Stability of Mycophenolate Mofetil as an Extemporaneous Suspension

1998 ◽  
Vol 32 (7-8) ◽  
pp. 755-757 ◽  
Author(s):  
Raman Venkataramanan ◽  
Jacqueline R McCombs ◽  
Sheila Zuckerman ◽  
Bill McGhee ◽  
Jaya Pisupati ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Chemical Stability ◽  
Mycophenolic Acid ◽  
Postoperative Period ◽  
Dosage Form ◽  
Room Temperature ◽  
Pediatric Patients ◽  
Early Postoperative Period ◽  
Time Points ◽  
Physical And Chemical

OBJECTIVE: To evaluate the physical and chemical stability of a suspension of mycophenolate mofetil (MMF) prepared in the hospital from commercially available MMF capsules. METHODS: Suspensions of MMF were prepared at room temperature and stored at 5, 25, 37, and 45 °C over a period of 50 to 210 days. The contents of MMF and its degradation product, mycophenolic acid, in the suspension were measured at various time points by HPLC. RESULTS: MMF suspensions were stable (as determined by the presence of ≥90% of the labeled amount) at 45 °C for at least 11 days, at 37 °C for at least 28 days, at 25 °C for at least 28 days, and at 5 °C for at least 210 days. The suspension was also physically stable at 5 °C during the entire test period. CONCLUSIONS: The compounded MMF suspension was stable for at least 11 days at all the temperatures studied and for as long as 210 days at 5 °C. This formulation appears to be clinically acceptable and provides a convenient dosage form for pediatric patients and for adults during the early postoperative period.

Vancomycin and daptomycin stability in heparin or sodium citrate lock solutions

2021 ◽  
pp. 112972982110458
Author(s):  
Julia Bodega-Azuara ◽  
Maria Dolores Bellés-Medall ◽  
Josep Edo-Peñarrocha ◽  
Raúl Ferrando-Piqueres ◽  
Alejandro Perez-Alba ◽  
...  
Keyword(s):  
Chemical Stability ◽  
Hospital Pharmacy ◽  
Room Temperature ◽  
Sodium Citrate ◽  
Optimal Combination ◽  
Pharmacy Services ◽  
Microbiological Activity ◽  
Initial Concentration ◽  
Time Points ◽  
Physical And Chemical

Background: We investigated physical and chemical stability of daptomycin and vancomycin in heparin or sodium citrate lock solutions. The aim of this study was to find the optimal combination of antimicrobials and additives for lock solutions, which maximized patient safety. Methods: Vancomycin and daptomycin were diluted with heparin or sodium citrate to achieve final concentrations of vancomycin-heparin 2.5 mg/mL–833.33 U/mL, vancomycin-citrate 2.5–33.3 mg/mL, daptomycin-heparin 5 mg/mL–800 U/mL, and daptomycin-citrate 5–32 mg/mL and they were stored at room temperature (+25°C), 4°C, −20°C, and 37°C. Physical and chemical stability were analyzed for each antibiotic-anticoagulant combination in all conditions immediately after preparation, at 24, 48, 72 h and at different time points until unstable concentrations were obtained. Daptomycin-sodium citrate microbiological activity was also studied by evaluating two Staphylococcus aureus cultures in a calcium enriched medium with a daptomycin E test, with and without sodium citrate. Results: After incubation at 37°C vancomycin and daptomycin combined with heparin retained at least 90% of the initial concentration over 48 h. Vancomycin-sodium citrate solution stored at 37°C reduced more than 10% of the initial concentration at 24 h. On the other hand, daptomycin-sodium citrate preparation was stable at 37°C for 72 h but the microbiological activity of daptomycin was lower in the presence of sodium citrate. Conclusions: The purpose is to prepare vancomycin and daptomycin lock solutions combined with heparin. They should be changed at 48 h and its stability is over 3 days at 25°C and 7 days at 4°C, which allow Hospital Pharmacy Services to manage their stocks. Daptomycin-sodium citrate combination is more stable for extended periods but its bioactivity has not been demonstrated.

scholarly journals Recovery of early postoperative muscle strength after deep neuromuscular block by means of ultrasonography with comparison of neostigmine versus sugammadex as reversal drugs: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043935
Author(s):  
Xuan Wang ◽  
Yingyuan Li ◽  
Chanyan Huang ◽  
Wei Xiong ◽  
Qin Zhou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Muscle Strength ◽  
Neuromuscular Blockade ◽  
Postoperative Period ◽  
Controlled Trial ◽  
Complete Recovery ◽  
Early Postoperative Period ◽  
Time Points ◽  
Muscle Groups ◽  
Randomised Controlled

