{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T08:05:32Z","timestamp":1779437132041,"version":"3.53.1"},"reference-count":40,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T00:00:00Z","timestamp":1779148800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Oncol Pharm Pract"],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>In pediatric practice, etoposide is a cytotoxic drug that can be prescribed under various routes of administration according to the indication. These prescriptions can imply frequent preparations, which can be secured through batch production and storage. However, this practice requires stability data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The HPLC-UV dosing method of etoposide and its degradation products was validated. Validation of microbiological analyses was also performed. All relevant parameters were also studied (particle contamination, pH, leachables, but also preservative efficacy and benzaldehyde content for oral etoposide and endotoxin for intrathecal etoposide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      10\u2005mg.mL\n                      <jats:sup>\u22121<\/jats:sup>\n                      etoposide for oral administration, both in normal saline or in dextrose 5% was proven to be stable for 15 days when stored at 25\u00b0C\/60% RH and 90 days at 2\u20138\u00b0C. 0.1\u2005mg.mL\n                      <jats:sup>\u22121<\/jats:sup>\n                      etoposide for intrathecal administration was stable in Luer-Lock syringes for 2 days when stored at 25\u00b0C\/60% RH and 14 days at 2\u20138\u00b0C, and in NRFit\n                      <jats:sup>\u00ae<\/jats:sup>\n                      syringes for 14 days both when stored at 25\u00b0C\/60% RH and at 2\u20138\u00b0C.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Etoposide 10\u2005mg\u00b7mL\n                      <jats:sup>\u20131<\/jats:sup>\n                      for oral administration must be prepared under strict aseptic conditions and can be stored for 15 days at ambient temperature and 90 days under refrigerated conditions. Etoposide 0.1\u2005mg\u00b7mL\n                      <jats:sup>\u20131<\/jats:sup>\n                      for intrathecal administration in normal saline should be compounded in NRFit\n                      <jats:sup>\u00ae<\/jats:sup>\n                      syringes and can be stored for 14 days under refrigerated conditions. This study demonstrates that the container\u2013closure system is an integral component of the drug product, as syringe type significantly influences impurity formation and leachable release, with direct implications for pharmaceutical quality and safety.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10781552261452549","type":"journal-article","created":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T14:45:16Z","timestamp":1779201916000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Stability studies of etoposide as syringes for intrathecal administration and syringes for pediatric oral administration"],"prefix":"10.1177","author":[{"given":"Jonathan","family":"Hua","sequence":"first","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9638-3774","authenticated-orcid":false,"given":"Chlo\u00e9","family":"Renon","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Jaud","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geoffroy","family":"Denniel","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romain","family":"Paoli-Lombardo","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"},{"name":"Equipe de Pharmaco-Chimie Radicalaire, Aix-Marseille Univ, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Rathelot","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"},{"name":"Equipe de Pharmaco-Chimie Radicalaire, Aix-Marseille Univ, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrice","family":"Vanelle","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"},{"name":"Equipe de Pharmaco-Chimie Radicalaire, Aix-Marseille Univ, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5919-4394","authenticated-orcid":false,"given":"Christophe","family":"Curti","sequence":"additional","affiliation":[{"name":"Assistance Publique \u2013 H\u00f4pitaux de Marseille (AP-HM)"},{"name":"Equipe