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Nicotine-containing pharmaceutical compositions

A technology of composition and nicotine, which is applied in the direction of drug combination, drug delivery, medical preparations containing active ingredients, etc., can solve the problem of uneven distribution of subtypes

Inactive Publication Date: 2013-01-23
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 said subtypes is heterogeneous

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] A lozenge having a generally similar shape and form to a lozenge containing 0.5 mg varenicline was prepared using generally similar excipient ingredients and processing conditions used to prepare commercial lozenges The form of varenicline is the tartrate salt of the active ingredient of a product marketed under the Chantix trade name from Pfizer Incorporated, except that the varenicline active ingredient is nicotine ion exchange resin complex and varenicline I'm using a mixture instead. The amount of nicotine ion exchange resin complex added to each lozenge is such that the amount of nicotine active ingredient per lozenge from this source is 2 mg; Varenic added to each lozenge The amount of Lin is such that the amount of the active ingredient in each lozenge is 0.5 mg. Therefore, each lozenge (ie, per dosage unit) contains the indicated effect on α 4 beta 2 The nicotinic receptor subtype is selective for nicotinic and nicotinic compounds.

Embodiment 2

[0062] A lozenge having a generally similar shape and form to a lozenge containing 0.5 mg varenicline and sold under the trade name Chantix is ​​commercially available, except that the varenicline active ingredient is replaced by a mixture of nicotine ion exchange resin complex and varenicline. The amount of nicotine ion exchange resin complex added per dosage unit (i.e., per lozenge) is such that the amount of nicotine active ingredient per lozenge from this source is 3 mg; The amount of varenicline in the tablet is such that the amount of the active ingredient in each lozenge is 0.1 mg. Therefore, each lozenge (ie, per dosage unit) contains the indicated effect on α 4 beta 2 The nicotinic receptor subtype is selective for nicotinic and nicotinic compounds.

Embodiment 3

[0064] Using generally similar excipient ingredients and processing conditions for the preparation of commercial chewing gums, a chewing gum having a generally similar shape and form to that of nicotine-containing gum containing 4 mg of nicotine and sold under the trade name Nicorette Original Flavor ( Nicorette Original Gum) (distributed by GlaxoSmithKline Consumer Healthcare, L.P.), except that its nicorette ion exchange resin complex is A mixture of compounds of Nicotine (for example, in the form of tartrate in Chantix) is substituted. The amount of nicotine ion exchange resin complex added to each chewable gum tablet is such that the amount of nicotine active ingredient in each chewable tablet from this source is 3 mg; varenicline added to each chewable gum tablet The amount of active ingredient is such that the amount of active ingredient per chewable tablet from this source is 1 mg. Therefore, each chewable tablet of a chewing gum product (i.e., per dosage unit) contain...

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PUM

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Abstract

A composition intended to be employed for therapeutic purposes incorporates nicotine and at least one other nicotinic compound. Representative forms of nicotine can be as a free base (e.g., as a mixture of nicotine and microcrystalline cellulose), as a form of nicotine salt (e.g., as nicotine bitartrate) or as nicotine polacrilex. The other nicotinic compound is a compound that can be considered to bind selectively to certain nicotinic receptor subtypes, and particularly those of the central nervous system. For example, the other nicotinic compound can be a compound that binds selectively to the nicotinic receptor subtypes a7 or a4ss2. The composition is useful for treatment of central nervous system conditions, diseases and disorders, and as a nicotine replacement therapy.

Description

[0001] related application [0002] This patent document claims priority to US Patent Application Serial No. 12 / 775,910, filed May 7, 2010, entitled "Pharmaceutical Compositions Containing Nicotine," which is incorporated herein by reference in its entirety. technical field [0003] The present invention relates to nicotine-containing compositions, and more particularly, to nicotine-containing pharmaceutical compositions for administration to provide a pharmacological effect or for therapeutic purposes. Background technique [0004] 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, behavioral, cognitive, and cognitive-affective disorders. The clinical manifestations of various CNS symptoms, diseases, or disorders are attributable to CNS ...

Claims

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Application Information

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IPC IPC(8): A61K31/455A61K31/498A61K45/06A61P25/34
CPCA61K31/455A61K31/498A61K31/465A61P25/00A61P25/34A61P43/00A61K2300/00A61K9/0053A61K9/0058A61K9/009A61K9/12A61K9/1652A61K9/20
Inventor A·J·波士克
Owner NICONOVUM USA
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