Vancomycin and daptomycin stability in heparin or sodium citrate lock solutions

2021 ◽  
pp. 112972982110458
Author(s):  
Julia Bodega-Azuara ◽  
Maria Dolores Bellés-Medall ◽  
Josep Edo-Peñarrocha ◽  
Raúl Ferrando-Piqueres ◽  
Alejandro Perez-Alba ◽  
...  

Background: We investigated physical and chemical stability of daptomycin and vancomycin in heparin or sodium citrate lock solutions. The aim of this study was to find the optimal combination of antimicrobials and additives for lock solutions, which maximized patient safety. Methods: Vancomycin and daptomycin were diluted with heparin or sodium citrate to achieve final concentrations of vancomycin-heparin 2.5 mg/mL–833.33 U/mL, vancomycin-citrate 2.5–33.3 mg/mL, daptomycin-heparin 5 mg/mL–800 U/mL, and daptomycin-citrate 5–32 mg/mL and they were stored at room temperature (+25°C), 4°C, −20°C, and 37°C. Physical and chemical stability were analyzed for each antibiotic-anticoagulant combination in all conditions immediately after preparation, at 24, 48, 72 h and at different time points until unstable concentrations were obtained. Daptomycin-sodium citrate microbiological activity was also studied by evaluating two Staphylococcus aureus cultures in a calcium enriched medium with a daptomycin E test, with and without sodium citrate. Results: After incubation at 37°C vancomycin and daptomycin combined with heparin retained at least 90% of the initial concentration over 48 h. Vancomycin-sodium citrate solution stored at 37°C reduced more than 10% of the initial concentration at 24 h. On the other hand, daptomycin-sodium citrate preparation was stable at 37°C for 72 h but the microbiological activity of daptomycin was lower in the presence of sodium citrate. Conclusions: The purpose is to prepare vancomycin and daptomycin lock solutions combined with heparin. They should be changed at 48 h and its stability is over 3 days at 25°C and 7 days at 4°C, which allow Hospital Pharmacy Services to manage their stocks. Daptomycin-sodium citrate combination is more stable for extended periods but its bioactivity has not been demonstrated.

1998 ◽  
Vol 32 (7-8) ◽  
pp. 755-757 ◽  
Author(s):  
Raman Venkataramanan ◽  
Jacqueline R McCombs ◽  
Sheila Zuckerman ◽  
Bill McGhee ◽  
Jaya Pisupati ◽  
...  

OBJECTIVE: To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules. METHODS: Suspensions of MMF were prepared at room temperature and stored at 5, 25, 37, and 45 °C over a period of 50 to 210 days. The contents of MMF and its degradation product, mycophenolic acid, in the suspension were measured at various time points by HPLC. RESULTS: MMF suspensions were stable (as determined by the presence of ≥90% of the labeled amount) at 45 °C for at least 11 days, at 37 °C for at least 28 days, at 25 °C for at least 28 days, and at 5 °C for at least 210 days. The suspension was also physically stable at 5 °C during the entire test period. CONCLUSIONS: The compounded MMF suspension was stable for at least 11 days at all the temperatures studied and for as long as 210 days at 5 °C. This formulation appears to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative period.


2005 ◽  
Vol 39 (2) ◽  
pp. 280-283 ◽  
Author(s):  
Lawrence A Trissel ◽  
Yanping Zhang

BACKGROUND: Palonosetron HCl is a selective 5-HT3 receptor antagonist used for the prevention of chemotherapy-induced nausea and vomiting. Palonosetron HCl may be administered with other drugs by Y-site administration, including doxorubicin HCI and epirubicin HCI. Consequently, stability and compatability information are needed to verify the acceptability of such Y-site administration. OBJECTIVE: To evaluate the physical and chemical stability of undiluted palonosetron HCl 50 μg/mL with doxorubicin HCl 1 mg/mL and epirubicin HCl 0.5 mg/mL during simulated Y-site administration. METHODS: Triplicate samples of palonosetron HCl with each of the anthracycline chemotherapy drugs were tested. Samples were stored and evaluated for up to 4 hours at room temperature near 23°C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed by HPLC. RESULTS: All of the admixtures were clear and red—orange when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and remained low throughout the study. The drug concentration was unchanged in any of the samples throughout the study. CONCLUSIONS: Palonosetron HCl is physically and chemically stable with doxorubicin HCl and epirubicin HCl during simulated Y-site administration of these drugs over 4 hours at ambient room temperature.


