Stability of topotecan infusion solutions in polyvinylchloride bags and elastomeric portable infusion devices

1999 ◽  
Vol 5 (2) ◽  
pp. 75-82 ◽  
Author(s):  
Irene Krämer ◽  
Judith Thiesen
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Room Temperature ◽  
Colour Change ◽  
Storage Period ◽  
Ultra Violet ◽  
Fluorescent Light ◽  
Nominal Concentration ◽  
Light Protection ◽  
Infusion Devices

Purpose. The purpose of this study was to determine the physicochemical stability of topotecan after reconstitution and after further dilution in two commonly used infusion fluids (0.9% sodium chloride, 5% dextrose) in both polyvinylchloride (PVC) bags and elastomeric portable infusion devices. Methods. Each vial of topotecan (Hycamtin®) was reconstituted with sterile water for injection, yielding a nominal concentration of 1 mg/mL. Topotecan infusion solutions were aseptically prepared by further dilution of reconstituted topotecan solutions with either 0.9% sodium chloride or 5% dextrose in both PVC bags and portable elastomeric infusion devices, in amounts yielding topotecan concentrations of 10 µg/mL, 25 µg/mL, or 50 µg/mL. Test solutions were stored light-protected at room temperature (25°C) or under refrigeration (2-8°C) in parallel. One test solution of the nominal concentration of 10 µg/mL topotecan in a 0.9% sodium chloride PVC infusion bag was stored under ambient light conditions (mixed daylight and normal laboratory fluorescent light) at room temperature. Topotecan concentrations were obtained periodically throughout a 4-week storage period via a stability-indicating high performance liquid chromatography assay with ultra-violet detection. In addition, measurements of pH values were performed regularly, and test solutions were visually examined for colour change and precipitation. Results. The stability tests revealed that the currently available topotecan formulation is stable (at a level of ≥90% topotecan) after reconstitution and dilution, independent of temperature (refrigerated, room temperature), the vehicle (0.9% sodium chlo-ride, 5% dextrose), the concentration (10 µg/mL, 25 µg/mL, or 50 µg/mL), or the container material (PVC bags, elastomeric portable infusion devices). The results were obtained over a test period of ≥4 weeks. Topotecan infusion solutions exposed to daylight were stable for only 17 days. Conclusions. Reconstituted and diluted topotecan infusion solutions are shown to be physicochemically stable for 4 weeks. Light protection during administration is not necessary.

scholarly journals Stability Determination of an Extemporaneously Compounded Ambrisentan Suspension by High Performance Liquid Chromatography Analysis

2021 ◽  
Vol 26 (3) ◽  
pp. 265-270
Author(s):  
Jesse Cramer ◽  
Mackenzie Bevry ◽  
Stephanie Handler ◽  
Kathryn Tillman ◽  
Ehab A. Abourashed
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Analysis ◽  
Room Temperature ◽  
Storage Period ◽  
Storage Conditions ◽  
Reversed Phase ◽  
Hplc Method ◽  
Fluorescent Light

OBJECTIVE Ambrisentan, an endothelin receptor antagonist FDA-approved for the treatment of pulmonary arterial hypertension in adult patients, lacks an acceptable pediatric dosage form. The objective of this investigation was to determine the stability of an extemporaneously compounded ambrisentan suspension. METHODS Ambrisentan suspension was compounded to a concentration of 1 mg/mL using commercially available suspending agents. The suspension was then evenly split into 2 plastic amber prescription bottles. One bottle was stored at room temperature and under continuous fluorescent light while the other bottle was stored under refrigeration and protection from light. A fast and selective reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the analysis of ambrisentan. HPLC analysis was performed on samples withdrawn from the stock bottles at predetermined time intervals, up to 90 days. RESULTS The developed HPLC method enabled the elution and detection of ambrisentan peak at 4.4 minutes. HPLC analysis revealed that all samples from both storage conditions retained >90% potency throughout the study timeframe. There were no signs of any ambrisentan breakdown products on HPLC analysis. Color and odor of the final product was also consistent throughout the 90-day storage period. CONCLUSION Ambrisentan suspension, compounded to 1 mg/mL, is stable at room temperature or under refrigeration for up to 90 days.

