Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Abstract

The stabilities of two kinds of solutions (30 mg/mL) of Ampicillin sodium in 0.9% NaCl in water (NS, normal saline) and in sterile water (SW) in the intravenous elastomeric infusion device (Accufuser ® ) were evaluated based on recommended solutions and storage periods. The injectable NS-and SW-Ampicillin solutions in the Accufuser ® device were stored and evaluated at controlled temperature (room temperature, 25˚C ± 2˚C and cold temperature, 4˚C ± 2˚C) during 7 days. Effects of the periods of storage (from 0 to 7 days) 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 Ampicillin were determined by stability-indicating high-performance liquid chromatography (HPLC)-ultraviolet (UV) detection. The results showed that the amount of Ampicillin in studied solutions gradually decreased with time. The Ampicillin in NS, which was stored in CT, was relatively stable, retaining 94% of its original amount up to 7 days. The solution that showed least stability was Ampicillin in SW, which was stored in RT, retaining 80% of its original amount. Generally, solutions that were stored in CT were more stable than the solutions that were stored in RT. No significant changes in physical appearance or color of the solutions were observed during the study. Particles were not detected in any solution samples. In summary, two kinds of solutions of Ampicillin sodium, in NS and SW, showed different chemical stabilities with time in intravenous infusion device without any significant physical changes and retained about 94% vs 89% and 83% vs 80% of initial concentrations after 7 days in CT and RT, respectively. We suggest that 30 mg/mL of Ampicillin sodium in NS solution in an Accufuser ® infusion device which is stored in CT can be applicable for 7 days in clinical situations.

Preparation and Characterization for Antibacterial Activities of 3D Printing Polyetheretherketone Disks Coated with Various Ratios of Ampicillin and Vancomycin Salts

“…Total amounts of drug released from the mixtures of ampicillin and vancomycin (samples (B)-(D)) in the buffer solution were higher than pure vancomycin (sample (A)) and ampicillin (sample (E)). From the results shown in Figure 3I, the amount of drug in the buffer solution for sample (A) is higher than that for sample (E), which agrees well with the pKa values for vancomycin and ampicillin [25,26]. A lower pKa value results in faster degradation of PLGA and releases more drug into the buffer solution.…”

“…However, the release profile for the ampicillin for sample (D) showed the maximum value compared with other samples at the same time. A possible reason is due to the number of acidic function groups and the molecular weight of ampicillin and vancomycin [23][24][25]. The values of PKa for vancomycin and ampicillin are 2.99 and 3.24, respectively [23].…”

Enterococcus faecalis Endocarditis and Outpatient Treatment: A Systematic Review of Current Alternatives

“…Moreover, the small population studied and the lack of synergistic activity studies for the penicillin G plus ceftriaxone combination lessen its utility. For a long time, ampicillin stability data were contradictory, whereas recent studies have solved the disagreement [ 38 , 39 , 40 ]. Besides, ampicillin and ceftriaxone daily doses diluted in the same solution were found to be stable, which could be considered as an alternative to administration through a single pump [ 40 ].…”

Stability of Nafcillin Sodium Solutions in the Accufuser<sup>®</sup> Elastomeric Infusion Device

“…The disposable silicon balloon infusion device (Accufuser ® , Woo Young Medical Co. LTD., Seoul, South Korea) is a well-established simplified silicon-based elastomeric system for the administration of antibiotics and other drugs or nutrients that are suitable for patients as well as healthcare providers. An increasing number of patients are being treated as outpatients, and for them, drugs are often infused using portable pumps or infusion devices outside the hospital [1,2]. The disposable silicon balloon infusion device is advantageous in home health care setting because it is disposable, relatively inexpensive compared to electronic pumps, and it is easy for the patient to fill and manipulate [3].…”