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.

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.

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.

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.

Compatibility of treprostinil sodium and dopamine hydrochloride during simulated Y-site administration

2020 ◽  
Vol 77 (8) ◽  
pp. 649-657
Author(s):  
Anna Bustin ◽  
E Zachary Ramsey ◽  
Brian D Hanna ◽  
Gagan Kaushal
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Chemical Stability ◽  
High Performance ◽  
Stability Testing ◽  
Visual Examination ◽  
Stability Indicating ◽  
Drug Concentrations ◽  
Dopamine Hydrochloride ◽  
Physical And Chemical

Abstract Purpose To evaluate the physical and chemical compatibilities of treprostinil sodium and dopamine hydrochloride. Methods Treprostinil sodium (4,000, 76,000, and 500,000 ng/mL) were mixed with dopamine hydrochloride (0.6, 3.2, 6, and 40 mg/mL). Samples were obtained at hours 0, 1, 2, and 4 for physical compatibility and chemical stability testing. Physical compatibility was assessed by visual examination and measurements of turbidity and pH. Drug concentrations were assessed using stability-indicating liquid chromatography mass spectrophotometry (LCMS) for treprostinil sodium and stability-indicating high-performance liquid chromatography (HPLC) for dopamine hydrochloride. Results Treprostinil sodium 4,000 and 76,000 ng/mL, when mixed with dopamine hydrochloride 0.6, 3.2, 6, and 40 mg/mL, were stable for 4 hours. Treprostinil sodium 500,000 ng/mL was stable when mixed with dopamine hydrochloride 0.6 mg/mL for 4 hours, but when mixed with dopamine hydrochloride 3.2, 6, and 40 mg/mL, significant precipitation was seen. Conclusion Treprostinil sodium 4,000 and 76,000 ng/mL were stable for 4 hours during simulated Y-site coadministration with dopamine hydrochloride 0.6, 3.2, 6, and 40 mg/mL. Treprostinil sodium 500,000 ng/mL is stable when mixed with dopamine hydrochloride 0.6 mg/mL.

Stability of vincristine sulfate, doxorubicin hydrochloride and etoposide phosphate admixtures in polyisoprene elastomeric pump supporting transition of the EPOCH regimen to outpatient care

2018 ◽  
Vol 25 (4) ◽  
pp. 831-840 ◽  
Author(s):  
Darren Svirskis ◽  
Sairam Behera ◽  
Neera Naidoo ◽  
Joanne Beachman ◽  
Tarsha Raina ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Chemical Stability ◽  
Healthcare Costs ◽  
Light Exposure ◽  
Outpatient Setting ◽  
Fluorescent Light ◽  
Doxorubicin Hydrochloride ◽  
Vincristine Sulfate ◽  
Etoposide Phosphate ◽  
Bed Days

Background The EPOCH regimen, consisting of vincristine sulfate, doxorubicin hydrochloride, and etoposide phosphate, is typically administered by continuous infusion over four days to oncology inpatients. If the EPOCH regimen was available to be administered through portable elastomeric pumps, chemotherapy could be transitioned to an outpatient setting, reducing inpatient bed days and overall healthcare costs. However, a lack of stability data for the admixtures in the elastomeric infusion devices currently prevents the transition of the regime to an outpatient setting. The purpose of this study is to determine the physical and chemical stability of the admixture in polyisoprene elastomeric pumps under different storage conditions to support the transition of the EPOCH regime to an outpatient setting. Methods The physico-chemical stability of three admixtures at a range of clinically relevant concentrations compounded in polyisoprene elastomeric infusors was determined when refrigerated at 2–6℃ over a 14-day period followed by 35℃ up to 7 days in the dark, and under standardized fluorescent light to simulate scenarios in clinical practice. Results All tested admixtures were compatible and the drugs were stable in the elastomeric infusors for up to 14 days when stored at 2–6℃ followed by 7 days at 35℃ in the dark, with nominal losses of <5%. The major degradant of etoposide phosphate was its active form etoposide. There was no degradation (<1% loss) found when the admixture was exposed to a standardized fluorescent light dose of 80 klux-h (25℃) for 10 h. The temperature and light conditions the infusors were exposed to during the stability study were more severe than the conditions determine during clinical administration. Conclusion The extended stability of the three infusional admixtures compounded in elastomeric infusion pumps demonstrated herein permits advance preparation and storage of these drugs, reducing pharmacy compounding resources. The demonstrated stability at 35℃ and under light exposure, conditions more severe than those experienced during clinical practice, support continuous infusions for up to seven days from the elastomeric infusors without a loss of potency. The proven stability of the EPOCH regimens in the tested elastomeric infusion device supports the transition of treatment to an outpatient setting which will reduce inpatient bed days and overall healthcare costs.

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 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.

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

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.

Sign in / Sign up

Export Citation Format

Share Document