RESUMO
A vaccine candidate against cholera was developed in the form of oral tablets to avoid difficulties during application exhibited by current whole cell inactivated cholera vaccines. In this study, enteric-coated tablets were used to improve the protection of the active compound from gastric acidity. Tablets containing heat-killed whole cells of Vibrio cholerae strain C7258 as the active pharmaceutical compound was enteric-coated with the polymer Kollicoat(®) MAE-100P, which protected them efficiently from acidity when a disintegration test was carried out. Enzyme-linked immunosorbent assay (ELISA) anti-lipopolysaccharide (LPS) inhibition test and Western blot assay revealed the presence of V. cholerae antigens as LPS, mannose-sensitive haemagglutinin (MSHA) and outer membrane protein U (Omp U) in enteric-coated tablets. Immunogenicity studies (ELISA and vibriocidal test) carried out by intraduodenal administration in rabbits showed that the coating process of tablets did not affect the immunogenicity of V. cholerae-inactivated cells. In addition, no differences were observed in the immune response elicited by enteric-coated or uncoated tablets, particularly because the animal model and immunization route used did not allow discriminating between acid resistances of both tablets formulations in vivo. Clinical studies with volunteers will be required to elucidate this aspect, but the results suggest the possibility of using enteric-coated tablets as a final pharmaceutical product for a cholera vaccine.
Assuntos
Vacinas contra Cólera/farmacologia , Vibrio cholerae/imunologia , Administração Oral , Análise de Variância , Animais , Anticorpos Antibacterianos/sangue , Carga Bacteriana , Western Blotting , Cólera/prevenção & controle , Vacinas contra Cólera/química , Vacinas contra Cólera/imunologia , Ensaio de Imunoadsorção Enzimática , Humanos , Imunoglobulina G/sangue , Lipopolissacarídeos/imunologia , Coelhos , Estatísticas não Paramétricas , Comprimidos com Revestimento Entérico/química , Comprimidos com Revestimento Entérico/farmacologia , Vacinas de Produtos Inativados/química , Vacinas de Produtos Inativados/imunologia , Vacinas de Produtos Inativados/farmacologiaRESUMO
Se realizó la reformulación de clorpromazina clorhidrato 25 mg en forma de tabletas revestidas. Se diseñó el proceso tecnológico, desde la elaboración de los núcleos hasta la formulación de revestimiento en sistema acuoso, factible para su introducción a escala piloto. Las tabletas obtenidas poseen buena estabilidad física y química en el tiempo, y mantienen su potencia dentro de los límites terapéuticos por un período de 2 años(AU)
Assuntos
Clorpromazina/química , Clorpromazina/farmacologia , Comprimidos/química , Comprimidos/farmacologia , Química FarmacêuticaRESUMO
Se realizó la reformulación de clorpromazina clorhidrato 25 mg en forma de tabletas revestidas. Se diseñó el proceso tecnológico, desde la elaboración de los núcleos hasta la formulación de revestimiento en sistema acuoso, factible para su introducción a escala piloto. Las tabletas obtenidas poseen buena estabilidad física y química en el tiempo, y mantienen su potencia dentro de los límites terapéuticos por un período de 2 años