Formulation and Use and Manufacture Thereof

a technology of liquid pharmaceuticals and pharmaceutical formulations, applied in the direction of medical preparations, pharmaceutical delivery mechanisms, tobacco, etc., can solve the problems of not satisfying the craving, not providing for a sufficiently rapid uptake of nicotine without, and not satisfactorily fulfilling the hitherto known means and methods, etc., to achieve rapid and/or sustained and/or complete reduction of the urge to smoke or use tobacco.

Inactive Publication Date: 2007-07-19
PHARMACIA AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0042] Use of said product will according to the invention rapidly deliver nicotine in any form to a subject and will also provide for obtaining a quick and / or sustained and / or complete reduction of the urge to smoke or use tobacco and / or for providing a sense of smoking satisfaction without smoking resembling the sense of smoking satisfaction obtained after regular smoking or use of tobacco.

Problems solved by technology

The captioned means and methods do not satisfy the craving that certain users of tobacco experience.
Specifically these means and methods generally do not provide for a sufficiently rapid uptake of nicotine without adverse effects.
This means that none of the hitherto known means and methods satisfactorily fulfills the following well-known NRT teaching by Russel et al:

Method used

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  • Formulation and Use and Manufacture Thereof
  • Formulation and Use and Manufacture Thereof
  • Formulation and Use and Manufacture Thereof

Examples

Experimental program
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Effect test

example 1

[0148] Manufacturing of a 1000 ml formulation with 10 mg nicotine / ml and around pH 8.5.

[0149] Mixture 1

[0150] To a beaker containing 800 ml water of 90° C. was added 0.7 g methyl para-hydroxybenzoate, acting as preservative, and 0.3 g propyl para-hydroxybenzoate, acting as preservative. The additives were dissolved during stirring for about 10 minutes. Then was added 10.45 g sodium dihydrogen phosphate, acting as buffering agent, and 0.5 g EDTA, acting as chelating agent, to the solution, which was stirred for about 5 minutes. Then the solution was cooled to 30° C. during stirring.

[0151] Mixture 2

[0152] To a beaker containing 15.9 g ethanol of room temperature, acting as solvent, was added 0.045 g peppermint oil, acting as flavoring agent. The liquid was mixed for 2 minutes.

[0153] Final Mixture

[0154] Mixture 2 was added during stirring to a beaker containing 150 ml water. Gently 10 g nicotine (base) was added to the beaker. Then Mixture 1 was added to the beaker and stirred fo...

example 2

[0155] Manufacturing of a 1000 ml formulation with 10 mg nicotine / ml and around pH 7.0.

[0156] This Example 2 differs from Example 1 only for pH. The formulation according to Example 2 contains a non-alkalizing buffering agent. This formulation was for use as a comparison in FIG. 2.

[0157] Mixture 1

[0158] To a beaker containing 800 ml water of 90° C. was added 0.7 g methyl para-hydroxybenzoate, acting as preservative, and 0.3 g propyl para-hydroxybenzoate, acting as preservative. The additives were dissolved during stirring for about 10 minutes. Then was added 10.45 g sodium dihydrogen phosphate, acting as buffering agent, and 0.5 g EDTA, acting as chelating agent, to the solution, which was stirred for about 5 minutes. Then the solution was cooled to 30° C. during stirring.

[0159] Mixture 2

[0160] To a beaker containing 15.9 g ethanol of room temperature, acting as solvent, was added 0.045 g peppermint oil, acting as flavoring agent. The liquid was mixed for 2 minutes.

[0161] Fina...

example 3

[0163] Manufacturing of a 1000 ml formulation with 10 mg nicotine / ml and around pH 6.0.

[0164] This Example 3 differs from Example 1 only for pH. The formulation according to Example 3 contains a non-alkalizing buffering agent. This formulation was for use as a comparison in FIG. 2.

[0165] Mixture 1

[0166] To a beaker containing 800 ml water of 90° C. was added 0.7 g methyl para-hydroxybenzoate, acting as preservative, and 0.3 g propyl para-hydroxybenzoate, acting as preservative. The additives were dissolved during stirring for about 10 minutes. Then was added 10.45 g sodium dihydrogen phosphate, acting as buffering agent, and 0.5 g EDTA, acting as chelating agent, to the solution, which was stirred for about 5 minutes. Then the solution was cooled to 30° C. during stirring.

[0167] Mixture 2

[0168] To a beaker containing 15.9 g ethanol of room temperature, acting as solvent, was added 0.045 g peppermint oil, acting as flavoring agent. The liquid was mixed for 2 minutes.

[0169] Fina...

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Abstract

This invention relates to a liquid pharmaceutical formulation for delivering nicotine to a subject. This invention also relates to a method and a system for delivering nicotine as well as manufacturing and use of said liquid pharmaceutical formulation.

Description

CROSS REFERENCE TO RELATED PATENT APPLICATIONS [0001] The present application is a divisional of U.S. patent application Ser. No. 10 / 345,676 filed Jan. 16, 2003 which claims benefit of U.S. Patent Application Ser. No. 60 / 351,178, filed Jan. 21, 2002, each of which is explicitly incorporated herein by reference in its entirety and for all purposes.FIELD OF THE INVENTION [0002] This invention relates to a liquid pharmaceutical formulation for delivering nicotine to a subject. This invention also relates to a method and a system for delivering nicotine as well as manufacturing and use of said liquid pharmaceutical formulation. BACKGROUND OF THE INVENTION Tobacco Dependence and Reduction Thereof [0003] In recent years, with the recognition of the harmful effects of tobacco smoking, there have been numerous campaigns and programs by governmental agencies and various health groups and other interested organisations to disseminate information about the adverse health effects resulting fro...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A24F47/00A61K31/465
CPCA61K31/465A61K45/06A61K9/0002
Inventor LINDELL, KATARINA E.A.BOSSON, BENGT A.BERGENGREN, GUNNAR A.SCHLUTER, ANETTE K.
Owner PHARMACIA AB
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