Therapeutic composition and configuration

A technology for therapeutic compositions and substrates, which can be used in drug delivery, food science, pharmaceutical formulations, etc., and can solve problems such as uneven distribution of subtypes

Inactive Publication Date: 2018-05-11
NICONOVUM USA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Subtypes of nAChR are present in the CNS and peripheral nervous system (PNS), but the distribution of the subtypes is heterogeneous

Method used

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  • Therapeutic composition and configuration
  • Therapeutic composition and configuration
  • Therapeutic composition and configuration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] A lozenge formulation of Nicotine Polacrilex Lozenge 2 mg (nicotine) sold by the company Perrigo is provided. However, rather than providing a generally round and slightly cylindrical tablet with a diameter of about 17 mm, a similar manufacturing technique was used to provide a lozenge having an outermost diameter of about 21 mm and a thickness of about 4 mm. A longitudinally extending passageway with a diameter of about 9 mm is formed or shaped through the center of the lozenge. A tubular substrate of the type sold under the trade name "Favor" is inserted in the passageway of the lozenge. The substrate has a porous plug near its most upstream end, and the plug serves as a carrier for nicotine. The exact size of the central passage of the tablet is such that the tablet and substrate are held securely in place by a friction fit. The lozenge is located in the mouth end region of the substrate such that the most distal mouth end of the lozenge is positioned in alignment ...

Embodiment 2

[0099] A system of the type generally described with reference to Example 1 is provided. However, prior to assembly, the inner surface of the passageway through the lozenge was wetted with distilled water; and the outer surface of the mouth end region of the substrate was wetted with distilled water. The system was then configured by inserting the mouth end of the substrate through the passageway of the lozenge such that the most distal mouth end region of the lozenge was about 4 mm upstream of the most distal mouth end region of the substrate. The resulting system was then dried by subjecting the system to a stream of drying air. The use of moisture and drying of the system serves to provide adhesion or bonding of the tablet to the substrate. Thereby, a system with good physical integrity is provided.

Embodiment 3

[0101] A lozenge was provided substantially of the type described with reference to Example 1, except that the longitudinally extending passage through the lozenge had a diameter of about 6 mm and the overall diameter of the lozenge was about 20 mm. In addition, the substrate chosen was a tube of about 80 mm in length and about 6.2 mm in diameter. Plastic tubes are provided by cutting plastic straws to the desired length. Straws for providing substrates have been marketed as Home 360° Flexible Straws by DZA Brands, LLC. The system was then configured by inserting one end of the substrate through the passageway of the lozenge such that the most distal mouth end region of the lozenge was about 4 mm upstream of the most distal mouth end region of the substrate. Thus, a system is provided that has a reference image 3 Describes many properties of the system.

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Abstract

A system intended to be employed for therapeutic purposes incorporates an active ingredient (e.g., a source of nicotine). Representative forms of nicotine include free base (e.g., as a mixture of nicotine and microcrystalline cellulose), a nicotine salt (e.g., as nicotine bitartrate) and nicotine polacrilex. The system preferably comprises a lozenge incorporating the active ingredient, adapted toprovide oral administration of nicotine. The lozenge is in contact with a substrate (e.g., hollow tube) that can be manipulated within the mouth of the user (e.g., the hollow tube can be drawn upon tosimulate the inhalation of cigarette smoke). As such, the active ingredient is administered and the user is able to experience certain other physiological sensations. The composition is useful for treatment of central nervous system conditions, diseases, and disorders, and can be used as a nicotine replacement therapy. The system comprising: a substrate portion (35) having an upstream end and a downstream end, the upstream end allowing for passage of drawn atmospheric air into the substrate and the downstream end adapted for positioning into a user's mouth for draw upon the substrate and inhalation of atmospheric air by the user, a lozenge portion (20) incorporating a source of active ingredient in a pharmaceutically acceptable form, the lozenge portion providing for oral ingestion of theactive ingredient, the lozenge portion and the substrate portion being physically separate from one another but in contact with each other, the lozenge being positioned at the downstream end of the substrate, and the lozenge and substrate portions being positioned so that the lozenge portion and a portion of the substrate portion can be located in the user's mouth during use, to provide for delivery of active ingredient from the lozenge and drawn air through the substrate.

Description

field of invention [0001] The present invention relates to systems containing active ingredients which may be characterized as having pharmacological effects and which may be considered useful for therapeutic purposes, and in particular to systems adapted to possess constituent assemblies or components having a predetermined structure or shape. Background technique [0002] Central nervous system (CNS) symptoms, diseases, or disorders can be drug-induced; can be attributed to genetic predisposition, infection, or trauma; or can be of unknown etiology. They include neuropsychiatric disorders, neurological diseases, and psychosis; and include neurodegenerative disorders, behavioral disorders, cognitive disorders, and cognitive affective disorders. The clinical manifestations of various CNS symptoms, diseases, or disorders are attributable to CNS dysfunction (e.g., due to inappropriate levels of neurotransmitter release, inappropriate properties of neurotransmitter receptors, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J7/00A24F42/20A24F42/60A24F47/00
CPCA61J7/003A24F47/00A24F42/20A24F42/60A61K9/0056A61K31/465
Inventor A·J·波士克
Owner NICONOVUM USA
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