Controlled, sustained release delivery system for smoking cessation
First Claim
1. A transdermal drug delivery device comprising:
- (a) a diffusion matrix layer, said diffusion matrix layer having a macroporous structure for holding a mixture of lobeline and an enhancer, and having a inner surface and an outer surface, said inner surface adapted to be applied on or toward the skin of a subject, said outer surface for application away from the skin of a subject,(b) a mixture of lobeline, a polymer and an enhancer, said mixture having a quantity of lobeline sufficient for delivery of an effective dose of lobeline to said subject to diminish said subject'"'"'s desire for nicotine, said enhancer controlling the solubility of said lobeline in said polymer to release said lobeline in said polymer over time to allow lobeline to be absorbed from said polymer by said skin; and
(c) a backing layer, said backing layer comprising a film of elastomer on said outer surface of said diffusion matrix layer to prevent said mixture from being transmitted from the device, said diffusion matrix layer releasing an effective amount of lobeline to diminish said subject'"'"'s desire for nicotine for a period of at least one day.
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Accused Products
Abstract
A drug delivery system useful in aiding individuals in the cessation of smoking or chewing nicotine containing products is described. The delivery system includes a physical constraint modulation system (PCMS™) containing lobeline. The drug delivery system is capable of delivering lobeline to an individual in a controlled, sustained release manner and providing long-term therapeutic levels of lobeline to the individual. The delivery of lobeline in such a manner reduces or eliminates the individual'"'"'s smoking or chewing habit. The PCMS may be a biodegradable polymer containing the lobeline capable of subcutaneous or intramuscular injection or implantation into the individual or may be part of a transdermal patch containing lobeline. Also described are methods of using the drug delivery systems and kits containing the drug delivery systems.
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Citations
17 Claims
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1. A transdermal drug delivery device comprising:
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(a) a diffusion matrix layer, said diffusion matrix layer having a macroporous structure for holding a mixture of lobeline and an enhancer, and having a inner surface and an outer surface, said inner surface adapted to be applied on or toward the skin of a subject, said outer surface for application away from the skin of a subject, (b) a mixture of lobeline, a polymer and an enhancer, said mixture having a quantity of lobeline sufficient for delivery of an effective dose of lobeline to said subject to diminish said subject'"'"'s desire for nicotine, said enhancer controlling the solubility of said lobeline in said polymer to release said lobeline in said polymer over time to allow lobeline to be absorbed from said polymer by said skin; and (c) a backing layer, said backing layer comprising a film of elastomer on said outer surface of said diffusion matrix layer to prevent said mixture from being transmitted from the device, said diffusion matrix layer releasing an effective amount of lobeline to diminish said subject'"'"'s desire for nicotine for a period of at least one day. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 17)
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11. A transdermal drug delivery device comprising:
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(a) a rate controlling membrane having a bottom for being placed on or toward the skin of a subject and a top for being placed away from the skin of a subject; (b) a backing layer fixed to said top of said rate controlling membrane to form a first chamber and a second chamber, said first chamber for containing lobeline and said second chamber for containing a delivery substance, said first and second chamber capable of being placed in fluid communication; (c) lobeline, held in a solid form in said first chamber, which upon dissolution in said first or second chamber enters said rate controlling membrane for transdermal delivery to the skin; and (d) a drug delivery substance, held within said second chamber, said drug delivery substance for dissolving said lobeline in said first chamber and carrying said lobeline through said rate controlling membrane to deliver an amount of lobeline to a subject effective to diminish the subject'"'"'s desire for nicotine. - View Dependent Claims (12, 13, 14, 15, 16)
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Specification