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Toward a greener multifunctional pharmaceutical excipient: in vivo safety evaluation of nanofibrillated cellulose from tobacco stalk.
Garcia, Keth Ribeiro; Menezes, Rafaella Câmara Rocha; Dos Santos, Venina; Koester, Letícia Scherer; Dallegrave, Eliane.
Afiliação
  • Garcia KR; Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.
  • Menezes RCR; Programa de Pós-Graduação em Ciências da Nutrição, Laboratório de Pesquisa em Toxicologia, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Rua Sarmento Leite, Porto Alegre, RS, Brazil.
  • Dos Santos V; Programa de Pós-Graduação em Engenharia de Processos e Tecnologias, Universidade de Caxias do Sul (UCS), Rua Francisco Getúlio Vargas, Caxias do Sul, RS, Brazil.
  • Koester LS; Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de Farmácia, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.
  • Dallegrave E; Programa de Pós-Graduação em Ciências da Saúde, Laboratório de Pesquisa em Toxicologia, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Rua Sarmento Leite, Porto Alegre, RS, Brazil.
Drug Chem Toxicol ; 47(5): 507-515, 2024 Sep.
Article em En | MEDLINE | ID: mdl-38326987
ABSTRACT
Tobacco stalk is a cellulose-rich material and a sustainable alternative to be applied as a plant-based nanofibrillated cellulose (NFC) source. NFC use has garnered attention in the development of oral pharmaceutical forms, despite concerns about its safety due to the adverse effects of nicotine on health. Therefore, we aimed at establishing the safety of NFC derived from tobacco stalk for its potential use as a novel pharmaceutical excipient, exploring its potential functions for tablet production. We conducted acute and subchronic oral toxicity tests in adult female Wistar rats. Initially, individual animals received sequential doses (175-5,000 mg·kg-1) for 24 hours followed by a careful observation of any toxic effects. Subsequently, 20 rats were divided into four groups for a subchronic assay, evaluating toxicity signs, body weight changes, hematological, biochemical, and histopathological parameters. No deaths or other clinical toxicity signs were observed in either the acute or the subchronic assays. We noticed a significant reduction in body weight gain (p < 0.05) after 14 days. We found statistical differences for hematological and biochemical parameters, unrelated to dosage. There were no observed toxic effects, and tobacco stalk ingestion did not adversely affect organ morphology in the histopathological evaluation. The oral administration of NFC at 5,000 mg·kg-1 per day for 28 days was well-tolerated by treated rats, with no reported deaths. In conclusion, NFC derived from tobacco stalk has shown to be a sustainable and safe alternative for use as an excipient at experimental doses, demonstrating compatibility with its proposed applications.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Nicotiana / Celulose / Ratos Wistar / Excipientes Limite: Animals Idioma: En Revista: Drug Chem Toxicol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Nicotiana / Celulose / Ratos Wistar / Excipientes Limite: Animals Idioma: En Revista: Drug Chem Toxicol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Brasil País de publicação: Estados Unidos