IntroductionDespite the use of quantitative neuromuscular monitoring together with the administration of reversal drugs (neostigmine or sugammadex), the incidence of residual neuromuscular blockade defined as a train-of-four ratio (TOFr) <0.9 remains high. Even TOFr >0.9 cannot ensure adequate recovery of neuromuscular function when T1 height is not recovered completely. Thus, a mathematical correction of TOFr needs to be applied because the return of a normal TOFr can precede the return of a normal T1 twitch height. On the other hand, different muscles have different sensitivities to neuromuscular blockade agents; thus, complete recovery of one specific muscle group does not represent complete recovery of all other muscles. Therefore, our study aims to assess the muscle strength recovery of respiratory-related muscle groups by ultrasound and evaluate global strength using handgrip dynamometry in the early postoperative period when TOFr=0.9 and corrected TOFr (cTOFr)=0.9 with comparison of neostigmine versus sugammadex as reversal drugs.Methods and analysisThis study will be a prospective, single-blinded, randomised controlled trial involving 60 patients with American Society of Anesthesiologists physical status I–II and aged between 18 and 65 years, who will undergo microlaryngeal surgery. We will assess geniohyoid muscle, parasternal intercostal muscle, diaphragm, abdominal wall muscle and handgrip strength at four time points: before anaesthesia, TOFr=0.9, cTOFr=0.9 and 30 min after admission to the post anaesthesia care unit. Our primary objective will be to compare the effects of neostigmine and sugammadex on the recovery of muscle strength of different muscle groups in the early postoperative period when TOFr=0.9 and cTOFr=0.9. The secondary objective will be to observe the difference of muscle strength between the time points of TOFr=0.9 and cTOFr=0.9 to find out the clinical significance of cTOFr >0.9.Ethics and disseminationThe protocol was reviewed and approved by the Ethics Committee of The First Affiliated Hospital, Sun Yat-sen University. The findings will be disseminated to the public through peer-reviewed scientific journals.Trial registration numberChiCTR2000033832.

scholarly journals Effects of an Ex Vivo Pediatric Extracorporeal Membrane Oxygenation Circuit on the Sequestration of Mycophenolate Mofetil, Tacrolimus, Hydromorphone, and Fentanyl

2019 ◽  
Vol 24 (4) ◽  
pp. 290-295
Author(s):  
Catherine S. Heith ◽  
Lizbeth A. Hansen ◽  
Rhonda M. Bakken ◽  
Sharon L. Ritter ◽  
Breeanna R. Long ◽  
...  
Keyword(s):  
Mycophenolate Mofetil ◽  
Extracorporeal Membrane Oxygenation ◽  
Mycophenolic Acid ◽  
Pediatric Patients ◽  
Ex Vivo ◽  
Centrifugal Pumps ◽  
Ecmo Circuit ◽  
Binding Characteristics ◽  
Membrane Oxygenation ◽  
Set Up

OBJECTIVES With the expanding use of extracorporeal membrane oxygenation (ECMO), understanding drug pharmacokinetics has become increasingly important, particularly in pediatric patients. This ex vivo study examines the effect of a pediatric Quadrox-iD ECMO circuit on the sequestration and binding of mycophenolate mofetil (MMF), tacrolimus, and hydromorphone hydrochloride, which have not been extensively studied to date in pediatric ECMO circuits. Fentanyl, which has been well studied, was used as a comparator. METHODS ECMO circuits were set up using Quadrox-iD pediatric oxygenators and centrifugal pumps. The circuit was primed with whole blood and a reservoir was attached to represent a 5-kg patient. Fourteen French venous and 12 French arterial ECMO cannulas were inserted into the sealed reservoir. Temperature, pH, PO2, and PCO2 were monitored and corrected. MMF, tacrolimus, hydromorphone, and fentanyl were injected into the ECMO circuit. Serial blood samples were taken from a postoxygenator site at intervals over 12 hours, and levels were measured. RESULTS Hydromorphone hydrochloride was not as significantly sequestered by the ex vivo pediatric ECMO circuit when compared with fentanyl. Both mycophenolic acid and tacrolimus serum concentrations were stable in the circuit over 12 hours. CONCLUSIONS Hydromorphone may represent a useful medication for pain control for pediatric patients on ECMO due to its minimal sequestration. Mycophenolic acid and tacrolimus also did not show significant sequestration in the circuit, which was unexpected given their lipophilicity and protein-binding characteristics, but may provide insight into unexplored pharmacokinetics of particular medications in ECMO circuits.

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.

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

Stability of Furosemide in Human Albumin Solution

2002 ◽  
Vol 36 (3) ◽  
pp. 423-426 ◽  
Author(s):  
Rowland J Elwell ◽  
Anne P Spencer ◽  
Julie F Barnes ◽  
James E Wynn ◽  
Curtis E Jones
Keyword(s):  
Chemical Stability ◽  
Room Temperature ◽  
Color Change ◽  
Fungal Growth ◽  
Human Albumin ◽  
Bulk Solution ◽  
Molar Ratio ◽  
Albumin Solution ◽  
Time Points ◽  
Human Albumin Solution

OBJECTIVE: To determine the chemical stability of furosemide in human albumin solution over a 28-day period and to assess admixtures for microbiologic contamination. METHODS: Samples were prepared by mixing furosemide injectable solution and 25% human albumin solution in a 1:1 molar ratio. Six bulk containers were prepared and stored in the dark: 3 under refrigeration (∼4 °C) and 3 at room temperature (∼25 °C). Study samples were withdrawn from each bulk solution immediately after preparation and at predetermined intervals over the subsequent 28 days. Containers were observed for color change and precipitation against a light and dark background at each sampling interval. Total furosemide concentration was determined using HPLC. Additional vials were prepared and assessed for microbiologic growth at time points corresponding with chemical stability results. RESULTS: A mean of 94.5% ± 1.33% of the initial furosemide concentration remained after 48 hours at room temperature. Under refrigeration, 100.6% ± 1.02% of the initial concentration remained at 14 days. Beyond these respective time points, <90% of the initial furosemide concentration remained. No bacterial or fungal growth was observed. CONCLUSIONS: When combined with 25% human albumin solution and stored under darkness, furosemide is chemically stable and free of microbiologic contamination for 48 hours at room temperature and 14 days under refrigeration.

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