scholarly journals Physical Compatibility and Chemical Stability of Fentanyl and Naloxone Hydrochloride in 0.9% Sodium Chloride Injection Solution for Patient-Controlled Analgesia Administration

2020 ◽  
Vol Volume 14 ◽  
pp. 4179-4187
Author(s):  
Peng Chen ◽  
Fuchao Chen ◽  
Jiexin Lei ◽  
Benhong Zhou
Keyword(s):  
Sodium Chloride ◽  
Chemical Stability ◽  
Patient Controlled Analgesia ◽  
Injection Solution ◽  
Naloxone Hydrochloride

Drug Stability: Rapid Loss of Fentanyl Citrate Admixed with Fluorouracil in Polyvinyl Chloride Containers

1997 ◽  
Vol 31 (3) ◽  
pp. 297-302 ◽  
Author(s):  
Quanyun A Xu ◽  
Lawrence A Trissel ◽  
Juan F Martinez
Keyword(s):  
Sodium Chloride ◽  
Polyvinyl Chloride ◽  
Chemical Stability ◽  
Drug Stability ◽  
Alkaline Ph ◽  
Rapid Loss ◽  
Fentanyl Citrate ◽  
Particle Content ◽  
Light Obscuration ◽  
Particle Sizer

Objective To study the physical compatibility and chemical stability of fluorouracil 1 and 16 mg/mL with fentanyl citrate 12.5 μg/mL in dextrose 5% and in sodium chloride 0.9% injection. Design Test solutions of the drugs in dextrose 5% injection and in sodium chloride 0.9% injection were prepared in triplicate and stored at −20, 4, 23, and 32 °C. Samples were removed immediately and at various times over 7 days and stored at −70 °C until analyzed. Physical compatibility was assessed visually and by measuring turbidity with a color-correcting turbidimeter; particle content was measured with a light-obscuration particle sizer and counter. Chemical stability was determined by measuring the concentration of each drug in the test solutions in duplicate with stability-indicating HPLC. Results Fentanyl citrate was rapidly lost when admixed with fluorouracil in polyvinyl chloride (PVC) containers, losing about 25% in the first 15 minutes and about 50% in the first hour. The loss of fentanyl citrate was so rapid that accurate time zero determinations were not possible. The extent of fentanyl loss increased with time and occurred more rapidly at the higher temperatures (i.e., 23,32 °C). Losses of 70% or more occurred in all samples within 24 hours. Fentanyl underwent rapid sorption to the containers at the high pH (9.0–9.5) of the fluorouracil admixtures. Adjusting the pH of a fentanyl citrate solution (containing no fluorouracil) in PVC containers to pH 9 with sodium hydroxide also resulted in rapid sorption loss. Fentanyl citrate sorption did not occur when admixtures were prepared in polyethylene containers. Fluorouracil remained stable for at least 7 days at all temperatures. There were no visual or subvisual changes in turbidity or particle content in any of the test solutions at any time. Conclusions When admixed with fluorouracil 1 and 16 mg/mL in dextrose 5% injection and sodium chloride 0.9% injection, fentanyl citrate 12.5 μg/mL underwent rapid and extensive loss due to sorption to the PVC containers, making the combination unacceptable within minutes of mixing. The sorption results from the alkaline pH of the admixture and, presumably, could occur from the admixture of fentanyl citrate with any sufficiently alkaline drug.

scholarly journals Physico-Chemical Stability of Sodium Thiosulfate Infusion Solutions in Polyolefin Bags at Room Temperature over a Period of 24 Hours

2018 ◽  
Vol 3 (3) ◽  
pp. 135-142
Author(s):  
Elise D’Huart ◽  
Jean Vigneron ◽  
Florence Ranchon ◽  
Nicolas Vantard ◽  
Catherine Rioufol ◽  
...  
Keyword(s):  
Sodium Chloride ◽  
Chemical Stability ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Sodium Thiosulfate ◽  
Colour Change ◽  
Array Detector ◽  
Intravenous Route ◽  
Uv Spectrophotometry ◽  
Renal Protection

