Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride

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
Administration, Oral
Amitriptyline - administration & dosage
Amitriptyline - analysis
Amitriptyline - pharmacokinetics
amitriptyline hydrochloride
Antidepressive Agents, Tricyclic - administration & dosage
Antidepressive Agents, Tricyclic - analysis
Antidepressive Agents, Tricyclic - pharmacokinetics
Biopharmaceutics Classification System (BCS)
biowaiver
Chemical Phenomena
Chemistry, Physical
Dosage Forms
Excipients
Isomerism
Permeability
Salts
Solubility
Therapeutic Equivalency
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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. © 2006 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:966–973, 2006
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.20615