Polyvinyl Chloride Bags Research Articles

Suitability of aromatic polyurethanes for use in nuclear applications

Plastic bags are used to facilitate the storage and transport of nuclear materials. In case the storage container becomes damaged, these bags act as a protection barrier against possible contamination. Polyvinyl chloride (PVC) is a polymer commonly used in such applications, but unfortunately, it contributes to the corrosion of the metal container due to HCl evolution. Thus, this work evaluated aging effects on chemical and thermo-mechanical properties of aromatic polyurethanes with the intent to find a replacement for PVC. Aromatic poly(ether)urethanes were aged for up to 21 months under combined gamma irradiation and thermal treatment conditions. A few samples were also placed into actual nuclear storage containers and aged for a similar time period. Experimental techniques, such as FT-IR, NMR, mass spectrometry, TGA, DSC, and tensile tests were employed to characterize two types of polyurethanes, one with and another one without a flame-retardant additive. Our unique aging approach shows that these aromatic polyurethanes are well placed to substitute PVC bags and thus, avoid corrosion of storage metal containers used by the nuclear industry.

"Evaluation of Phenylephrine Stability in 0.9% Sodium Chloride Polyvinyl Chloride Bags"

"Evaluation of Phenylephrine Stability in 0.9% Sodium Chloride Polyvinyl Chloride Bags"

1733. Stability of Imipenem/Cilastatin/Relebactam under Different Temperature and Administration Conditions

Abstract Background Imipenem/Cilastatin/Relebactam is an FDA-approved combination antibiotic indicated for resistant infections. There is a practical need to extend the shelf life of parenterals given to patients with such life-threatening infections in the hospital setting. The reconstituted drug's shelf life can be extended by storing at subzero temperatures to slow the degradation kinetics. Package insert indicate stability is 2 hrs at room temperature and refrigeration up to 24 hr. The study aims to determine the stability of the combination in polyvinyl chloride (PVC) infusion (IV) bags when stored at room temperature, refrigerated in addition to continuous infusion CADD pumps. Methods Drug vials (Merck & Co) were reconstituted to 5mg/mL (imipenem) in a 100mL normal saline. To avoid further degradation, samples were collected and mixed 1:1 with stabilizing buffer, then frozen at -80 °C within 5 minutes. For room temperature stability, 6 bags were prepared and stored at (24°C). 0.5ml samples were collected at 0, 2, 4, 6, 8, 12, 24 h from each bag at each time point. For refrigeration stability, 6 bags were prepared and refrigerated at 4 °C. At each time point (24, 36, 48, 60, 72, 84, 96,108, 120h), a sample of 0.5-mL is taken from each bag and frozen at −80 °C. For continuous ambulatory drug delivery (CADD) infusion devices stability, the reconstituted drug is loaded to 2g/200 mL cassettes (for 24-hr infusion) continuous infusion and 1g/100mL (for 12-hr infusion). The cassettes are immediately attached to the infusion pump and placed in a cold pouch with gel packs. After the initial 0.5 mL, 0-h samples from each pump, the pumps are sampled at 4, 8,12, 16, 20, and 24 hours for 2g/ 200mL cassettes and 2, 4, 8, 12 h for 1g/100 mL. Cut off for stability was set at 90% of the original concentration. Chemical assay was performed by a validated HPLC method. Results See tables Table 1:CADD pumps, concentrations are in mg/mL. Imi; imipenem, Rel; relebactam, Cil; Cilastatin, CADD; continuous ambulatory delivery device, SD; standard deviationTable 2:PCV bags, concentrations are in mg/mL. Imi; imipenem, Rel; relebactam, Cil; Cilastatin, PVC; polyvinyl chloride, SD; standard deviation Conclusion Imipenem/relebactam/cilastatin drug product was stable for 12 hrs in CADD pumps 100mL, 16 hrs in 200 mL, 108 hours in refrigerated PVC bags and 12 hrs at room temperature. The extended stability data will assistant pharmacy departments in optimizing drug preparation and storage, nursing time and minimize drug waste improving overall cost and efficiency of drug administration. Disclosures Islam Ghazi, PharmD, Merck And Co Inc: Grant/Research Support David Nicolau, PharmD, Marck and Co Inc: Advisor/Consultant|Marck and Co Inc: Grant/Research Support.

