Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista Fitos |
Texto Completo: | https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935 |
Resumo: | This work, of partnerships between a Community University and national pharmaceutical companies reports the development of new and effective phytotherapics obtained from the leaves of Aleurites mollucanus (Euphorbiaceae), an exotic species, from Asia, adapted in Brazil. The project, although it has not yet reached the final stage of clinical studies and registration with ANVISA, represents a relevant experience to be analyzed in light of the difficulties and overcomes during the stages that make up the chain of establishment of a new herbal medicine in Brazil. Tablets were developed based on the standardized dry extract of A. moluccanus, on pilot scale, with approval in the stages of non-clinical studies and in the clinical stage-phase I. In addition, formulations such as topical cream and oral suspension were established. The overcoming of challenges related to the standardization of the extract on an industrial scale, under good manufacturing practices (GMP) and the stability aspects of the formulations, the continuity of studies depends on the scenario and consequent market direction. Therefore, this report provides an insight into the setbacks and overcoming experienced by researchers from Brazilian Community University with a focus on research and development of new, effective and safe analgesic and anti-inflammatory herbal medicine. |
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Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical companyDesenvolvimento de fitoterápicos a partir das folhas da nogueira-da-índia (Aleurites moluccanus): relato de experiência de parceria entre uma Universidade Comunitária e indústrias farmacêuticas nacionaisAleurites mollucanusHerbal medicineCommunity UniversityTherapeutical innovationAnalgesy. InflammationAleurites mollucanusFitoterápicosUniversidade ComunitáriaInovação terapêuticaAnalgesiaInflamaçãoThis work, of partnerships between a Community University and national pharmaceutical companies reports the development of new and effective phytotherapics obtained from the leaves of Aleurites mollucanus (Euphorbiaceae), an exotic species, from Asia, adapted in Brazil. The project, although it has not yet reached the final stage of clinical studies and registration with ANVISA, represents a relevant experience to be analyzed in light of the difficulties and overcomes during the stages that make up the chain of establishment of a new herbal medicine in Brazil. Tablets were developed based on the standardized dry extract of A. moluccanus, on pilot scale, with approval in the stages of non-clinical studies and in the clinical stage-phase I. In addition, formulations such as topical cream and oral suspension were established. The overcoming of challenges related to the standardization of the extract on an industrial scale, under good manufacturing practices (GMP) and the stability aspects of the formulations, the continuity of studies depends on the scenario and consequent market direction. Therefore, this report provides an insight into the setbacks and overcoming experienced by researchers from Brazilian Community University with a focus on research and development of new, effective and safe analgesic and anti-inflammatory herbal medicine.Este trabalho, de parcerias entre uma Universidade Comunitária e empresas farmacêuticas nacionais relata o desenvolvimento de novos e efetivos fitoterápicos obtidos a partir das folhas de Aleurites mollucanus (Euphorbiaceae), uma espécie exótica, proveniente da Ásia, adaptada no Brasil. Este projeto, embora ainda não tenha alcançado o estágio final de estudos clínicos e registro junto à ANVISA, representa uma experiência relevante a ser analisada à luz das dificuldades e superações no decorrer das etapas que compõem a cadeia de estabelecimento de um novo medicamento fitoterápico no Brasil. Com aprovação nas etapas de estudos não clínicos e na etapa clínica-fase I foram desenvolvidos, em escala piloto, comprimidos a base do extrato seco padronizado de A. moluccanus. Além disso, foram estabelecidas formulações como creme tópico e suspensão oral. A superação dos desafios para padronização do extrato em escala industrial, sob boas práticas de fabricação (BPF) e os aspectos de estabilidade das formulações, assim como a continuidade dos estudos, depende do cenário e consequente direcionamento do mercado. Este relato proporcionou uma visão sobre os percalços e as superações vivenciadas por pesquisadores de uma Universidade Comunitária brasileira, com foco na pesquisa e desenvolvimento de novo, efetivo e seguro fitoterápico analgésico e anti-inflamatório.Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz2020-12-18info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdftext/htmlhttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/93510.32712/2446-4775.2020.935Revista Fitos; Vol. 14 No. 4 (2020); 538-546Revista Fitos; Vol. 14 Núm. 4 (2020); 538-546Revista Fitos; v. 14 n. 4 (2020); 538-5462446-47751808-9569reponame:Revista Fitosinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935/758https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935/759Copyright (c) 2020 Revista Fitoshttps://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessBresolin, Tania Mari Bellé Silva, Ruth Meri Lucinda daMeyre-Silva, ChristianeQuintão, Nara Lins MeiraCechinel Filho, Valdir2020-12-18T10:45:56Zoai:ojs.revistafitos.far.fiocruz.br:article/935Revistahttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/PUBhttp://revistafitos.far.fiocruz.br/index.php/revista-fitos/oairevistafitos@far.fiocruz.br || eugenio.telles@far.fiocruz.br2446-47752446-4775opendoar:2020-12-18T10:45:56Revista Fitos - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company Desenvolvimento de fitoterápicos a partir das folhas da nogueira-da-índia (Aleurites moluccanus): relato de experiência de parceria entre uma Universidade Comunitária e indústrias farmacêuticas nacionais |
