Formulation and evaluation of levofloxacin hemihydrate immediate release tablets by wet granulation technique
Abstract
The present study was undertaken to formulate and evaluate immediate release tablets of Levofloxacin hemihydrate using the wet granulation method. The objective was to develop a formulation comparable to the innovator product (Levaquin®) with improved disintegration and dissolution characteristics. Pre-formulation studies including description, solubility, loss on drying, melting point, flow properties, sieve analysis, and compatibility studies were performed. Levofloxacin hemihydrate exhibited good physicochemical properties suitable for formulation development. Tablets were prepared using microcrystalline cellulose as diluent, croscarmellose sodium as superdisintegrant, crospovidone as binder, and magnesium stearate as lubricant. The prepared tablets were evaluated for hardness, thickness, friability, weight variation, disintegration time, and in vitro dissolution. Among eight formulations (F1–F8), formulation F8 showed optimized performance with acceptable mechanical strength, rapid disintegration, and dissolution profile comparable to the innovator product (f2 similarity factor ≈ 66.64). Stability and processing feasibility confirmed its suitability for large-s cale production. The study concludes that wet granulation is an effective and reproducible method for developing Levofloxacin immediate release tablets with equivalent performance to marketed products.
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