Long-term stability of vancomycin hydrochloride in intravenous infusions.

BACKGROUND AND OBJECTIVE: Vancomycin is often used in antibiotic infusions for hospitalized patients and it is advantageous to prepare such intravenous solutions in advance. The objective of this study was to investigate the long-term stability of this antibiotic stored at 4 degrees C in polyvinyl chloride (PVC) bags. METHOD: Five bags each of 0.5 or 1 g vancomycin hydrochloride per 100 ml of 5% dextrose were studied for 2 months by high-performance liquid chromatography, visual inspection and pH measurement. RESULTS: No colour change or precipitation was observed. The pH values of the preparations increased significantly over the period of study without influencing the antibiotic concentration. Based on a shelf-life of 90% residual potency, the vancomycin solutions were stable for at least 58 days at 4 degrees C. CONCLUSION: From a chemical stability viewpoint, the antibiotic may be prepared in advance by a centralized intravenous admixture service for use within the limits described

Long-term stability of cefuroxime and cefazolin sodium in intravenous infusions.

Cefazolin and cefuroxime sodium are often used as antibiotic infusions for hospitalized patients. Because advance preparation of these intravenous solutions is efficient, the stability of both antibiotics stored at 4 degrees C in polyvinyl chloride (PVC) bags was studied. Five bags of solutions containing either 1 g of cefazolin sodium or 1.5 g of cefuroxime sodium per 100 ml of 5% dextrose were studied for 1 month by high-performance liquid chromatography (HPLC), visual inspection and pH measurement. No colour change or precipitation was observed. The pH values of both drugs increased significantly over the period of study. Based on a shelf-life of 90% residual potency, the cefuroxime sodium concentration was stable for 13 days when stored at 4 degrees C, and the cefazolin sodium concentration was stable for at least 30 days at 4 degrees C. Within these limits, both antibiotics may be prepared in advance by a centralized intravenous admixture service

Effect of freezing, long-term storage, and microwave thawing on the stability of cefepime in 5% dextrose infusion polyvinyl chloride bags.

Cefepime is often used in antibiotic infusions for the hospitalized patients. Using intravenous solutions of cefepime prepared in advance can be efficient, but little information is available about the stability of that antibiotic after freezing followed by microwave thawing. The purpose of this study was to investigate how freezing, long-term storage, and microwave thawing can affect the stability of cefepime in 5% dextrose injection. The stability of 5 polyvinyl chloride bags of solution containing 2g of cefepime per 100 mL of 5% dextrose injection was studied after the bags had remained frozen for 1 month at -20 deg C, were thawed in a microwave oven with a validated cycle, and were stored at 4 deg C. The concentration of cefepime was measured by high-performance liquid chromatography by means of a reversed phase column, a mobile phase consisting of 10% acetonitrile and pentane sulfate buffer, and ultraviolet detection at 254 nm with a diode array detecor. Visual inspection was also conducted, and pH measurements were obtained. No color change or precipitation in the solution was observed. Cefepime remained stable for 11 days. During this period, the 95% lower confidence limit of the estimated regression line of the concentration-time profile remained above 90% of the initial concentration and the pH value increased slightly without affecting chromatographic parameters. Within those limits, cefepime may be prepared in advance by a centralized intravenous admixture service; it may be frozen and then thawed in a microwave before use in clinical units

Long-term stability of tramadol hydrochloride and droperidol mixture in 5% dextrose infusion polyolefin bags at 5+/-3 degrees C.

