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 compo...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.展开更多
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 ev...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℃ ± 2℃ and cold temperature, 4℃ ± 2℃) during 7 days. Effects of the periods of storage (from 0 to 7 days) and the temperatures of storage (RT and CT) on the physico-chemical 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.展开更多
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 ...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.展开更多
基金supported by Hanyang University and Woo Young Medical Co.LTD.,Seoul,South Korea.
文摘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.
基金supported by Division of Molecular Therapeutics Development,Hanyang Biomedical Research Institute,Hanyang University and Woo Young Medical Co.LTD.,Seoul,South Korea.
文摘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℃ ± 2℃ and cold temperature, 4℃ ± 2℃) during 7 days. Effects of the periods of storage (from 0 to 7 days) and the temperatures of storage (RT and CT) on the physico-chemical 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.
基金supported by Division of Molecular Therapeutics Development,Hanyang Biomedical Research Institute,Hanyang University and Woo Young Medical Co.LTD.,Seoul,South Korea.
文摘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.
