Stability of Cefepime Hydrochloride in AutoDose Infusion System Bags

2003 ◽  
Vol 37 (6) ◽  
pp. 804-807 ◽  
Author(s):  
Lawrence A Trissel ◽  
Quanyun A Xu
Keyword(s):  
Chemical Stability ◽  
Room Temperature ◽  
Visual Inspection ◽  
Physical Stability ◽  
Ethylene Vinyl Acetate ◽  
Light Yellow ◽  
Drug Loss ◽  
Physical And Chemical ◽  
Plastic Containers ◽  
Infusion System

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.

Palonosetron HCl Compatibility and Stability with Doxorubicin HCl and Epirubicin HCl During Simulated Y-Site Administration

2005 ◽  
Vol 39 (2) ◽  
pp. 280-283 ◽  
Author(s):  
Lawrence A Trissel ◽  
Yanping Zhang
Keyword(s):  
Receptor Antagonist ◽  
Chemical Stability ◽  
Drug Concentration ◽  
Room Temperature ◽  
Visual Inspection ◽  
Physical Stability ◽  
Chemotherapy Drugs ◽  
Ambient Room Temperature ◽  
Physical And Chemical ◽  
Anthracycline Chemotherapy

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.

Stability of Imipenem-Cilastatin Sodium in AutoDose Infusion System Bags

2003 ◽  
Vol 38 (2) ◽  
pp. 130-134
Author(s):  
Lawrence A. Trissel ◽  
Quanyun A. Xu
Keyword(s):  
Sodium Chloride ◽  
Chemical Stability ◽  
High Performance ◽  
Physical Stability ◽  
Analytical Techniques ◽  
Storage Condition ◽  
Evaluation Procedure ◽  
Drug Concentrations ◽  
Physical And Chemical ◽  
Infusion System

The objective of this study was to evaluate the physical and chemical stability of imipenem-cilastatin sodium 250 mg/100 mL and 500 mg/100 mL (of each drug component) admixed in 0.9% sodium chloride injection packaged in AutoDose Infusion System bags. Triplicate test samples were prepared by bringing the required amount of imipenem-cilastatin sodium injection to volume with 0.9% sodium chloride injection. A total of 100 mL of each of the test solutions was packaged in each of three ethylene vinyl acetate (EVA) AutoDose bags designed for use in the AutoDose Infusion System for each storage condition. Samples were protected from light and evaluated at appropriate intervals for up to three days at 23°C and 14 days at 4°C. Physical stability was assessed using a multistep evaluation procedure that included turbidimetric and particulate measurement in addition to visual inspection. Chemical stability was assessed with stability-indicating high performance liquid chromatography (HPLC) analytical techniques, based on initial drug concentrations and concentrations at appropriate intervals over the study periods. The admixtures were clear throughout the study when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change throughout the study. HPLC analysis revealed extensive decomposition in the samples, with imipenem being the less stable component. The instability of the imipenem-cilastatin sodium admixtures is consistent with previous studies. Admixtures stored under refrigeration should be used immediately upon warming to room temperature due to the rapid rate of imipenem decomposition. The AutoDose Infusion System bags were not found to affect adversely or improve the physical and chemical stability of this drug.

scholarly journals PHYSICAL AND CHEMICAL STABILITY TEST OF NEEM OIL CREAM (AZADIRACHTA INDICA) USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2021 ◽  
pp. 128-134
Author(s):  
FEBRINA AMELIA SAPUTRI ◽  
PATIHUL HUSNI ◽  
NORISCA ALIZA PUTRIANA
Keyword(s):  
Chemical Stability ◽  
High Performance ◽  
Room Temperature ◽  
Packed Column ◽  
Physical Stability ◽  
Hplc Method ◽  
Neem Oil ◽  
Isocratic Elution ◽  
Validation Parameters ◽  
Physical And Chemical