Abstract Background Many publications described sodium thiosulfate used to prevent the renal toxicity induced by cisplatin hyperthermic intraperitoneal chemotherapy. After around 60 or 90 minutes of hyperthermic chemotherapy, cisplatin was drained and then, sodium thiosulfate was infused by intravenous route. Sodium thiosulfate is used in two steps: a first step, at 9 g/m2 in 250 mL of 0.9 % sodium chloride over 10 minutes followed by a second step, at 12 g/m2 in 1000 mL of 0.9 % sodium chloride over 6 hours. The purpose of this work was to study the stability of sodium thiosulfate at 16 mg/mL in 0.9 % sodium chloride polyolefin bags 1000 mL and at 72 mg/mL in 0.9 % sodium chloride polyolefin bags 250 mL, at 25 °C, protected or unprotected from light. Methods Chemical stability was analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector after preparation and after 6-hour or 24-hour storage. The method was validated according to the International Conference on Harmonisation (ICH). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry at 550 nm). Three bags for each condition were prepared. On each time of the analysis, three samples were prepared for each bag and analysed by HPLC. pH values were evaluated on each moment of the analysis. Results Sodium thiosulfate solutions diluted in 0.9 % sodium chloride at 16 and 72 mg/mL retained more than 95 % of the initial concentration during 24 hours. Concerning pH measurements, the maximum variation was 0.24 pH unit. No visual modification such as colour change, precipitation or gas formation was observed. The absorbance at 550 nm obtained for each sample was less than 0.010 AU. Conclusions Sodium thiosulfate solutions at 16 mg/mL in 1000 mL 0.9 % sodium chloride and at 72 mg/mL in 250 mL 0.9 % sodium chloride are stable physically and chemically over a period of 24 hours at 25 °C, with or without protection from light. This stability study allows the use of sodium thiosulfate in renal protection protocols during cisplatin hyperthermic intraperitoneal chemotherapy.

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.

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.

scholarly journals Compatibility and Stability of Morphine Sulphate and Naloxone Hydrochloride in 0.9% Sodium Chloride for Injection

2013 ◽  
Vol 66 (3) ◽  
Author(s):  
Charlotte Kistner ◽  
Mary H H Ensom ◽  
Diane Decarie ◽  
Gillian Lauder ◽  
Roxane R Carr
Keyword(s):  
Sodium Chloride ◽  
Morphine Sulphate ◽  
Naloxone Hydrochloride

scholarly journals Stability of Butorphanol–Tropisetron Mixtures in 0.9% Sodium Chloride Injection for Patient-Controlled Analgesia Use

Medicine ◽  
2015 ◽  
Vol 94 (6) ◽  
pp. e432 ◽  
Author(s):  
Fu-Chao Chen ◽  
Xiao-Ya Shi ◽  
Peng Li ◽  
Jin-Guo Yang ◽  
Ben-Hong Zhou
Keyword(s):  
Sodium Chloride ◽  
Patient Controlled Analgesia

scholarly journals Managing the Intravenous Calcium Shortage: Evaluation of Calcium Chloride Stability in 0.9% Sodium Chloride and Dextrose 5% Water Polyvinyl Chloride Bags

2012 ◽  
Vol 47 (1) ◽  
pp. 27-30 ◽  
Author(s):  
H. Kiser Tyree ◽  
R. Barber Gerard ◽  
Robinson Aubrey
Keyword(s):  
Sodium Chloride ◽  
Calcium Chloride ◽  
Polyvinyl Chloride ◽  
Chemical Stability ◽  
Room Temperature ◽  
Life Support ◽  
Physical Stability ◽  
Final Concentration ◽  
Fluorescent Light ◽  
Intravenous Calcium

Background Intravenous calcium chloride (CaCl) is commonly used by inpatient practitioners for a myriad of indications from electrolyte abnormalities to advanced cardiac life support. Currently, a paucity of data is available regarding the stability of CaCl after preparation of intravenous admixtures. Purpose This study evaluated the physical and chemical stability of CaCl 10% diluted in 0.9% sodium chloride or dextrose 5% water polyvinyl chloride bags. Method CaCl 10% solution (1000 mg) was diluted with 0.9% sodium chloride or dextrose 5% water 100 mL for injection to a final concentration of 10 mg/mL. CaCl 10% solution (2000 mg) was diluted with 0.9% sodium chloride or dextrose 5% water 150 mL for injection to a final concentration of 13.3 mg/mL. Each of the preparations were stored at room temperature (23–25°C) and exposed to fluorescent light. Samples of each preparation were analyzed on days 0, 2, 3, 5, and 7. Sterility and physical stability were assessed. Chemical stability of CaCl was evaluated by indirect potentiometry. Results CaCl 10 mg/mL and 13.3 mg/mL solutions in polyvinyl chloride bags were physically stable during the entire 7-day study period. CaCl retained >90% of the original concentration at 7 days after preparation in 0.9% sodium chloride and dextrose 5% water. Conclusion CaCl diluted to 10 mg/mL or 13.3 mg/mL with 0.9% sodium chloride or dextrose 5% water for injection is both physically and chemically stable for a period of 7 days with ≤10% degradation under conditions of room temperature with fluorescent lighting.

scholarly journals The physical and chemical stability of cisplatin (Teva) in concentrate and diluted in sodium chloride 0.9%

2012 ◽  
Vol 5 ◽  
pp. 435-439 ◽  
Author(s):  
Agnieszka Karbownik ◽  
Edyta Szałek ◽  
Hanna Urjasz ◽  
Aleksandra Głęboka ◽  
Emilia Mierzwa ◽  
...  
Keyword(s):  
Sodium Chloride ◽  
Chemical Stability ◽  
Physical And Chemical
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