GB2641294A — An orodispersible tablet of Lamotrigine and its process of preparation

USPTO Abstract

E An orodispersible tablet of lamotrigine for oral administration is provided comprising: a) lamotrigine or a pharmaceutically salt thereof, present in an amount of 25%w/w to 40%w/w; b) at least one diluent, preferably calcium carbonate, microcrystalline cellulose and/or mannitol; c) at least one disintegrant, preferably croscarmellose sodium, present in an amount of 0.5%w/w to 10%w/w; d) at least one lubricant, preferably sodium stearyl fumarate, present in an amount of 0.5%w/w to 3%w/w; e) at least one binder, preferably povidone K30, present in an amount of 0.1%w/w to about 5%w/w; f) at least one glidant, preferably colloidal anhydrous silica, present in an amount of 0.5%w/w to 8%w/w; g) at least one solubilizer, preferably polysorbate 80, present in an amount of 0.005%w/w to 0.1%w/w; and h) at least one or more pharmaceutically acceptable excipients, wherein the orodispersible tablet is disintegrated upon contact with saliva in less than 3 minutes. A method of manufacturing the orodispersible lamotrigine tablet via wet granulation as herein defined is also provided.