Biorelevant intrinsic dissolution profiling in early drug development: Fundamental, methodological, and industrial aspects.
Eur J Pharm Biopharm
; 139: 101-114, 2019 Jun.
Article
em En
| MEDLINE
| ID: mdl-30862481
ABSTRACT
Intrinsic dissolution rate (IDR) is the surface specific dissolution rate of a drug. In early drug development, this property (among other parameters) is measured in order to compare different polymorphs and salt forms, guide formulation decisions, and to provide a quality marker of the active pharmaceutical ingredient (API) during production. In this review, an update on different methods and small-scale techniques that have recently evolved for determination of IDR is provided. The importance of biorelevant media and the hydrodynamic conditions of dissolution are also discussed. Different preparation techniques for samples are presented with a focus on disc, particle- and crystal-based methods. A number of small-scale techniques are then described in detail, and their applicability domains are identified. Finally, an updated industrial perspective is provided about IDR's place in the early drug development process.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Composição de Medicamentos
/
Liberação Controlada de Fármacos
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Desenvolvimento de Medicamentos
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article