de Pharmaco-Chimie Radicalaire, Aix-Marseille Univ, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Marseille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertrand","family":"Pourroy","sequence":"additional","affiliation":[{"name":"AP-HM, H\u00f4pital de la Timone"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,5,19]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2023.4437"},{"key":"e_1_3_2_3_2","unstructured":"European Medicines Agency 2018 List of nationally authorised medicinal products. Active substance: etoposide. https:\/\/www.ema.europa.eu\/en\/documents\/psusa\/etoposide-list-nationally-authorised-medicinal-products-psusa00001333201708_en.pdf (accessed 22 December 2025)."},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(93)90210-7"},{"key":"e_1_3_2_5_2","first-page":"2784","article-title":"Stability of etoposide solution for oral use","volume":"49","author":"McLeod HL","year":"1992","unstructured":"McLeod HL, Relling MV. Stability of etoposide solution for oral use. Am J Hosp Pharm 1992; 49: 2784\u20132785.","journal-title":"Am J Hosp Pharm"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/0959-8049(93)90025-b"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1994.12.7.1452"},{"key":"e_1_3_2_8_2","first-page":"251","article-title":"Traitement par \u00e9toposide oral : pr\u00e9sentation adapt\u00e9e \u00e0 une meilleure observance p\u00e9diatrique hospitali\u00e8re","volume":"18","author":"Drouard S","year":"1999","unstructured":"Drouard S, Vigneron J, May I. Traitement par \u00e9toposide oral : pr\u00e9sentation adapt\u00e9e \u00e0 une meilleure observance p\u00e9diatrique hospitali\u00e8re. J Pharm Clin 1999; 18: 251\u2013257. (article in French).","journal-title":"J Pharm Clin"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1472945"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40268-014-0037-9"},{"key":"e_1_3_2_11_2","unstructured":"Gras C Sautou-Miranda V Bagel-Boithias S et al. Compatibility of etoposide solution with polyvinyl chloride and low density polyethylene containers and its stability in different storage conditions. Eur J Hosp Pharm 2002; 2: 33\u201340."},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2018-001571"},{"key":"e_1_3_2_13_2","first-page":"26","article-title":"Studies on the stability and compatibility of cytotoxic drug infusion with the Tevadaptor system","volume":"8","author":"Sewell G","year":"2014","unstructured":"Sewell G, Massimini M. Studies on the stability and compatibility of cytotoxic drug infusion with the Tevadaptor system. Eur J Onc Pharm 2014; 8: 26\u201330.","journal-title":"Eur J Onc Pharm"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2019.112896"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/0031-6865(95)00007-V"},{"key":"e_1_3_2_16_2","first-page":"2706","article-title":"Stability and compatibility of etoposide in 0.9% sodium chloride injection in three containers","volume":"51","author":"Barthes DM","year":"1994","unstructured":"Barthes DM, Rochard EB, Pouliquen IJ, et al. Stability and compatibility of etoposide in 0.9% sodium chloride injection in three containers. Am J Hosp Pharm 1994; 51: 2706\u20132709.","journal-title":"Am J Hosp Pharm"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00685638"},{"key":"e_1_3_2_18_2","first-page":"108","article-title":"Chemical and physical stability of etoposide and teniposide in commonly used infusion fluids","volume":"45","author":"Beijnen JH","year":"1991","unstructured":"Beijnen JH, Beijnen-Bandhoe AU, Dubbelman AC, et al. Chemical and physical stability of etoposide and teniposide in commonly used infusion fluids. J Parenter Sci Technol 1991; 45: 108\u2013112.","journal-title":"J Parenter Sci Technol"},{"key":"e_1_3_2_19_2","first-page":"338","article-title":"Stability and compatibility of etoposide in normal saline","volume":"53","author":"Lepage R","year":"2000","unstructured":"Lepage R, Walker SE, Godin J. Stability and compatibility of etoposide in normal saline. Can J Hosp Pharm 2000; 53: 338\u2013345.","journal-title":"Can J Hosp Pharm"},{"key":"e_1_3_2_20_2","first-page":"33","article-title":"Etude de la stabilit\u00e9 dans des solutions dilu\u00e9es destin\u00e9es \u00e0 la perfusion de deux antimitotiques d\u00e9riv\u00e9s