Comparative Quality Evaluation, Dissolution Profiling, and Release Kinetics of Six Commercial Cetirizine Hydrochloride Tablet Brands
Department of Pharmaceutics, College of Pharmacy, University of Al-Ameed, Karbala, Iraq.
* Corresponding Author; Email: kamil_altameemi@alameed.edu.iq
ORCID Details
Author name 1: https://orcid.org/0009-0005-7104-5382.
Research Article
International Journal of Biological and Pharmaceutical Sciences Archive, 2026, 12(02), 048–056.
Article DOI: 10.53771/ijbpsa.2026.12.2.0097
Publication history:
Received on 01 September 2026; revised on 10 October 2026; accepted on 12 October 2026
Abstract:
Cetirizine hydrochloride is an extensively used second generation antihistamine that treats allergic rhinitis, chronic urticaria and other allergic disorders. Comparative evaluation is significant in assessing the pharmaceutical quality of products, in order to guarantee consistent product performance, reliability in therapy and compliance with the requirements of the pharmacopeia, when multisource of Cetirizine HCl tablets are available. The aim of the present work was to compare the pharmaceutical properties of some brands of Cetirizine Hydrochloride tablets available in the market in Iraq. Six brands of cetirizine HCl 10mg tablets (CTZ1 to CTZ6) were purchased from community pharmacies and tested for standard quality control. Profile similarity was determined using (f2) similarity factor. The release profile was modeled into Zero Order, First Order, and Higuchi models, with Korsmeyer–Peppas analysis identifying the solute transport mechanism. All brands complied with standard pharmacopeial limits for physical parameters and drug content. Dissolution profile similarity analysis revealed that test formulations CTZ5 and CTZ6 successfully satisfied regulatory biowaiver criteria (f2 ≥ 50). Conversely, CTZ2, CTZ3, and CTZ4 failed to demonstrate similarity (f2 < 50). Kinetic modeling confirmed that CTZ1, CTZ5, CTZ6, and CTZ2 follow First-Order kinetics (R2 ≥ 0.989). Korsmeyer–Peppas analysis verified that bioequivalent products (CTZ5 and CTZ6) match the exact Anomalous (Non-Fickian) Transport mechanism of CTZ1. Non-equivalent products exhibited mechanistic shifts toward pure Fickian Diffusion (CTZ3) or immediate, disintegration-driven Burst Release (CTZ4). Finally, the tested cetirizine HCl tablet brands showed good pharmaceutical quality and high drug release. Achieving regulatory equivalence requires matching both the overall dissolution rate and the underlying solute transport mechanism, confirming CTZ5 and CTZ6 as biowaiver-eligible alternatives to the Reference product CTZ1.
Keywords:
Cetirizine hydrochloride; Quality control; Dissolution profile; Iraq
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