Buffered gum base for high pH release

Patent metadata

Field	Value
Publication number	US-9420806-B2
Application number	US-201113330452-A
Country	US
Kind code	B2
Filing date	Dec 19, 2011
Priority date	Jun 19, 2009
Publication date	Aug 23, 2016
Grant date	Aug 23, 2016

Abstract

A chewing gum composition with high pH-release includes an insoluble gum base matrix and a soluble bulk portion, wherein the gum base matrix and the bulk portion is mixed and extruded to form a final chewing gum core, and wherein the gum base matrix is buffered before mixing with the bulk portion. Furthermore, a method of producing a chewing gum core, wherein a gum base matrix and a bulk portion is mixed and extruded to form a final chewing gum core, and wherein the gum base matrix is buffered before mixing with the bulk portion, and the gum base matrix includes a first amount of buffer from 2 to 20 percent by weight of the gum base matrix before mixing with the bulk portion.

First claim

What is claimed is:

1. Chewing gum composition for high pH-release, the chewing gum composition comprising a water insoluble gum base matrix and a water soluble bulk portion, wherein the gum base matrix and the bulk portion is mixed and extruded to form a final chewing gum core, and wherein the gum base matrix is buffered before mixing with the bulk portion, wherein the pH level in the saliva is above 8.0 after the initial 10 minutes of in vivo chewing of the chewing gum composition measured at a chewing frequency of 60 per minute, wherein the gum base matrix comprises a first amount of buffer from 2 to 20 percent by weight of the gum base matrix before mixing with the bulk portion and wherein the buffer loading capacity of the final chewing gum is greater than the buffer loading capacity of the same chewing gum formulation prepared by including the buffer during mixing with the bulk portion.

2. Chewing gum composition according to claim 1 , wherein the chewing gum composition comprises an additional amount of buffer from 1 to 5 percent by weight of the chewing gum composition.

3. Chewing gum composition according to claim 2 , wherein the additional amount of buffer is comprised in the chewing gum core, in an outer coating or both in the chewing gum core and in the outer coating.

4. Chewing gum composition according to claim 1 , wherein the buffer is selected from the group consisting of a carbonate, glycerinate, phosphate, glycerophosphate, acetate, glyconate or citrate of an alkali metal, or ammonium, and mixtures thereof.

5. Chewing gum composition according to claim 1 , wherein the buffer is sodium carbonate.

6. Chewing gum composition according to claim 1 further comprising at least one active ingredient.

7. Chewing gum composition according to claim 6 , wherein the saliva has a pH above the pK a of said active ingredient within the initial 5 minutes of in vivo chewing of the chewing gum composition measured at a chewing frequency of 60 per minute.

8. Chewing gum composition according to claim 6 , wherein the active ingredient is nicotine.

9. Chewing gum composition according to claim 8 , wherein the nicotine is selected from the group consisting of a nicotine salt, the free base form of nicotine, a nicotine derivative, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, or starch microspheres, and mixtures thereof.

10. Chewing gum composition according to claim 6 , wherein said active ingredient is selected from the group consisting of phytochemicals; herbals; antioxidants; mouth moisteners; throat soothing ingredients; appetite suppressors; breath fresheners; diet supplements; cold suppressors; cough suppressors; vitamins; minerals; metal ions; alkaline materials; salts; herbals, dental care agents; and combinations thereof.

11. Chewing gum composition according to claim 1 , wherein the pH level in the saliva is increased by 0.5 to 2 pH units within the initial 5 minutes of in vivo chewing of the chewing gum composition measured at a chewing frequency of 60 per minute.

12. Chewing gum composition for high pH-release, the chewing gum composition comprising a water insoluble gum base matrix and a water soluble bulk portion, wherein the gum base matrix and the bulk portion is mixed and extruded to form a final chewing gum core, and wherein the gum base matrix is buffered before mixing with the bulk portion, the gum base matrix comprises a first amount of buffer from 2 to 20 percent by weight of the gum base matrix before mixing with the bulk portion, and wherein the chewing gum composition comprises an additional amount of buffer from 1 to 5 percent by weight of the chewing gum composition, and wherein the chewing gum composition comprises nicotine polacrilex resin and sodium carbonate, wherein the pH level in the saliva is above 8.0 after the initial 10 minutes of in vivo chewing of the chewing gum composition measured at a chewing frequency of 60 per minute, whereby a sustained release rate of nicotine is achieved after the initial 10 minutes of in vivo chewing and wherein the buffer loading capacity of the final chewing gum is greater than the buffer loading capacity of the same chewing gum formulation prepared by including the buffer during mixing with the bulk portion.

13. Method of producing a chewing gum core according to claim 1 , wherein a gum base matrix and a bulk portion is mixed and extruded to form a final chewing gum core, and wherein the gum base matrix is buffered before mixing with the bulk portion, and the gum base matrix comprises a first amount of buffer from 2 to 20 percent by weight of the gum base matrix before mixing with the bulk portion.

Assignees

• Andersen Carsten
• Lorenzen Gitte
• Arent Nicolai
• Thorengaard Bitten
• Wittorff Helle
• Fertin Pharma As

Inventors

• Andersen Carsten
• Lorenzen Gitte
• Arent Nicolai
• Thorengaard Bitten
• Wittorff Helle

Classifications

• A61P3/02

  Nutrients, e.g. vitamins, minerals · CPC title

• A61P25/34

  Tobacco-abuse · CPC title

• A61P3/04

  Anorexiants; Antiobesity agents · CPC title

• A23G4/126

  containing vitamins, antibiotics · CPC title

• A23G4/064 Primary

  containing inorganic compounds · CPC title