Nicotine-containing oral dosage form

An oral dose and form technology, applied in biocides, pill delivery, animal repellants, etc., can solve the problem of rapid release of addiction

Inactive Publication Date: 2004-12-08
SMITHKLINE BECKMAN CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, the inventors are aware that commercial tablets are designed to have a long dissolution period so that the release of the craving may not be as rapid as desired

Method used

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  • Nicotine-containing oral dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0075] Nicotine lozenges were prepared as follows. In a 500ml beaker, combine 100g of ISOMALT powder, 25g of water and 0.4g of menthol. Heat the mixture using a hot plate while stirring until all of the ISOMALT is melted. Continue mixing and heating to about 165°C. Continue stirring and lower the temperature to about 120°C. At about 120°C, add about 1.2 g of sodium carbonate to adjust the pH to about 7.5-9.0 (pH can be measured from a solution of 0.1 g of this mixture in 10 ml of deionized water), and all other desired optional ingredients such as flavoring and / or vitamins. At about 120°C, 185 g of nicotine bitartrate dihydrate (equivalent to 60 mg of nicotine free base) was added to the mixture, mixed well and the molten mixture maintained at about 120°C. This mixture is pushed through a confectionery former to produce nicotine lozenges. Alternatively, the mixture may be deposited in suitable molds, cooled and demolded to obtain nicotine lozenges. By the time it solidif...

Embodiment 2

[0078] Mix 75% ISOMALT and 25% purified water by weight. While mixing, heat the ISOMALT / water mixture until all the ISOMALT is melted. Continue mixing and heating to about 165°C. Continue mixing and lower the temperature to about 120°C. At about 120°C, sodium carbonate was added to adjust the pH to about 7.5-9.0 (pH can be measured on a solution of 0.1 g of this mixture dissolved in 10 ml of deionized water), nicotine component and sesame oil. The molten mixture is maintained at about 120°C and formed into lozenges using suitable molds.

[0079] By the time the tablet has set, most of the processing water will have evaporated, leaving only residual water.

Embodiment 3

[0081] The in vitro dissolution profile of the lozenges was determined using a VanKel model VK7000 Dissolution Bath under the following conditions:

[0082] a.USP instrument I (Basket)

[0083] b. Dissolving medium: 900ml USP phosphate buffer (pH=7.4)

[0084] c. Dissolving temperature: 37℃+ / -0.5℃

[0085] d. Shaft peripheral speed: 100rpm

[0086] e. per container, each predetermined time interval (e.g. 5, 10, 20 and 30 minutes,

[0087] and 1, 2, 3, 4, 5, 6, 7 and 8 hours until 100% or steady state release

[0088] put), collect a 2ml sample with an automatic sampling device. Use 2ml for each time interval

[0089] Phosphate buffered saline replaces the removed media.

[0090] f. directly analyzing the nicotine content of the sample by HPLC method.

[0091] The in vitro dissolution curve of the lozenge prepared according to Example 2 is shown in figure 1 . Such as figure 1 As shown, the nicotine is completely released within about 20 minutes; at least about 50% is ...

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Abstract

The present invention is directed to glassy matrix solid oral dosage forms useful for transmucosal oral administration of a nicotine active.

Description

field of invention [0001] The present invention relates to solid oral dosage forms containing a nicotine active which are useful for reducing or preventing nicotine craving caused by oral transmucosal administration of a nicotine active. The invention also relates to methods of reducing or preventing nicotine craving or tobacco use using said compositions. Background of the invention [0002] Active as well as passive smoking of herbal products such as cigarettes, cigars and pipe tobacco are known to pose serious health hazards to users and second-hand smokers. The use of other forms of tobacco, such as chewing tobacco, is also known to pose serious health risks to users. In addition, the use of tobacco products in public places is increasingly restricted or socially unpopular. [0003] It is recognized that reducing tobacco use or quitting is often very difficult for habitual tobacco users. Much of this difficulty arises from the addictive properties of nicotine. Effort...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/00A61K31/465A61K47/02A61K47/10A61K47/26A61P25/34
CPCA61K9/0056A61K31/465A61K47/26A61P25/34
Inventor J·刘S·J·莱赫S·普拉特考
Owner SMITHKLINE BECKMAN CORP
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