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

AMPHOTERICIN B TOPICAL EXTEMPORANEOUS PREPARATIONS FOR THE TREATMENT OF NON-DERMATOPHYTIC ONYCHOMYCOSIS

2020 ◽  
pp. 135-139
Author(s):  
KOMESMUNEEBORIRAK PHOJANA ◽  
WERAWATGANONE PORNPEN ◽  
MUANGSIRI WALAISIRI
Keyword(s):  
Amphotericin B ◽  
Chemical Stability ◽  
High Performance ◽  
Sodium Lauryl Sulfate ◽  
Physical Stability ◽  
Lauryl Sulfate ◽  
Physical And Chemical ◽  
Injection Product

Objective: At present, the nail preparation to cure onychomycosis, caused by non-dermatophyte molds, is not commercially available in Thailand. The physical and chemical stability of amphotericin B (AmB) extemporaneous preparations in the presence of 30% dimethyl sulfoxide (DMSO) and their in vitro nail permeation was evaluated. Methods: AmB extemporaneous preparations in the presence of 30% DMSO were prepared from a commercial sterile injection product, and cream or hydrophilic ointment. Physical stability was tested at 30°C for 2 months, or using 6 heating-cooling cycles. The chemical stability and in vitro nail permeation of AmB content were analyzed using high-performance liquid chromatography (HPLC). In vitro nail permeation was performed by applying 3.5 mg/mm2 of the tested formulation on nail clippings for 5 consecutive days. Results: The AmB cream and ointment extemporaneous preparations containing 30% DMSO, a permeation enhancer, were homogeneous and pale yellow to yellow cream or ointment. The AmB ointment was stable for up to 60 days. The ointment preparation allows in vitro penetration through nails up to 14.17 μg/cm2. The ointment preparation allows significantly better penetration through than the cream preparation due to the presence of DMSO, sodium lauryl sulfate (SLS), and water in the ointment preparation. Conclusion: The AmB extemporaneous ointment was successfully compounded from a commercial sterile injection product with a beyond-use date of 60 days. The ointment preparation is currently under further investigation for in vivo efficacy.

Compatibility and Stability of Paclitaxel Combined with Doxorubicin Hydrochloride in Infusion Solutions

1998 ◽  
Vol 32 (10) ◽  
pp. 1013-1016 ◽  
Author(s):  
Lawrence A Trissel ◽  
Quanyun A Xu ◽  
Doward L Gilbert
Keyword(s):  
Chemical Stability ◽  
High Intensity ◽  
Physical Stability ◽  
Visual Observation ◽  
Fluorescent Light ◽  
Doxorubicin Hydrochloride ◽  
Particle Content ◽  
Drug Concentrations ◽  
Physical And Chemical ◽  
Storage Temperatures

OBJECTIVE: To evaluate the physical compatibility and chemical stability of paclitaxel at concentrations of 300 and 1200 μg/mL with doxorubicin hydrochloride 200 μg/mL in NaCl 0.9% injection and dextrose 5% injection over 7 days at 4, 23, and 32 °C. DESIGN: The test samples were prepared in polyolefin bags of the infusion solutions at the required drug concentrations. Evaluations were performed initially and after 4 hours, and 1, 3, 5, and 7 days of storage at 4, 23, and 32 °C for physical and chemical stability. Physical stability was assessed by using visual observation in normal fluorescent light and a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the two drugs was evaluated by using two stability-indicating HPLC analytic techniques. RESULTS: All samples were physically stable through 1 day. However, microcrystalline precipitation of paclitaxel occurred within 3 days in some samples and within 5 days in all samples. Paclitaxel concentrations remained at more than 97% in all samples throughout the study. Doxorubicin hydrochloride also was stable throughout the study period, remaining above 90% in all samples at all storage temperatures. CONCLUSIONS: Admixtures of paclitaxel 300 and 1200 μg/mL with doxorubicin hydrochloride are limited in their utility time by paclitaxel microcrystalline precipitation. All combinations were physically and chemically stable for at least 24 hours at 4, 23, and 32 °C.

