Stable lozenge compositions providing rapid release of nicotine

A composition, nicotine technology, applied in the directions of drug delivery, food science, medical preparations containing active ingredients, etc., can solve the problems of nicotine addiction, difficulty in quitting smoking, etc.

Inactive Publication Date: 2009-05-20
NICONOVUM AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, smokers are addicted to nicotine, which makes quitting quite difficult for most smokers

Method used

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  • Stable lozenge compositions providing rapid release of nicotine
  • Stable lozenge compositions providing rapid release of nicotine
  • Stable lozenge compositions providing rapid release of nicotine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0129] Chewing gum compositions A, B, C and D for direct compression tablets containing 1.5 mg nicotine

[0130] Nicotine is absorbed on microcrystalline cellulose (MCC) as described in WO 2004 / 056363. Accordingly, in this example, 2.40ml of nicotine was dissolved in 25ml of ethanol (99.5%). 47.6g of PH-102 type MCC was loaded into a high speed mixer and the nicotine was added slowly. After the obtained wet material is vacuum dried, a fine-grained white powder of the nicotine-microcrystalline cellulose carrier complex is obtained. It is then mixed with the ingredients in the table below (except the magnesium stearate) in a suitable blender. Magnesium stearate was sieved and added and the resulting powder mixture was compressed into tablets using a tableting machine with 17 mm punches. A chewing gum having an average weight of 1.25 g was obtained.

[0131] Table 1: Rubber powders of compositions A, B, C and D

[0132] A B C D Element Concentration (%

...

Embodiment 2

[0136] In vitro release of nicotine from direct compression chewing gum compositions

[0137] The in vitro release of compositions A, B, C and D prepared as described in Example 1 was tested and compared with a commercially available product all containing 2 mg nicotine and Compare in vitro release.

[0138] The in vitro dissolution test was carried out on the above-mentioned chewing gum, and the nicotine concentration in the solvent was determined by HPLC.

[0139] The results are shown in Table 4.

[0140] Furthermore, the in vitro release of nicotine from composition A is the same as that of formulation A and A comparison of the in vitro release of nicotine is shown below:

[0141] time,

[0142] In conclusion, this example shows that the direct compression chewing gum composition provides a very rapid initial release of nicotine in vitro. Furthermore, the initial release is faster compared to known compositions.

Embodiment 3

[0144] Buffer effect of nicotine uptake in vivo from DC

[0145] In vivo studies have shown that by adjusting the pH of saliva to a pH greater than 7, nicotine is absorbed more quickly from the oral cavity.

[0146] The effect of buffering agents in the in vivo uptake of nicotine was tested in a comparative study in which the following formulations were administered to individuals. Formulations 1, 2, 3 and 4 had substantially the same ingredients and the same amounts as Composition A in Example 1. In order to vary the amount of nicotine and contain buffer substances, the amount of isomalt is adjusted accordingly.

[0147] Formula 1: 4 mg nicotine, buffered (10 mg carbonate and 10 mg sodium bicarbonate).

[0148] Formula 2: 4mg nicotine, unbuffered.

[0149] Formulation 3: 2 mg nicotine, buffered (10 mg carbonate and 10 mg sodium bicarbonate).

[0150] Formula 4: 2mg nicotine, unbuffered.

[0151] contrast, including 2mg and 4mg chewing gum.

[0152] The results are sho...

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Abstract

Use of a nicotine-cellulose combination and a gum base for the preparation of a chewing gum composition for achieving a fast onset of nicotine effect after initiation of chewing the chewing gum composition by a subject. The chewing gum composition is preferably prepared by direct compression and it does not disintegrate during chewing. The invention also relates to chewing gum compositions comprising nicotine, which compositions provide a rapid release of nicotine.

Description

field of invention [0001] The present invention relates to the use of a nicotine-cellulose conjugate for the preparation of a chewing gum composition which provides a rapid onset of nicotine after an individual starts chewing. The present invention also relates to nicotine-containing chewing gum compositions which provide rapid release of nicotine. Background of the invention [0002] The act of smoking associates serious health risks not only with the smoker, but also with those around him who are passive smokers. So for years, experts have advised quitting smoking. However, smokers are addicted to nicotine, which makes quitting smoking quite difficult for most smokers. Other forms of delivery of nicotine are used in an effort to help smokers give up their unhealthy habit. Current smokers who want to quit smoking are available with several products that apply nicotine orally or dermally, such as chewing gum, inhalers, patches or mouth sprays. [0003] Since tobacco itse...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/68A61K31/465A24B15/14
CPCA24B15/14A61K9/0056A61K9/0058A61K31/465A61K9/146A61K9/009
Inventor A·埃克塞尔松A·克里斯滕森H·汉森
Owner NICONOVUM AB
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