Granted Patent B1

US 7,425,341 · App. 11/853,355 · Granted Sep 16, 2008

Abstract

Claims (33)

1. A process for producing a rapidly disintegrating tablet, wherein the process comprises:

(i) wet-granulating a mixture comprising a directly compressible, water soluble carbohydrate; a directly compressible, water insoluble filler; a beneficial ingredient; and a solvent, to form a wet granulate;

(ii) drying the wet granulate, to produce a directly compressible dry granulate;

(iii) adding one or more ingredients selected from the group consisting of disintegrants, lubricants, water soluble fillers, and water insoluble fillers;

(iv) optionally adding one or more ingredients selected from the group consisting of surface active agents, flavorants, sweeteners, and colorants; and,

(v) compressing, to form the tablet, wherein, when contacted with an aqueous fluid, the tablet disintegrates rapidly to form a suspension, slurry or dispersion.

2. The process of claim 1 , wherein the tablet has a friability of not more than about 1.5% and a porosity of from about 15% to about 45%.

3. The process of claim 1 , wherein the directly compressible, water soluble carbohydrate is directly compressible mannitol, directly compressible sorbitol, directly compressible maltitol, directly compressible lactose, directly compressible sucrose, directly compressible xylose, directly compressible trehalose, directly compressible dextrose, or a combination thereof.

4. The process of claim 1 , wherein the directly compressible, water soluble carbohydrate comprises directly compressible mannitol.

5. The process of claim 4 , wherein the directly compressible mannitol comprises crystalline particles having a substantially rounded shape.

6. The process of claim 4 , wherein the directly compressible mannitol comprises spray dried mannitol.

7. The process of claim 4 , wherein the directly compressible mannitol comprises particles having a diameter of from about 75 μm to about 150 μm.

8. The process of claim 7 , wherein about 60% of the mannitol particles have a diameter of from about 75 μm to about 150 μm.

9. The process of claim 1 , wherein the directly compressible, water insoluble filler is a directly compressible polysaccharide.

10. The process of claim 9 , wherein the directly compressible, water insoluble filler is microcrystalline cellulose.

11. The process of claim 1 , wherein the solvent is an aqueous solvent.

12. The process of claim 1 , wherein the solvent is water.

13. The process of claim 1 , wherein (i) comprises wet granulating a mixture comprising a directly compressible, water soluble carbohydrate; a directly compressible, water insoluble filler; the beneficial ingredient; and water, to form the wet granulate.

14. The process of claim 1 , wherein the tablet is a round, flat-faced tablet.

15. The process of claim 1 , wherein the tablet has a porosity of from about 15% to about 35%.

16. The process of claim 1 , wherein the tablet has a porosity of from about 20% to about 30%.

17. The process of claim 1 , wherein the tablet disintegrates in from within about 2 seconds to within about 120 seconds.

18. The process of claim 1 , wherein the tablet disintegrates in from within about 2 seconds to within about 60 seconds.

19. The process of claim 1 , wherein (i) comprises wet-granulating a mixture of directly compressible mannitol; directly compressible microcrystalline cellulose; a beneficial ingredient; and water, to form a wet granulate, and wherein the tablet has a friability of not more than about 1.5% and a porosity of from about 15% to about 45%.

20. The process of claim 19 , wherein the directly compressible mannitol comprises crystalline particles having a substantially rounded shape.

21. The process of claim 20 , wherein the directly compressible mannitol is spray dried mannitol.

22. The process of claim 20 , wherein about 60% of the mannitol particles have a diameter of from about 75 μm to about 150 μm.

23. The process of claim 20 , wherein the microcrystalline cellulose has a bulk density of from about 0.2 g/cm 3 to about 0.4 g/cm 3 .

24. The process of claim 23 , wherein the microcrystalline cellulose has a mean particle size of from about 20 μm to about 200 μm.

25. The process of claim 20 , wherein the tablet has a friability of at most about 1%.

26. The process of claim 20 , wherein the tablet has a hardness of from about 10 N to about 47 N.

27. The process of claim 20 , wherein the tablet has a hardness of from about 14 N to about 35 N.

28. The process of claim 20 , wherein the beneficial ingredient is ondansetron.

Assignments (15)