Lacosamide pharmaceutical composition and dosage form thereof

A dosage form of lacosamide or a pharmaceutically acceptable salt thereof, comprising:

• (a) a first plurality of the particulates, each comprising
• i. a core comprising lacosamide or a pharmaceutically acceptable salt thereof, and
• ii. an extended release layer enclosing the core, wherein the extended release layer is free from lacosamide or a pharmaceutically acceptable salt thereof and comprises an extended release agent which is pH independent;
• wherein the core is free from the extended release agent, and
• (b) an immediate release portion of lacosamide or a pharmaceutically acceptable salt thereof in the form of a second plurality of particulates, wherein the lacosamide or the pharmaceutically acceptable salt thereof of the immediate release portion ranges from about 5% to about 30% by weigh in the total amount of the lacosamide or the pharmaceutically acceptable salt thereof in the dosage form,
• wherein the dosage form is configured to have an in-vitro dissolution according to the following:
• (a) less than about 20% in 1 hour;
• (b) about 20%-80% in 4 hours;
• and
• (c) more than about 80% in 12 hours;
• wherein the dissolution is determined using a USP type 1 dissolution system (Basket Apparatus) at 100 rpm and a temperature of 37±0.5° C. in 900 ml of pH 6.8 phosphate buffer for 12 hours.