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Pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent

A technology of trometamol and buffering agent, which is applied in the direction of medical preparations containing active ingredients, drug combination, drug delivery, etc., and can solve the problem of bad taste of buffering agent, etc.

Inactive Publication Date: 2009-07-15
MCNEIL AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the buffering agent proposed in WO 02 / 102357 has a bad taste and it is necessary to add one or more flavoring agents to the chewing gum to overcome this bad taste

Method used

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  • Pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent
  • Pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent
  • Pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent

Examples

Experimental program
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Effect test

other Embodiment approach

[0064] Other embodiments include the combination of trometamol and trisodium or tripotassium citrate and mixtures thereof. The application ratios between trometamol and such agents are provided in the following examples.

[0065] Still other embodiments include the use of trometamol with different phosphate buffer systems, such as trisodium phosphate, disodium hydrogen phosphate; and tripotassium phosphate, dipotassium hydrogen phosphate, and calcium hydroxide, sodium glycinate, and their mixture.

[0066] Alkali metal carbonates, glycinates and phosphates are preferred added buffers.

[0067] In order to increase the buffering capacity without a corresponding increase in pH, in particular embodiments a second or auxiliary buffer, such as sodium bicarbonate or potassium bicarbonate buffer, is used for the first buffer. Therefore, one should strive to maintain a pleasant taste. Preferably for this purpose such secondary or auxiliary buffers are selected from alkali metal bic...

Embodiment approach

[0102] The present invention can employ various methods to deliver nicotine to a subject (human). According to one embodiment of the invention, a method of delivering nicotine in any form to a subject comprises the steps of:

[0103] a) administering to the oral cavity of a subject an oral formulation containing any form of nicotine according to the invention, and

[0104] b) If desired, any form of nicotine in this oral formulation is released into the saliva of the subject's mouth for absorption into the blood plasma.

[0105] The method of delivering nicotine in any form also includes the steps of:

[0106] c) administering nicotine in any form to the subject for a sustained period of at least 5, 10, 20, 30 or 40 minutes.

[0107] Ways to reduce the urge to smoke or reduce the urge to use tobacco

[0108] Another feature of the present invention is the ability to use the present invention to reduce the urge to smoke. The method of the present invention for reducing the ...

other Embodiment approach

[0130] Other embodiments suggest the use of slowly reducing the urge to smoke or use tobacco.

[0131] Application of treatment and treatment t

[0132] Oral formulations of the invention are useful in therapy and treatment. The treatment may be 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, ulcerative colitis, and post-smoking weight loss control.

[0133] Nicotine can also be used in the oral formulations of the present invention to treat such diseases.

[0134] In addition, nicotine can be used in the nicotine-containing oral formulation product of the present invention to treat said diseases.

[0135] Production of Oral Dosages

[0136] The oral formulation of the present invention is basically produced according to methods known in the art, such as but not limited to the production methods provided in the following examples.

[0137] Methods o...

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Abstract

A pharmaceutical oral formulation for delivering nicotine in any form to a subject by transmucosal uptake in the oral cavity comprising nicotine in any form, wherein said oral formulation is buffered with at least trometamol. 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 the oral formulation for obtaining transmucosal uptake of nicotine in the oral cavity of a subject, and use of nicotine for the production of an oral formulation 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 nicotine-containing pharmaceutical formulations for intraoral delivery of nicotine to a subject. This formulation contains the buffering agent trometamol. Also contemplated are methods and systems for delivering nicotine, as well as the use and manufacture of such formulations. Background of the invention [0002] Reducing dependence on tobacco is the goal that people want. Recognizing the dangers of smoking in recent years, several campaigns have been launched by government departments and various health groups and other interested organizations to disseminate the message that smoking can lead to health hazards. Moreover, in recognition of its harmful effects, many programs have been devised to try to reduce the smoking rate. [0003] Nicotine is an organic compound that is the main alkaloid of tobacco. Nicotine is the main addictive ingredient in tobacco used in cigarettes, cigars, snuff, etc. Nicotine is also an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/18A61K31/465A61K9/00A61P1/04A61P25/16A61P25/28A61P25/34
CPCA61K9/2013A61K9/12A61K9/006A61K9/4858A61K9/2018A61K9/0056A61K9/0058A61K9/7007A61K31/465A61P1/00A61P1/04A61P25/00A61P25/16A61P25/28A61P25/34A61K47/18
Inventor P·斯蒂恩D·迪米特罗维克斯A·胡格斯A·沃尔特莫M·帕尔森R·奥尔森F·尼科拉森A·舒尔特K·西瑞森S·K·莫迪B·博森K·林德尔
Owner MCNEIL AB
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