Development and Assessment of Fast-Dissolving Tablets of Levocetirizine Dihydrochloride Using Super Disintegrants
Abstract
Background: Several novel technologies for oral drug delivery have recently become available to address the physicochemical and pharmacokinetic characteristics of drugs, while improving patient compliance. The basic disadvantage of conventional tablets is the high first-pass metabolism, which can be overcome by designing fast dissolving tablets (FDT). Objective: The limited oral bioavailability of Levocetirizine Dihydrochloride, primarily due to its extensive first-pass metabolism, necessitated the development of fast-dissolving tablets that rapidly disintegrate in the oral cavity. Methods: Fast-dissolving tablets containing 5 mg of Levocetirizine Dihydrochloride were formulated using the direct compression method with three synthetic super disintegrants in varying concentrations. Tablet thickness, Hardness Test, Friability Test, etc., were done for evaluation. Three tablets from each formulation were randomly selected, and in vitro dispersion time was performed. The formulation development was primarily influenced by the type and concentration of polymers and the physicochemical properties of the drug. Results: FTIR analysis confirmed the compatibility of the polymers with the drug. Various evaluation parameters, including thickness, weight variation, hardness, friability, in vitro dispersion time, wetting time, water absorption ratio, drug content uniformity, and in vitro drug release, were assessed. The optimized formulation (PF-9) exhibited an in vitro drug release of…
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