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Nicotine-containing pharmaceutical compositions

A composition and drug technology, applied in the field of pharmaceutical compositions containing nicotine, can solve problems such as uneven distribution of subtypes

Inactive Publication Date: 2013-02-13
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 subtypes is heterogeneous

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0029] The pharmaceutical compositions of the present invention may conveniently be presented in unit dosage form and such formulations may thus be prepared by any of the methods generally known in the art of pharmacy. Such preparations include (by various means) bringing into association the active agent with a suitable carrier or other adjuvant (which may consist of one or more ingredients). The active ingredient in combination with one or more adjuvants is then physically processed to present a formulation in a suitable delivery form (eg, shaped into a tablet, or formed into an aqueous suspension).

[0030] The nicotine-containing pharmaceutical composition of the present invention may also contain various pharmaceutically acceptable excipients in addition to the levulinate moiety. "Pharmaceutically acceptable carrier" or "pharmaceutically acceptable excipient" is intended to mean a carrier or excipient that is conventionally used in the art to facilitate the administration...

Embodiment 1

[0056] Chewing gum is produced using generally similar excipient ingredients and processing conditions used to produce commercial chewing gum, but with the nicotine pollack resin replaced by a mixture of nicotine pollack resin and nicotine levulinate, the chewing gum's The shape and form are generally similar to nicotine-containing chewing gum that contains 4 mg nicotine and is commercially available as Nicorette Original Gum (distributed by GlaxoSmithKline Consumer Healthcare, L.P.). The amount of nicotine pollack phosphoresin incorporated in each chewing gum is such that the amount of nicotine active ingredient from this source is 3 mg in each chewing; The amount of nicotine levulinate was such that the amount of nicotine active ingredient from this source in each cud was 1 mg. Thus, each chew of the chewing gum product contains 4 mg of the nicotine active ingredient. Each unit or chew contains forms of nicotine from 2 sources.

Embodiment 2

[0058] Coated chewing gum is produced using generally similar excipient ingredients and processing conditions used to produce commercial chewing gum, but with the nicotine pollack resin replaced by a mixture of nicotine pollack resin and nicotine levulinate, said The shape and form of the chewing gum is generally similar to nicotine-containing chewing gum that contains 4 mg of nicotine and is commercially available as Coated Nicotine Gum (distributed by Walgreen Co.). The amount of nicotine pollack phosphoresin incorporated in each chewing gum is such that the amount of nicotine active ingredient from this source is 3 mg in each chewing; The amount of nicotine levulinate was such that the amount of nicotine active ingredient from this source in each cud was 3 mg. Thus, each chew of the coated chewing gum product contains 6 mg of the nicotine active ingredient.

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PUM

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Abstract

A composition intended to be employed for therapeutic purposes incorporates a source of nicotine and at least one levulinate moiety. 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) or nicotine polacrilex. The levulinate moiety can have the form of an acid (e.g., levulinic acid), a levulinate salt (e.g., sodium levulinate), or an ester of levulinic acid (e.g., methyl levulinate or ethyl levulinate). The composition can incorporate nicotine and levulinic acid in a salt form (e.g., nicotine levulinate). The composition can be composed of at least two forms of nicotine, and one of the forms of nicotine is in the form of nicotine levulinate. The composition is useful for treatment of central nervous system conditions, diseases, and disorders, and as a nicotine replacement therapy.

Description

technical field [0001] The present invention relates to nicotine-containing compositions and, in particular, to nicotine-containing pharmaceutical compositions intended to be administered to provide a pharmacological effect or otherwise for therapeutic purposes. Background technique [0002] Central nervous system (CNS) conditions, diseases, or disorders may be drug-induced; may be due to genetic predisposition, infection, or trauma; or may have unknown etiology. They include neuropsychiatric disorders, neurological diseases, and psychosis; and include neurodegenerative diseases, behavioral disorders, cognitive disorders, and cognitive affective disorders. The clinical manifestations of several CNS conditions, diseases, or disorders have been attributed to CNS dysfunction (i.e., caused by inappropriate levels of neurotransmitter release, inappropriate neurotransmitter receptor properties, and / or neurotransmitter-to-neurotransmitter disorders caused by inappropriate interact...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/465A61K31/19A61M15/00B65D83/52
CPCA61K9/006A61K31/19A61M15/0091A61K31/787A61M15/009A61K9/0056A61K9/0058A61K31/465A61P25/00A61P25/34
Inventor P·A·布林克雷A·J·波士克
Owner NICONOVUM USA
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