Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients

Autores
de Lafuente, Yanina; García, Mónica Cristina; Jimenez Kairuz, Alvaro Federico
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Indomethacin (IND) is used for off-label prescription for the treatment of patent ductus arteriosus (PDA) in premature infants. In Argentina, IND is only available as a suppository, dermic cream, injectable ampoules, and delayed-release capsules. Aiming to improve paediatric treatment and minimise the risk associated with improper dosage, this work focused on the development of an extemporaneous 0.2% IND oral suspension, starting from the commercially injectable formulation. Two 150mL batches of suspension were prepared using GRAS excipients. The suspensions were stored for 17 days at room temperature. Physical stability, morphological analysis of suspended particles, sedimentation volume, easy re-suspension, and dynamic viscosity were studied. The IND content, dissolution studies and microbiological attributes of non-sterile pharmaceutical products were also evaluated. After 17 days of storage, the suspension was easily re-dispersed after 15 s of simple hand-shaking. There were no detectable changes in colour, odour, and/or flavour. The suspension showed minimal changes in pH, viscosity, shape, and mean size of the suspended IND particles. The content uniformity and drug dissolution remained within the acceptable range during storage. This oral liquid suspension is an interesting alternative to be prepared by hospital pharmacy services for optimising the paediatric treatment of PDA.
Fil: de Lafuente, Yanina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: García, Mónica Cristina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Jimenez Kairuz, Alvaro Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Materia
INDOMETHACIN
COMPOUNDING
EXTEMPORANEOUS ORAL SUSPENSION
PEDIATRIC TREATMENT
HOSPITAL PHARMACEUTICAL SERVICE
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/215408
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/215408
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patientsde Lafuente, YaninaGarcía, Mónica CristinaJimenez Kairuz, Alvaro FedericoINDOMETHACINCOMPOUNDINGEXTEMPORANEOUS ORAL SUSPENSIONPEDIATRIC TREATMENTHOSPITAL PHARMACEUTICAL SERVICEhttps://purl.org/becyt/ford/3.1https://purl.org/becyt/ford/3Indomethacin (IND) is used for off-label prescription for the treatment of patent ductus arteriosus (PDA) in premature infants. In Argentina, IND is only available as a suppository, dermic cream, injectable ampoules, and delayed-release capsules. Aiming to improve paediatric treatment and minimise the risk associated with improper dosage, this work focused on the development of an extemporaneous 0.2% IND oral suspension, starting from the commercially injectable formulation. Two 150mL batches of suspension were prepared using GRAS excipients. The suspensions were stored for 17 days at room temperature. Physical stability, morphological analysis of suspended particles, sedimentation volume, easy re-suspension, and dynamic viscosity were studied. The IND content, dissolution studies and microbiological attributes of non-sterile pharmaceutical products were also evaluated. After 17 days of storage, the suspension was easily re-dispersed after 15 s of simple hand-shaking. There were no detectable changes in colour, odour, and/or flavour. The suspension showed minimal changes in pH, viscosity, shape, and mean size of the suspended IND particles. The content uniformity and drug dissolution remained within the acceptable range during storage. This oral liquid suspension is an interesting alternative to be prepared by hospital pharmacy services for optimising the paediatric treatment of PDA.Fil: de Lafuente, Yanina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: García, Mónica Cristina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaFil: Jimenez Kairuz, Alvaro Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; ArgentinaInternational Journal of Pharmaceutical Compounding2018-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/215408de Lafuente, Yanina; García, Mónica Cristina; Jimenez Kairuz, Alvaro Federico; Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 23; 12-2018; 324-3311516-5140CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4640info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:37:18Zoai:ri.conicet.gov.ar:11336/215408instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:37:18.463CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
title Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
spellingShingle Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
de Lafuente, Yanina
INDOMETHACIN
COMPOUNDING
EXTEMPORANEOUS ORAL SUSPENSION
PEDIATRIC TREATMENT
HOSPITAL PHARMACEUTICAL SERVICE
title_short Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
title_full Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
title_fullStr Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