Physical compatibility and chemical stability of dezocine and ramosetron in 0.9% sodium chloride injection for patient-controlled analgesia administration.

As an antiemetic, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist (ramosetron) is generally administered to prevent and treat postoperative nausea and vomiting induced by intravenous dezocine for patient-controlled analgesia. To date, the physicochemical stability of dezocine-ramosetron admixtures has not been assessed. The primary objective of this study was to evaluate the physicochemical stability of a combination of dezocine and ramosetron in 0.9% sodium chloride (normal saline [NS]) injections. Dezocine-ramosetron admixtures were prepared and stored in glass bottles and polyvinyl chloride (PVC) bags refrigerated at 4°C or stored at ambient temperatures (25°C) for up to 14 days. Initial concentrations were 5.0 mg/100 mL for dezocine and 0.3 mg/100 mL for ramosetron used as the diluents. Stability parameters (drug concentrations and pH values) were determined using high-performance liquid chromatography and pH measurements, respectively. Compatibility (cloudiness, discoloration, and precipitation) was assessed visually. After 14 days at 4 °C or 25 °C, the concentration losses of dezocine and ramosetron were both < 4%. Furthermore, there were no significant changes in color, turbidity, or pH values were observed in any of the batches. The results indicated that mixtures of dezocine and ramosetron in NS injections were continuously physically and chemically stable for 14 days in glass bottles or PVC bags stored at 4 °C or 25 °C.

Extended Stability of Vasopressin Injection in Polyvinyl Chloride Bags and Polypropylene Syringes and Its Impact on Critically Ill Patient Care and Medication Waste.

Background. Vasopressin is frequently utilized for a variety of shock states in critically ill patients. Short stability (≤24 hours) after intravenous admixture with current manufacturer labeling requires just in time preparation and may lead to delays in therapy and increased medication waste. We aimed to evaluate vasopressin stability in 0.9% sodium chloride stored in polyvinyl chloride bags and polypropylene syringes for up to 90 days. Additionally, we evaluated the impact of extended stability on the time to administration and cost savings from reduced medical waste at an academic medical center. Methods. Dilutions of vasopressin to concentrations of 0.4 and 1.0 unit/mL were performed under aseptic conditions. The bags and syringes were stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at each point and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of vasopressin was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Results. Vasopressin diluted to 0.4 and 1.0 unit/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags and syringes diluted to 0.4 units/mL had <10% degradation. Vasopressin diluted to 1 unit/mL and stored under refrigeration had <10% degradation at all measured days, but when stored under room temperature was found to have >10% degradation at day 30. Implementation of a batching process resulted in reduced waste ($185 300) and improved time to administration (26 vs 4 minutes). Conclusion. Vasopressin diluted to a concentration of 0.4 units/mL with 0.9% sodium chloride injection is stable for 90 days at room temperature and under refrigeration. When diluted to 1.0 unit/mL with 0.9% sodium chloride injection it is stable for 90 days under refrigeration. Use of extended stability and sterility testing to batch prepare infusions may lead to improved time to administration and cost savings from reduced medication waste.

Extended stability of vasopressin 0.2 unit/mL in PVC containers.

Vasopressin is used to maintain blood pressure in vasodilatory shock. Vasopressin is diluted from concentrated vials prior to administration as a continuous infusion. This study evaluates the physical and chemical stability changes of vasopressin diluted to 0.2 units/mL with 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags stored under refrigeration. Vasopressin Injection, USP, 20 unit/mL solution was diluted to 0.2 unit/mL with 0.9% sodium chloride injection, and stability changes were evaluated over 10 days via mass spectrometry on days 0, 7, and 10. Solutions of vasopressin 0.2 unit/mL in 0.9% sodium chloride injection in PVC bags were physically stable and showed less than 10% degradation over 10 days of refrigerated storage. Vasopressin 0.2 unit/mL may be given a beyond-use date (BUD) of 10 days based on United States Pharmacopeia BUD recommendations, with this study showing less than 10% degradation over 10 days of refrigerated storage.

