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 José, 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/10314/2485
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 formulationsThe 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.Brazilian Journal of Pharmaceutical Sciences2016-07-272013-06-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10314/2485http://hdl.handle.net/10314/2485eng1984-8250Roque, FátimaRama, Ana CristinaSousa, João JoséPina, 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:RCAAP2024-01-14T02:55:26Zoai:bdigital.ipg.pt:10314/2485Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T01:42:04.230747Repositório 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
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 José
Pina, Maria Eugénia
author_role author
author2 Rama, Ana Cristina
Sousa, João José
Pina, Maria Eugénia
author2_role author
author
author
dc.contributor.author.fl_str_mv Roque, Fátima
Rama, Ana Cristina
Sousa, João José
Pina, Maria Eugénia
dc.subject.por.fl_str_mv Chemical stability
Microbiological stability
Sildenafil citrate
Paediatric formulations
topic Chemical stability
Microbiological stability
Sildenafil citrate
Paediatric formulations
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 2013-06-01T00:00:00Z
2016-07-27
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10314/2485
http://hdl.handle.net/10314/2485
url http://hdl.handle.net/10314/2485
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
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dc.publisher.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences
publisher.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences
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
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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
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