Patent ID: 8231904

Claim:
A two-layer extended release tablet for the oral administration of pralnacasan, or a salt thereof, comprising a rapid release layer comprising pralnacasan and croscarmellose as a disintegrant, and an extended release layer comprising pralnacasan and hydroxypropylmethylcellulose as a gel former, wherein both layers comprise at least one filler, at least one binder and at least one lubricant; wherein the rapid release layer consists essentially of: 200 mg pralnacasan, 31 mg lactose D 80, 10 mg croscarmellose, 9 mg hydroxypropylcellulose, 15 mg microcrystalline cellulose type 102, and 1.5 mg magnesium stearate; and the extended release layer consists essentially of: 400 mg pralnacasan, 62 mg lactose D 80, 18 mg hydroxypropylcellulose, 30 mg microcrystalline cellulose type 102, 40 mg hydroxypropylmethylcellulose 4000 mPas, 30 mg mannitol, and 10 mg magnesium stearate; and wherein at least 60% of the pralnacasan is released from the tablet not more than 30 minutes after administration, and at least 90% is released not more than 180 minutes after administration.