Extended Stability of Isoproterenol Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light Blocking Bags.

Purpose:Evaluate the stability of isoproterenol hydrochloride injection in 0.9% sodium chloride in polyvinyl chloride bags for up to 90 days. Methods: Dilutions of isoproterenol hydrochloride injection to a concentration of 4 μg/mL were performed under aseptic conditions. The bags were stored in amber ultraviolet light blocking bags at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 2, 14, 30, 45, 60, and 90. Physical stability was performed by visual examination. The pH was assessed at baseline, each analysis day, and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of isoproterenol hydrochloride was evaluated using liquid chromatography with tandem mass spectrometry. Samples were considered stable if there was <10% degradation of the initial concentration. Results: Isoproterenol hydrochloride diluted to 4 μg/mL with 0.9% sodium chloride injection was physically stable throughout the study. No precipitation was observed. At days 2, 14, 30, 45, 60, and 90 all bags diluted to 4 μg/mL had <10% degradation when stored under refrigeration (3°C-5°C) or stored at room temperature (23°C-25°C). Conclusion: Isoproterenol hydrochloride diluted to a concentration of 4 μg/mL with 0.9% sodium chloride for injection in ultraviolet light blocking bags was stable for 90 days at room temperature and under refrigeration.

Compatibility and stability of methylprednisolone sodium succinate and granisetron hydrochloride in 0.9% sodium chloride solution.

A combination of methylprednisolone sodium succinate (MSS) and granisetron hydrochloride (GH) is generally devoted to treating the chemotherapy-induced nausea and vomiting. To date, none of these novel mixtures have been commercially available. The present study was aimed at investigating physical and chemical compatibility and stability of a combination of MSS with GH in 0.9% sodium chloride injection for 72 hours at 4°C and 25°C. A mixture of MSS (0.4-0.8 mg/mL) with GH (0.03 mg/mL) was prepared and stored in both polyvinyl chloride bags and glass bottles using 0.9% sodium chloride injection as a diluent. The study was performed using a validated and stability-indicating high-performance liquid chromatography method. The physical compatibility was assessed by a spectrometer. Furthermore, the pH measurement of each sample was measured electronically. All test solutions stored at 4°C or 25°C had a no >2% loss of the initial concentration throughout the 72-hour study period. All solutions remained clear and colorless throughout the study and were without precipitation or turbidity in any of the batches. The drug mixtures of MSS (0.4-0.8 mg/mL) and GH (0.03 mg/mL) in 0.9% sodium chloride injections were physically and chemically stable for at least 72 hours when stored at 4°C or 25°C in polyvinyl chloride bags or glass bottles.

Quantitative determination of trace amounts of Diethylhexyl phthalate content in Dextrose injection proficiently by a simplistic Gas Chromatography Technique

The objective of present study was to analyze Diethylhexyl phthalate content in 5% Dextrose injection and other reconstituting diluents for pharmaceutical injectable formulations. Reconstituting diluents for pharmaceutical injectable formulations are mainly stored and supplied in polyvinyl chloride bags. This may lead to leaching of Diethylhexyl phthalate, a toxic content from polyvinyl chloride bags into reconstituting formulations. In the current study, a proficient and simple method by using a Gas Chromatograph was developed and validated for the quantitation of trace amounts of Diethylhexyl phthalate in 5% Dextrose injection. The method was optimized by using silica fused short capillary column (DB-1; USP G2 phase) with dimensions 5 m length x 0.53 mm inner diameter and 2.65µm film thickness. The method involves a simple extraction procedure for sample preparation by means of extraction with n-Hexane solvent and evaporation with a stream of nitrogen gas. An Internal standard (1-Phenydodecane) was added to standard and sample preparations by using n-Hexane as diluent. The method was validated as per the current regulatory guidance for analytical method validation.The projected methodology was found to be selective, accurate, precise, and linear in the test concentration range from 0.004 µg/mL to 5.065µg/mL for Diethylhexyl phthalate. The method was effectively used to analyze the Diethylhexyl phthalate content in 5% Dextrose Injection and other reconstituting diluents for pharmaceutical injectable formulations.