OBJECTIVE: To investigate the stability of tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100ml of 5% dextrose solution stored at 5+/-3 degrees C. METHODS: Solutions of 5% dextrose 100ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100mg associated with droperidol 2.5mg were prepared under aseptic conditions and stored about 32 days at 5+/-3 degrees C. The tramadol hydrochloride and droperidol concentrations were measured by high performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage. Stability of the solutions was defined as the common regression line 95% lower confidence limit of the concentration remaining superior to 90% of the initial concentration as recommended by the Food and Drug Administration (FDA). RESULTS: No colour change or precipitation in the solutions was observed. Tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100 ml of 5% dextrose infusions was stable when stored at 5+/-3 degrees C during 32 days. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. There was no significant change in pH during storage. CONCLUSION: Under the conditions of this study, tramadol hydrochloride 100mg associated with droperidol 2.5mg in 100 ml of 5% dextrose infusions stored up to 32 days at 5+/-3 degrees C remain stable and may be prepared in advance by CIVAS to improve safety and management

Long-term stability of the hydrochlorides of tramadol and alizapride in dextrose 5% polyolefin bag at 5+/-3 degrees C.

OBJECTIVE: To investigate the stability of tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose solution stored at 5+/-3 degrees C. METHODS: Solutions of 5% dextrose 100ml in polyolefin bags (n=5) containing approximately tramadol hydrochloride 100mg associated with alizapride 50mg were prepared under aseptic conditions and stored about 32 days at 5+/-3 degrees C. The tramadol hydrochloride and alizapride concentrations were measured by high-performance liquid chromatography (HPLC). Visual inspection was performed and pH was measured periodically during the storage. Stability of the solutions was defined as the common regression line 95% lower confidence limit of the concentration remaining superior to 90% of the initial concentration as recommended by the Food and Drug Administration (FDA). RESULTS: No color change or precipitation in the solutions was observed. Tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions was stable when stored at 5+/-3 degrees C during 32 days. Throughout this period, the lower confidence limit of the estimated regression line of concentration-time profile remained above 90% of the initial concentration. There was no significant change in pH during storage. CONCLUSION: Under the conditions of this study, tramadol hydrochloride 100mg associated with alizapride 50mg in 100ml of 5% dextrose infusions stored up to 32 days at 5+/-3 degrees C remain stable and may be prepared in advance by a Centralized Intravenous Additive Service (CIVAS) to improve safety and management

Long-term stability of sodium folinate in dextrose 5% polyolefin bags at 4degreesC.

OBJECTIVES: Preparation of intravenous solutions in advance could be an efficient approach to improve quality assurance, security, time management, and cost saving of drug provision. The purpose of this paper is to investigate the stability of sodium folinate solutions at 3.2 mg mL-1 in 5% dextrose polyolefin bags at 4degreesC. METHODS: The stability of five polyolefin bags of solution containing approximately 3.2 mg mL-1 of sodium folinate in 5% dextrose prepared under aseptic conditions and stored at 48degreesC have been studied over 30 days. Sodium folinate concentrations have been measured by high performance liquid chromatography and the results have been analysed by regression analysis. Solutions have been visually inspected and pH measured. RESULTS: No colour change or precipitation occurred in the preparations. Based on a shelf-life of 90% residual potency, sodium folinate solutions have been observed to be stable for a period of at least 30 days at 4degreesC, where lower confidence limits of the results value remain above 90% of the initial concentration. During this stability period, the pH values of infusions have been observed to decrease slightly without affecting chromatographic parameters. CONCLUSION: Within these limits, sodium folinate in 5% dextrose infusion may be prepared and stored in advance by a centralized intravenous admixture service

Effects of Freezing, Long-Term Storage, and Microwave Thawing on the Stability of Piperacillin Plus Tazobactam in 5% Dextrose for Infusion

