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PREPARATION AND EVALUATION OF MELOXICAM SOLID DISPERSION BY MELTING METHOD

ANMAR ADHAM ISSA^1,2*, DANIELA MARCHIDAN², VICTOR COJOCARU², VALENTINA ANUȚA²

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Drug formulation as solid dispersion (SD) represents a good method for the enhancement in solubility of poorly water soluble drugs, as well as for the reduction of ulcergenicity of non-sterodial anti-inflammatory drugs (NSAID). The poorly water soluble Meloxicam (MLX) was used as model drug to prepare solid dispersion. Solid dispersion of MLX was prepared by melting method, using Poloxamer 188 as hydrophilic carrier. A 32 factorial design was used to study the influence of individual and combined effects of 2 factors (drug:polymer ratio and cooling temperature) on the responses. Using the polynomial equation describing the effect estimates on the dependent variables and the surface response methodology, an optimal formulation was developed. A drug:polymer ratio of 1:4.69 and a cooling temperature of 5°C were found to be the optimum values for the independent variables. The optimized solid dispersion was further characterized by differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FT-IR) and X-ray powder diffraction (XRD) analysis, whereas the dissolution behavior was studied in 900 ml of 0.25% w/v sodium lauryl sulphate solution by means of USP Apparatus 2 (50 rpm). The results confirmed obtaining of a solid dispersion of low crystallinity with a complete in vitro release of the active substance within 60 minutes.