Orodispersible domperidone tablets

摘要

The present invention relates to an orodispersible tablet comprised of, by weight: a maximum of 15% of a low-dose, therapeutically active substance; from 55% to 70% of mannitol of a particle size between 30 μm and 300 μm; at least 2% of maltodextrin; from 3.5% to 8% of croscarmellose sodium; from 10% to 20% of microcrystalline cellulose; from 0.5% to 1.5% of magnesium stearate; and from 1% to 5% of flavoring (s) and sweetener (s).

主权项

1. An orodispersible tablet comprised of, by weight:
a maximum of 15% of a low-dose, therapeutically active substance; from 55% to 70% of mannitol of a particle size between 30 μm and 300 μm; at least 2% of maltodextrin; from 3.5% to 8% of croscarmellose sodium; from 10% to 20% of microcrystalline cellulose; from 0.5% to 1.5% of magnesium stearate; and from 1% to 5% of flavoring (s) and sweetener (s);
wherein the tablet comprises a combination of an internal phase containing the therapeutic active substance and an initial portion of croscarmellose sodium, and an external phase containing a second portion of croscarmellose sodium; andwherein approximately half of the total quantity of sodium croscarmellose is distributed in the internal phase and approximately half is distributed in the external phase of the tablet.