2020 ◽  
pp. 001857872092538
Author(s):  
Mariah Huskey ◽  
Paul Lewis ◽  
Stacy D. Brown

Objective: Use of ampicillin in outpatient parenteral antimicrobial therapy (OPAT) has historically been complicated by frequent dosing and limited stability. The purpose of this study was to evaluate stability of ampicillin using high-pressure liquid chromatography (HPLC) in an OPAT dosing model using continuous infusion at room temperature over 24 hours immediately following preparation compared with batches stored under refrigeration for 24 hours, 72 hours, and 7 days. Methods: An HPLC method was developed and validated as stability indicating using guidance in USP general Chapter <1225>. Four ampicillin batches were prepared for each experimental condition (immediate use and refrigerated storage for 24 hours, 72 hours, and 7 days). A pump was used to recirculate the solutions through medical-grade tubing for 24 hours. Triplicate 1-mL aliquots were removed from each batch at time 0, 4, 8, 12, and 24 hours and analyzed for ampicillin concentration. Results: Each batch was assayed for initial concentration (20.34-21.50 mg/mL), and percent recovery compared with that concentration thereafter. For the duration of infusion, the average recoveries were 96.4%, 95.8%, 94.6%, and 90.3% for immediate use, 24-hour storage, 72-hour storage, and 7-day storage, respectively. The recovery remained above 90% for all batches and time points, except for 7-day storage, which fell below 90% after 4 hours of circulation. Conclusion: Ampicillin can be prepared and stored in a refrigerator for up to 72 hours prior to continuously infusing at room temperature over 24 hours with less than a 10% loss of potency over the dosing period. This model supports twice weekly OPAT delivery of ampicillin.


2003 ◽  
Vol 37 (6) ◽  
pp. 804-807 ◽  
Author(s):  
Lawrence A Trissel ◽  
Quanyun A Xu

OBJECTIVE: To evaluate the physical and chemical stability of cefepime (as the hydrochloride) 1 g/100 mL and 4 g/100 mL admixed in NaCl 0.9% injection and packaged in AutoDose Infusion System bags. DESIGN: Triplicate test samples of cefepime hydrochloride in NaCl 0.9% injection were packaged in ethylene vinyl acetate plastic containers, AutoDose bags, designed for use in the AutoDose Infusion System. Samples were stored protected from light and evaluated at appropriate intervals for up to 7 days at room temperature of approximately 23 °C and 30 days under refrigeration at 4 °C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual inspection. Chemical stability was assessed by HPLC. RESULTS: All of the admixtures were initially clear and light yellow when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially but increased over time, eventually becoming a yellow or orange precipitate. The higher concentration precipitated earlier; refrigeration slowed precipitation for both test concentrations. HPLC analysis found that the 1-g/100 mL concentration maintained adequate stability for 2 days at 23 °C and up to 30 days at 4 °C. The 4-g/100 mL concentration maintained adequate stability for 1 day at room temperature and 7 days under refrigeration; however, unacceptable drug loss and precipitation developed after those time points. CONCLUSIONS: Cefepime hydrochloride exhibited physical and chemical stability consistent with previous stability studies. The AutoDose Infusion System bags were not found to affect adversely the physical and chemical stability of this drug.


Author(s):  
FEBRINA AMELIA SAPUTRI ◽  
PATIHUL HUSNI ◽  
NORISCA ALIZA PUTRIANA

Objective: This study aims to examine the physical and chemical stability of neem oil cream. Methods: Physical stability was conducted by storing the cream at room temperature (25±2 °C/65 %RH±5 %RH) and high temperature (40±2 °C/75 % RH±5 % RH) for 3 mo. HPLC method using Dionex with UV detection at 219 nm, Shodex (C-18) HPLC packed column (4.6 mmID x 250 mmL), acetonitrile: water [30:70] as mobile phase, 10 min isocratic elution with a flow rate of 1.0 ml/min with volume injection 20 μL was validated then was carried out to measure azadirachtin levels in neem oil cream. The chemical stability of azadirachtin in the cream was determined for 90 days by using this validated method. Results: The neem oil cream was physically stable. The HPLC method of azadirachtin meets all the validation parameters and can be used to analyze the chemical stability of azadirachtin in neem oil cream. Neem oil cream was stable for 4 w at 25 °C and for 1 w at 40 °C. Conclusion: The neem oil cream was either physically or chemically stable for 4 weeks at 25 oC and 1 week at 40 oC


2002 ◽  
Vol 36 (3) ◽  
pp. 423-426 ◽  
Author(s):  
Rowland J Elwell ◽  
Anne P Spencer ◽  
Julie F Barnes ◽  
James E Wynn ◽  
Curtis E Jones

OBJECTIVE: To determine the chemical stability of furosemide in human albumin solution over a 28-day period and to assess admixtures for microbiologic contamination. METHODS: Samples were prepared by mixing furosemide injectable solution and 25% human albumin solution in a 1:1 molar ratio. Six bulk containers were prepared and stored in the dark: 3 under refrigeration (∼4 °C) and 3 at room temperature (∼25 °C). Study samples were withdrawn from each bulk solution immediately after preparation and at predetermined intervals over the subsequent 28 days. Containers were observed for color change and precipitation against a light and dark background at each sampling interval. Total furosemide concentration was determined using HPLC. Additional vials were prepared and assessed for microbiologic growth at time points corresponding with chemical stability results. RESULTS: A mean of 94.5% ± 1.33% of the initial furosemide concentration remained after 48 hours at room temperature. Under refrigeration, 100.6% ± 1.02% of the initial concentration remained at 14 days. Beyond these respective time points, <90% of the initial furosemide concentration remained. No bacterial or fungal growth was observed. CONCLUSIONS: When combined with 25% human albumin solution and stored under darkness, furosemide is chemically stable and free of microbiologic contamination for 48 hours at room temperature and 14 days under refrigeration.


