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Yanping Zhang - One of the best experts on this subject based on the ideXlab platform.

  • physical and chemical stability of palonosetron hydrochloride with dacarbazine and with Methylprednisolone Sodium Succinate during simulated y site administration
    International journal of pharmaceutical compounding, 2006
    Co-Authors: Lawrence A Trissel, Yanping Zhang, Quanyun A Xu
    Abstract:

    : The objective of this study was to evaluate the physical and chemical stability of mixtures of undiluted palonosetron hydrochloride 50 micrograms/mL with dacarbazine 4 mg/mL and with Methylprednisolone Sodium Succinate 5 mg/mL in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of dacarbazine solution and, separately, Methylprednisolone Sodium Succinate solution. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques that determined drug concentrations. Evaluations were performed immediately after mixing and 1 and 4 hours after mixing. The palonosetron hydrochloride-dacarbazine samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidities remained unchanged; particulate contents were low and exhibited little change. High-performance liquid chromatography analysis revealed that palonosetron hydrochloride and dacarbazine remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is, therefore, physically compatible and chemically stable with dacarbazine during Y-site administration. Within 4 hours, the mixtures of palonosetron hydrochloride and Methylprednisolone Sodium Succinate developed a microprecipitate that became a white precipitate visible to the unaided eye. The precipitate was analyzed and identified as Methylprednisolone. Palonosetron hydrochloride is incompatible with Methylprednisolone Sodium Succinate.

  • stability of Methylprednisolone Sodium Succinate in autodose infusion system bags
    Journal of the American Pharmaceutical Association, 2002
    Co-Authors: Lawrence A Trissel, Yanping Zhang
    Abstract:

    Objective To evaluate the physical and chemical stabilities of Methylprednisolone Sodium Succinate solutions packaged in sterile AutoDose Infusion System bags. Setting Laboratory. Interventions The test samples were prepared by reconstituting the Methylprednisolone Sodium Succinate, adding the required amount of drug to the AutoDose Infusion System bags, and diluting to the target concentrations of 100 mg/100 mL and 1 gram/100 mL with 0.9% Sodium Chloride Injection. Main Outcome Measures Physical stability and chemical stability based on drug concentrations initially and at appropriate intervals over periods up to 3 days at 23°C and 30 days at 4°C. Results The admixtures initially were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change. All samples were essentially colorless throughout the study. High-performance liquid chromatography analysis revealed some decomposition in the samples. Methylprednisolone Sodium Succinate exhibited about 8% loss after 2 days and about 13% loss after 3 days at 23°C. In the samples stored at 4°C, Methylprednisolone Sodium Succinate exhibited acceptable stability through 21 days of storage, but losses exceeded 10% after 30 days. Conclusion Methylprednisolone Sodium Succinate exhibited physical and chemical stabilities consistent with those found in previous studies. The AutoDose Infusion System bags did not adversely affect the physical or chemical stability of this drug.

Mireille Favier - One of the best experts on this subject based on the ideXlab platform.

  • compatibility of ondansetron hydrochloride and Methylprednisolone Sodium Succinate in multilayer polyolefin containers
    American Journal of Health-system Pharmacy, 2005
    Co-Authors: Christelle Bougouin, Chloei Thelcide, Fabienne Crespinmaillard, Christian Maillard, Jean Marie Kinowski, Mireille Favier
    Abstract:

    Purpose. The compatibility of ondansetron hydrochloride and Methylprednisolone Sodium Succinate in 5% dextrose injection and 0.9% Sodium chloride injection was studied. Methods. Test solutions of ondansetron hydrochloride 0.16 mg/mL and Methylprednisolone Sodium Succinate 2.4 mg/mL were prepared in triplicate and tested in duplicate. Total volumes of 4 and 2 mL of ondansetron hydrochloride solution and Methylprednisolone Sodium Succinate solution, respectively, were added to 50-mL multilayer polyolefin bags containing 5% dextrose injection or 0.9% Sodium chloride injection. Bags were stored for 24 hours at 20–25 °C and for 48 hours at 4–8 °C. Chemical compatibility was measured with high-performance liquid chromatography, and physical compatibility was determined visually. Results. Ondansetron hydrochloride was stable for up to 24 hours at 20–25 °C and up to 48 hours at 4–8 °C. Methylprednisolone Sodium Succinate was stable for up to 48 hours at 4–8 °C. When stored at 20–25 °C, Methylprednisolone Sodium Succinate was stable for up to 7 hours in 5% dextrose injection and up to 24 hours in 0.9% Sodium chloride injection. Compatibility data for solutions containing ondansetron hydrochloride plus Methylprednisolone Sodium Succinate revealed that each drug was stable for up to 24 hours at 20–25 °C and up to 48 hours at 4–8 °C. Conclusion. Ondansetron 0.16 mg/mL (as the hydrochloride) and Methylprednisolone 2.4 mg/mL (as the Sodium Succinate) mixed in 50-mL multilayer polyolefin bags were stable in both 5% dextrose injection and 0.9% Sodium chloride injection for up to 24 hours at 20–25 °C and up to 48 hours at 4–8 °C.