Compatibility and Stability of Paclitaxel Combined with Cisplatin and with Carboplatin in Infusion Solutions

1997 ◽  
Vol 31 (12) ◽  
pp. 1465-1470 ◽  
Author(s):  
Yanping Zhang ◽  
Quanyun A Xu ◽  
Lawrence A Trissel ◽  
Doward L Gilbert ◽  
J Frank Martinez
Keyword(s):  
Light Beam ◽  
Chemical Stability ◽  
High Intensity ◽  
Physical Stability ◽  
Analytical Techniques ◽  
Visual Observation ◽  
Particle Content ◽  
Drug Concentrations ◽  
Normal Light ◽  
Physical And Chemical

OBJECTIVE: To evaluate the physical compatibility and chemical stability of paclitaxel at concentrations of 0.3 and 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection and with carboplatin 2 mg/mL in NaCl 0.9% injection and dextrose 5% injection over 7 days at 4, 23, and 32°C. DESIGN: The test samples were prepared in polyolefin bags of the infusion solutions at the required drug concentrations. Evaluations were performed initially and after 4 hours, and 1, 3, 5, and 7 days of storage at temperatures of 4, 23, and 32°C for physical and chemical stability. Physical stability was assessed by using visual observation in normal light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the three drugs was evaluated by using three stability-indicating HPLC analytical techniques. RESULTS: All samples were physically stable through 1 day. However, microcrystalline precipitation of paclitaxel occurred in 3 days in some samples and within 5 days in all samples. Paclitaxel concentrations remained above 90% in all samples throughout the study. Cisplatin admixtures exhibited paclitaxel concentration-dependent decomposition with cisplatin losses of approximately 5–8% in 4 hours and approximately 20% in 1 day at 23 and 32°C in the paclitaxel 1.2 mg/mL admixtures. With paclitaxel 0.3 mg/mL in the admixtures, cisplatin losses were about 10% in 7 days at these temperatures. Carboplatin in admixtures with both concentrations of paclitaxel was stable for 7 days at 4°C, but sustained losses of about 10% and 12% in 3 days at 23 and 32°C, respectively. CONCLUSIONS: Admixtures of paclitaxel 0.3 and 1.2 mg/mL with cisplatin and carboplatin are limited in their utility time by both paclitaxel microcrystalline precipitation and decomposition of cisplatin and carboplatin. The admixture of paclitaxel 1.2 mg/mL with cisplatin 0.2 mg/mL in NaCl 0.9% injection exhibits unacceptable cisplatin loss in 24 hours. All other combinations were physically and chemically stable for at least 24 hours at 4, 23, and 32°C.

The Stability of Diluted Vincristine Sulfate Used as a Deterrent to Inadvertent Intrathecal Injection

2001 ◽  
Vol 36 (7) ◽  
pp. 740-745 ◽  
Author(s):  
Lawrence A. Trissel ◽  
Yanping Zhang ◽  
Michael R. Cohen
Keyword(s):  
Sodium Chloride ◽  
Chemical Stability ◽  
High Performance ◽  
Intrathecal Injection ◽  
Physical Stability ◽  
High Performance Liquid Chromatographic ◽  
Intrathecal Administration ◽  
Vincristine Sulfate ◽  
Analytical Technique ◽  
Physical And Chemical

