Oral product tablet and method of manufacture

Patent metadata

Field	Value
Publication number	US-2022409549-A1
Application number	US-202217845017-A
Country	US
Kind code	A1
Filing date	Jun 21, 2022
Priority date	Jun 21, 2021
Publication date	Dec 29, 2022
Grant date	—

Abstract

The disclosure provides products configured for oral use, and methods of making the products. The products include a plurality of granules, the granules including at least one filler; at least one sugar alcohol; a cellulose ether, polyvinylpyrrolidone, or a combination thereof; and at least one active ingredient, at least one flavorant, or a combination thereof. The products may be in a granular form, or in the form of a tablet or pellet.

First claim

What is claimed is:

1 . A method of preparing a product configured for oral use, the method comprising:
blending at least one filler, at least one sugar alcohol, and an active ingredient, a flavorant, or both to form a dry blend; and granulating a combination of the dry blend and an aqueous binder solution to form a plurality of granules.

2 . The method of claim 1 , wherein the dry blend comprises an active ingredient and a flavorant.

3 . The method of claim 1 , wherein the dry blend comprises an active ingredient and is substantially free of flavorant.

4 . The method of claim 1 , wherein the granules have a size range from about 60 μm to about 500 μm.

5 . The method of claim 1 , further comprising compressing the plurality of granules into a predetermined shape.

6 . The method of claim 5 , wherein the predetermined shape is a pellet or a tablet

7 . The method of claim 5 , further comprising mixing the plurality of granules with at least one flavorant, or with a flow aid, or both prior to said compressing.

8 . The method of claim 5 , further comprising mixing the plurality of granules with at least one flavorant and with a flow aid prior to said compressing.

9 . The method of claim 8 , wherein the flow aid is selected from the group consisting of microcrystalline cellulose, silica, polyethylene glycol, stearic acid, calcium stearate, magnesium stearate, zinc stearate, sodium stearyl fumarate, carnauba wax, and combinations thereof.

10 . The method of claim 1 , further comprising applying a coating composition to the product.

11 . The method of claim 10 , wherein the coating composition comprises a cellulosic material.

12 . The method of claim 10 , wherein the coating composition comprises a flavorant.

13 . The method of claim 1 , wherein the at least one filler comprises calcium carbonate, microcrystalline cellulose, maltodextrin, rice starch, or a combination thereof.

14 . The method of claim 1 , wherein the aqueous binder solution comprises a binder selected from the group consisting of methylcellulose, hydroxyethyl cellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, polyvinylpyrrolidone, and combinations thereof.

15 . The method of claim 1 , wherein the aqueous binder solution comprises polyvinylpyrrolidone.

16 . The method of claim 1 , wherein the at least one sugar alcohol is selected from the group consisting of erythritol, isomalt, maltitol, mannitol, sorbitol, and combinations thereof.

17 . The method of claim 1 , wherein the at least one sugar alcohol is mannitol.

18 . The method of claim 1 , wherein the active ingredient is selected from the group consisting of a nicotine component, botanical materials, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations thereof.

19 . The method of claim 1 , wherein the active ingredient is a non-tobacco botanical material.

20 . The method of claim 19 , wherein the non-tobacco botanical material is in milled form or is in the form of an extract.

21 . The method of claim 1 , wherein the product configured for oral use comprises from about 0.001 to about 10% by weight of a nicotine component, calculated as the free base and based on the total dry weight of the composition.

22 . The method of claim 1 , wherein the product configured for oral use is substantially free of tobacco material, excluding any nicotine component present.

23 . The method of claim 1 , further comprising adding one or more salts, sweeteners, buffering agents, colorants, humectants, oral care additives, preservatives, disintegration aids, flow aids, compressibility aids, or combinations thereof to the dry blend, the aqueous binder solution, or both.

24 . A product configured for oral use, the product comprising a plurality of granules, the granules comprising at least one filler, a liquid binder, at least one sugar alcohol, and an active ingredient, a flavorant, or both.

25 . The product of claim 24 , wherein:
the at least one filler comprises a filler selected from the group consisting of calcium carbonate, microcrystalline cellulose, maltodextrin, rice starch, and combinations thereof; the liquid binder comprises polyvinylpyrrolidone; the at least one sugar alcohol comprises mannitol; and the at least one active ingredient is a milled non-tobacco botanical material.

26 . The product of claim 25 , wherein the product is in the form of a compressed pellet or tablet having an exterior surface, and further comprising a coating on said exterior surface, the coating comprising a flavorant.

Assignees

• Nicoventures Trading Ltd

Inventors

• Hutchens Ronald K
• Holton Jr Darrell Eugene
• Mua John Paul
• Monsalud Luis
• St Charles Frank Kelley
• Alderman Steven Lee
• Marshall Jerry Wayne
• Lampe Matthew
• Debusk Samuel Mark

Classifications

• A61K9/2059

  Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin · CPC title

• A61K9/2018

  Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates · CPC title

• A61K9/2009

  Inorganic compounds · CPC title

• A61K9/1694

  resulting in granules or microspheres of the matrix type containing more than 5% of excipient · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title