In general, the importance of using nanoparticles as carriers of drug was duo to high carrier capacity, high stability, probability of incorporation of both lipophilic and lipophobic drugs, and probability of various routes of administration, including inhalation rout and oral rout. The cyclodextrins (CDs) as drug delivery system are used to solve the problem of hydrophobicity of drugs. Therefore, methotrexate (MTX) as hydrophobic drug was incorporated into ?-CD/Alg nanoparticles to forming MTX-?-CD/Alg nanocomposites. The independent variable was beta-cyclodextrin, sodium alginate and calcium chloride, whereas the dependent variable was loading efficiency, Encapsulation efficiency and particle size, using full factorial design Minitab 18 software.The analysis of the model was carried out using graphical analysis such as Pareto chart, surface and contour plots, main effect plots, interaction plots, normal probability plot of the residuals and residuals versus corresponding predicted values plots. Analysis of variance (ANOVA) is structured to obtain the significant independent variables affecting on the dependent response by using P value lower than 0.05.The ?-CD/Alg nanoparticlessamples were prepared by using different amounts of ?-CD (50, 100, 200 and 500 mg) with sodium alginate at different amounts (25, 50, 100, 150 and 200 mg) and calcium chloride (30,45,60 and 75 mg) under pH at 10 with constant mass of MTX at 50 mg. The final product of nanocomposites was separated via centrifugation at 11000 rpm for 20 min and then dried. The final nanocomposites was characterized by Fourier transform infrared(FTIR), X-ray diffraction (XRD) and in vitro release. FTIR test was used to evaluate the functional groups of MTX loaded ?-CD/Alg nanocomposites.While XRD pattern was used to explain the interaction between MTX and its carrier (?-CD/Alg) nanoparticles. This result could be clarified bythe strong interaction which destroyed the close packing for beta cyclodextrin for the formation of crystallites between methotrexate and beta cyclodextrin.After in vitro release study of MTX from final formulation, the results suggested that the MTX exhibited prolongedrelease from nanocomposites of formulation.

Development and evaluation of methotrexate nanocomposites using Β-cyclodextrins/alginate polymers and response surface methodology