Flash flow formed solloid delivery systems

• US 5,582,855 A
• Filed: 07/01/1994
• Issued: 12/10/1996
• Est. Priority Date: 07/01/1994
• Status: Expired due to Term

• Current Assignee: Nutravail, LLC (Catalent, Inc.)
• Original Assignee: Fuisz Technologies Limited (Bausch Health Cos., Inc.)
• Inventors: Cherukuri, Subraman R., Battist, Gerald E., Perkins, James H.
• Primary Examiner(s): HUNTER, JEANETTE M
• Application Number:
  US08/269,679
• Time in Patent Office: 893 Days
• Field of Search: 426/96, 426/98, 426/307, 426/3-6, 426/658, 426/573-79, 426/660, 426/661, 426/104, 426/650, 426/651
• US Class Current: 426/5
• CPC Class Codes: A23G 4/20 Composite products, e.g. centre-filled , multi-layer, laminated
• CPC Class Codes: A23L 27/70 Fixation, conservation, or encapsulation of flavouring agents
• CPC Class Codes: A23L 27/80 Emulsions
• CPC Class Codes: A23L 29/262 Cellulose; Derivatives thereof, e.g. ethers
• CPC Class Codes: A23P 10/25 Agglomeration or granulation by extrusion or by pressing, e.g. through small holes, through sieves or between surfaces
• CPC Class Codes: A61K 8/025 Explicitly spheroidal or spherical shape
• CPC Class Codes: A61K 9/1617 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

Discrete entities of a solid suspension are made from a solid fat matrix and a non-fat solid substrate having an active associated with said substrate. These entities are spheroidal in shape, have uniform size and substantially the same active content due to the flash flow process used to make them. They are especially useful as delivery systems for comestibles, pharmaceuticals and personal products.

Claims

1. A chewing gum composition comprising:

(a) a chewing gum base present in an amount between about 5% and about 85% by weight;

(b) a plurality of solloids comprising a solid suspension of a non-fat solid substrate having a flavorant associated therewith dispersed in a solid fat which is solidifiable at room temperature and having an intraparticle flow point lower than the melting point of said solid substrate, wherein a predominant amount of said solloids have substantially the same flavorant content and at least about 60% of said solloids have a particle size less than about 300 to about 400 microns.

2. The chewing gum composition of claim 1, wherein the non-fat solid substrate is a muco-adhesive.

3. The delivery system of claim 1, wherein the flavorant is selected from the group consisting of flavor oils, sweeteners, food acids and mixtures thereof.

4. The chewing gum composition of claim 3, wherein the flavor oils are selected from the group consisting of spearmint oil, peppermint oil, oil of wintergreen (methylsalicylate), cinnamon oil, menthol, citrus oil, fruit essences and mixtures thereof.

5. The chewing gum composition of claim 3, wherein the sweetener is selected from the group consisting of saccharides, saccharin and its salts, cyclamic acid and its salts, aspartame, sucralose, dihydrochalcone, glycyrrhin, stevioside, polyhydric alcohols, hydrogenated starch hydrolysate, acesulfame-K and mixtures thereof.

6. The chewing gum composition of claim 3, wherein the food acids are selected from the group consisting of citric acid, malic acid, ascorbic acid, tartaric acid, adipic acid, fumaric acid, succinic acid, lactic acid, glucono delta-lactone and mixtures thereof.

7. The chewing gum composition of claim 1, further including a bulking component.

8. The chewing gum composition of claim 2, wherein the gum base is selected from the group consisting of synthetic or natural elastomers.

9. The chewing gum composition of claim 1, containing one or more of the additional components selected from the group consisting of fillers, plasticizers, softeners, coloring agents, sweeteners, flavors and mixtures thereof.

10. The chewing gum composition of claim 1, wherein the plurality of solids constitutes from greater than zero to about 30% by weight of the total chewing gum composition.

11. The chewing gum composition of claim 1, wherein the percentage of flavorant in the solloid composition is from about 0.1% to about 35% by weight.

12. The chewing gum composition of claim 1, wherein the flavorant comprises peppermint oil.

13. The chewing gum composition of claim 1, wherein the flavorant comprises spearmint oil.

14. The chewing gum composition of claim 1, wherein the flavorant comprises menthol.

15. The chewing gum composition of claim 1, wherein the solid fat portion of the solloid has a flavorant present separate from the flavorant associated with said non-fat substrate.

16. The chewing gum composition of claim 1, wherein the solid fat is selected from the group consisting of hydrogenated and partially hydrogenated animal and vegetable fats and their glyceride esters.

17. The chewing gum composition of claim 2, wherein the non-fat solid substrate is selected from the group consisting of cellulosics, silicas, microcrystalline substances, water swellable gums and mucilages, alginates, carageenens, tragacanth, starches, titanium dioxide, zein and mixtures thereof.

18. The chewing gum composition of claim 17, wherein the non-fat solid substrate is hydroxypropylmethyl cellulose.

19. The chewing gum composition of claim 18, wherein the fat is partially hydrogenated soybean oil.

20. The chewing gum composition of claim 19, wherein the flavorant is selected from the group consisting of peppermint oil, spearmint oil, menthol, cinnamon oil, oil of wintergreen (methylsalicylate) and mixtures thereof.

21. A composition of matter comprising:

a plurality of solloids, said solloids comprising a solid suspension of a solid non-fat substrate having an active associated therewith dispersed in a solid fat which is solidifiable at room temperature and having a flow point lower than the melting point of said non-fat solid substrate, wherein a predominant amount of said solloids have substantially the same active content and at least about 60% of said solloids in said plurality have a particle size less than about 300 to about 400 microns.

22. The composition of claim 21, wherein the percentage of active in a solloid is about 5% to about 50% of the total substrate/active weight.

23. The composition of claim 21, wherein the solid non-fat substrate is an absorbent or adsorbent material.

24. The composition of claim 23, wherein the solid non-fat substrate is selected from the group consisting of cellulosics, silicas, microcrystalline substances, water sellable gums, alginates, carageenanes, tragacanth, starches, titanium dioxide, zein and mixtures thereof.

25. The composition of claim 21, wherein the active is a liquid.

26. The composition of claim 25, wherein the active is a flavorant.

27. The composition of claim 21, wherein the flavorant is selected from the group consisting of flavor oils, sweeteners, food acids and mixtures thereof.

28. The composition of claim 21, wherein the flavor oils are selected from the group consisting of spearmint oil, peppermint oil, oil of wintergreen (methylsalicylate), cinnamon oil, menthol, citrus oil, fruit essences and mixtures thereof.

29. The composition of claim 28, wherein the food acids are selected from the group consisting of citric acid, malic acid, ascorbic acid, tartaric acid, adipic acid, fumaric acid, succinic acid, lactic acid, glucono delta-lactone and mixtures thereof.

30. The composition of claim 21, wherein said fat is selected from the group consisting of hydrogenated and partially hydrogenated animal and vegetable oils and their glyceride esters.

31. A chewing gum composition containing the composition of claim 21.

32. A solloid delivery system for actives formed by the process of:

a) providing a mixture of non-fat solid substrate having an active associated therewith and a solid fat which is solidifiable at room temperature and having an intraparticle flow point lower than the melting point of said non-fat solid substrate;

b) subjecting said mixture to conditions of temperature and force sufficient to cause said solid fat to undergo intraparticle flow but below the melting point of the non-fat solid substrate; and

c) applying a disruptive force to said heated mixture to cause said mixture to form discrete solloids comprising a solid suspension of said solid substrate in said fat.