ABSTRACT Background: A combination of piperacillin with tazobactam is often administered to hospital patients by infusion. Advance preparation of IV solutions of these drugs could be an efficient way to improve the quality, time management, and cost associated with drug delivery, but little is known about the stability of these drugs after freezing followed by microwave thawing.Objective: The purpose of the study was to investigate how a process of freezing, long-term storage, and microwave thawing affects the stability of piperacillin with tazobactam in 5% dextrose for infusion.Methods: Five replicates of a mixture of 4 g piperacillin and 0.5 g tazobactam in 20 mL of water plus 100 mL of 5% dextrose were prepared and stored in polyvinyl chloride (PVC) bags. The stability of the mixtures was studied after freezing for 3 months at –20°C followed by thawing in a microwave oven and additional storage at 4°C for up to 60 days. The concentrations of piperacillin and tazobactam in each sample were measured by high-pressure liquid chromatography. The samples were inspected visually, and pH was measured.Results: After 3 months of storage at –20°C, microwave thawing, and 35 days of storage at 4°C, more than 90% of the initial concentration of both piperacillin and tazobactam remained. At this point, the lower 95% confidence limit of the best-fit line by linear regression of percent remaining was 90.1% for piperacillin and 90.3% for tazobactam. The pH decreased by 1.16 units over 35 days of storage at 4°C, but no colour change or precipitation was observed. From 35 to 60 days, the concentrations of both piperacillin and tazobactam fell below the acceptable limit and pH values continued to decrease slightly.Conclusions: The combination of piperacillin (4 g/120 mL) and tazobactam (0.5 g/120 mL) in 5% dextrose stored in PVC bags, frozen for 3 months at –20°C, thawed in a microwave oven, and then stored at 4°C for an additional 35 days retained more than 90% of the initial concentration of each drug. This should allow for advance preparation of this drug combination.RÉSUMÉ Historique : On administre souvent par perfusion de la pipéracilline en association avec du tazobactam aux patients hospitalisés. Les mélanges préalablement préparés de solutions i.v. de ces médicaments peuvent s’avérer un moyen efficace d’améliorer la qualité et de réduire le temps ainsi que les coûts associés à leur distribution, mais on ne sait que peu de choses quant à la stabilité de ces médicaments une fois congelés puis décongelés au micro-ondes.Objectif : Le but de cette étude était d’évaluer de quelle manière le processus de congélation, d’entreposage à long terme et de décongélation au micro-ondes influe sur la stabilité de la pipéracilline mélangée à du tazobactam dans du dextrose à 5 % pour perfusion.Méthodes : Cinq mesures de 4 g de pipéracilline mélangée à 0,5 g de tazobactam dans 20 mL de l’eau plus 100 mL de dextrose à 5 % ont été préparées et conservées dans des sacs de polychlorure de vinyle (PVC). Ces mélanges ont été étudiés pour évaluer leur stabilité après une période de congélation de trois mois à –20 °C, suivie de leur décongélation dans un micro-ondes, puis d’une période d’entreposage jusqu’à 60 jours à 4 °C. Les concentrations de pipéracilline et de tazobactam dans chaque échantillon ont été mesurées par chromatographie liquide à haute pression. Les échantillons ont été inspectés visuellement et leur pH mesuré.Résultats : Après avoir été entreposés pendant trois mois à –20 °C, décongelés au micro-ondes, puis entreposés à nouveau pendant 35 jours à 4 °C, les mélanges ont conservé plus de 90 % de leur concentration initiale de pipéracilline et de tazobactam. À ce point, la limite inférieure de confiance à 95 % de la régression linéaire du pourcentage restant était de 90,1 % pour la pipéracilline et de 90,3 % pour le tazobactam. Le pH a diminué de 1,16 unité après 35 jours d’entreposage à 4 °C, mais aucun changement de couleur ni précipité n’a été observé. Durant la période d’entreposage de 35 à 60 jours, les concentrations de la pipéracilline et du tazobactam ont toutes deux chuté sous le seuil acceptable et les valeurs de pH ont continué à diminuer légèrement.Conclusions : Les mélanges de pipéracilline (4 g/120 mL) et de tazobactam (0,5 g/120 mL) dans du dextrose à 5 %, entreposés dans des sacs en PVC, congelés pendant trois mois à –20 °C, décongelés dans un micro-ondes, puis entreposés de nouveau pendant 35 jours à 4 °C ont conservé plus de 90 % de leur concentration initiale de chaque médicament. Les mélanges de cette association médicamenteuse préparés à l’avance peuvent donc être recommandés