2004 ◽  
Vol 9 (4) ◽  
pp. 254-258
Author(s):  
Wan-Man Ellaria Lee ◽  
Ralph A. Lugo ◽  
William J. Rusho ◽  
Mark MacKay ◽  
John Sweeley

The objective of this study was to determine the chemical stability of extemporaneously prepared lorazepam suspension (1 mg/mL) stored at two temperatures (4°C and 22°C) for 3 months. Lorazepam tablets marketed by two manufacturers (Mylan Pharmaceuticals and Watson Laboratories) were used to extemporaneously formulate two independently prepared suspensions. Each suspension was prepared using sterile water, Ora-Plus® and Ora-Sweet® to achieve a final concentration of 1 mg/mL. The two brands of tablets required different volumes of vehicles to prepare a pharmaceutically optimal suspension. The suspensions were stored in amber glass bottles at 4°C and 22°C for 91 days. Samples were analyzed by high performance liquid chromatography at baseline and on days 2, 3, 7, 14, 21, 28, 42, 63, and 91. The suspensions were considered stable if the mean lorazepam concentration remained greater than 90% of the initial concentration. The chemical stabilities of these two extemporaneously prepared lorazepam suspensions were comparable throughout the study. Both lorazepam suspensions were stable for 63 days when stored at 4°C or 22°C, and both were stable for 91 days when refrigerated at 4°C. When stored at room temperature, the suspension prepared from the Watson tablet retained 88.9 ± 1.4% of the initial concentration on day 91 and was therefore considered unstable, while the suspension prepared from the Mylan tablet was stable for the entire 91-day study.


Reactive extraction of levulinic acid using trin-octylamine (TOA) in 1-hexanol was investigated by physical and chemical extractions from aqueous solution at room temperature. Using the equilibrium data, the distribution coefficient (KD), extraction efficiency (E%), loading ratio (Z), stoichiometric loading factor (ZS) and modified separation factor (Sf ) are evaluated. It was observed that chemical extraction provided a better yield than physical extraction. A maximum KD was obtained as 10.715 using 40% TOA (0.9059 mol/L) while 91.46% of the levulinic acid was extracted. By increasing the initial concentration of levulinic acid resulted in a decrease of KD and E%. The KD and E% increased by increasing the TOA concentration from 10 to 40% (0.2264 mol/L to 0.9059 mol/L).


2021 ◽  
Vol 5 (4) ◽  
pp. 110
Author(s):  
Flaminio Sales ◽  
Andrews Souza ◽  
Ronaldo Ariati ◽  
Verônica Noronha ◽  
Elder Giovanetti ◽  
...  

Polydimethylsiloxane (PDMS) is a polymer that has attracted the attention of researchers due to its unique properties such as transparency, biocompatibility, high flexibility, and physical and chemical stability. In addition, PDMS modification and combination with other materials can expand its range of applications. For instance, the ability to perform superhydrophobic coating allows for the manufacture of lenses. However, many of these processes are complex and expensive. One of the most promising modifications, which consists of the development of an interchangeable coating, capable of changing its optical characteristics according to some stimuli, has been underexplored. Thus, we report an experimental study of the mechanical and optical properties and wettability of pure PDMS and of two PDMS composites with the addition of 1% paraffin or beeswax using a gravity casting process. The composites’ tensile strength and hardness were lower when compared with pure PDMS. However, the contact angle was increased, reaching the highest values when using the paraffin additive. Additionally, these composites have shown interesting results for the spectrophotometry tests, i.e., the material changed its optical characteristics when heated, going from opaque at room temperature to transparent, with transmittance around 75%, at 70 °C. As a result, these materials have great potential for use in smart devices, such as sensors, due to its ability to change its transparency at high temperatures.


2003 ◽  
Vol 807 ◽  
Author(s):  
T. Advocat ◽  
F. Jorion ◽  
T. Marcillat ◽  
G. Leturcq ◽  
X. Deschanels ◽  
...  

ABSTRACTZirconolite is a potential inorganic matrix that is currently investigated in France, in the framework of the 1991 radioactive waste management law, with a view to provide durable containment of the trivalent and tetravalent minor actinides like neptunium, curium, americium and small quantities of unrecyclable plutonium separated from other nuclear waste. To confirm the actinide loading capacity of the zirconolite calcium site and to study the physical and chemical stability of this type of ceramic when subjected to alpha self-irradiation, zirconolite ceramic pellets were fabricated with 10 wt% plutonium oxide (isotope 239 or 238). The 55 pellets are dense (> 93.3% of the theoretical density on average) and free of cracks. They are characterized by a grain size of between 10 and 20 micrometers. X-ray diffraction analyses confirmed the presence of the zirconolite 2M crystalline structure.


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