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Coated pharmaceutical product for intraoral delivery of nicotine comprising trometamol as buffering agent

A tromethamine, intraoral technology, applied in the field of delivering nicotine, can solve the problems of unacceptable, long drying time, etc., and achieve the effect of reducing the urge to smoke

Inactive Publication Date: 2009-07-01
MCNEIL AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the drying time required for the coating layer of the coated chewing gum disclosed in WO 02 / 102357 is unacceptably long

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

other Embodiment approach

[0076] Other embodiments may comprise combinations of tromethamine and trisodium citrate or trippotassium citrate, and mixtures thereof.

other Embodiment approach

[0077] Other embodiments may include the use of tromethamine in combination with different phosphate systems, such as trisodium phosphate, disodium hydrogen phosphate; and tripotassium phosphate, dipotassium hydrogen phosphate, and calcium hydroxide, sodium glycinate; and mixtures of the foregoing .

[0078] Alkali metal carbonates, glycinates and phosphates are preferred additional buffers.

[0079] In order to increase buffering capacity without a corresponding increase in pH, in particular embodiments, a second or auxiliary buffer, such as sodium bicarbonate or potassium bicarbonate buffer, may be added in addition to the first buffer trometamol agent. The secondary or secondary buffering agent may be selected from the group consisting of alkali metal bicarbonates which are preferably used for this purpose. Accordingly, other embodiments of the invention may comprise trometamol and a mixture of alkali metal carbonates or phosphates and alkali metal bicarbonates.

[0080]...

Embodiment 1

[0232] Example 1 Buffered Hard Coating

[0233] Purpose

[0234] The purpose of this example is to provide a nicotine-containing hard coat and buffer coat. The content of nicotine is 0.5, 1, 2, 3 or 4mg respectively.

[0235] hard coating material *

[0236] A. Nicotine free base as active ingredient

[0237]

[0238] * The hard coating of this example refers to sugar alcohols, not sucrose-based sugars.

[0239] ** q.s. = appropriate amount.

[0240] B. Nicotine hydrogen bitartrate as active ingredient

[0241]

[0242]

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PUM

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Abstract

Coated oral dosage forms for the delivery of nicotine in any form to a subject by rapid intraoral delivery of nicotine comprising at least one core, nicotine in any form and / or a nicotine mimicking agent, at least one coating layer and optionally at least one or more other additives, wherein said at last one coating layer is buffered, whereby is used at least trometamol as buffering agent. Also contemplated are a method for the delivery of nicotine in any form, a method for the reduction of the urge to smoke or use tobacco as well as a method for producing said coated product and the use of the same for obtaining a rapid intraoral uptake of nicotine.

Description

technical field [0001] The present invention relates to coated oral dosage forms for delivering nicotine into the oral cavity of a subject. Coated oral dosage forms comprise the buffering agent trometamol. The invention also relates to methods and systems for the delivery of nicotine and the use and preparation of said coated oral dosage forms. Background of the invention [0002] Tobacco Dependence and Ways to Relieve it [0003] In recent years, as awareness of the dangers of smoking has grown, government agencies and various health groups and other interested organizations have launched a variety of campaigns and programs to disseminate the message that smoking is harmful to health. Moreover, because of the recognition of its harmfulness, many programs have been launched in an attempt to directly reduce smoking rates. [0004] Nicotine is an organic compound that is the main alkaloid in tobacco. Nicotine is the main addictive ingredient in tobacco used in cigarettes, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/465A61K47/18A61K9/68A61K9/00A61P1/04A61P25/16A61P25/28A61P25/34
CPCA61K9/0056A61K31/465A61P1/04A61P25/16A61P25/26A61P25/28A61P25/34A61P3/04A61K47/18
Inventor P·斯蒂恩D·迪米特罗维克斯A·沃尔特莫R·奥尔森K·林德尔
Owner MCNEIL AB
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