title_full_unstemmed Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
title_sort Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients
dc.creator.none.fl_str_mv de Lafuente, Yanina
García, Mónica Cristina
Jimenez Kairuz, Alvaro Federico
author de Lafuente, Yanina
author_facet de Lafuente, Yanina
García, Mónica Cristina
Jimenez Kairuz, Alvaro Federico
author_role author
author2 García, Mónica Cristina
Jimenez Kairuz, Alvaro Federico
author2_role author
author
dc.subject.none.fl_str_mv INDOMETHACIN
COMPOUNDING
EXTEMPORANEOUS ORAL SUSPENSION
PEDIATRIC TREATMENT
HOSPITAL PHARMACEUTICAL SERVICE
topic INDOMETHACIN
COMPOUNDING
EXTEMPORANEOUS ORAL SUSPENSION
PEDIATRIC TREATMENT
HOSPITAL PHARMACEUTICAL SERVICE
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.1
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Indomethacin (IND) is used for off-label prescription for the treatment of patent ductus arteriosus (PDA) in premature infants. In Argentina, IND is only available as a suppository, dermic cream, injectable ampoules, and delayed-release capsules. Aiming to improve paediatric treatment and minimise the risk associated with improper dosage, this work focused on the development of an extemporaneous 0.2% IND oral suspension, starting from the commercially injectable formulation. Two 150mL batches of suspension were prepared using GRAS excipients. The suspensions were stored for 17 days at room temperature. Physical stability, morphological analysis of suspended particles, sedimentation volume, easy re-suspension, and dynamic viscosity were studied. The IND content, dissolution studies and microbiological attributes of non-sterile pharmaceutical products were also evaluated. After 17 days of storage, the suspension was easily re-dispersed after 15 s of simple hand-shaking. There were no detectable changes in colour, odour, and/or flavour. The suspension showed minimal changes in pH, viscosity, shape, and mean size of the suspended IND particles. The content uniformity and drug dissolution remained within the acceptable range during storage. This oral liquid suspension is an interesting alternative to be prepared by hospital pharmacy services for optimising the paediatric treatment of PDA.
Fil: de Lafuente, Yanina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: García, Mónica Cristina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
Fil: Jimenez Kairuz, Alvaro Federico. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Unidad de Investigación y Desarrollo en Tecnología Farmacéutica; Argentina
description Indomethacin (IND) is used for off-label prescription for the treatment of patent ductus arteriosus (PDA) in premature infants. In Argentina, IND is only available as a suppository, dermic cream, injectable ampoules, and delayed-release capsules. Aiming to improve paediatric treatment and minimise the risk associated with improper dosage, this work focused on the development of an extemporaneous 0.2% IND oral suspension, starting from the commercially injectable formulation. Two 150mL batches of suspension were prepared using GRAS excipients. The suspensions were stored for 17 days at room temperature. Physical stability, morphological analysis of suspended particles, sedimentation volume, easy re-suspension, and dynamic viscosity were studied. The IND content, dissolution studies and microbiological attributes of non-sterile pharmaceutical products were also evaluated. After 17 days of storage, the suspension was easily re-dispersed after 15 s of simple hand-shaking. There were no detectable changes in colour, odour, and/or flavour. The suspension showed minimal changes in pH, viscosity, shape, and mean size of the suspended IND particles. The content uniformity and drug dissolution remained within the acceptable range during storage. This oral liquid suspension is an interesting alternative to be prepared by hospital pharmacy services for optimising the paediatric treatment of PDA.
publishDate 2018
dc.date.none.fl_str_mv 2018-12
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/215408
de Lafuente, Yanina; García, Mónica Cristina; Jimenez Kairuz, Alvaro Federico; Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 23; 12-2018; 324-331
1516-5140
CONICET Digital
CONICET
url http://hdl.handle.net/11336/215408
identifier_str_mv de Lafuente, Yanina; García, Mónica Cristina; Jimenez Kairuz, Alvaro Federico; Extemporaneous indomethacin oral suspension prepared from injectable ampoules for therapy in premature infants and paediatric patients; International Journal of Pharmaceutical Compounding; International Journal Of Pharmaceutical Compounding; 23; 12-2018; 324-331
1516-5140
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4640
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv International Journal of Pharmaceutical Compounding
publisher.none.fl_str_mv International Journal of Pharmaceutical Compounding
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.069144

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