standards,” Current Opinion in Clinical Nutrition & Metabolic Care, Vol. 8, 2005, pp. 297-303. doi:10.1097/01.mco.0000165009.24202.64