Stability of Captisol-enabled versus propylene glycol–based melphalan at room temperature and after refrigeration

In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To compare the chemical stability of Captisol-enabled (CE) melphalan ("CE-melphalan"; Evomela, Acrotech Biopharma LLC) and propylene glycol-(PG)-based melphalan ("PG-melphalan"; Alkeran, GlaxoSmithKline) admixtures prepared with 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags or reconstituted vials stored at room temperature (RT) and under refrigeration. Lyophilized CE-melphalan and generic PG-melphalan were reconstituted to 5 mg/mL with 0.9% sodium chloride injection or manufacturer-supplied diluent, respectively. The reconstituted vials were then diluted to the desired concentrations with 0.9% sodium chloride injection in PVC bags and were stored at RT (23 °C) or under refrigeration (4 °C). Aliquots were withdrawn from the bags and reconstituted vials of CE-melphalan and PG-melphalan immediately after preparation and at predetermined time intervals. Melphalan concentrations were measured using a validated high-performance liquid chromatography method. CE-melphalan reconstituted in PVC bags at concentrations of 1 and 2 mg/mL was stable for 6 and 24 hours, respectively, at RT and for 8 and 24 hours, respectively, at 4 °C. PG-melphalan reconstituted in bags at 1, 1.5, and 2 mg/mL was stable for 1, 2, and 2 hours, respectively, at RT and for 2, 4, and 4 hours, respectively, at 4 °C. Reconstituted CE-melphalan vials were stable for 48 hours at both RT and 4 °C, whereas PG-melphalan vials were stable for 6 hours at RT but formed precipitate within 2 hours at 4 °C. CE-melphalan remained stable longer than generic PG-melphalan under the test conditions. CE-melphalan at 2 mg/mL has 24-hour stability at RT and can be used for extended infusion times or may be compounded ahead of time. Reconstituted CE-melphalan vials are stable for 48 hours at both RT and 4 °C.

High‐performance liquid chromatography–ultraviolet detection method to evaluate the migration of di(2‐ethylhexyl) terephthalate and its metabolite from polyvinyl chloride bag in four labile blood products

AbstractA liquid chromatography with UV detection method has been developed and validated for the quantitation of di(2‐ethylhexyl)terephthalate, a blood bag plasticizer, and its monoester metabolite, mono(2‐ethylhexyl)terephthalate, in the four labile blood products: whole blood, red cells concentrate, plasma and platelet concentrate. Quantitation thresholds were compared with those obtained using the more conventional tandem mass spectrometry detection and revealed that UV performed better than mass spectrometry for the quantitation of di(2‐ethylhexyl)terephthalate.Liquid‐liquid extraction was selected for sample preparation. Recoveries ranged from 101 to 106 and from 80 to 83%, for di(2‐ethylhexyl)terephthalate and mono(2‐ethylhexyl)terephthalate, respectively, depending on the labile blood product. Repeatability and intermediate precision expressed as relative standard deviation were lower than 20% at the lower limit of quantitation and ranged from 1.9 to 11.2% for the other concentration levels. Regarding the trueness, bias ranged from ‐13.6 to 11.8%. The method was validated considering a total error of ± 20%. Lower limits of quantitation ranged from 500 to 680 nM for di(2‐ethylhexyl)terephthalate and were equal to 500 nM for mono(2‐ethylhexyl)terephthalate. Migration of di(2‐ethylhexyl)terephthalate from polyvinyl chloride blood bags was investigated and mono(2‐ethylhexyl)terephthalate concentrations were determined in each labile blood product.

