Stability of carboplatin infusion solutions used in desensitization protocol

Carboplatin hypersensitivity reactions are one of the major clinical challenges in treating patients with relapse/recurrent ovarian malignancies. Desensitization protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions by gradually re-introducing small...

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Autores: Vázquez-Sánchez, Rocío, Sánchez-Rubio-Ferrández, Javier, Córdoba Díaz, Damián, Córdoba Díaz, Manuel, Molina-Garcia, Teresa
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universidad Complutense de Madrid (UCM)
Repositorio:Docta Complutense
Idioma:inglés
OAI Identifier:oai:docta.ucm.es:20.500.14352/115518
Acceso en línea:https://hdl.handle.net/20.500.14352/115518
Access Level:acceso abierto
Palabra clave:Carboplatin
desensitization
hypersensitivity
stability
Tecnología farmaceútica
3209.08 Preparación de Medicamentos
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spelling Stability of carboplatin infusion solutions used in desensitization protocolVázquez-Sánchez, RocíoSánchez-Rubio-Ferrández, JavierCórdoba Díaz, DamiánCórdoba Díaz, ManuelMolina-Garcia, TeresaCarboplatindesensitizationhypersensitivitystabilityTecnología farmaceútica3209.08 Preparación de MedicamentosCarboplatin hypersensitivity reactions are one of the major clinical challenges in treating patients with relapse/recurrent ovarian malignancies. Desensitization protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions by gradually re-introducing small amounts of the drug up to full therapeutic doses. Carboplatin desensitization protocol is based on three solutions that are usually prepared in the chemotherapy centralized units of hospital pharmacies. First and second solutions are diluted under the established concentration limit to guarantee the stability of the preparation. We developed a specific high-performance liquid chromatography assay to determine the stability of carboplatin infusion solutions that have been diluted to 0.2 mg/mL and 0.02 mg/mL in 250 mL of 5% dextrose in polypropylene infusion bags which were stored 24 h protected from light at room temperature. Samples were withdrawn at t ¼ 0 h, 3 h, 6 h, and 24 h. The analytical column was a Zorbax eclipse XDB-C18 (150 mm 4.6 mm; 5 mm particle size). The mobile phase had a flow rate of 1 mL/min under isocratic conditions of water–methanol (98:2, v/v). For 0.2 mg/mL solution, the high-performance liquid chromatography assay revealed no significant losses in carboplatin concentration. However, in 0.02 mg/mL solution remaining carboplatin was > 105% the initial dose after 3 h of storage at room temperature. The ultraviolet–visible spectra analysis showed that carboplatin remained intact during the study in 0.2 mg/mL solution, but some changes were detected in 0.02 mg/mL solution. Thus, 0.2 mg/mL carboplatin solution is stable for 24 h at room temperature in 5% dextrose polypropylene infusion bags but stability could not be proved for 0.02 mg/mL solution.SAGEUniversidad Complutense de Madrid20192019-01-0120192019-01-01journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.14352/115518reponame:Docta Complutenseinstname:Universidad Complutense de Madrid (UCM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:docta.ucm.es:20.500.14352/1155182026-06-02T12:44:21Z
dc.title.none.fl_str_mv Stability of carboplatin infusion solutions used in desensitization protocol
title Stability of carboplatin infusion solutions used in desensitization protocol
spellingShingle Stability of carboplatin infusion solutions used in desensitization protocol
Vázquez-Sánchez, Rocío
Carboplatin
desensitization
hypersensitivity
stability
Tecnología farmaceútica
3209.08 Preparación de Medicamentos
title_short Stability of carboplatin infusion solutions used in desensitization protocol
title_full Stability of carboplatin infusion solutions used in desensitization protocol
title_fullStr Stability of carboplatin infusion solutions used in desensitization protocol
title_full_unstemmed Stability of carboplatin infusion solutions used in desensitization protocol
title_sort Stability of carboplatin infusion solutions used in desensitization protocol
dc.creator.none.fl_str_mv Vázquez-Sánchez, Rocío
Sánchez-Rubio-Ferrández, Javier
Córdoba Díaz, Damián
Córdoba Díaz, Manuel
Molina-Garcia, Teresa
author Vázquez-Sánchez, Rocío
author_facet Vázquez-Sánchez, Rocío
Sánchez-Rubio-Ferrández, Javier
Córdoba Díaz, Damián
Córdoba Díaz, Manuel
Molina-Garcia, Teresa
author_role author
author2 Sánchez-Rubio-Ferrández, Javier
Córdoba Díaz, Damián
Córdoba Díaz, Manuel
Molina-Garcia, Teresa
author2_role author
author
author
author
dc.contributor.none.fl_str_mv Universidad Complutense de Madrid
dc.subject.none.fl_str_mv Carboplatin
desensitization
hypersensitivity
stability
Tecnología farmaceútica
3209.08 Preparación de Medicamentos
topic Carboplatin
desensitization
hypersensitivity
stability
Tecnología farmaceútica
3209.08 Preparación de Medicamentos
description Carboplatin hypersensitivity reactions are one of the major clinical challenges in treating patients with relapse/recurrent ovarian malignancies. Desensitization protocols allow the continuation of treatment in patients who have presented hypersensitivity reactions by gradually re-introducing small amounts of the drug up to full therapeutic doses. Carboplatin desensitization protocol is based on three solutions that are usually prepared in the chemotherapy centralized units of hospital pharmacies. First and second solutions are diluted under the established concentration limit to guarantee the stability of the preparation. We developed a specific high-performance liquid chromatography assay to determine the stability of carboplatin infusion solutions that have been diluted to 0.2 mg/mL and 0.02 mg/mL in 250 mL of 5% dextrose in polypropylene infusion bags which were stored 24 h protected from light at room temperature. Samples were withdrawn at t ¼ 0 h, 3 h, 6 h, and 24 h. The analytical column was a Zorbax eclipse XDB-C18 (150 mm 4.6 mm; 5 mm particle size). The mobile phase had a flow rate of 1 mL/min under isocratic conditions of water–methanol (98:2, v/v). For 0.2 mg/mL solution, the high-performance liquid chromatography assay revealed no significant losses in carboplatin concentration. However, in 0.02 mg/mL solution remaining carboplatin was > 105% the initial dose after 3 h of storage at room temperature. The ultraviolet–visible spectra analysis showed that carboplatin remained intact during the study in 0.2 mg/mL solution, but some changes were detected in 0.02 mg/mL solution. Thus, 0.2 mg/mL carboplatin solution is stable for 24 h at room temperature in 5% dextrose polypropylene infusion bags but stability could not be proved for 0.02 mg/mL solution.
publishDate 2019
dc.date.none.fl_str_mv 2019
2019-01-01
2019
2019-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14352/115518
url https://hdl.handle.net/20.500.14352/115518
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv SAGE
publisher.none.fl_str_mv SAGE
dc.source.none.fl_str_mv reponame:Docta Complutense
instname:Universidad Complutense de Madrid (UCM)
instname_str Universidad Complutense de Madrid (UCM)
reponame_str Docta Complutense
collection Docta Complutense
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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