Orally disintegrating tablet
View Patent ↗The present invention features a tablet containing at least one first material, at least one second material, and at least one pharmaceutically active agent, wherein: (a) the first material is a dielectric water-containing material (i) containing from about 1 to about 5 percent, by weight, of bound water and (ii) having a dielectric loss, when measured at a density of between 0.15 and 0.5 g/cc, of from about 0.05 to about 0.7; and (b) the second material (i) having a water solubility from about 20 to about 400 g per 100 g of water at 25° C., (ii) having a dielectric loss, when measured at a density between 0.5 and 1 g/cc, of less than about 0.05.
1. A tablet comprising at least one first material, at least one second material, and at least one pharmaceutically active agent, wherein:
(a) said first material comprises maltodextrin;
(b) said second material is a sugar or sugar alcohol;
(c) said tablet comprises from at least 15% to about 45%, by weight, of said first material and from about 20% to about 64%, by weight, of said second material;
(d) the combined weight of said at least one first material and said at least one second material comprises at least 60%, by weight, of said tablet;
(e) said tablet has a friability of less than about 5%;
(f) said tablet has a density less than about 0.8 g/cc;
(g) said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds; and
(h) said tablet comprises less than 5%, by weight, of a polyethylene glycol.
2. A tablet of claim 1 , wherein said tablet comprises at least 20%, by weight, of said first material.
3. A tablet of claim 1 , wherein said at least one first material has a bulk density of less than 0.2 g/cc.
4. A tablet of claim 1 , wherein said at least one second material comprises erythritol.
5. A tablet of claim 1 , wherein the combined weight of said at least one first material, said at least one second material, and said at least one pharmaceutically active agent comprises at least 90%, by weight, of said tablet.
6. A tablet of claim 5 wherein said tablet comprises from about 20% to about 45%, by weight, of said first material.
7. A tablet of claim 1 , wherein said at least one pharmaceutically active agent are comprised within polymer-coated particles, and said tablet comprises at least 15%, by weight, of said particles.
8. A tablet of claim 1 , wherein said tablet does not comprise a polyethylene glycol.
9. A tablet of claim 1 , wherein at least 90%, by weight, of the tablet is comprised of material having a melting point greater than 80 C.
10. A tablet of claim 1 , wherein the peak penetration resistance at the center of the major face of the tablet is from about 50 to about 600 grams.
11. A tablet of claim 1 , wherein said tablet meets the criteria for orally disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007.
12. A tablet of claim 1 , wherein said tablet comprises from about 39 to about 56%, by weight, of said at least one second material.
13. A tablet of claim 1 , wherein said tablet comprises from about 10 to about 40%, by weight, of particles comprising said pharmaceutically active agent.
14. A tablet of claim 1 , wherein said tablet disintegrates in the mouth when placed on the tongue in less than about 15 seconds.
15. A tablet of claim 1 , wherein the combined weight of said at least one first material, said at least one second material, and said at least one pharmaceutically active agent comprises at least 95%, by weight, of said tablet.