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Modified release oral dosage form

A technology for oral dosage forms and dosage forms, applied in the field of solid oral dosage forms

Inactive Publication Date: 2005-11-09
SMITHKLINE BECKMAN CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it has been found that although these dosage forms are desirable and aesthetically appealing, the release rate of the mixture is significantly greater than the transport rate of nicotine through the buccal mucosa, resulting in unwanted levels of nicotine being absorbed in the gastrointestinal tract

Method used

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  • Modified release oral dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-9

[0085] Nine batches of the lozenges of the present invention were prepared as follows.

[0086] 600Kg of isomalt powder type M was dissolved in 300Kg of water and steamed to 160°C, and then placed in a Hamac-Hansella candy processing machine under vacuum for 3 minutes to form a molten matrix. Then, when the bolted matrix is ​​cooled to about 125°C, the nicotine ion exchange resin complex, xanthan gum, acesulfame potassium, sodium carbonate and flavoring agent are added and mixed. The mixture thus formed was transferred to the Ruffinatti kneading table for kneading. Then, the mixture is formed, rotated and sizing into a rope shape, and punched into lozenges with Bosch Uniplast.

[0087] The amount of lozenges per example *

[0088] Acesulfame potassium

[0089] * (The amount is calculated as "after processing" Kg)

Embodiment 10

[0091] The measurement was performed according to the above Example 3 containing 3.5% xanthan gum nicotine tablets, according to Example 3 but containing 5.0% xanthan gum nicotine tablets, and the above-mentioned simultaneous pending PCT international application filed on March 22, 2002. The dissolution profile of the non-gelled gel formulation of No. PCT / US02 / 08914 (similar to Example 3 herein, but without gel).

[0092] The dissolution profile was determined by USP standard 3Bio.Dis., the tablet was immersed in a buffer solution of pH 7.4 at a standard rate to imitate the conditions in the oral cavity. figure 1 The graph in plots the measured percentage of nicotine release versus time (minutes).

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PUM

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Abstract

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

Description

[0001] Related application [0002] This application is a partial continuation application of U.S. Patent Application No. 10 / 244,782 filed on September 16, 2002. Invention field [0003] The present invention relates to a solid oral dosage form containing an active agent such as nicotine, which is useful when it is necessary to improve the release of the active agent in the oral mucosa. In more detail, the present invention relates to a nicotine-containing dosage form, which is used to release a nicotine active agent through the oral mucosa to reduce or prevent nicotine addiction. The present invention also relates to methods of using these compositions to reduce or prevent nicotine addiction or reduce tobacco use. Background of the invention [0004] It is well known that active and passive smoking of tobacco products such as cigarettes, cigars and pipe tobacco poses serious health risks to users and those exposed to second-hand smoke. It is also known that the use of other forms...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/14A61K9/20A61K9/68A61K31/4439
CPCA61K9/2018A61K9/0056A61K9/2059A61P25/34
Inventor A·H·格拉夫S·J·普拉特考
Owner SMITHKLINE BECKMAN CORP
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