Pharmaceutical compositions comprising brivaracetam
The present invention relates to a pharmaceutical composition comprising brivaracetam as active ingredient, the invention relates specifically to a prolonged release formulation.
1. A sustained release pharmaceutical composition in the form of a tablet comprising Brivaracetam and, within the core of the tablet, 5% to 80% per weight of at least one hydrophilic matrix agent with respect to the total weight of the core of the tablet, wherein the hydrophilic matrix agent is hydroxypropyl methylcellulose having a viscosity of more than 100 mPa·s in 2 percent aqueous solution (20° C.), and wherein the specific surface area of the core tablet is between 2 mm −1 and 0.3 mm −1 .
2. The pharmaceutical composition according to claim 1 comprising granules and an external phase, said granules containing brivaracetam and said external phase containing at least one hydrophilic matrix agent.
3. The pharmaceutical composition according to claim 1 , comprising brivaracetam and a water dispersible, rate controlling polymer as hydrophilic matrix agent.
4. The pharmaceutical composition according to claim 1 , comprising 20 to 60% per weight of hydrophilic matrix agent.
5. The pharmaceutical composition according to claim 1 , comprising 0.0 to 1.5% per weight of gliding agent with respect to the total weight of the core of the tablet.
6. The pharmaceutical composition according to claim 1 , comprising 0.5 to 2.0% per weight of lubricant with respect to the total weight of the core of the tablet.
7. The pharmaceutical composition according to claim 1 , comprising 1 to 70% per weight of binder with respect to the total weight of the core of the tablet.
8. The pharmaceutical composition according to claim 7 , comprising, as binder, a water soluble polymer having viscosity values lower than 500 mPa·s in 2 percent aqueous solution.
9. The pharmaceutical composition according to claim 1 , comprising
0.0 to 75% of diluent,
0.0 to 80% of binder,
0.0 to 3.0% of gliding agent, and
0.0 to 5.5% of lubricant,
with respect to the total weight of the core of the tablet.
10. The pharmaceutical composition according to claim 1 , comprising
0.0 to 75% of lactose,
0.0 to 80% of microcrystalline cellulose,
0.0 to 3.0% of anhydrous colloidal silica, and
0.0 to 5.5% of magnesium stearate,
with respect to the total weight of the core of the tablet;
wherein the composition is prepared by direct compression.
11. The pharmaceutical composition according to claim 1 , comprising
0.0 to 80% of microcrystalline cellulose,
0.0 to 40% of lactose,
0.0 to 5% of polyvinylpyrolidone,
0.0 to 3.0% of anhydrous colloidal silica, and
0.0 to 5.5% of magnesium stearate,
with respect to the total weight of the core of the tablet;
wherein the composition is prepared by wet granulation.
12. The pharmaceutical composition according to claim 1 , comprising
0.0 to 80% of microcrystalline cellulose,
0.0 to 75% of lactose,
0.0 to 40% of pregelatinized maize starch,
0.0 to 3.0% of anhydrous colloidal silica, and
0.0 to 5.5% of magnesium stearate,
with respect to the total weight of the core of the tablet; wherein the composition is prepared by wet granulation.