title |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
spellingShingle |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company Bresolin, Tania Mari Bellé Aleurites mollucanus Herbal medicine Community University Therapeutical innovation Analgesy. Inflammation Aleurites mollucanus Fitoterápicos Universidade Comunitária Inovação terapêutica Analgesia Inflamação |
title_short |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
title_full |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
title_fullStr |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
title_full_unstemmed |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
title_sort |
Development of herbal medicines from the leaves of the walnut tree (Aleurites moluccanus): report experience of Community University and national pharmaceutical company |
author |
Bresolin, Tania Mari Bellé |
author_facet |
Bresolin, Tania Mari Bellé Silva, Ruth Meri Lucinda da Meyre-Silva, Christiane Quintão, Nara Lins Meira Cechinel Filho, Valdir |
author_role |
author |
author2 |
Silva, Ruth Meri Lucinda da Meyre-Silva, Christiane Quintão, Nara Lins Meira Cechinel Filho, Valdir |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Bresolin, Tania Mari Bellé Silva, Ruth Meri Lucinda da Meyre-Silva, Christiane Quintão, Nara Lins Meira Cechinel Filho, Valdir |
dc.subject.por.fl_str_mv |
Aleurites mollucanus Herbal medicine Community University Therapeutical innovation Analgesy. Inflammation Aleurites mollucanus Fitoterápicos Universidade Comunitária Inovação terapêutica Analgesia Inflamação |
topic |
Aleurites mollucanus Herbal medicine Community University Therapeutical innovation Analgesy. Inflammation Aleurites mollucanus Fitoterápicos Universidade Comunitária Inovação terapêutica Analgesia Inflamação |
description |
This work, of partnerships between a Community University and national pharmaceutical companies reports the development of new and effective phytotherapics obtained from the leaves of Aleurites mollucanus (Euphorbiaceae), an exotic species, from Asia, adapted in Brazil. The project, although it has not yet reached the final stage of clinical studies and registration with ANVISA, represents a relevant experience to be analyzed in light of the difficulties and overcomes during the stages that make up the chain of establishment of a new herbal medicine in Brazil. Tablets were developed based on the standardized dry extract of A. moluccanus, on pilot scale, with approval in the stages of non-clinical studies and in the clinical stage-phase I. In addition, formulations such as topical cream and oral suspension were established. The overcoming of challenges related to the standardization of the extract on an industrial scale, under good manufacturing practices (GMP) and the stability aspects of the formulations, the continuity of studies depends on the scenario and consequent market direction. Therefore, this report provides an insight into the setbacks and overcoming experienced by researchers from Brazilian Community University with a focus on research and development of new, effective and safe analgesic and anti-inflammatory herbal medicine. |
publishDate |
2020 |
dc.date.none.fl_str_mv |
2020-12-18 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935 10.32712/2446-4775.2020.935 |
url |
https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935 |
identifier_str_mv |
10.32712/2446-4775.2020.935 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935/758 https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/935/759 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2020 Revista Fitos https://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2020 Revista Fitos https://creativecommons.org/licenses/by/4.0/ |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf text/html |
dc.publisher.none.fl_str_mv |
Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz |
publisher.none.fl_str_mv |
Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz |
dc.source.none.fl_str_mv |
Revista Fitos; Vol. 14 No. 4 (2020); 538-546 Revista Fitos; Vol. 14 Núm. 4 (2020); 538-546 Revista Fitos; v. 14 n. 4 (2020); 538-546 2446-4775 1808-9569 reponame:Revista Fitos instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
Revista Fitos |
collection |
Revista Fitos |
repository.name.fl_str_mv |
Revista Fitos - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
revistafitos@far.fiocruz.br || eugenio.telles@far.fiocruz.br |
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1798313475420717056 |