de la podophyllotoxine : l\u2019\u00e9toposide (VP 16), le t\u00e9niposide (VM 26)","volume":"3","author":"Hamon M","year":"1987","unstructured":"Hamon M, Plas-Remoissenet D, Kubab-Alajati S. Etude de la stabilit\u00e9 dans des solutions dilu\u00e9es destin\u00e9es \u00e0 la perfusion de deux antimitotiques d\u00e9riv\u00e9s de la podophyllotoxine : l\u2019\u00e9toposide (VP 16), le t\u00e9niposide (VM 26). Sci Tech Pharm 1987; 3: 33\u201340. (article in French).","journal-title":"Sci Tech Pharm"},{"key":"e_1_3_2_21_2","first-page":"4396","volume-title":"The United States pharmacopeia","year":"2019","unstructured":"The United States pharmacopeia. Vol. 2. Rockville (MD): USP 42 NF 37; 2019, pp.4396\u20134398. Etoposide.","edition":"42"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2018.03.044"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.3390\/ph18020204"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.3390\/ph16010072"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharma.2011.07.002"},{"key":"e_1_3_2_26_2","unstructured":"Food and Drug Administration Office of Regulatory Affairs. ORA Lab Manual Vol. II - Methods Method Verification and Validation (ORALAB. 5.4.5.). https:\/\/www.fda.gov\/media\/73920\/download (accessed 22 December 2025)."},{"key":"e_1_3_2_27_2","unstructured":"American Society of Health-System Pharmacists injectable drug information etoposide: https:\/\/publications.ashp.org\/previewpdf\/book\/9781585287079\/ch163.xml?pdfJsInlineViewToken=590193057&inlineView=true (accessed 25 March 2026)"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2710.1986.tb00853.x"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.1213\/01.ANE.0000148617.98716.EB"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics15020563"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-7158.1957.tb12342.x"},{"key":"e_1_3_2_32_2","first-page":"251","article-title":"Excipients in neonatal medicinal products: never prescribed, commonly administered","volume":"32","author":"Valeur KS","year":"2018","unstructured":"Valeur KS, Holst H, Allegaert K. Excipients in neonatal medicinal products: never prescribed, commonly administered. Pharmaceut Med 2018; 32: 251\u2013258.","journal-title":"Pharmaceut Med"},{"key":"e_1_3_2_33_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2024.115985"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2024.116215"},{"key":"e_1_3_2_35_2","doi-asserted-by":"publisher","DOI":"10.1002\/mas.21591"},{"key":"e_1_3_2_36_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2023.115640"},{"key":"e_1_3_2_37_2","doi-asserted-by":"publisher","DOI":"10.1080\/10837450.2017.1365370"},{"key":"e_1_3_2_38_2","unstructured":"European Medicines Agency 2025 ICH Q3E Extractables and leachables - scientific guideline. https:\/\/www.ema.europa.eu\/en\/ich-q3e-extractables-leachables-scientific-guideline. (accessed 22 December 2025)."},{"key":"e_1_3_2_39_2","unstructured":"European Medicines Agency 2017 Questions and answers on benzyl alcohol used as an excipient in medicinal products for human use. https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/questions-and-answers-benzyl-alcohol-used-excipient-medicinal-products-human-use_en.pdf. (accessed 25 March 2026)."},{"key":"e_1_3_2_40_2","doi-asserted-by":"publisher","DOI":"10.5694\/j.1326-5377.2000.tb125570.x"},{"key":"e_1_3_2_41_2","doi-asserted-by":"publisher","DOI":"10.1136\/ejhpharm-2019-001977"}],"container-title":["Journal of Oncology Pharmacy Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552261452549","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10781552261452549","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10781552261452549","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T07:17:30Z","timestamp":1779434250000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10781552261452549"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,19]]},"references-count":40,"alternative-id":["10.1177\/10781552261452549"],"URL":"https:\/\/doi.org\/10.1177\/10781552261452549","relation":{},"ISSN":["1078-1552","1477-092X"],"issn-type":[{"value":"1078-1552","type":"print"},{"value":"1477-092X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,19]]},"article-number":"10781552261452549"}}