IP Library Granted Patent US 11,058,633
Granted Patent B2
US 11,058,633 · App. 15/982,556 · Granted Jul 13, 2021

Disintegrating oral tablet suitable for active pharmaceutical ingredients

Inventor: Helle Wittorff (Vejle Ost, DK)
Assignee: Fertin Pharma A/S
A61K9/0056A61K9/2018A61K9/2086A61K9/2095
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Quick Facts
Patent No.
US 11,058,633
App. No.
15/982,556
Granted
Jul 13, 2021
Kind
B2
Abstract

The invention relates to a disintegrating oral tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet.

Claims (19)

1. A disintegrating oral direct compression tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient in an amount of 1-10% by weight of the tablet, the population of particles comprising non-directly compressible (non-DC) sugar alcohol particles consisting essentially of pure sugar alcohol, the non-DC particles providing the direct compression tablet with a plurality of discrete non-DC areas formed by single non-DC sugar alcohol particles or small groups of non-DC sugar alcohol particles, the at least one flavor ingredient being dispersed within the direct compression tablet in a matrix comprising the non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet.

2. The oral tablet according to claim 1 , wherein the tablet is designed to release at least 50% by weight of the at least one flavor ingredient within 20 seconds from onset of mastication.

3. The oral tablet according to claim 1 , wherein the burst of the at least one flavor ingredient involves a burst of flavors to the lungs upon mastication.

4. The oral tablet according to claim 1 , wherein the burst of the at least one flavor ingredient involves a burst of flavors to the nasal cavity upon mastication.

5. The oral tablet according to claim 1 , wherein the at least one flavor ingredient comprises a volatile flavor.

6. The oral tablet according to claim 1 , wherein the tablet is designed to disintegrate within 20 seconds from onset of mastication.

7. The oral tablet according to claim 1 , wherein the tablet obtains the burst through salivation promoted by the non-DC sugar alcohol particles during mastication in combination with a resulting dissolving of sweetener.

8. The oral tablet according to claim 1 , wherein the oral tablet is designed to disintegrate within 20 seconds of in vivo chewing, where the in vivo chewing is carried out by a chewing panel comprising at least 10 individuals, chewing at a rate of 60 chews per minute.

9. The oral tablet according to claim 1 , wherein the non-DC areas are evenly distributed in the tablet or at least one module of the tablet.

10. The oral tablet according to claim 1 , wherein the tablet is a chewable tablet.

11. The oral tablet according to claim 1 , wherein the non-DC sugar alcohol particles are selected from non-DC particles of erythritol, maltitol, xylitol, and combinations thereof.

12. The oral tablet according to claim 1 , wherein the non-DC sugar alcohol particles are non-DC erythritol particles.

13. The oral tablet according to claim 1 , wherein the tablet comprises said non-DC sugar alcohol particles in an amount of at least 10% by weight of the tablet.

14. The oral tablet according to claim 1 , wherein the population of particles further comprises directly compressible (DC) sugar alcohol particles, and the tablet has a weight ratio between said non-DC sugar alcohol particles and said DC sugar alcohol particles, which is between 0.3 and 0.7.

15. The oral tablet according to claim 1 , wherein saliva generation upon mastication of the tablet is induced compared to a tablet where the discrete areas are based on DC sugar alcohol particles.

16. A disintegrating oral direct compression tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising non-directly compressible (non-DC) sugar alcohol particles consisting essentially of pure sugar alcohol, the non-DC particles providing the direct compression tablet with a plurality of discrete non-DC areas formed by single non-DC sugar alcohol particles or small groups of non-DC sugar alcohol particles, the at least one flavor ingredient being dispersed within the direct compression tablet in a matrix comprising the non-DC areas, and, the tablet being designed to turn into liquid within 20 seconds of mastication.

17. A disintegrating oral direct compression tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles consisting essentially of pure sugar alcohol, the at least one flavor ingredient being dispersed in within the direct compression tablet in a matrix comprising the non-DC areas, and the tablet being designed to dissolve within 20 seconds of mastication.

18. The oral tablet according to claim 1 , wherein the tablet comprises the at least one flavor in an amount of 2-10% by weight of the tablet.

19. The oral tablet according to claim 1 , wherein the tablet comprises the at least one flavor in an amount of 2-6% by weight of the tablet.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 11, 2018
From: WITTORFF, HELLE
To: FERTIN PHARMA A/S
Reel/Frame 047131/0467 →
Continuity (1)
Related Publication 20190350847A1 · Nov 21, 2019
Cited By (2)
US 12,295,412 US 12,484,617