Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Amitriptyline HydrochlorideThis paper reflects the scientific opinion of the authors and not the policies of regulating agencies

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...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2006-05, Vol.95 (5), p.966-973
Main Authors: Manzo, R.H., Olivera, M.E., Amidon, G.L., Shah, V.P., Dressman, J.B., Barends, D.M.
Format: Article
Language:English
Subjects:
absorption
amitriptyline hydrochloride
Biopharmaceutics Classification System (BCS)
biowaiver
permeability
solubility
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Summary: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.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20615