GB2639602A — An orodispersible tablet of pregabalin and its process of preparation

USPTO Abstract

An orodispersible tablet of pregabalin for oral administration comprising 15-60%w/w pregabalin or a pharmaceutically acceptable salt thereof; at least one diluent; a least one disintegrant comprising 0.1-10 %w/w; at least one lubricant comprising 0.1-5 %w/w; at least one binder comprising 0.1-10 %w/w; at least one glidant comprising 0.1-10 %w/w; and at least one or more pharmaceutically acceptable excipients; wherein the orodispersible table is disintegrated upon contact with saliva in less than 3 minutes. The diluent is preferably a combination of microcrystalline cellulose and mannitol; the disintegrant is preferably croscarmellose sodium; the binder is preferably low substituted hydroxypropyl cellulose; the glidant is preferably a combination of talc and colloidal anhydrous silica; and the lubricant is preferably magnesium stearate. The ratio of the lubricant to the diluent may be in the range of 1:70 to 1:90, preferably 1:75 to 1:85. The tablet may further comprise a sweetener, flavouring agent and/or sucralose. Methods of manufacturing the tablet via wet granulation are also provided. The tablet may release 85% of the pregabalin within 80 minutes, preferably within 60 minutes.