Development Of Nanoparticles Of Dimethyl Fumarate For Better Treatment Of Multiple Sclerosis

Abstract

Dimethyl fumarate (DMF) and monomethyl fumarate (metabolite of DMF) are known to newlinebe effective in treating psoriasis, multiple sclerosis, an inflammatory bowel disease, newlineasthma, chronic obstructive pulmonary disease, and arthritis. Tecfidera , formerly called newlineBG-12, is a delayed release oral dosage form (i.e., a capsule containing enteric-coated newlineminitablets) of dimethyl fumarate. Tecfidera (DMF) was approved by USFDA in 2013, newlineand is dosed two times per day at 240 mg/day for the treatment of multiple Sclerosis. newlineThe present study aimed to synthesize and characterize novel drug delivery system of newlineDMF loaded polymeric and solid lipid nanoparticles. Formulations were optimized on the newlinebasis of particle size, entrapment efficiency and zeta potential using Design of newlineexperiment, Box-Behnken Design. newlineThe procured DMF was identified and confirmed by organoleptic properties physical newlineparameters, FT-IR, XRD and and#955;max value. Drug-excipient compatibility was studied by FTIR and XRD; this evaluation result revealed that there is no in-compatibility between newlinedrug and added excipients. newlinePolymeric chitosan (CS) nanoparticles were prepared using polyelctrolyte complexation newlinetechnique. Chitosan was an ideal polymer because of its biocompatibility, newlinebiodegradability, nontoxicity and a high positive charge density. Dextran sulphate (DS) newlinealso possesses similar properties with negative charge density. These two opposite newlinecharged polymers were used to form nanoparticles through electrostatic interaction. DMF newlineloaded nanoparticles were formed as a result of crosslinking of these polymers. newlineSolid lipid nanoparticles were prepared by hot microemulsion method. DMF loaded Solid newlinelipid nanoparticles were prepared by diluting a warm microemulsion (o/w) with cold newlinewater at a ratio 1:20. newline3 factor, 3 level, Box Behnken statistical design was used to optimize and derive a newlinepolynomial equation and construct contour plots to predict dependent responses. newlinePredicted results were compared with the actual experimental results and % error was newlinecalculated. The % error was