Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride.
J Pharm Sci
; 95(5): 966-73, 2006 May.
Article
em En
| MEDLINE
| ID: mdl-16557529
ABSTRACT
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amitriptyline hydrochloride are reviewed. Its therapeutic uses, its pharmacokinetic properties, the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. Literature data indicates that amitriptyline hydrochloride is a highly permeable active pharmaceutical ingredient (API). Data on the solubility according to the current Biopharmaceutics Classification System (BCS) were not fully available and consequently amitriptyline hydrochloride could not be definitively assigned to either BCS Class I or BCS Class II. But all evidence taken together, a biowaiver can currently be recommended provided that IR tablets are formulated with excipients used in existing approved products and that the dissolution meets the criteria defined in the Guidances.
Buscar no Google
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Amitriptilina
/
Antidepressivos Tricíclicos
Tipo de estudo:
Guideline
/
Prognostic_studies
Idioma:
En
Ano de publicação:
2006
Tipo de documento:
Article