Effects of Transportation of IV Bags Containing Protein Formulations Via Hospital Pneumatic Tube System: Particle Characterization by Multiple Methods

In hospitals, often drug products in intravenous (IV) bags are transported via pneumatic tube systems (PTS). The goal of this study was to evaluate the effects of such transportation of protein products on particle formation in polyvinyl chloride (PVC) and polyolefin (PO) IV bags, containing either IV saline or dextrose. We studied intravenous immunoglobulin (IVIG) and a monoclonal antibody (mAb). Particles were quantified with flow imaging, light obscuration and nanoparticle tracking analysis. PTS transportation of IVIG caused large increases in protein particle concentrations, with much greater increases observed in saline than in dextrose. The increases were greater in IV solutions in PO than those in PVC bags. With the mAb, PTS transportation in saline caused increases in protein particle levels in PO bags, but not in PVC bags. Transportation in dextrose did not result in significant increases in mAb particle concentrations in IV bags made of either material. Overall, the results document that the PTS transportation can result in large increases in protein particles and that magnitude of these increases depends the protein itself, the bag material and the IV solution. The main conclusion is that protein products in IV solutions should not be transported in hospital PTS.

Impact of the pathogen inactivation process on the migration of di(2-ethylhexyl) phthalate from plasma bags.

Di(2-ethylhexyl) phthalate (DEHP) is a toxic plasticizer that is commonly used in the manufacture of polyvinyl chloride (PVC) blood bags. It is well known that DEHP can migrate from a medical device into the blood plasma. For safety reasons, pathogens in plasma must be inactivated; however, this process may increase DEHP migration. Here, we assessed the impact of illumination-based pathogen inactivation on the migration of DEHP from PVC bags into plasma. Pairs of native PVC-DEHP plasma bags were pooled. Each pool was then split into a pathogen-inactivated bag and a control bag. After illumination, the plasma concentrations of DEHP and its main metabolite (mono(2-ethylhexyl) phthalate, MEHP) in each bag were assayed and compared using liquid chromatography-tandem mass spectrometry. Concentrations were evaluated in repeated-measures, two-way analyses of variance. The MEHP concentration was significantly associated with storage but not with illumination (p= 0.0001). The DEHP concentration stayed constant throughout the storage period. The DEHP equivalent concentration (corresponding to the overall plasticizer migration rate into plasma) was not significantly associated with illumination (p= 0.3) or storage (p= 0.09; mean ± standard deviation of the mean DEHP concentration for all conditions: 147.9± 11.3μg/ml). Illumination-based inactivation of pathogens in plasma did not increase the DEHP equivalent concentration, relative to control (non-inactivated) plasma.

Stability of N-Acetylcysteine 60 mg/mL in Extemporaneously Compounded Injectable Solutions.

N-Acetylcysteine (NAC) administered by the IV route is the current treatment of choice for acetaminophen overdose. However, the protocol approved by health authorities in most countries has a complex dosing regimen, which leads to dosage errors in one-third of cases. Therefore, the Canadian Antidote Guide in Acute Care Toxicology and individual poison centres have begun to recommend a simplified regimen using continuous IV infusion. Unfortunately, no study has demonstrated the stability of IV solutions of NAC at concentrations above 30 mg/mL or in solutions other than 5% dextrose. To evaluate the stability of solutions of NAC 60 mg/mL in 0.9% sodium chloride, 0.45% sodium chloride, or 5% dextrose, stored for up to 72 hours in polyvinyl chloride (PVC) bags at 25°C. Solutions of the desired concentration were prepared from a commercial solution of NAC 200 mg/mL, with dilution in 0.9% sodium chloride, 0.45% sodium chloride, or 5% dextrose, and were then stored at room temperature in PVC bags for up to 72 hours. At predetermined time points (0, 16, 24, 40, 48 and 72 h), samples were collected and analyzed using a stability-indicating high-performance liquid chromatography method. A solution was considered stable if it maintained at least 90.0% of its initial concentration. Particulate matter count was also evaluated to confirm chemical stability. Finally, organoleptic properties, such as odour and colour, were evaluated to assess the stability of the solutions. All solutions maintained at least 98.7% of their initial concentration. No obvious changes in odour or colour were observed. Moreover, particle counts remained acceptable throughout the study, according to the criteria specified in United States Pharmacopeia (USP) General Chapter <788>. NAC 60 mg/mL, diluted in 0.9% sodium chloride, 0.45% sodium chloride, or 5% dextrose and stored in PVC bags at 25°C, was chemically and physically stable for a period of at least 72 hours.

