Lacosamide pharmaceutical composition as well as preparation method and applications thereof

A pharmaceutical composition, wherein the pharmaceutical composition is a 24-hour sustained-release gastro-retentive tablet comprising an active pharmaceutical ingredient, a skeleton material, a swelling material and a disintegrant,

• wherein the active pharmaceutical ingredient is lacosamide or a pharmaceutically acceptable salt of lacosamide, and the weight percentage of the active pharmaceutical ingredient is 5.0%-40.0%,
• the skeleton material is selected from one or more of a polyvinyl acetate povidone mixture, sodium alginate, and hydroxypropyl methylcellulose,
• when the skeleton material is the polyvinyl acetate povidone mixture, the polyvinyl acetate povidone mixture comprises polyvinyl acetate povidone (PVAc) and polyvinylpyrrolidone (PVP) in a weight ratio of 80:19 and has a weight percentage of 18.36%-24.68%,
• when the skeleton material is the sodium alginate, the skeleton material has a weight percentage of 5%-35.09%,
• when the skeleton material is the hydroxypropyl methylcellulose, the skeleton material has a weight percentage of 8%-17.27%;
• the swelling material is selected from one or two of polyoxyethylene and carbomer, and the weight percentage of the swelling material is 1.0%-60.0%;
• the disintegrant is selected from one or more of crospovidone, sodium carboxymethyl starch, croscarmellose sodium, carboxymethylcellulose calcium, and low-substituted hydroxypropylcellulose, and the weight percentage of the disintegrant is 5%-30.0%;
• and
• under the United States Pharmacopeia (USP) dissolution apparatus method 2 that uses 900 mL of 0.1N hydrochloric acid at 50 rpm, or uses 900 mL of an acetate buffer with a pH of 4.5 at 50 rpm, dissolution of the pharmaceutical composition simultaneously satisfies the following three criteria:
• A) no more than 40% of the active pharmaceutical ingredient is dissolved within 1 hour;
• B) 20%-70% of the active pharmaceutical ingredient is dissolved within 6 hours;
• and
• C) no less than 65% of the active pharmaceutical ingredient is dissolved within 24 hours.