Orodispersible tablets
This invention relates to a an orally disintegrating tablet obtainable by direct compression of a dry powdered mixture, said mixture comprising up to 15% by weight of calcium silicate, at least 50% of a diluent, a disintegrant agent and an active ingredient. It also relates to a process for preparing the tablets by homogeneous blending the specific excipients in powder form and subsequent direct compression of the mixture. Said tablets disintegrate quickly in the cavity of the mouth, in particular in less than 15 seconds.
1. An orally disintegrating tablet obtained by direct compression of a dry powdered mixture, said mixture comprising:
up to 15% by weight of calcium silicate;
at least 50% by weight of lactose;
at least one disintegrant; and
olanzapine,
wherein said orally disintegrating tablet presents a friability no greater than 1% and a disintegration time of less than 20 seconds, and wherein the dry powder mixture has not been subjected to any granulation process, dissolution, or dispersion in a liquid medium.
2. The tablet according to claim 1 , wherein the tablet's thickness is less than 30% of the tablet's major diameter.
3. The tablet according to claim 1 , wherein the calcium silicate is crystalline.
4. The tablet according to claim 1 , wherein the calcium silicate is ortho-, meta- or alpha triclinic-calcium silicate.
5. The tablet according to claim 1 , wherein said calcium silicate is amorphous.
6. The tablet according to claim 1 , wherein the lactose is lactose, anhydrous lactose, lactose monohydrate, agglomerated lactose or atomised forms of lactose.
7. The tablet according to claim 1 , wherein the disintegrant is selected from the group consisting of crospovidone, sodium croscarmellose, sodium starch glycolate, low-substituted hydroxypropyl cellulose and pregelatinized starch.
8. The tablet according to claim 7 , wherein the disintegrant is crospovidone or sodium croscarmellose.
9. The tablet according to claim 1 , wherein the powdered mixture further comprises an effervescent component.
10. The tablet according to claim 1 , wherein the dry powder comprises from 1 to 20% by weight of olanzapine.
11. The tablet according to claim 1 , wherein said calcium silicate, lactose, at least one disintegrant, and olanzapine have been previously and independently passed through a sieve with mesh size lower than 650 μm.
12. A process for the preparation of a tablet as defined in claim 1 , said process comprising:
i. mixing the dry powdered ingredients in the required amount, and
ii. applying direct compression to the mixture obtained in step i),
wherein the mixture obtained in step i) has not been subjected to any granulation process, dissolution, or dispersion in a liquid medium.
13. The tablet according to claim 1 , wherein the mixture comprises up to 10 weight % of calcium silicate.
14. The process of claim 12 , wherein said calcium silicate, lactose, at least one disintegrant, and olanzapine have been previously and independently passed through a sieve with mesh size lower than 650 μm.