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Current status of selected oral peptide technologies in advanced preclinical development and in clinical trials.
Aguirre, T A S; Teijeiro-Osorio, D; Rosa, M; Coulter, I S; Alonso, M J; Brayden, D J.
Afiliação
  • Aguirre TA; Centro de Ciências Exatas e Tecnologia, Universidade de Caxias do Sul (UCS), Caxias do Sul, Brazil.
  • Teijeiro-Osorio D; CIMUS Research Institute, University of Santiago de Compostela, Santiago de Compostela, Spain.
  • Rosa M; Sigmoid Pharma, Dublin City University, Invent Centre, Dublin 9, Ireland.
  • Coulter IS; Sigmoid Pharma, Dublin City University, Invent Centre, Dublin 9, Ireland.
  • Alonso MJ; CIMUS Research Institute, University of Santiago de Compostela, Santiago de Compostela, Spain. Electronic address: mariaj.alonso@usc.es.
  • Brayden DJ; UCD School of Veterinary Medicine and UCD Conway Institute, University College Dublin, Belfield, Dublin 4, Ireland. Electronic address: david.brayden@ucd.ie.
Adv Drug Deliv Rev ; 106(Pt B): 223-241, 2016 11 15.
Article em En | MEDLINE | ID: mdl-26921819
The development of oral dosage forms that allows absorption of therapeutic peptides to the systemic circulation is one of the greatest challenges for the pharmaceutical industry. Currently, a number of technologies including either mixtures of penetration enhancers or protease inhibitors and/or nanotechnology-based products are under clinical development. Typically, these formulations are presented in the form of enteric-coated tablets or capsules. Systems undergoing preclinical investigation include further advances in nanotechnology, including intestinal microneedle patches, as well as their combination with regional delivery to the colon. This review critically examines four selected promising oral peptide technologies at preclinical stage and the twelve that have progressed to clinical trials, as indicated in www.clinicaltrials.gov. We examined these technologies under the criteria of peptide selection, formulation design, system components and excipients, intestinal mechanism of action, efficacy in man, and safety issues. The conclusion is that most of the technologies in clinical trials are incremental rather than paradigm-shifting and that even the more clinically advanced oral peptide drugs examples of oral bioavailability appear to yield oral bioavailability values of only 1-2% and are, therefore, only currently suitable for a limited range of peptides.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Peptídeos / Sistemas de Liberação de Medicamentos / Absorção Intestinal Limite: Animals / Humans Idioma: En Revista: Adv Drug Deliv Rev Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda
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: Peptídeos / Sistemas de Liberação de Medicamentos / Absorção Intestinal Limite: Animals / Humans Idioma: En Revista: Adv Drug Deliv Rev Assunto da revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Ano de publicação: 2016 Tipo de documento: Article País de afiliação: Brasil País de publicação: Holanda