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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/215408
Ver los metadatos del registro completo
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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 Técnicas2025-09-03T10:08:30Zoai: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:34982025-09-03 10:08:31.021CONICET 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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1842270047885590528 |
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13.13397 |