IP Library Granted Patent US 43,582
Granted Patent E1
US 43,582 · App. 12/426,396 · Granted Aug 14, 2012

Semi-moist delivery system

Assignee: EZ-Med Holdings, Inc.
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Quick Facts
Patent No.
US 43,582
App. No.
12/426,396
Granted
Aug 14, 2012
Kind
E1
Abstract

The subject invention is a carrier or product formed of a matrix having starch, sugar, fat, polyhydric alcohol and water in suitable ratios such that there exists a water activity of 0.6-0.75. The water activity of the product matrix may be adjusted up or down so that the availability of water in the finished product is not detrimental to the included active ingredient, be it pharmaceutical, nutraceutical, or a vitamin mineral complex.

Claims (68)

1. A composition for the oral administration of an additive selected from the group consisting of pharmaceutical, nutritional supplements, vitamins and minerals, and mixtures thereof mammals in a discrete dosage form, said discrete dosage from comprising:

said additive,

an extrudate comprising a matrix having about 10 to about 50% wt starch,

a sweetener consisting essentially of sucrose, corn syrup and sorbitol, said sucrose being in an amount of at least 10%, and

at least about 5% wt water,

said composition having A w of about 0.60 to about 0.75, and a soft and chewy texture, and said A w being adjusted to permit an appropriate amount of free water in the presence of the additive.

2. The carrier of claim 1 wherein the water content is about 10%.

3. The carrier of claim 1 wherein the polyhydric alcohol content is about 40%.

4. The carrier of claim 1 wherein the starch content is about 32%.

5. The carrier of claim 1 wherein said carrier has a pregelatinized starch content of about 15%.

6. The carrier of claim 1 where the A w is 0.65 and the additive is aspirin.

7. The carrier of claim 1 wherein the polyhydric alcohol is sorbitol.

8. The carrier of claim 1 wherein the sugar content is about 15%.

9. A method of making a carrier and additive mixture for use in an oral administration of a therapeutically effective amount of the additive in a discrete dosage form, comprising the steps of:

a) forming a matrix and additive admixture by mixing, in a one-step procedure additive,

about 10 to about 50% wt starch,

0 to about 40% wt fat or oil,

a sweetener consisting of sucrose, corn syrup and sorbitol, said sucrose being in an amount of at least 10%,

and water,

and mixing;

adjusting the relative amounts of polyhydric alcohol and water to control the A w of said admixture to adjust the level of moisture in the carrier to be a level not inimical to the additive and extruding said admixture to form an extrudate.

10. The method of claim 9 including adjusting the water content to about 10%.

11. The method of claim 9 including adjusting the polyhydric alcohol content to about 40%.

12. The method of claim 9 including adjusting the starch content to about 32%.

13. The method of claim 9 including adjusting the sugar content to about 15%.

14. The method of claim 9 further including adding pregelatinized starch to about 15% of the total carrier.

15. The method of claim 9 including the step of mixing in a pharmaceutical.

16. The method of claim 9 including the step of mixing in a nutraceutical.

17. The method of claim 9 including the step of mixing in a vitamin and mineral mix.

18. The method of claim 9 including the step of adding sorbitol.

19. The method of claim 9 including the step of controlling the A w to be at about 0.60 to about 0.75.

20. The method of claim 9 including the step of adding aspirin as the active ingredient and controlling the A w of said carrier to about 0.65.

21. The carrier of claim 2 , wherein the additive constitutes from about 0.1% to about 5.0% of the resulting mixture.

22. The method of claim 9 , further including adding about 0.1% to about 5.0% additive.

23. A composition for the oral administration of a pharmaceutical additive to mammals in a discrete dosage form, said discrete dosage form comprising:

an extrudate having a matrix, and comprising:

10-50% starch,

0-40% fat or oil,

a sweetener consisting essentially of sucrose, corn syrup and sorbitol, said sucrose being in an amount of least 10%,

at least about 5% water,

said composition having an A w of about 0.60 to about 0.75, and a soft and chewy texture, and said A w being adjusted to permit an appropriate amount of free water in the presence of the additive.

24. A method of making a carrier and additive mixture for use in an oral administration of a therapeutically effective amount of the additive in a discrete dosage form, comprising the steps of:

a) forming an additive admixture by mixing, in a one-step procedure:

additive,

about 10 to about 50% wt starch,

0 to about 40% wt fat or oil,

a polyhydric alcohol,

a sweetener consisting of sucrose, said sucrose being in the amount of at least 10%

and water,

adjusting the relative amounts of polyhydric alcohol sweetener and water to control the A w of said admixture to adjust the level of moisture in the carrier to be at a level not inimical to the additive and extruding said admixture to form an extrudate.

25. The method of claim 24 including adjusting the water content to about 10%.

26. The method of claim 24 including adjusting the polyhydric alcohol content to about 40%.

27. The method of claim 24 including adjusting the starch content to about 32%.

28. The method of claim 24 including adjusting the sweetener content to about 15%.

29. The method of claim 24 further including adding pregelatinized starch to about 15% of the total carrier.

30. The method of claim 24 including the step of mixing in a pharmaceutical.

31. The method of claim 24 including the step of mixing in a nutraceutical.

32. The method of claim 24 including the step of mixing in a vitamin and mineral mix.

33. The method of claim 24 including the step of controlling the A w to be at about 0.60 to about 0.75.

34. The method of claim 24 including the step of adding aspirin as the active ingredient and controlling A w of said carrier to about 0.65.

35. The method of claim 24, further including adding about 0.1% to about 5.0% additive.

36. An extrudate for the oral administration of an additive to mammals in a discrete dosage form, said discrete dosage comprising an extruded composition having

4.5-22.5% starch,

0-40% fat or oil,

polyhydric alcohol,

a sweetener consisting of sucrose, corn syrup and sorbitol, said sucrose being in the amount of at least 10%,

water, and

said extrudate having an A w of about 0.60 to about 0.75, and a soft and chewy texture, and said A w being adjusted to permit an appropriate amount of free water in the presence of the additive.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2016
From: EZ-MED HOLDINGS, INC.
To: VETS PLUS, INC.
Reel/Frame 038635/0540 →
TERMINATION OF SECURITY INTEREST Recorded Jun 25, 2014
From: FLAVORTEK, LLC; LEHMKUHL, ALFRED
To: EZ-MED HOLDINGS, INC.
Reel/Frame 033227/0306 →
SECURITY AGREEMENT Recorded May 21, 2012
From: EZ-MED HOLDINGS, INC.
To: FLAVORTEK, LLC; LEHMKUHL, ALFRED
Reel/Frame 028244/0568 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2010
From: EZ-MED COMPANY
To: EZ-MED HOLDINGS, INC.
Reel/Frame 025039/0010 →
Continuity (2)
Reissue 09160618 · Sep 24, 1998
Division 10639909 · Aug 13, 2003