ADRENALINE AMPOULES QUALITY ASSESSMENT–THE ISRAELI EXPERIENCE

2020 ◽  
pp. 144-146
Author(s):  
MEITAL ZUR ◽  
DAVID STEPENSKY ◽  
PAVEL GORENBEIN
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Period ◽  
Clinical Effectiveness ◽  
Storage Conditions ◽  
Chiral Hplc ◽  
Drug Products ◽  
Variable Content ◽  
Israel Defense Forces ◽  
Israeli Experience

Objective: To characterize the differences in stability of L-adrenaline in adrenaline ampoules from different manufacturers that are used by the Israel Defense Forces (IDF). Methods: Adrenaline ampoules from three different vendors (Products A, B and C; 52, 13, and 19 batches, respectively) were purchased by the IDF and were stored under the recommended storage conditions (room temperature) for different time periods. The content of L-adrenaline in these samples was determined using a chiral high-performance liquid chromatography (HPLC) assay with UV detection. Results: The three analyzed drug products showed very dissimilar patterns of L-adrenaline degradation. The content of L-adrenaline in Product C was variable and declined below the 85% threshold much earlier than at the end of the 24-months storage period. Products A and B had less variable content of L-adrenaline and were more stable. Conclusion: L-adrenaline is prone to degradation in solution. Its content in adrenaline ampoules from certain vendors can decline rapidly, below the stipulated threshold, and compromise their clinical effectiveness (e. g., during resuscitation). Stability of adrenaline ampoules from individual vendors should be analyzed at different storage conditions, using a chiral HPLC-based assay, to define the shelf-life period that can differ substantially between the vendors.

Stability of Donepezil in an Extemporaneously Prepared Oral Liquid

2006 ◽  
Vol 19 (5) ◽  
pp. 282-285 ◽  
Author(s):  
Weeranuj Yamreudeewong ◽  
Eric Kurt Dolence ◽  
Deborah Pahl
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Time ◽  
Microbial Growth ◽  
Storage Period ◽  
Significant Loss ◽  
Ambient Room Temperature ◽  
Oral Liquid ◽  
Liquid Preparation ◽  
The Stability

The stability of donepezil in an extemporaneously prepared oral liquid was studied. An aqueous liquid formulation of donepezil was prepared by reconstituting the powder from triturated 5-mg tablets with equal amounts of deionized water and 70% sorbitol solution with an expected donepezil concentration of 1 mg/mL. Polyethylene terephthalate plastic bottles containing donepezil liquid preparation were stored at ambient room temperature (22° C-26° C) and in the refrigerator (4° C-8° C). After a storage time of 1, 2, 3, and 4 weeks, donepezil liquid samples were analyzed in triplicate for donepezil concentrations by high-performance liquid chromatography. The concentrations of donepezil were found to be within the acceptable limit (± 10% of the initial concentration) in all test samples, which indicated that donepezil liquid preparation was stable at room temperature and in the refrigerator for up to 4 weeks. In addition, our study findings indicated that there was no microbial growth in the extemporaneously prepared donepezil liquid preparation after a storage period of 4 weeks in the refrigerator. In summary, the results of our study revealed that donepezil is stable (no significant loss of donepezil concentration and no microbial growth) in an extemporaneously prepared oral liquid when stored in the refrigerator for up to 4 weeks.

scholarly journals Long-Term Stability of Lorazepam in Sodium Chloride 0.9% Stored at Different Temperatures in Different Containers

2019 ◽  
Vol 55 (3) ◽  
pp. 188-192
Author(s):  
M. L. Colsoul ◽  
A. Breuer ◽  
N. Goderniaux ◽  
J. D. Hecq ◽  
L. Soumoy ◽  
...  
Keyword(s):  
Time Management ◽  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Period ◽  
Term Stability ◽  
Long Term Stability ◽  
Glass Bottles ◽  
The Stability

