Oral nicotine formulation buffered with amino acid

A technology for oral preparation and nicotine, applied in the field of nicotine-containing pharmaceutical preparations

Inactive Publication Date: 2010-08-04
MCNEIL AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] To date, there has been no disclosure regarding the utility of amino acids as buffering agents in nicotine-containing pharmaceutical formulations

Method used

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  • Oral nicotine formulation buffered with amino acid
  • Oral nicotine formulation buffered with amino acid
  • Oral nicotine formulation buffered with amino acid

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0160] Example 1 tablet

[0161] 275mg tablet with 2mg nicotine

[0162] Element

Amount in the composition (mg)

Nicotine bitartrate dihydrate

6.1

[0163] Element

Amount in the composition (mg)

L-Arginine

17.9

Mannitol

210.9

xanthan gum

11.0

Cross-linked polyvinylpyrrolidone

11.0

flavoring agent

9.9

aspartame

1.6

Acesulfame Potassium

1.1

Magnesium stearate

5.5

[0164] making process :

[0165] Mix the above ingredients. The blend is then compressed into tablets by direct compression according to methods known in the art.

example 2

[0166] Example 2 Fusion film

[0167] This is a tablet designed to melt in the mouth when the melting substance adheres to the oral mucosa where nicotine is deposited to enter the tissues.

[0168] 400mg mouth-melting tablet with 2mg nicotine

[0169] Element

Relative amount in composition (% w / w)

Nicotine bitartrate dihydrate

1.5

cocoa powder

35.0

vegetable oil

41.6

L-Arginine

4.5

Mannitol

10.4

Titanium dioxide

2.7

Soy Lecithin

1.0

aspartame

0.4

[0170] Element

Relative amount in composition (% w / w)

Acesulfame Potassium

0.2

flavoring agent

2.7

[0171] making process :

[0172] The preparation of this formulation is carried out at room temperature. A portion of the fat component (ie vegetable oil) is melted. The solid ingredients (ie nicotine salt, cocoa powder, buffer, mannitol, titanium dioxide, sweetener ...

example 3

[0174] Instance 3A mouth spray

[0175] Nicotine mouth spray containing 14.3 mg nicotine per ml and pH 9.0

[0176] Element

[0177] Element

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PUM

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Abstract

A pharmaceutical oral formulation for delivering nicotine in any form to a subject by transmucousal uptake in the oral cavity comprising nicotine in any form, wherein said oral formulation is buffered with at least one amino acid, preferably at least one endogenous amino acid. Also contemplated is a method for the oral delivery of nicotine in any form, a method for the reduction of the urge to smoke or use tobacco as well as methods for manufacturing the oral formulation, the use of said oral formulation for obtaining transmucousal uptake of nicotine in the oral cavity of a subject, and use of nicotine for the production of an oral formulation as per above for the treatment of a disease selected from the group consisting of tobacco or nicotine dependence, Alzheimer's disease, Crohn's disease, Parkinson's disease, Tourette's syndrome, ulcerous colitis and post-smoking-cessation weight control.

Description

technical field [0001] The present invention relates to a nicotine-containing pharmaceutical formulation for the oral delivery of nicotine to a subject. The formulation includes one or more amino acids as a buffering agent. Of particular concern are endogenous amino acids. Also contemplated are methods and systems for delivering nicotine and the use and manufacture of such formulations. Background technique [0002] Nicotine dependence and its reduction is a desired goal. In recent years, with awareness of the harmful effects of tobacco smoking, many campaigns and projects have been launched by government ministries and various health groups and other relevant organizations to disseminate information about the adverse health effects of tobacco smoking. Furthermore, because of the recognition of this harmful effect, there have been many projects involved in trying to reduce the incidence of smoking. [0003] Nicotine is an organic compound and the main alkaloid of tobacco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/18A61K9/20A61K9/48A61K9/68A61K31/465A61K9/08A24B15/16A24B15/30A61P25/34
CPCA23G3/44A23L1/3051A24B15/16A61K9/006A23G4/14A61K9/0056A61K9/0058A61K31/465A23L33/175A61P1/04A61P25/16A61P25/26A61P25/28A61P25/34A61P43/00A61K9/20A61K31/198
Inventor S·-B·安德森G·伯根伦B·博森A·胡格斯F·尼科拉森R·奥尔森
Owner MCNEIL AB
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