Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

Published on April 2023 | Pharmaceutical science

Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride

Authors: Naseem A. Charoo a , Daud B. Abdallah b , Daoud T. Ahmed c , Bertil Abrahamsson d , Rodrigo Cristofoletti e , et.al

View Author: Dr. Daoud Tajeldeinn Ahmed

Journal Name: Journal of Pharmaceutical Sciences

Volume: 112 Issue: 4 Page No: 893-903

Indexing: SCI/SCIE

DOI URL: https://doi.org/10.1016/j.xphs.2022.12.021

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Abstract:

Levocetirizine, a histamine H1-receptor antagonist, is prescribed to treat uncomplicated skin rashes associated with chronic idiopathic urticaria as well as the symptoms of both seasonal and continual allergic rhinitis. In this monograph, the practicality of using Biopharmaceutics Classification System (BCS) based methodologies as a substitute for pharmacokinetic studies in human volunteers to appraise the bioequivalence of immediate-release (IR) oral, solid dosage forms containing levocetirizine dihydrochloride was investigated, using data from the literature and in-house testing.

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