دورية أكاديمية
Physico-Chemical Stability of Busulfan in Injectable Solutions in Various Administration Packages
| العنوان: | Physico-Chemical Stability of Busulfan in Injectable Solutions in Various Administration Packages |
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| المؤلفون: | Houot, Mélanie, Poinsignon, Vianney, Mercier, Lionel, Valade, Cyril, Desmaris, Romain, Lemare, François, Paci, Angelo |
| المساهمون: | Département de biologie et pathologie médicales Gustave Roussy, Institut Gustave Roussy (IGR), Département de pharmacie clinique Gustave Roussy, École des Hautes Études en Santé Publique EHESP (EHESP), EA Management des Organisations de Santé (EA MOS), École des Hautes Études en Santé Publique EHESP (EHESP)-PRES Sorbonne Paris Cité |
| المصدر: | ISSN: 1174-5886 ; Drugs in R&D ; https://hal.science/hal-01514079Test ; Drugs in R&D, 2013, 13 (1), pp.87 - 94. ⟨10.1007/s40268-013-0003-y⟩. |
| بيانات النشر: | HAL CCSD Springer Verlag |
| سنة النشر: | 2013 |
| المجموعة: | EHESP - Productions scientifiques de l'Ecole des hautes études en santé publique |
| مصطلحات موضوعية: | Chronic Myeloid Leukemia, Storage Temperature, Glass Bottle, Busulfan, Autologous Hematopoietic Stem Cell Transplantation, MESH: Busulfan/chemistry, MESH: Busulfan/standards, MESH: Chemical Phenomena, MESH: Chemical Precipitation/drug effects, MESH: Drug Packaging/standards, MESH: Drug Stability, MESH: Injections, MESH: Pharmaceutical Solutions/chemistry, MESH: Pharmaceutical Solutions/standards, MESH: Time Factors, [CHIM.THER]Chemical Sciences/Medicinal Chemistry, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences |
| الوصف: | International audience ; BACKGROUND AND OBJECTIVES: Busulfan is used as part of a conditioning regimen prior to hematopoietic stem cell transplantation for the treatment of certain cancers and immune deficiency syndromes. Due to its instability in aqueous preparations, busulfan for infusion is prepared from a concentrate and has a relatively short shelf life once prepared. The purpose of this study was to identify the most suitable storage container and temperature to maximize the shelf life of busulfan therapeutic infusions prepared from Busilvex(®).METHODS: Busilvex(®) 6 mg/mL was diluted to 0.55 mg/mL with 0.9 % NaCl and aliquots dispensed into polypropylene syringes, polyvinyl chloride bags, and glass bottles. Three storage temperatures were evaluated: 2-8 °C, 13-15 °C (thermostatically controlled chamber), and room temperature (20 ± 5 °C). At set time points, samples were analysed for busulfan content, using a high-performance liquid chromatography (HPLC) system with ultraviolet detection. The change in pH and osmolarity on storage was also determined, and solutions were inspected visually for formation of a precipitate or colour change. To determine the contribution of precipitation to loss of busulfan content on storage, samples from one time series were treated with the solvent dimethylacetamide prior to HPLC separation and quantitation of busulfan.RESULTS: The results of the active substance content monitoring study over a 48-h period demonstrate that busulfan solution is stable at a 5 % threshold, at 2-8 °C for 16 h in syringes, 14 h in glass bottles, and 6 h in bags. In addition, the period of stability decreases as the temperature increases (4 h at 20 ± 5 °C). The solution is considered to be stable, subject to precipitation liable to be observed regardless of the temperature.CONCLUSION: The best stability was observed for busulfan solutions placed at 2-8 °C in syringes. This study demonstrated that precipitation, in addition to hydrolysis, has a significant influence on the busulfan content. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | hal-01514079; https://hal.science/hal-01514079Test; https://hal.science/hal-01514079/documentTest; https://hal.science/hal-01514079/file/40268_2013_Article_3.pdfTest |
| DOI: | 10.1007/s40268-013-0003-y |
| الإتاحة: | https://doi.org/10.1007/s40268-013-0003-yTest https://hal.science/hal-01514079Test https://hal.science/hal-01514079/documentTest https://hal.science/hal-01514079/file/40268_2013_Article_3.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.4AA4298B |
| قاعدة البيانات: | BASE |
| DOI: | 10.1007/s40268-013-0003-y |
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