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5. 3PC-002 Stability of mixtures of ondansetron and haloperidol stored in infusors at different temperatures

Author

M Espinosa-Bosch, F Sánchez Rojas, C Bosch-Ojeda, and IM Muñoz-Castillo

Subjects
Section 3: Production and compounding
Abstract

BACKGROUND: Mixing different drugs for use in continuous infusion systems is a common practice in palliative care, but the analytical study of compatibility and stability is not always available. PURPOSE: To evaluate the compatibility and stability of two admixtures of ondansetron and haloperidol at different temperatures (25°C, 37°C). The concentrations of the admixtures are: 0.15 mg/ml – 0.25 mg/ml and 0.3 mg/ml – 0.4 mg/ml of haloperidol and ondansetron respectively in NaCl 0.9% stored in elastomeric infusors protected from light. MATERIAL AND METHODS: The samples were prepared and diluted in NaCl 0.9% in elastomeric infusors in triplicate to obtain four different conditions of concentration and/or temperature of storage (concentration: 0.15 mg/ml – 0.25 mg/ml and 0.3 mg/ml – 0.4 mg/ml of haloperidol and ondansetron respectively: temperature of storage 25°C and 37°C). The concentration of each constituent drug into different mixtures was periodically determined using a HPLC-UVmethod. The drugs were chromatographed on a C(18) reverse phase column: the mobile phase was methanol:KH(2)PO(4)0.05 M, adjusted to pH 3 with H(3)PO(3) (60:40, v/v) delivered at a flow rate of 1.0 mL min(-1). The sample injection volume was 20 µL, and triplicate injections were performed for every sample. The signal was recorded during 8 min and the retention times were 3.6 min for ondansetron and 6.6 min for haloperidol. Ondansetron and haloperidol concentrations were determined at 254 nm by interpolation from the calibration curves prepared from the standards. The Statgraphics centurion XVI program has been used for data treatment. RESULTS: All solutions were initially clear and colourless but visible particles appear, in all cases, in the infusers after 2 days since their preparation. Chemical stability of the admixtures diluted in NaCl 0.9% are as follows: haloperidol-ondansetron (0.15 mg/ml – 0.25 mg/ml) is stable (retained >90% of their initial concentration) 2 days at 25°C and 37°C; and (0.3 mg/ml 0.4 mg/ml) is stable two days at 25°C and 37°C. CONCLUSION: The mixture of haloperidol and ondansetron stored in infusor devices is not stable because visible particles appear in less than 48 hours. Physical pressure by the elastomeric infusor may have a role in the instability, since precipitate is not appreciated when stored in flasks. No conflict of interest

Published
2018

7. [Effectiveness of plerixafor in patients undergoing mobilization autologous haematopoietic progenitor cell].

Author

Ruano Camps R, Ortiz Pareja M, Vidales Mancha I, Muñoz Castillo IM, and Heiniger Mazo AI

Subjects
Adult, Antigens, CD34 analysis, Antineoplastic Combined Chemotherapy Protocols pharmacology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Benzylamines, Blood Cell Count, Blood Component Removal, Choriocarcinoma blood, Choriocarcinoma drug therapy, Choriocarcinoma secondary, Choriocarcinoma surgery, Combined Modality Therapy, Cyclams, Drug Evaluation, Drug Synergism, Female, Hematologic Neoplasms blood, Hematologic Neoplasms drug therapy, Hematologic Neoplasms surgery, Humans, Male, Middle Aged, Pregnancy, Retrospective Studies, Transplantation, Autologous, Uterine Neoplasms blood, Uterine Neoplasms drug therapy, Granulocyte Colony-Stimulating Factor pharmacology, Hematopoietic Stem Cell Mobilization methods, Heterocyclic Compounds pharmacology, Peripheral Blood Stem Cell Transplantation
Abstract

Objective: To evaluate effectiveness of treatment with plerixafor in patients undergoing posterior mobilization for hematopoietic transplant at our hospital., Methods: Retrospective study of all patients who until September 2012, received plerixafor in their scheme of mobilization into peripheral blood hematopoietic progenitors. We reviewed the medical records and records of drug dispensing outpatient consultation. Effectiveness variables used were: CD34/kg in apheresis product obtained, and day dose received colony stimulating factor (G-CSF) and Plerixafor. Each patient was compared to the effectiveness of the drug results with those obtained earlier mobilization schemes where Plerixafor not used, if present. Data were analyzed using IBM SPSS v19., Results: A total of 24 patients received plerixafor in our hospital. Diagnoses were distributed: 15 NHL, 6 patients with multiple myeloma, 2 Hodgkin's disease, and one metastatic choriocarcinoma. The effectiveness outcomes were no plerixafor mobilization (n = 18): 5 patients were mobilized with G-CSGF only, 13 with G-CSF and chemotherapy. The G-CSF dose / day was mcg 931.1 (± 179.5) for 9.5 days (± 4.7). The average product obtained CD34/kg in cells was 0.2 (± 0.5). No patient received sufficient product (≥ 2 x 106 cells/kg) for subsequent autologous transplantation. 100% of the demonstrations failed. Mobilization with plerixafor (n = 24): 13 patients were mobilized with GCSGF only, 11 with G-CSF and chemotherapy. The G-CSF dose/ day and averaged Plerixafor mcg 885.1 (± 240.1) and 19.8 (± 4.4), respectively, administered for 8.9 (± 5.1) and 1 , 5 (± 0.6) days, respectively. The average product obtained in CD34/kg was 2.3 x 106 cells (± 1.7) (p = 0.014 in relation to the demonstrations without Plerixafor). Only 12.5% (n = 3) patients were unable to undergo autologous transplant., Conclusions: In our patients, plerixafor has proven effective in mobilizing hematopoietic progenitors for autologous back., (Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.)

Published
2013
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8. [Infliximab in rheumatoid arthritis-use in a third level hospital].

Author

Ruano Camps R, Ordóñez Martí-Aguilar MV, Gallego Fernández C, Coret Cagigal V, and Muñoz Castillo IM

Subjects
Antibodies, Monoclonal adverse effects, Antirheumatic Agents adverse effects, Female, Humans, Infliximab, Male, Middle Aged, Retrospective Studies, Severity of Illness Index, Treatment Outcome, Antibodies, Monoclonal administration & dosage, Antirheumatic Agents administration & dosage, Arthritis, Rheumatoid drug therapy
Abstract

Objectives: To study the conditions of infliximab use in rheumatoid arthritis, as well as the effectiveness and adverse effects of this therapy, and to perform an economic assessment of infliximab therapy in a third-level hospital., Material and Methods: A retrospective study was performed including patients treated with infliximab from January 2001 to March 2003., Results: Twenty-five percent of patients received doses greater than 3 mg/kg, and 12% of them at intervals shorter than 8 weeks; 78% also received methotrexate concurrently. Adverse effects reported were similar in type to those described in the pro-duct's data sheet. Regarding therapy effectiveness, objective para-meters were seen to improve, less so the remaining parameters. Therapy cost was 5.6% of day hospital costs., Conclusions: Anti-TNF drugs are a relevant alternative in the treatment of rheumatoid arthritis because of their effectiveness-safety profile, but understanding their frame of use and following recommendations issued by scientific societies are important considerations.

Published
2005
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