Effects of whole blood storage in a polyolefin blood bag on platelets for acute normovolemic hemodilution

Acute normovolemic hemodilution (ANH) is a potential transfusion method for platelets, as well as for red blood cells. However, previous studies have shown that whole blood storage in ANH decreases platelet aggregability by 14.7–76.3% and that this decrease is not recovered by reinfusion. We investigated whether a new whole blood storage method for 6 h using a polyolefin bag, based on the platelet concentrates storage method, would maintain platelet function better than the conventional method using a polyvinyl chloride bag. We demonstrated that storage of whole blood in a polyolefin bag maintained ADP-induced aggregation rates at more than twofold higher than those in a polyvinyl chloride bag, and also significantly suppressed P-selectin expression, a platelet activation marker (ADP-induced aggregation rates: 24.6 ± 5.1% vs. 51.7 ± 11.5%, p = 0.002; P-selectin expression; 50.3 ± 8.4MFI vs. 31.6 ± 9.3MFI, p = 0.018). These results could be attributed to the high gas permeability of polyolefin, which lowered PCO2 and maintained a high pH with or without agitation. There were no significant changes in platelet count and red blood cell parameters due to the storage methods. Our results suggest that ANH using polyolefin bags is advantageous in improving hemostatic function compared to the conventional method.

Impact of insulin adsorption in various containers during hyperkalaemia treatment

BackgroundInsulin–glucose therapy in hyperkalaemia treatment has a narrow therapeutic index for a safe and efficient use. We assess the variability of the effective delivered insulin under conditions used in the setting of hyperkalaemia treatment.MethodsA range of simulated insulin infusions was studied using different containers (bag or syringes) according to the different hyperkalaemia treatment procedures of our institution. Insulin concentration was assayed using a chromatographic method on an automatic high-performance liquid chromatography. We calculated the effective delivered insulin and compared the time average of percentage delivered insulin (TAdi) between all the procedures.ResultsThe TAdi was significantly decreased to 63.3% of the expected insulin delivery in the polyurethane (PE) bag compared with allover container. The procedure duration and the insulin concentration influenced the variability of the insulin delivery in the PE and glass bag. The polyvinyl chloride bag had the highest TAdi at 93.8%, without significant variation during the time. TAdi reaches ∼90% of the expected insulin with all the syringe procedure without variation according to the solute used to dilute insulin.ConclusionsClinically significant variations in intravenous insulin delivery occur in the setting of hyperkalaemia treatment according to the container. The use of propylene syringe limits the insulin delivery variation. In the future, clinical studies on hyperkalaemia treatment by insulin–glucose therapy should detail the procedure precisely.

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

Background and ObjectiveThe combination of naloxone hydrochloride (NH) and fentanyl citrate (FC) in patient-controlled analgesia (PCA) is examined to reduce the risk of opioid-induced nausea and vomiting. However, there are no such commercially available drug mixtures, and there is also no published evidence on the compatibility and stability of NH and FC. Thus, the primary purpose of the current research is to investigate the physical compatibility and chemical stability of NH when mixed with FC over a 72-h period in a 0.9% sodium chloride injection solution for PCA administration under storage at 4°C and 25°C.MethodsTest solutions of 20 μg/mL FC and 4 μg/mL NH were prepared and stored in polyvinyl chloride (PVC) bags or glass bottles with a 0.9% sodium chloride injection solution as the diluent. During the 72-h storage period at 4°C or 25°C without light protection, the concentrations of the test drugs were assayed via high-performance liquid chromatography (HPLC), and the physical compatibility was determined with the naked eye. Furthermore, pH measurement of each sample was also performed with a pH meter.ResultsThe percentages of the initial concentrations of FC and NH in the various solutions were maintained at a minimum of 98% over the 72-h study period. All of the mixtures remained clear and colourless throughout the observation period, and no precipitation or turbidity was observed in any of the batches.ConclusionThe 20 μg/mL FC test solution was physically compatible and chemically stable with the 4 μg/mL NH test solution when stored at 4°C or 25°C in PVC bags or glass bottles containing the 0.9% sodium chloride injection solution.

