First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation

Autores
Morri, Mauro Gaspar; Castellano, Patricia Margarita; Leonardi, Darío; Vignaduzzo, Silvana Edit
Año de publicación
2018
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Liquid formulations can be used in children of different ages by varying the volume of the administered dose in order to ensure an exact dosage. The aim of this work was to develop and to optimize a safe liquid atenolol formulation and to carry out the corresponding chemical and microbiological stability studies. A Plackett-Burman design was used to determine the factors that could be critical in the development of the formulations, and a central composite design was used to determine the optimal working conditions. As a result of these analyses, three formulations were selected and their stability studied in three storage conditions, 4, 25, and 40°C. After 6 months of stability testing, the optimal systems showed no pH change or atenolol loss; however, only glycerin-based formulations showed no microbial development. These systems, employing excipients in a range that the EMA has recommended, showed chemical and microbiological stability for at least 6 months even at the worst storage conditions.
Fil: Morri, Mauro Gaspar. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas; Argentina
Fil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Vignaduzzo, Silvana Edit. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Materia
ATENOLOL
DEVELOPMENT
EXPERIMENTAL DESIGN
PEDIATRICS
STABILITY
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:11336/87179
Acceder
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repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol FormulationMorri, Mauro GasparCastellano, Patricia MargaritaLeonardi, DaríoVignaduzzo, Silvana EditATENOLOLDEVELOPMENTEXPERIMENTAL DESIGNPEDIATRICSSTABILITYhttps://purl.org/becyt/ford/1.4https://purl.org/becyt/ford/1Liquid formulations can be used in children of different ages by varying the volume of the administered dose in order to ensure an exact dosage. The aim of this work was to develop and to optimize a safe liquid atenolol formulation and to carry out the corresponding chemical and microbiological stability studies. A Plackett-Burman design was used to determine the factors that could be critical in the development of the formulations, and a central composite design was used to determine the optimal working conditions. As a result of these analyses, three formulations were selected and their stability studied in three storage conditions, 4, 25, and 40°C. After 6 months of stability testing, the optimal systems showed no pH change or atenolol loss; however, only glycerin-based formulations showed no microbial development. These systems, employing excipients in a range that the EMA has recommended, showed chemical and microbiological stability for at least 6 months even at the worst storage conditions.Fil: Morri, Mauro Gaspar. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas; ArgentinaFil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaFil: Vignaduzzo, Silvana Edit. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; ArgentinaSpringer2018-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/87179Morri, Mauro Gaspar; Castellano, Patricia Margarita; Leonardi, Darío; Vignaduzzo, Silvana Edit; First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation; Springer; AAPS Pharmscitech; 19; 4; 5-2018; 1781-17881530-9932CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1208/s12249-018-0992-5info:eu-repo/semantics/altIdentifier/url/https://link.springer.com/article/10.1208%2Fs12249-018-0992-5info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-12-23T13:37:36Zoai:ri.conicet.gov.ar:11336/87179instacron: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:34982025-12-23 13:37:36.398CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
title First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
spellingShingle First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
Morri, Mauro Gaspar
ATENOLOL
DEVELOPMENT
EXPERIMENTAL DESIGN
PEDIATRICS
STABILITY
title_short First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
title_full First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
title_fullStr First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
title_full_unstemmed First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
title_sort First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation
dc.creator.none.fl_str_mv Morri, Mauro Gaspar
Castellano, Patricia Margarita
Leonardi, Darío
Vignaduzzo, Silvana Edit
author Morri, Mauro Gaspar
author_facet Morri, Mauro Gaspar
Castellano, Patricia Margarita
Leonardi, Darío
Vignaduzzo, Silvana Edit
author_role author
author2 Castellano, Patricia Margarita
Leonardi, Darío
Vignaduzzo, Silvana Edit
author2_role author
author
author
dc.subject.none.fl_str_mv ATENOLOL
DEVELOPMENT
EXPERIMENTAL DESIGN
PEDIATRICS
STABILITY
topic ATENOLOL
DEVELOPMENT
EXPERIMENTAL DESIGN
PEDIATRICS
STABILITY
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.4
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Liquid formulations can be used in children of different ages by varying the volume of the administered dose in order to ensure an exact dosage. The aim of this work was to develop and to optimize a safe liquid atenolol formulation and to carry out the corresponding chemical and microbiological stability studies. A Plackett-Burman design was used to determine the factors that could be critical in the development of the formulations, and a central composite design was used to determine the optimal working conditions. As a result of these analyses, three formulations were selected and their stability studied in three storage conditions, 4, 25, and 40°C. After 6 months of stability testing, the optimal systems showed no pH change or atenolol loss; however, only glycerin-based formulations showed no microbial development. These systems, employing excipients in a range that the EMA has recommended, showed chemical and microbiological stability for at least 6 months even at the worst storage conditions.
Fil: Morri, Mauro Gaspar. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas; Argentina
Fil: Castellano, Patricia Margarita. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Leonardi, Darío. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
Fil: Vignaduzzo, Silvana Edit. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Rosario. Instituto de Química Rosario. Universidad Nacional de Rosario. Facultad de Ciencias Bioquímicas y Farmacéuticas. Instituto de Química Rosario; Argentina
description Liquid formulations can be used in children of different ages by varying the volume of the administered dose in order to ensure an exact dosage. The aim of this work was to develop and to optimize a safe liquid atenolol formulation and to carry out the corresponding chemical and microbiological stability studies. A Plackett-Burman design was used to determine the factors that could be critical in the development of the formulations, and a central composite design was used to determine the optimal working conditions. As a result of these analyses, three formulations were selected and their stability studied in three storage conditions, 4, 25, and 40°C. After 6 months of stability testing, the optimal systems showed no pH change or atenolol loss; however, only glycerin-based formulations showed no microbial development. These systems, employing excipients in a range that the EMA has recommended, showed chemical and microbiological stability for at least 6 months even at the worst storage conditions.
publishDate 2018
dc.date.none.fl_str_mv 2018-05
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/11336/87179
Morri, Mauro Gaspar; Castellano, Patricia Margarita; Leonardi, Darío; Vignaduzzo, Silvana Edit; First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation; Springer; AAPS Pharmscitech; 19; 4; 5-2018; 1781-1788
1530-9932
CONICET Digital
CONICET
url http://hdl.handle.net/11336/87179
identifier_str_mv Morri, Mauro Gaspar; Castellano, Patricia Margarita; Leonardi, Darío; Vignaduzzo, Silvana Edit; First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation; Springer; AAPS Pharmscitech; 19; 4; 5-2018; 1781-1788
1530-9932
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1208/s12249-018-0992-5
info:eu-repo/semantics/altIdentifier/url/https://link.springer.com/article/10.1208%2Fs12249-018-0992-5
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
application/pdf
dc.publisher.none.fl_str_mv Springer
publisher.none.fl_str_mv Springer
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 12.952241

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