Rapidly dissolving pharmaceutical compositions comprising pullulan
The present invention provides an orally dissolving capsule comprising pullulan, a plasticizer and a dissolution enhancing agent.
1. An orally dissolving capsule comprising pullulan, in an amount from 60 wt % to 85 wt % based on total capsule shell solids, polydextrose, from 5 wt % to 10 wt % based on total capsule shell solids of a plasticizer and a dissolution enhancing agent wherein the capsule has a normalized breakthrough of less than 30 seconds in water at 37° C.
2. The capsule of claim 1 comprising pullulan in an amount from about 65 wt % to about 80 wt % based on total capsule shell solids.
3. The capsule of claim 1 wherein the plasticizer is a polyol.
4. The capsule of claim 3 wherein the polyol is selected from at least one of the group consisting of glycerol, propylene glycol, polyvinyl alcohol, sorbitol, pluronic and maltitol.
5. The capsule of claim 4 wherein the plasticizer is glycerol.
6. The capsule of claim 1 wherein the dissolution enhancing agent is selected from at least one of maltose, lactose, sorbitol, mannitol, gluconic acid lactone, xylitol, maltitol, and isomalt.
7. The capsule of claim 6 wherein the dissolution enhancing agent is selected from at least one of maltose, lactose, and sorbitol.
8. The capsule of claim 1 comprising dissolution enhancing agent in an amount from about 0.1 to about 35 wt % based on total capsule shell solids.
9. The capsule of claim 1 further comprising up to about 5 wt % sweetener based on total capsule shell solids.
10. The capsule of claim 1 further comprising up to about 5 wt % flavoring agent based on total capsule shell solids.
11. The capsule of claim 1 further comprising up to about 5 wt % saliva inducing agent based on total capsule shell solids.
12. The capsule of claim 1 wherein the width of the capsule shell is in the range of about 50 to about 200 micrometers.
13. The capsule of claim 1 wherein the normalized breakthrough time is less than about 20 seconds.
14. The capsule of claim 1 wherein the normalized breakthrough time is less than about 18 seconds.
15. The capsule of claim 1 wherein the normalized breakthrough time is less than about 15 seconds.
16. The capsule of claim 1 wherein the normalized breakthrough time is less than about 13 seconds.
17. The capsule of claim 1 wherein the normalized breakthrough time is less than about 11 seconds.
18. The capsule of claim 1 comprising about 70-85 wt % pullulan, about 5-10 wt % glycerin, about 5-10 wt % polydextrose, about 5-10 wt % maltose, and about 0.5-2 wt % acesulfame.
19. The capsule of claim 1 comprising about 65-75 wt % pullulan, about 5-10 wt % glycerin, about 5-10 wt % polydextrose, and about 10-20 wt % sorbitol.
20. A pharmaceutical composition comprising a hard capsule shell, the capsule shell comprising:
i. pullulan in an amount from 65 wt % to about 80 wt % based on total capsule shell solids,
ii. from 5 wt % to 10 wt % based on total capsule shell solids of one or more plasticizers,
iii. one or more dissolution enhancing agents; and
iv. polydextrose; wherein the capsule has a normalized breakthrough of less than 30 seconds in water at 37° C., and wherein the hard capsule shell is filled with a capsule fill formulation comprising one or more pharmaceutical agents and one or more excipients.
21. The capsule of claim 1 , wherein the polydextrose is present in an amount from 5 wt % to 20 wt % based on total capsule shell solids.