GB2643925A — An orodispersible tablet of topiramate and its process of preparation

USPTO Abstract

An orodispersible tablet of topiramate with masked bitter taste, comprising: topiramate or pharmaceutically acceptable salt(s) thereof at 20-40 %w/w; a diluent at 35-80 %w/w (e.g., microcrystalline cellulose (MCC), spray-dried mannitol); two or more disintegrants at 3-25 %w/w (e.g., croscarmellose sodium, pregelatinized starch); a lubricant at 0.1-3 %w/w (e.g., magnesium stearate); a glidant at 0.05-2 %w/w (e.g., colloidal silica anhydrous); and a flavouring agent at 0.05-2 %w/w (e.g., mint flavour); wherein the tablet is uncoated and packaged in an HDPE bottle with a child-resistant cap canister. Also disclosed is a process for preparing the tablet by direct compression, comprising steps of: weighing and sieving raw materials; adding topiramate, mannitol, and MCC to a blender, and dry mixing; mixing sifted colloidal anhydrous silica, croscarmellose sodium, pregelatinised starch, and mint flavor and blending; transferring sifted magnesium stearate and blending; and compressing into tablet dosage form. Also disclosed is use of the orally disintegrant tablets (ODTs) for treating epilepsy and migraine headaches.