Abstract

Fast dissolving dosage forms have acquired great importance in pharmaceutical industry. The aim of this study was to formulate and characterize fast dissolving film containing meloxicam (MLX) for oral use. In this study, as an approach to improve the solubility of MLX, solid dispersions (SD) of MLX were prepared by melting and solvent evaporation methods using Poloxamer 188 and Gelucire 44/14 alone as carrier and combination of both. The physicochemical characterizations were done by X-ray diffraction (XRD) and differential scanning calorimetry (DSC) for MLX-loaded SD and their corresponding physical mixtures as well as the individual components to investigate the drug polymer interaction. The solubility was enhanced 5-8 folds using the solid dispersion technique (F1, F4 and F9). All the prepared formulations showed about 65-100% MLX release after 60 min compared to a maximum of 23% release from the pure MLX sample. The obtained DSC and XRD results indicated that MLX was molecularly dispersed in the matrix of SD. Then, the promising formula (F9) that contained (15:42.5:42.5, drug: poloxamer: Gelucire, w/w) and prepared by melting was further incorporated into fast dissolving film (FDF) formulations. Films were prepared by solvent casting method using different quantity of film former HPMC E6. The prepared films were found to contain almost a uniform quantity of the drug. Film 2 (contained 400 mg polymer) showed the best property concerning drug release, fast disintegration time (46.3sec), mechanical strength and surface pH.

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