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Solid nicotine-comprising dosage form with reduced organoleptic disturbance

A nicotine and dosage form technology, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of lack of nicotine, undisclosed, and lack of buffers in film coating.

Inactive Publication Date: 2014-09-17
MCNEIL AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It does not disclose that these lozenges can be provided with a film coating comprising a film-forming polymer, which additionally lacks nicotine and lacks buffering agents

Method used

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  • Solid nicotine-comprising dosage form with reduced organoleptic disturbance
  • Solid nicotine-comprising dosage form with reduced organoleptic disturbance
  • Solid nicotine-comprising dosage form with reduced organoleptic disturbance

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0078] Manufacturing method

[0079]The composition of the batches for the tablet cores is given in Table A1 below. The material is sieved using a vibrating sieve with a mesh size of 1 mm, and thereafter blended for 10 to 30 minutes according to methods known in the art, eg, using a double cone mixer. The blended material is then compressed into tablets by means of direct compression. Powder compression can be performed, for example, using a rotary tablet press with 15mm round concave punches. The tablets are compressed to a sufficient hardness to allow an acceptable coating process and to achieve the desired in vivo dissolution time.

[0080] Table 1A: Components of Tablet Cores .

[0081] Element

percentage (w / w)

mg / part

Nicotine Resin Complex (20% Nicotine)

1.5

15*

Sorbitol

89.0

890

Xylitol

5.75

57.5

sodium bicarbonate

0.25

2.5

Sodium carbonate

0.5

5

mint flavoring

...

example 2

[0107] According to the manufacture method of the tablet of example 1

[0108] Table 2A: Components of Tablet Cores .

[0109] Element

percentage (w / w)

mg / part

Nicotine Resin Complex (20% Nicotine)*

1.67

10.0

Isomalt

93.56

561.36

Sodium carbonate

0.5

3.0

mint flavoring

1.67

10.02

coolant

0.1

0.6

Magnesium stearate

2

12.0

Silica (colloid)

0.5

3.0

total

100

600

[0110] *Equivalent to a 2.0mg dose of nicotine base. If a nicotine resin complex is used with other levels of nicotine loading such as 15%, the amount of polyol is adjusted accordingly.

[0111] Film coating of the tablets produced in 2A can be performed using, for example, a standard modern pan coater equipped with an air atomized spray nozzle dispensing the film coating fluid and a perforated drum of appropriate size. Membrane solutions were prepared by adding hydroxypr...

example 3

[0118] Following Example 2, a total tablet core weight of 650 mg was used, with oval 14.5 mm punches, but without sodium bicarbonate and / or sodium carbonate (which was compensated by the amount of mannitol). Additionally, the components of the film coating are provided in Table 3A.

[0119] Table 2B: Components of the film coating .

[0120]

[0121]

[0122] *Total excipients except purified water

[0123] **Add the appropriate amount of pure water to achieve a dry content suitable for the coating process parameter settings to be applied, for example the dry content can be 16% w / w.

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Abstract

Solid pharmaceutical dosage form for the release of nicotine in the oral cavity comprising a core encapsulated by at least one film coating, wherein the core comprises nicotine and wherein the film coating comprises at least one film-forming polymer and at least one component for reduction of one or more organoleptically disturbing sensations, and where the at least one film coating is devoid of nicotine and devoid of buffer.

Description

technical field [0001] The present invention relates to solid pharmaceutical dosage forms intended for the release of nicotine in the oral cavity provided with means for reducing one or more sensory disturbance sensations. Background technique [0002] Tobacco dependence and its reduction are desirable goals. In recent years, with the awareness of the harmful effects of tobacco smoking, many campaigns and projects have been carried out by government departments and various health groups and other related organizations to disseminate information about the adverse health effects of tobacco smoking. Furthermore, because of the recognition of this harmful effect, there have been many projects involved in trying to reduce the incidence of smoking. [0003] Nicotine is an organic compound and the main alkaloid of tobacco. Nicotine is the main addictive ingredient in tobacco used in cigarettes, cigars, snuff, etc. Nicotine is also an addictive drug, and smokers characteristicall...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K9/30A61K31/465A61P25/34
CPCA61K31/465A61K9/2009A61K9/2826A61K9/2018A61K9/0056A61K9/284A61K9/2866A61K9/205A61P1/00A61P1/04A61P25/00A61P25/16A61P25/28A61P25/34A61P3/04A61K9/28A61K47/34
Inventor A·胡格斯K·林德尔F·尼科拉森K·西瑞森
Owner MCNEIL AB
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