Oral product

• US 9,884,015 B2
• Filed: 01/18/2013
• Issued: 02/06/2018
• Est. Priority Date: 01/20/2012
• Status: Active Grant

• Current Assignee: Altria Client Services LLC (Altria Group, Inc.)
• Original Assignee: Altria Client Services LLC (Altria Group, Inc.)
• Inventors: Gao, Feng, Atchley, Frank Scott, Griscik, Gregory, DiNovi, Christopher Joseph, Hulan, Phillip M., Gee, Diane, Kobal, Gerd
• Primary Examiner(s): WORSHAM, JESSICA N
• Application Number:
  US13/744,905
• Publication Number:
  US 20130189333A1
• Time in Patent Office: 1,845 Days
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2095 Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing mechanical aspects A61J3/00

Abstract

An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and an additive dispersed in the mouth-stable polymer matrix. The oral product is adapted to release the additive from the body when the body is received within the oral cavity and exposed to saliva.

Claims

1. An oral product, comprising a body that is wholly receivable in an oral cavity, the body comprising:

an extruded mouth-stable polymer matrix comprising between 40 and 80 weight percent polyurethane;

cellulosic fibers embedded in the mouth-stable polymer matrix that form a porous fiber-polymer matrix, the cellulosic fibers having an average fiber size of less than 200 micrometers; and

an additive dispersed in the mouth-stable polymer matrix such that the additive is released from the body when the body is received within the oral cavity and exposed to saliva, wherein the cellulosic fibers provide passages in the mouth-stable polymer matrix to pores retaining the additive, the pores having a diameter of between 40 microns and 60 microns, between 1 micron and 10 microns, or both;

wherein the body has a compressibility @ 250 N of between 45% and 90% and a percentage of springiness of between 75% and 90%.

2. The oral product of claim 1, further comprising a plasticizer dispersed in the mouth-stable polymer matrix.

3. The oral product of claim 2, wherein the plasticizer is selected from the group consisting of propylene glycol, glycerin, vegetable oil, triglycerides, and combinations thereof.

4. The oral product of claim 1, further comprising a sweetener dispersed in the body.

5. The oral product of claim 1, wherein the additive comprises a sweetener selected from the group consisting of saccharine, sucralose, aspartame, acesulfame potassium, and combinations thereof.

6. The oral product of claim 1, wherein the additive is selected from the group consisting of minerals, vitamins, dietary supplements, nutraceuticals, energizing agents, soothing agents, amino acids, chemsthetic agents, antioxidants, botanicals, teeth whitening agents, therapeutic agents, and combinations thereof.

8. The oral product of claim 1, further comprising a flavorant dispersed in the body such that the flavorant is released when the body is held within a mouth of a consumer.

9. The oral product of claim 8, wherein the flavorant is selected from the group consisting of licorice, wintergreen, cherry and berry type flavorants, Dramboui, bourbon, scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon, apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage, fennel, pimenta, ginger, anise, coriander, coffee, mint oils from a species of the genus Mentha, and combinations thereof.

10. The oral product of claim 1, wherein the body is shield shaped.

12. The oral product of claim 1, wherein the body comprises at least 10 weight percent cellulosic fibers.

13. The oral product of claim 1, wherein the body further comprises soluble fibers, wherein a ratio of soluble fiber to cellulosic fibers is between 1:

60 and 60;

1.

21. The oral product of claim 1, wherein the additive comprises a therapeutic agent.

22. The oral product of claim 21, wherein the therapeutic agent is released at a rate such that a majority of the therapeutic agent is absorbed transbuccally.

23. The oral product of claim 1, wherein the fiber-polymer matrix absorbs one or more additives and provides a pathway for one or more additives to be released from the oral product.

7. An oral product, comprising a body that is wholly receivable in an oral cavity, the body comprising:

an extruded mouth-stable polymer matrix comprising between 40 and 80 weight percent polyurethane;

cellulosic fibers embedded in the mouth-stable polymer matrix that form a porous fiber-polymer matrix, the cellulosic fibers having an average fiber size of less than 200 micrometers; and

an additive dispersed in the mouth-stable polymer matrix such that the additive is released from the body when the body is received within the oral cavity and exposed to saliva, wherein the additive is a therapeutic agent selected from the group consisting of Buprenorphin, Nitroglycerin, Diclofenac, Fentanyl, Carbamazepine, Galantamine, Acyclovir, Polyamidoamine Nanoparticles, Chlorpheniramine, Testosterone, Estradiol, Progesterone, Calcitonin, Fluorouracil, Naltrexone, Ondansetron, Decitabine, Selegiline, Lamotrigine, Prochlorperazine, and combinations thereof, wherein the cellulosic fibers provide passages in the mouth-stable polymer matrix to pores retaining the additive, the pores having a diameter of between 40 microns and 60 microns, between 1 micron and 10 microns, or both and wherein the body has a compressibility @ 250 N of less than 95%.

11. An oral product, comprising a body that is wholly receivable in an oral cavity, the body comprising:

an extruded mouth-stable polymer matrix comprising between 40 and 80 weight percent polyurethane;

cellulosic fibers embedded in the mouth-stable polymer matrix that form a porous fiber-polymer matrix, the cellulosic fibers having an average fiber size of less than 200 micrometers; and

an additive dispersed in the mouth-stable polymer matrix such that the additive is released from the body when the body is received within the oral cavity and exposed to saliva, wherein the cellulosic fibers provide passages in the mouth-stable polymer matrix to pores retaining the additive, the pores having a diameter of between 40 microns and 60 microns, between 1 micron and 10 microns, or both;

wherein the body has a diameter of between 5 mm and 25 mm and a thickness of between 1 mm and 10 mm and wherein the body has a compressibility @ 250 N of less than 95%.

14. The oral product of claim 11, wherein the body has a compressibility @ 250 N of less than 80%.

15. The oral product of claim 11, wherein the body has a compressibility @ 250 N of between 45% and 90%.

16. The oral product of claim 11, wherein the body has a compressibility @ 425 N of less than 99%.

17. The oral product of claim 11, wherein the body has a compressibility @ 425 N of between 60% and 98%.

18. The oral product of claim 11, wherein the body has a percentage of springiness of at least 20%.

19. The oral product of claim 11, wherein the body has a percentage of springiness of at least 70%.

20. The oral product of claim 11, wherein the body has a percentage of springiness of between 75% and 90%.