Michael G Fehlings - One of the best experts on this subject based on the ideXlab platform.

  • a clinical practice guideline for the management of patients with acute spinal cord injury recommendations on the use of Methylprednisolone Sodium Succinate
    Global Spine Journal, 2017
    Co-Authors: Michael G Fehlings, Jefferson R Wilson, Lindsay Tetreault, Bizhan Aarabi, Paul A Anderson, Paul M Arnold, Darrel S Brodke, Anthony S Burns
    Abstract:

    Introduction:The objective of this guideline is to outline the appropriate use of Methylprednisolone Sodium Succinate (MPSS) in patients with acute spinal cord injury (SCI).Methods:A systematic rev...

  • efficacy and safety of Methylprednisolone Sodium Succinate in acute spinal cord injury a systematic review
    Global Spine Journal, 2017
    Co-Authors: Michael G Fehlings, Jefferson R Wilson, Lindsay Tetreault, Paul M Arnold, James S Harrop, Brian K Kwon, Jeffrey M Singh
    Abstract:

    Study Design:Systematic review and meta-analysis.Objective:The objective of this study was to conduct a systematic review to assess the comparative effectiveness and safety of high-dose Methylprednisolone Sodium Succinate (MPSS) versus no pharmacological treatment in patients with traumatic spinal cord injury (SCI).Methods:A systematic search was performed in PubMed and the Cochrane Collaboration Library for literature published between January 1956 and June 17, 2015. Included studies were critically appraised, and Grades of Recommendation Assessment, Development and Evaluation methods were used to determine the overall quality of evidence for primary outcomes. Previous systematic reviews on this topic were collated and evaluated using the Assessment of Multiple Systematic Reviews scoring system.Results:The search yielded 723 citations, 13 of which satisfied inclusion criteria. Among these, 6 were primary research articles and 7 were previous systematic reviews. Based on the included research articles, th...

  • Efficacy and Safety of Methylprednisolone Sodium Succinate in Acute Spinal Cord Injury: A Systematic Review.
    Global spine journal, 2017
    Co-Authors: Michael G Fehlings, Jefferson R Wilson, Lindsay Tetreault, Paul M Arnold, James S Harrop, Brian K Kwon, Jeffrey M Singh, Gregory Hawryluk, Joseph R Dettori
    Abstract:

    Systematic review and meta-analysis. The objective of this study was to conduct a systematic review to assess the comparative effectiveness and safety of high-dose Methylprednisolone Sodium Succinate (MPSS) versus no pharmacological treatment in patients with traumatic spinal cord injury (SCI). A systematic search was performed in PubMed and the Cochrane Collaboration Library for literature published between January 1956 and June 17, 2015. Included studies were critically appraised, and Grades of Recommendation Assessment, Development and Evaluation methods were used to determine the overall quality of evidence for primary outcomes. Previous systematic reviews on this topic were collated and evaluated using the Assessment of Multiple Systematic Reviews scoring system. The search yielded 723 citations, 13 of which satisfied inclusion criteria. Among these, 6 were primary research articles and 7 were previous systematic reviews. Based on the included research articles, there was moderate evidence that the 24-hour NASCIS II (National Acute Spinal Cord Injury Studies) MPSS regimen has no impact on long-term neurological recovery when all postinjury time points are considered. However, there is also moderate evidence that subjects receiving the same MPSS regimen within 8 hours of injury achieve an additional 3.2 points (95% confidence interval = 0.10 to 6.33; P = .04) of motor recovery compared with patients receiving placebo or no treatment. Although safe to administer, a 24-hour NASCIS II MPSS regimen, when all postinjury time points are considered, has no impact on indices of long-term neurological recovery. When commenced within 8 hours of injury, however, a high-dose 24-hour regimen of MPSS confers a small positive benefit on long-term motor recovery and should be considered a treatment option for patients with SCI.

  • A Clinical Practice Guideline for the Management of Patients With Acute Spinal Cord Injury: Recommendations on the Use of Methylprednisolone Sodium Succinate.
    Global spine journal, 2017
    Co-Authors: Michael G Fehlings, Jefferson R Wilson, Lindsay Tetreault, Bizhan Aarabi, Paul M Arnold, Darrel S Brodke, Anthony S Burns, Paul Anderson, Kazuhiro Chiba, Joseph R Dettori
    Abstract:

    The objective of this guideline is to outline the appropriate use of Methylprednisolone Sodium Succinate (MPSS) in patients with acute spinal cord injury (SCI). A systematic review of the literature was conducted to address key questions related to the use of MPSS in acute SCI. A multidisciplinary Guideline Development Group used this information, in combination with their clinical expertise, to develop recommendations for the use of MPSS. Based on GRADE (Grading of Recommendation, Assessment, Development and Evaluation), a strong recommendation is worded as "we recommend," whereas a weaker recommendation is indicated by "we suggest." The main conclusions from the systematic review included the following: (1) there were no differences in motor score change at any time point in patients treated with MPSS compared to those not receiving steroids; (2) when MPSS was administered within 8 hours of injury, pooled results at 6- and 12-months indicated modest improvements in mean motor scores in the MPSS group compared with the control group; and (3) there was no statistical difference between treatment groups in the risk of complications. Our recommendations were: (1) "We suggest not offering a 24-hour infusion of high-dose MPSS to adult patients who present after 8 hours with acute SCI"; (2) "We suggest a 24-hour infusion of high-dose MPSS be offered to adult patients within 8 hours of acute SCI as a treatment option"; and (3) "We suggest not offering a 48-hour infusion of high-dose MPSS to adult patients with acute SCI." These guidelines should be implemented into clinical practice to improve outcomes and reduce morbidity in SCI patients.

Lawrence A Trissel - One of the best experts on this subject based on the ideXlab platform.

  • physical and chemical stability of palonosetron hydrochloride with dacarbazine and with Methylprednisolone Sodium Succinate during simulated y site administration
    International journal of pharmaceutical compounding, 2006
    Co-Authors: Lawrence A Trissel, Yanping Zhang, Quanyun A Xu
    Abstract:

    : The objective of this study was to evaluate the physical and chemical stability of mixtures of undiluted palonosetron hydrochloride 50 micrograms/mL with dacarbazine 4 mg/mL and with Methylprednisolone Sodium Succinate 5 mg/mL in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of dacarbazine solution and, separately, Methylprednisolone Sodium Succinate solution. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques that determined drug concentrations. Evaluations were performed immediately after mixing and 1 and 4 hours after mixing. The palonosetron hydrochloride-dacarbazine samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidities remained unchanged; particulate contents were low and exhibited little change. High-performance liquid chromatography analysis revealed that palonosetron hydrochloride and dacarbazine remained stable throughout the 4-hour test with no drug loss. Palonosetron hydrochloride is, therefore, physically compatible and chemically stable with dacarbazine during Y-site administration. Within 4 hours, the mixtures of palonosetron hydrochloride and Methylprednisolone Sodium Succinate developed a microprecipitate that became a white precipitate visible to the unaided eye. The precipitate was analyzed and identified as Methylprednisolone. Palonosetron hydrochloride is incompatible with Methylprednisolone Sodium Succinate.

  • stability of Methylprednisolone Sodium Succinate in autodose infusion system bags
    Journal of the American Pharmaceutical Association, 2002
    Co-Authors: Lawrence A Trissel, Yanping Zhang
    Abstract:

    Objective To evaluate the physical and chemical stabilities of Methylprednisolone Sodium Succinate solutions packaged in sterile AutoDose Infusion System bags. Setting Laboratory. Interventions The test samples were prepared by reconstituting the Methylprednisolone Sodium Succinate, adding the required amount of drug to the AutoDose Infusion System bags, and diluting to the target concentrations of 100 mg/100 mL and 1 gram/100 mL with 0.9% Sodium Chloride Injection. Main Outcome Measures Physical stability and chemical stability based on drug concentrations initially and at appropriate intervals over periods up to 3 days at 23°C and 30 days at 4°C. Results The admixtures initially were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change. All samples were essentially colorless throughout the study. High-performance liquid chromatography analysis revealed some decomposition in the samples. Methylprednisolone Sodium Succinate exhibited about 8% loss after 2 days and about 13% loss after 3 days at 23°C. In the samples stored at 4°C, Methylprednisolone Sodium Succinate exhibited acceptable stability through 21 days of storage, but losses exceeded 10% after 30 days. Conclusion Methylprednisolone Sodium Succinate exhibited physical and chemical stabilities consistent with those found in previous studies. The AutoDose Infusion System bags did not adversely affect the physical or chemical stability of this drug.

Bruce N Cronstein - One of the best experts on this subject based on the ideXlab platform.

  • clinical use of Methylprednisolone Sodium Succinate a review
    Current Therapeutic Research-clinical and Experimental, 1995
    Co-Authors: Bruce N Cronstein
    Abstract:

    Abstract Methylprednisolone Sodium Succinate is an injectable form of the corticosteroid Methylprednisolone. Because it is extremely soluble in water, intravenous Methylprednisolone can be administered in a small volume of diluent. This characteristic is particularly beneficial when high blood levels of Methylprednisolone must be achieved rapidly. Methylprednisolone Sodium Succinate therapy is useful in the management of many conditions seen by primary care and emergency department physicians, including allergic states, collagen disease, dermatologic conditions, cerebral and spinal edema, gastrointestinal disorders, neoplastic disease, nervous system disorders, rejection of transplanted organs, respiratory tract disease, and acute spinal cord injuries. Although intravenous Methylprednisolone has widespread therapeutic uses, long-term therapy is associated with potentially serious adverse effects. Therefore, whenever Methylprednisolone Sodium Succinate is prescribed, the clinician must individualize the dosage to ensure that the patient receives the lowest effective dose.