IP Library Granted Patent US 9,402,810
Granted Patent B2
US 9,402,810 · App. 14/734,509 · Granted Aug 2, 2016

Pouch containing nicotine in free salt form

Inventor: Per-Gunnar Nilsson (Malmo, SE)
Assignees: NYZ AB; WM17 HOLDING AG
A61K9/0056A24B15/16A61K9/006A61K9/009A61K9/145A61K9/1611A61K9/1623A61K9/1635A61K9/1652A61K31/465A61K47/12A61K47/22A61K47/26A61K47/32A61K47/38
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Quick Facts
Patent No.
US 9,402,810
App. No.
14/734,509
Granted
Aug 2, 2016
Kind
B2
Abstract

The invention relates to a product for oral delivery of nicotine containing a core comprising a powder of at least one free nicotine salt, at least one pH adjusting agent and at least one filler, and a water insoluble pouch, wherein said pouch is permeable for saliva and therein dissolved parts of the powder, wherein said product upon contact with purified water gives a pH of at least 6. The invention also relates to a method to manufacture such a product.

Claims (25)

1. A product for oral delivery of nicotine containing a core comprising a powder of

a) at least one free nicotine salt wherein said nicotine salt is selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and mixtures thereof

b) at least one pH adjusting agent

c) at least one filler

and a water insoluble pouch, wherein said pouch is permeable for saliva and therein dissolved parts of the powder, wherein said product upon contact with purified water gives a pH of at least 6.

2. The product according to claim 1 , wherein said nicotine salt is water soluble.

3. The product according to claim 1 , wherein said nicotine salt is nicotine bitartrate dihydrate.

4. The product according to claim 1 , wherein said pH adjusting agent is selected from the group consisting of carbonates, monocarbonate, bicarbonate, sesquicarbonate, acetates, glycinates, gluconates, borates, glycerophosphates, citrates of alkaline metals, ammonium, phosphate systems, monohydrogenphosphate, dihydrogenphosphate, trihydrogenphosphate, metal hydroxides, sodium hydroxide, potassium hydroxide and mixtures thereof.

5. The product according to claim 1 , wherein said pH adjusting agent is sodium bicarbonate, sodium carbonate and mixtures thereof.

6. The product according to claim 1 , wherein said pH adjusting agent is encapsulated or embedded.

7. The product according to claim 1 , wherein said pH adjusting agent is encapsulated or embedded with a polymer which physically separates the pH adjusting agent from the nicotine salt.

8. The product according to claim 1 , wherein said filler is selected from the group consisting of polysaccharides, polyols, sugars, natural fibres, microcrystalline cellulose, cellulose and cellulose derivatives and mixtures thereof.

9. The product according to claim 1 , wherein said product comprises at least one filler which is a sweetener or a flavoring agent.

10. The product according to claim 9 wherein said sweetener is selected from the group consisting of mono- di- tri- and polysaccharides, polyols, mannitol, maltitol, natural and synthetic sweeteners, sucrose, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, sucralose, saccharin, cyclamates and mixtures thereof.

11. The product according to claim 1 wherein said flavoring agent is selected from the group consisting of bergamot, eucalyptus, orange, mandarin, citrus, lemon, peppermint, mint, menthol, liquorice, wintergreen, tobacco, coffee, vanilla, lime, apple, peach and mixtures thereof.

12. The product according to claim 1 , wherein said pouch is manufactured from material selected from the group consisting of pharmaceutically acceptable membrane materials.

13. The product according to claim 1 , wherein said product comprises nicotine in an amount of from 0.1 to 10 mg per unit dose calculated as nicotine base.

14. The product according to claim 10 , wherein said product comprises nicotine in an amount of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0 or 9.0 mg per unit dose calculated as nicotine base.

15. The product according to claim 1 , wherein said product comprises from 50 mg to 1000 mg of said powder.

16. The product according to claim 1 , wherein said product comprises 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900 or 950 mg of said powder.

17. A method of making a product comprising the steps of

a) providing a powder of at least on free nicotine salt and at least one pH adjusting agent and at least one filler, and a water insoluble pouch; and

b) obtaining a product according to claim 1 .

18. The method according to claim 17 further comprising encapsulating or embedding the pH adjusting agent.

19. The method according to claim 17 further comprising granulating the powder.

Assignments (6)
MERGER Recorded Aug 18, 2021
From: WM17 HOLDING GMBH
To: WM15 HOLDING GMBH
Reel/Frame 057215/0893 →
MERGER Recorded Aug 18, 2021
From: WM15 HOLDING GMBH; BURGER SÖHNE HOLDING GMBH; HELIX INNOVATIONS INTERNATIONAL GMBH
To: HELIX INNOVATIONS GMBH
Reel/Frame 057318/0964 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 9, 2020
From: CHILL OF SWEDEN AB
To: TILLCE AB; WM17 HOLDING AG
Reel/Frame 052054/0780 →
CHANGE OF NAME Recorded Mar 9, 2020
From: WM17 HOLDING AG
To: WM17 HOLDING GMBH
Reel/Frame 052055/0796 →
CHANGE OF ADDRESS Recorded Mar 16, 2017
From: NYZ AB
To: NYZ AB
Reel/Frame 042023/0927 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 27, 2016
From: TILLCE AB
To: NYZ AB
Reel/Frame 039016/0829 →
Priority Claims (1)
SE 1150273 · Mar 29, 2011 · national
Continuity (3)
Continuation 14008367
Provisional Application 61470264 · Mar 31, 2011
Related Publication 20150272878A1 · Oct 1, 2015