Encapsulated flavor with bioadhesive character in pressed mints and confections

• US 5,284,659 A
• Filed: 03/30/1990
• Issued: 02/08/1994
• Est. Priority Date: 03/30/1990
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Raman, Krishna P., Cherukuri, Subraman R., Mansukhani, Gul, Orama, Angel M.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Spear, James M.
• Application Number:
  US07/502,464
• Time in Patent Office: 1,411 Days
• Field of Search: 424/441, 424/499, 424/435, 424/439, 424/472, 424/471, 424/473
• US Class Current: 424/441
• CPC Class Codes: A23G 3/2061 Compression moulding of paste, e.g. in the form of a ball or rope or other preforms, or of powder or granules
• CPC Class Codes: A23G 3/36 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 3/50 characterised by shape, structure or physical form, e.g. products with supported structure
• CPC Class Codes: A23G 3/54 Composite products, e.g. layered, coated, filled
• CPC Class Codes: A23L 27/72 Encapsulation
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Abstract

A confectionery compressed tablet designed to dissolve in the oral cavity and containing a flavor ingredient intimately bound with a bioadhesive is disclosed. The flavor and bioadhesive composition provide a unique mouthfeel so that as the confection dissolves in the oral cavity, a coating of flavor adheres to the moist areas of the oral cavity. There is also provided a confectionery compressed tablet characterized by a single product body with discrete phases contained therein which act to provide timed release of at least one flavor ingredient sequentially. A flavor and bioadhesive mixture can be prepared with a hydrophilic delivery system providing rapid initial delivery of the flavor and unique mouthfeel or as a part of a hydrophobic delivery system providing extended periods of flavor delivery and unique mouthfeel. There is also provided a process for preparing confectionery compressed tablets containing the unique flavor delivery system and mouthfeel.

Claims

1. A two phase system in a single compressed confection tablet for delivering at least one active ingredient in a timed release manner through the buccal route or through releasing a first ingredient into the oral cavity, wherein said phases define separate regions within said compressed confection tablet comprising:

(a) at least 82% by weight of a hydrophilic component comprising a flavor and a matrix selected from the group consisting of polymer systems, gums, gelatin, starches, modified starches and film forming compounds; and

(b) up to 18% by weight of a separate hydrophobic component comprising;

(i) said active ingredient;

(ii) said first ingredient;

(iii) a bioadhesive compound; and

(iv) a hydrophobic encapsulation medium, wherein said first ingredient is selected from the group consisting of flavors, sweeteners and mixtures thereof.

2. The system of claim 1, wherein said flavor is selected from the group consisting of:

spearmint oil, cinnamon oil, oil of wintergreen (methyl silicylate), peppermint oil, lemon oil, orange oil, grape oil, lime oil, grapefruit oil, apple essence, strawberry essence, cherry essence, pineapple essence, banana oil and mixtures thereof.

3. The system of claim 1, wherein said sweetener is selected from the group consisting of:

amino acid-based sweeteners, dipeptide sweeteners, glycyrrhizin, saccharine and salts thereof, acesulfame salts, cyclamates, steviosides, talin, chloro-derivatives of sucrose, dihydrochalcone compounds and mixtures thereof.

4. The system of claim 1, wherein said bioadhesive compound is selected from the group consisting of:

amylopectin, carboxymethylcelluloses, hydroxyethylcelluloses, acrylates, gelatin, guar gum, karaya gum, tragacanth, agar, alginic acid, dextran, methylcellulose, pectin, polyethylene glycol, polyvinylpyrrolidone and mixtures thereof.

5. The system of claim 1, wherein said bioadhesive compound comprises less than about 1% by weight of said system.

6. The system of claim 1, wherein said active ingredient comprises a bio-effecting agent.

7. The system of claim 1, wherein said bio-effecting agent is selected from the group consisting of:

breath fresheners, breath deodorants, antigingivitis agents and mixtures thereof.

8. The system of claim 7, wherein said breath freshener is selected from the group consisting of alpha ionone, methyl ionone, menthol, licorice, rose oil, violet leaves, salicylates, cyclamen, jasmine oil, elemi oil, clove oil, cardamon oil, anise oil, myrrh resin and mixtures thereof.

9. The system of claim 7, wherein said breath deodorant is copper gluconate.

10. The system of claim 7, wherein said antigingivitis agent is selected from the group consisting of chlorhexidine, thymol, menthol, methyl salicylates, eucalyptol and mixtures thereof.

11. The system of claim 1, wherein said bioadhesive compound comprises between about 0.5% and about 30% by weight of said hydrophobic component.

12. The system of claim 1, wherein said bioadhesive compound comprises between about 7% to about 25% by weight of said hydrophobic component.

13. The system of claim 12, wherein said bioadhesive compound comprises between about 18% to about 22% by weight of said hydrophobic component.

14. The system of claim 1, wherein said hydrophilic component further comprises said active ingredient.

15. The system of claim 1, wherein said hydrophilic component further comprises a second active ingredient, whereby said second active ingredient is delivered for absorption through mucosa more rapidly than said first ingredient.

16. The system of claim 1, wherein said hydrophilic component is selected from the group consisting of polymers, gelatin, gum arabic, starches, modified starches, maltodextrin, corn syrup solids, hydrocolloids, carrageenan and acrylates.

17. The system of claim 1, wherein said hydrophilic component completely envelops said hydrophobic phase.

18. The system of claim 1, wherein said hydrophobic component comprises between about 0.1% and about 18% by weight of said tablet.

19. The system of claim 18, wherein said hydrophobic component comprises between about 4% and about 14% by weight of said system.

20. The system of claim 19, wherein said hydrophobic component comprises between about 6% and about 10% by weight of said system.

21. The system of claim 1, wherein said hydrophobic encapsulation medium is selected from the group consisting of fats, waxes, resins and mixtures thereof.

22. The system of claim 21, wherein said fat is selected from the group consisting of hydrogenated and partially hydrogenated oils.

23. The system of claim 21, wherein said fat is selected from the group consisting of monoglycerides, diglycerides, triglycerides, polyglycerol esters, sorbitol esters and mixtures thereof.

24. A method for preparing a two phase system in a single compressed confection tablet for delivering at least one active ingredient in a time release manner through the buccal route or through releasing a first ingredient into the oral cavity, wherein said phases define separate regions within said compressed confection tablet comprising the steps of:

(a) preparing a hydrophilic component comprising a flavor and a matrix selected from the group consisting of polymer systems, gums, gelatin, starches, modified starches and film forming compounds;

(b) separately preparing a separate hydrophobic component comprising;

(i) said active ingredient;

(ii) said first ingredient;

(iii) a bioadhesive compound; and

(iv) a hydrophobic encapsulation medium, wherein said first ingredient is selected from the group consisting of flavors, sweeteners and mixtures thereof; and

(c) combining at least 82% by weight of said hydrophilic phase and up to 18% by weight of said hydrophobic phase to form a compressed confection tablet having separate regions for said hydrophilic phase and said hydrophobic phase.