Data/hora: 11/06/2024 07:06:09

Provedor de dados: | 60
País: | Brazil
Título: | Prednisone raw material characterization and formulation development
Autores: | Toehwé,Leonardo Henrique; Prado,Livia Deris; Rocha,Helvécio Vinícius Antunes.
Data: | 2017-01-01
Ano: | 2017
Palavras-chave: | Prednisone/tablets/dissolution; Solubility; Formulation; Stability.
Resumo: | ABSTRACT Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API) prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.
Tipo: | Info:eu-repo/semantics/article
Idioma: | Inglês
Identificador: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000400604
Editor: | Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Relação: | 10.1590/s2175-97902017000400088
Formato: | text/html
Fonte: | Brazilian Journal of Pharmaceutical Sciences  v.53 n.4 2017
Fonte: | info:eu-repo/semantics/openAccess