The objective of this study was to evaluate the physical and chemical stability of vincristine sulfate diluted to a variety of concentrations in 0.9% sodium chloride injection and packaged in minibags and 30 mL syringes, to help deter inadvertent intrathecal injection of the drug. Test samples were prepared by diluting vincristine sulfate quantities of 0.5 mg, 1 mg, 2, mg, and 3 mg in 0.9% sodium chloride injection. These quantities were selected to span the range of doses normally expected for this cytotoxic drug. The vincristine was diluted with 0.9% sodium chloride injection in volumes of 25 mL and 50 mL packaged in polyvinyl chloride minibags and to 20 mL packaged in 30 mL polypropylene syringes. Physical and chemical stability evaluations were performed initially and after 1, 3, and 7 days of storage at 4°C followed by an evaluation at 9 days after 2 additional days of storage at a temperature of 23°C. Physical stability was assessed using visual observation in normal light and a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drug was evaluated by using a stability-indicating high performance liquid chromatographic (HPLC) analytical technique. No physical instability was noted and no unacceptable loss of vincristine sulfate concentration was found in any sample throughout the study period. The use of vincristine sulfate doses diluted in infusion volumes of 0.9% sodium chloride injection and packaged in minibags or in 30 mL syringes to help deter inadvertent intrathecal administration may be performed with no unacceptable physical or chemical instability occurring.

Stability of Mycophenolate Mofetil as an Extemporaneous Suspension

1998 ◽  
Vol 32 (7-8) ◽  
pp. 755-757 ◽  
Author(s):  
Raman Venkataramanan ◽  
Jacqueline R McCombs ◽  
Sheila Zuckerman ◽  
Bill McGhee ◽  
Jaya Pisupati ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Chemical Stability ◽  
Mycophenolic Acid ◽  
Postoperative Period ◽  
Dosage Form ◽  
Room Temperature ◽  
Pediatric Patients ◽  
Early Postoperative Period ◽  
Time Points ◽  
Physical And Chemical

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.

Chemical and Physical Stability of an Admixture Containing Cefepime and Vancomycin in Lactated Ringer Solution

2020 ◽  
pp. 001857871990127
Author(s):  
Pegah Shakeraneh ◽  
Risako Robinson ◽  
Wesley D. Kufel ◽  
L. Nathan Tumey ◽  
Samantha R. Benjamin ◽  
...  
Keyword(s):  
Liquid Chromatography ◽  
Chemical Stability ◽  
Visual Inspection ◽  
Physical Stability ◽  
Ringer Solution ◽  
Sterile Water ◽  
Time Curve ◽  
Concentration Time ◽  
Auc Value

Purpose: To evaluate the chemical and physical stability of an admixture containing cefepime and vancomycin in a single volume of lactated Ringer solution at refrigerated temperatures. Methods: Cefepime 2000 mg and vancomycin 1000 mg were, respectively, reconstituted with 10 and 20 mL of sterile water for injection (SWFI) per manufacturer instructions. This resulted in cefepime and vancomycin concentrations of 200 and 50 mg/mL, respectively. The resulting cefepime and vancomycin solutions at 10 and 20 mL, respectively, were drawn up and injected into 1000 mL lactated Ringer solution. Aliquot samples were obtained on days 0 to 9, visually inspected for gross incompatibility, and then stored at −80°C. Samples were thawed on the day of the analysis and run through ultraperformance liquid chromatography. Area under the concentration-time curve (AUC) on each day was compared with baseline AUC values. Chemical stability was defined as an AUC more than 93% of the baseline value. Results: No evidence of gross physical incompatibility was observed by visual inspection. Cefepime and vancomycin replicants were more than 94.5% and 98% of baseline AUC values. Therefore, all sample replicants were found to be more than 93% of their baseline AUC value. Conclusion: An admixture containing cefepime 2000 mg and vancomycin 1000 mg in 1000 mL lactated Ringer solution appears to be chemically and physically stable at refrigerated temperatures for up to 9 days.

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 ◽  
...  
Keyword(s):  
Chemical Stability ◽  
Hospital Pharmacy ◽  
Room Temperature ◽  
Sodium Citrate ◽  
Optimal Combination ◽  
Pharmacy Services ◽  
Microbiological Activity ◽  
Initial Concentration ◽  
Time Points ◽  
Physical And Chemical

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.

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