Formulations of viloxazine

A method of treating a CNS disorder in a mammalian subject in need thereof, the method comprising administration to the subject a formulation comprising:

• (a) an immediate release (IR) component comprising an inert core and a layer comprising viloxazine and, optionally, a pharmaceutically acceptable excipient, surrounding the core, and
• (b) an extended release (XR) component comprising:
• (i) an inert core, (ii) a first layer comprising viloxazine and, optionally, a pharmaceutically acceptable excipient, surrounding the core, and (iii) a second layer comprising a release rate controlling compound and a pore former in a weight ratio of 19:1 to 8.5:1.5, respectively, surrounding the first layer,
• wherein the pore former is selected from the group consisting of povidone, hypromellose, hydroxyethyl cellulose, hydroxypropyl cellulose, and organic acids,
• wherein the release rate controlling compound is selected from the group consisting of ethylcellulose;
• cellulose acetate;
• cellulose acetate butyrate;
• waxes;
• hydrogenated vegetable oils;
• glyceryl behenate;
• glyceryl palmitostearate;
• PEG glyceryl esters;
• poly(ethyl acrylate-co-methyl methacrylate) ethyl acrylate methyl methacrylate copolymer;
• poly (ethyl acrylate-co-methyl methacrylate-cotrimethylammonioethyl methacrylate chloride);
• polyvinyl acetate;
• cellulose acetate propionate, and combinations thereof, and is present in an amount of from 5% (w/w) to 65% (w/w) of the XR component,
• wherein the formulation comprises, as a percentage of the total formulation, 25% (w/w) to 75% (w/w) viloxazine,
• wherein the viloxazine is released immediately and continuously upon administration, and
• wherein at least 80% of the viloxazine or salt thereof in the formulation is released from the formulation over a period of time of at least 2 hours in vitro.