GB2643926A — An orodispersible tablet of levetiracetam and its process of preparation

USPTO Abstract

An orodispersible tablet of levetiracetam, comprising: 55-85 %w/w levetiracetam or pharmaceutically acceptable salts thereof; a diluent at 2-35 %w/w (e.g. microcrystalline cellulose (MCC) (1-20 %w/w), mannitol (1-15 %w/w)); a disintegrant at 1-15 %w/w (e.g., croscarmellose sodium (0.5-6 %w/w), crospovidone (0.5-9 %w/w)); a lubricant at 0.5-5 %w/w (e.g., magnesium stearate); a binder at 0.5-5 %w/w (e.g., povidone K30); a glidant at 0.05-0.5 %w/w (e.g., colloidal anhydrous silica); and a pharmaceutically acceptable excipient. Also disclosed is a process for preparing the tablet via wet granulation, comprising: sieving levetiracetam, MCC, mannitol, croscarmellose sodium, colloidal anhydrous silica, crospovidone, acesulfame potassium, raspberry flavour, and magnesium stearate; dissolving and stirring povidone K30 in isopropyl alcohol to form a clear viscous binder solution; dry mixing levetiracetam and mannitol in a rapid mixer granulator; adding the binder solution the dry mixed blend; drying the granulated blend in a dryer at 50℃ ± 5℃; sieving and milling retained granules; mixing the granules with MCC, colloidal anhydrous silica, croscarmellose sodium, and magnesium stearate; compressing into a tablet dosage form; and packing the tablet into an HDPE bottle with a child-resistant cap containing silica gel. Also disclosed is use of the orally disintegrating tablets for treating partial-onset seizures in epilepsy.