Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements.
Drug Discov Today
; 23(2): 251-259, 2018 Feb.
Article
em En
| MEDLINE
| ID: mdl-29030242
ABSTRACT
Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their prescription can ameliorate patient adherence and/or compliance. Here, we review the main features of orodispersible tablets, including oral lyophilisates, and orodispersible films along with their main production technologies. We summarize the bioavailability data and critically discussed their potential to improve patient adherence and/or compliance. We revisit this information in light of both the European Union (EU) and US regulatory frameworks, focusing on the differences in the definitions of such dosage forms and the requirements for marketing authorization.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Comprimidos
/
Preparações Farmacêuticas
/
Formas de Dosagem
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article