Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies.
Manzo, R. H.; Olivera, M. E.; Amidon, Gordon L.; Shah, V. P.; Dressman, Jennifer B.; Barends, D. M.
Manzo, R.H.; Olivera, M.E.; Amidon, G.L.; Shah, V.P.; Dressman, J.B.; Barends, D.M. (2006). "Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride This paper reflects the scientific opinion of the authors and not the policies of regulating agencies. ." Journal of Pharmaceutical Sciences 95(5): 966-973. <http://hdl.handle.net/2027.42/50637>
AbstractLiterature 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. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:966–973, 2006
Wiley Subscription Services, Inc., A Wiley Company
MetadataShow full item record
Accessibility: If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.