Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride
Identifieur interne : 001D69 ( Main/Exploration ); précédent : 001D68; suivant : 001D70Biowaiver monographs for immediate release solid oral dosage forms: Amitriptyline hydrochloride
Auteurs : R. H. Manzo [Argentine] ; M. E. Olivera [Argentine] ; G. L. Amidon [États-Unis] ; V. P. Shah [Pays-Bas] ; J. B. Dressman [Allemagne] ; D. M. Barends [Pays-Bas]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2006-05.
English descriptors
- Teeft :
- Administracion nacional, American pharmacists association, Amitriptylin beta1, Amitriptyline, Amitriptyline hydrochloride, Amitriptyline hydrochloride tablets, Bioavailability, Biopharmaceutics, Biopharmaceutics system, Biowaiver, Biowaiver monographs, Different formulations, Different tablet strengths, Dissolution testing, Dosage forms, Drug evaluation, Drug products, Drug substances, Filmtabletten, Hydrochloride, Immediate release, Katwijk farma, Literature data, Marketing authorization, Monograph, Oral dosage forms, Oral solution, Original literature, Other apis, Permeability, Pharm, Pharmaceutical, Pharmaceutical press, Pharmaceutical sciences, Public health, Republica argentina, Rote liste1 service gmbh, Saroten1 tabs, Shah, Solubility, Tablet, Tablet strengths, Tabletten, Vivo bioavailability, Vivo bioequivalence, Vivo dissolution.
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. © 2006 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 95:966–973, 2006
Url:
DOI: 10.1002/jps.20615
Affiliations:
- Allemagne, Argentine, Pays-Bas, États-Unis
- District de Darmstadt, Hesse (Land), Hollande-Méridionale, Michigan
- Francfort-sur-le-Main, La Haye
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Le document en format XML
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