Assessment of Meropenem and Vaborbactam Room Temperature and Refrigerated Stability in Polyvinyl Chloride Bags and Elastomeric Devices

PurposeMeropenem and vaborbactam is an intravenous beta-lactam/beta-lactamase inhibitor combination antibiotic active against multidrug resistant gram-negative bacteria. It may be a suitable treatment for inpatient and outpatient management of infections, and the intravenous admixture stability is therefore important for optimal utilization. The purpose of this study was to determine the stability of meropenem and vaborbactam in polyvinyl chloride (PVC) infusion bags and elastomeric pumps at room and refrigerated temperatures. MethodsMeropenem and vaborbactam vials were reconstituted according to manufacturer instructions and diluted in PVC infusion bags to final concentrations of 4, 8, and 16 mg/mL and in elastomeric pumps to 11.4 mg/mL (n = 5 replicates per concentration and per temperature). PVC bags and elastomeric pumps were stored at room temperature (~24 °C) or in the refrigerator (~4 °C) and sampled over 12 and 144 h, respectively. Stability was defined as the duration that meropenem and vaborbactam concentrations remained ≥90% of the original concentrations. FindingsAll room temperature replicates across the tested concentrations retained meropenem and vaborbactam stability over 12 h and displayed concentration-dependent degradation. Refrigerated studies resulted in meropenem and vaborbactam stability at all tested concentrations up to 120 h. ImplicationsMeropenem and vaborbactam in PVC bags (4, 8, and 16 mg/mL) and elastomeric pumps (11.4 mg/mL) were stable for 12 h at room temperature and 120 h when refrigerated. These stability data allow for enhanced flexibility in the preparation, storage, wastage, and administration of meropenem and vaborbactam in the hospital and outpatient setting.

Evaluation of the stability of vancomycin solutions at concentrations used in clinical services

Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. This antibiotic is active against Gram-positive aerobic and anaerobic bacteria1...

Physical and Chemical Stability of Dexamethasone Sodium Phosphate in Intravenous Admixtures Used to Prevent Chemotherapy-Induced Nausea and Vomiting.

Purpose: Dilute intravenous (IV) admixtures of dexamethasone sodium phosphate (DSP) are becoming increasingly used in antiemetic regimens to prevent chemotherapy-induced nausea and vomiting (CINV). Based on its chemical structure and previous studies, DSP is known to be susceptible to hydrolysis and oxidation under certain conditions. There are limited data to directly support the selection of IV diluents, storage conditions, and beyond-use dates for the dilute IV solutions of DSP used in the antiemetic regimens. This study was designed to investigate these parameters. Methods: A stability-indicating high-performance liquid chromatography (HPLC) method was first developed for the analysis of DSP. Commercially available 100 mg/10 mL DSP injection vials were used to prepare the IV admixtures of DSP in 0.9% sodium chloride injection or 5% dextrose injection. The final DSP concentrations were 0.08 or 0.4 mg/mL, which bracketed the range commonly used in antiemetic regimens. These admixtures were packaged in 50-mL polyvinylchloride (PVC) bags and stored at room temperature or under refrigeration for 14 days. Samples from each IV bag underwent visual, pH, and HPLC assessments on days 0, 1, 3, 7, and 14. Results: Immediately after preparation, the IV admixtures of DSP appeared clear, colorless, and free of particulate matters. The initial pH values were 6.4 to 6.8 and 7.0 to 7.8 for samples in 0.9% sodium chloride and 5% dextrose, respectively. The initial DSP concentrations of all samples were within 96% to 100% of the expected values. Over the 14 days of storage at room temperature or refrigeration, no significant change was observed for the visual appearance of any IV bags. The pH of all samples remained within one pH unit from the initial values. The HPLC results confirmed that all samples retained 94% to 100% of original drug concentrations and that no significant degradation products were observed. Conclusions: Intravenous admixtures of DSP at 0.08 to 0.4 mg/mL are compatible with 0.9% sodium chloride and 5% dextrose in PVC bags. These admixtures are also chemically and physically stable when stored at room temperature or under refrigeration for up to 14 days.