Background and Objective: Infusion containing lorazepam is used by geriatric department to limit anxiety disorders in the elderly. Currently, these infusions are prepared according to demand by the nursing staff, but the preparation in advance in a centralized service could improve quality of preparation and time management. The aim of this study was to investigate the long-term stability of this infusion in polypropylene syringes stored at 5 ± 3°C. Then, results obtained were compared with stability data of lorazepam in syringes stored at room temperature, glass bottles at 5 ± 3°C, and glass bottles at room temperature. Method: Eight syringes and 6 bottles of infusion were prepared by diluting 1 mL lorazepam 4 mg in 23 mL of NaCl 0.9% under aseptic conditions. Five syringes and 3 bottles were stored at 5 ± 3°C and 3 syringes and 3 bottles were stored at room temperature for 30 days. During the storage period, particle appearance or color change were periodically checked by visual and microscope inspection. Turbidity was assessed by measurements of optical density (OD) at 3 wavelengths (350 nm, 410 nm, 550 nm). The stability of pH was also evaluated. The lorazepam concentrations were measured at each time point by high-performance liquid chromatography with ultraviolet detector at 220 nm. Results: Solutions were physically unstable in syringes at 5 ± 3°C after 4 days: crystals and a drop of OD at 350 nm were observed. However, pH was stable. After 2 days, solutions were considered as chemically unstable because a loss of lorazepam concentration higher than 10% was noticed: the lower 1-sided confidence limit at 95% was below 90% of the initial concentration. To assess temperature and polypropylene influence, results were compared with those obtained for syringes at room temperature and bottles at 5 ± 3°C and room temperature. Precipitation, drop of OD at 350 nm, and chemical instability were observed in all conditions. Conclusion: Solutions of lorazepam were unstable after 2 days in syringes at 5 ± 3°C. Preparation in advance appears, therefore, not possible for the clinical use. Storage conditions (temperature and form) do not improve the stability.

scholarly journals Changes in the Physicochemical Quality Characteristics of Cabbage Kimchi with respect to Storage Conditions

2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
Su-Yeon You ◽  
Ji-Su Yang ◽  
Sung Hyun Kim ◽  
In Min Hwang
Keyword(s):  
Organic Acids ◽  
High Performance ◽  
Room Temperature ◽  
Gradual Increase ◽  
Storage Period ◽  
Storage Conditions ◽  
Quality Characteristics ◽  
Analytical Technique ◽  
Ph Values ◽  
Organic Acid Content

In this study, the changes in pH, organic acid content, acidity, and salinity of kimchi prepared at 0 days, stored 1–8 weeks at 4 and 10°C, and stored at room temperature for two days were analyzed. Organic acids content was analyzed by using analytical technique of high-performance liquid chromatography (HPLC). This method was also validated using quality assurance parameters of linearity, limits of detection and quantification (LOD and LOQ), precision, and spike recovery experiments. In the analysis of organic acids content (mg/kg), it was found that the kimchi stored for 1–8 weeks at 4 and 10°C showed gradual increase in the organic acids content during storage period. The order of organic acids was lactic acid > acetic acid > citric acid > malic acid > succinic acid > oxalic acid > fumaric acid. The pH values of kimchi stored at 4°C, 10°C, and 25°C were 4.1, 3.6–3.7, and 4.1, respectively.

scholarly journals Stability of Bendamustine Solutions: Influence of Sodium Chloride Concentration, Temperature and Container

2018 ◽  
Vol 3 (1) ◽  
pp. 13-21
Author(s):  
Jean Vigneron ◽  
Elise D’Huart ◽  
Béatrice Demoré
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Room Temperature ◽  
Chloride Concentration ◽  
Chloride Ion ◽  
Daily Practice ◽  
Ion Concentration ◽  
Chromatography Method ◽  
Non Hodgkin Lymphoma ◽  
The Stability

Abstract Background Bendamustine is used for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukaemia and myeloma. The stability of bendamustine is highly dependent on temperature and chloride-ion concentration. Limited stability data are available. The objective of this work was to study the stability of the bendamustine reconstituted solution at 2.5 mg/mL and the diluted solution in normal saline and 1.5 % sodium chloride to evaluate a potential increase in stability. Methods A stability indicating High Performance Liquid Chromatography method with Diode Array Detection was used. A first study was carried out in glass vials and then in polyolefin containers at 0.25 and 0.60 mg/mL. Solutions were stored at room temperature and at 2–8 °C for 7 days. Results Stability was defined as a concentration above 95 % of the initial concentration [10]. The reconstituted solution at 2.5 mg/mL was stable for only 2 hours at room temperature and 8 hours at 2–8 °C. The stability of diluted solutions was in accordance with the manufacturer’s recommendations of 3.5 hours at room temperature and 48 hours at 2–8 °C. The addition of sodium chloride doesn’t increase the stability for preparation in infusion in daily practice. Conclusions The information brought by this study is an 8-hour stability of the reconstituted solution at 2–8 °C.

