Patent ID: 11883374
Assignee: SHANGHAI AUCTA PHARMACEUTICALS CO., LTD.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 0:
1. 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.