Development and stability assessment of liquid paediatric formulations containing sildenafil citrate

Detalhes bibliográficos
Autor(a) principal: Roque, Fátima
Data de Publicação: 2013
Outros Autores: Rama, Ana Cristina, Sousa, João, Pina, Maria Eugénia
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10316/109720
https://doi.org/10.1590/S1984-82502013000200021
Resumo: The purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.
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spelling Development and stability assessment of liquid paediatric formulations containing sildenafil citrateChemical stabilityMicrobiological stabilitySildenafil citratePaediatric formulationsEstabilidade químicaEstabilidade microbiológicaCitrato de sildenafilFormulações pediátricasThe purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.O objetivo deste trabalho é desenvolver e otimizar formulações líquidas orais de citrato de sildenafil adequadas ao uso pediátrico. Foram desenvolvidas quatro formulações diferentes: duas soluções aquosas de citrato de sildenafila (2,5 mg/mL) com ou sem conservantes e duas soluções de citrato de sildenafil em xarope simples (1,25 mg/mL) com ou sem conservantes. Todas as formulações desenvolvidas apresentaram estabilidade quer físico-química quer microbiológica durante 3 meses. Os resultados dos estudos de estabilidade permitiram otimizar as formulações isentas de conservantes, uma vez que estas eram mais simples e apresentavam do mesmo modo uma boa estabilidade, comparando com as formulações que continham conservantes. O período de utilização de ambas as formulações é de três meses, no entanto, após abertura do frasco, a solução aquosa deve ser utilizada durante 10 dias, acondicionada no refrigerador e o xarope deve ser utilizado durante 14 dias, mesmo em ambiente hospitalar.Universidade de Sao Paulo2013info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10316/109720http://hdl.handle.net/10316/109720https://doi.org/10.1590/S1984-82502013000200021eng1984-8250Roque, FátimaRama, Ana CristinaSousa, JoãoPina, Maria Eugéniainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-10-24T09:58:01Zoai:estudogeral.uc.pt:10316/109720Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:25:52.411974Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
title Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
spellingShingle Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
Roque, Fátima
Chemical stability
Microbiological stability
Sildenafil citrate
Paediatric formulations
Estabilidade química
Estabilidade microbiológica
Citrato de sildenafil
Formulações pediátricas
title_short Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
title_full Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
title_fullStr Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
title_full_unstemmed Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
title_sort Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
author Roque, Fátima
author_facet Roque, Fátima
Rama, Ana Cristina
Sousa, João
Pina, Maria Eugénia
author_role author
author2 Rama, Ana Cristina
Sousa, João
Pina, Maria Eugénia
author2_role author
author
author
dc.contributor.author.fl_str_mv Roque, Fátima
Rama, Ana Cristina
Sousa, João
Pina, Maria Eugénia
dc.subject.por.fl_str_mv Chemical stability
Microbiological stability
Sildenafil citrate
Paediatric formulations
Estabilidade química
Estabilidade microbiológica
Citrato de sildenafil
Formulações pediátricas
topic Chemical stability
Microbiological stability
Sildenafil citrate
Paediatric formulations
Estabilidade química
Estabilidade microbiológica
Citrato de sildenafil
Formulações pediátricas
description The purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.
publishDate 2013
dc.date.none.fl_str_mv 2013
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10316/109720
http://hdl.handle.net/10316/109720
https://doi.org/10.1590/S1984-82502013000200021
url http://hdl.handle.net/10316/109720
https://doi.org/10.1590/S1984-82502013000200021
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1984-8250
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Universidade de Sao Paulo
publisher.none.fl_str_mv Universidade de Sao Paulo
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
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