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.

Physicochemical stability of carfilzomib (Kyprolis®) containing solutions in glass vials, ready-to-administer plastic syringes and infusion bags over a 28-day storage period

2017 ◽  
Vol 25 (2) ◽  
pp. 339-350
Author(s):  
Sun Hee Kim ◽  
Irene Krämer
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Room Temperature ◽  
Visual Inspection ◽  
Storage Period ◽  
Reversed Phase ◽  
Profound Knowledge ◽  
Physicochemical Stability ◽  
Study Results

Centralized aseptic preparation of ready-to-administer carfilzomib containing parenteral solutions in plastic syringes and polyolefine (PO) infusion bags needs profound knowledge about the physicochemical stability in order to determine the beyond-use-date of the preparations. Therefore, the purpose of this study was to determine the physicochemical stability of carfilzomib solution marketed as Kyprolis® powder for solution for infusion. Reconstituted solutions and ready-to-administer preparations of Kyprolis® stored under refrigeration (2–8℃) or at room temperature (25℃) were analyzed at predetermined intervals over a maximum storage period of 28 days. Chemical stability of carfilzomib was planned to be determined with a stability-indicating reversed-phase high-performance liquid chromatography assay. Physicochemical stability was planned to be determined by visual inspection of clarity and color as well as pH measurement. The study results show that reconstituted carfilzomib containing parenteral solutions are stable in glass vials as well as diluted solutions in plastic syringes and PO infusion bags over a period of at least 28 days when stored light protected under refrigeration. When stored at room temperature, reconstituted and diluted carfilzomib solutions are physicochemically stable over 14 days and 10 days, respectively. The physicochemical stability of carfilzomib infusion solutions allows cost-saving pharmacy-based centralized preparation of ready-to-administer preparations.

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

2019 ◽  
pp. 001857871988891
Author(s):  
Ina Buga ◽  
Joy I. Uzoma ◽  
Kristin Reindel ◽  
Kateryna Rashid ◽  
Tuong Diep ◽  
...  
Keyword(s):  
Sodium Chloride ◽  
High Performance ◽  
Sodium Phosphate ◽  
Room Temperature ◽  
Degradation Products ◽  
Storage Conditions ◽  
Hplc Method ◽  
Nausea And Vomiting ◽  
Dexamethasone Sodium Phosphate ◽  
Drug Concentrations

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.

Stability of Ziprasidone Mesylate in an Extemporaneously Compounded Oral Solution

2010 ◽  
Vol 15 (2) ◽  
pp. 138-141
Author(s):  
Kelsey Green ◽  
Roy C. Parish
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Physical Stability ◽  
Storage Condition ◽  
High Performance Liquid Chromatographic ◽  
Oral Solution ◽  
Fluorescent Light ◽  
Light Illumination ◽  
Liquid Preparation ◽  
Liquid Chromatographic

ABSTRACT OBJECTIVES To formulate a liquid preparation of ziprasidone in a convenient concentration to allow dosing of less than 20 mg and of sufficient chemical and physical stability to enable an entire prescription or course of treatment to be prepared in a single batch. METHODS Geodon for injection (ziprasidone mesylate), 20 mg/mL, was diluted to 2.5 mg/mL in a commercially available sugar-free and alcohol-free, flavored syrup and stored at room temperature under ambient fluorescent light illumination, at room temperature in darkness, and under refrigeration. The ziprasidone content was measured in samples at various time intervals using a stability-indicating high-performance liquid chromatographic method. RESULTS When refrigerated, the ziprasidone syrup that was compounded in a commercially available, sugar-free and alcohol-free vehicle maintained at least 90% of stated potency for at least 6 weeks. Samples stored under other conditions were less stable, underscoring the manufacturer's labeling regarding refrigerated storage of the reconstituted injection. CONCLUSIONS The findings suggest that chemical and physical stability are maintained for 2 weeks under refrigeration, allowing the convenience of compounding for the long-term needs of a particular patient, rather than daily compounding. The only storage condition we recommend is refrigeration at 5°C.

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