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Multi-portion intra-oral dosage form with organoleptic properties

An organoleptic, multi-part technology, applied in the direction of organic active ingredients, medical preparations containing active ingredients, inhalers, etc., which can solve the problems of introduction compliance and effectiveness

Inactive Publication Date: 2010-09-29
MCNEIL AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0029] In conclusion, none of the references mentioned above adequately and adequately address compliance and effectiveness

Method used

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  • Multi-portion intra-oral dosage form with organoleptic properties

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0142] Preparation of two-part tablets, each part of which has different flavor, cooling intensity and hardness. The fast dissolving part contains 0.5mg nicotine (NRC) and has a menthol flavor, and the slow dissolving part contains 1.5mg nicotine (NRC) and has a lemon fragrance. Therefore different fragrances are associated with different parts of the pharmaceutically active agent, and the pharmaceutically active agent is released at different rates. The dissolution end of the rapidly disintegrating part and the lemon scent suggest that approximately 25% of the pharmaceutically active agent has been released.

[0143] Preparation

[0144] The ingredients listed in Table A1 and Table A2 are each sieved according to a known method in the prior art, such as a double cone mixer, and then mixed. Then the two parts of the mixture are compressed into tablets by a direct compression device. Powder compression can be implemented, for example, using a double-sided rotary tablet press with...

Embodiment 2

[0153] The preparation of two-part tablets, each part has different texture and flavor, one part has rough geometric pattern or shape or form, and the other part has smooth surface. The initial mint scent provides an organoleptic sensation that prompts the patient to start the release of the pharmaceutically active agent, while the cinnamon scent and the rough surface texture of the corresponding part are indicative of a buffering agent that promotes the absorption of the pharmaceutically active agent. Tablet preparation also facilitates the inclusion of drugs with potential compatibility issues.

[0154] Preparation

[0155] The same method as in Example 1 was used, but the upper punch had a rough geometric pattern.

[0156] Table B1: Composition of parts with rough geometric patterns

[0157]

[0158] Table B2: Composition of parts with smooth geometric patterns

[0159]

[0160] * Equivalent to 2.0mg dose of nicotine base

Embodiment 3

[0162] Two-part tablets are prepared, each part of which has a different texture, one part is harder and has a rough geometric pattern, and the other part is softer and has a smooth surface.

[0163] Preparation

[0164] The same method and the same formula as in Example 1 were used, but the upper punch used had a rough geometric pattern. Further, no fragrance is added. Therefore, the difference in flakeability / fragmentation between different parts becomes more significant than in Example 1. The "smell of nicotine" in itself is used as a conceptual aid to the patient: the pharmaceutically active agent has begun to be released, and the rapid dissolution of flakes / fragments and smooth surface parts will serve as an indication to the patient: about 25% The pharmaceutically active agent has been released from the dosage form.

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Abstract

The present invention relates to a multi portion intra-oral dosage form comprising at least one pharmaceutically active agent or health promoting agent wherein at least one portion comprises a component for creating a noticeable organoleptic sensation. Of certain interest is use of sensory markers / signals as conceptual aids for a subject using the dosage form whereby the organoleptic sensation / s is / are such that it / they facilitate / s for the subject to identify a portion and differentiate between different portions thereof. Also contemplated are a dosage form, a method and a system for delivering active agents, such as nicotine and / or metabolites thereof, such as cotinine, nicotine N'-oxide, nornicotine, (S)-nicotine-N--glucuronide and mixtures, isomers, salts and complexes thereof as well as use and production of said dosage forms.

Description

Technical field [0001] The present invention relates to a multi-part intraoral dosage form containing at least one pharmaceutically active agent or health promoting agent, wherein at least a part contains a component that can produce significant organoleptics. [0002] It is very important to use sensory markers / signals as a conceptual aid for patients using this dosage form to help patients recognize different parts and distinguish the differences between different parts through organoleptic perception. The present invention also relates to methods and systems for delivering active agents, such as nicotine and / or its metabolites, such as cotinine, nicotine N′-oxide, nornicotine, (S)-nicotine-N-β -Glucuronic acid glycosides and their mixtures, isomers, salts and complexes, and the use and preparation of said dosage forms. Background technique [0003] Tobacco dependence and its reduction are the desired goals. In recent years, with the recognition of the harmful effects of smokin...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K45/00A61K31/465A61P25/34A61P25/28A61P1/00A61P25/16A61P25/00A61P1/04A61P3/04A61M15/00
CPCA61K9/209A61K9/4808A61P1/00A61P1/04A61P3/04A61P25/00A61P25/16A61P25/28A61P25/34
Inventor A·胡格斯K·林德尔K·西瑞森F·尼科拉森
Owner MCNEIL AB
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