FORMULATION FOR DECREASING TOBACCO, ALCOHOL, DRUG OR FOOD CONSUMPTION

• US 20090130178A1
• Filed: 11/19/2007
• Published: 05/21/2009
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Comgenrx, Inc.
• Original Assignee: Xvasive, Inc.
• Inventors: Oronsky, Bryan T., Oronsky, Neil C., Oronsky, Arnold L.
• Granted Patent: US 8,784,872 B2
• Time in Patent Office: Days
• US Class Current: 424/440
• CPC Class Codes: A24B 15/16 of tobacco substitutes
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Formulations have been developed which assist individuals having an addiction such as smoking to reduce or quit engaging in the addictive behavior. Representative behaviors include smoking, excessive alcohol or food ingestion, drug addiction, and ingestion of caffeine or junk food providing quick “highs”. The formulations assist the smoker to become dissatisfied with smoking, until he or she willingly gives up the habit or at least cuts down on the number of cigarettes smoked per day as an initial step towards quitting in the future. The formulations can also be used in conjunction with other known formulations, such as nicotine gum or patch. The formulations contain hydrophilic polymers, for example, polyethylene glycol (PEG) alone or in combination or polyvinyl pyrrolidone (PVP) (also known as povidone or polyvidone alone or in combination.), sweeteners and/or flavorings, viscosity modifiers/binders, and pH or buffering agents.

Claims

1. A formulation diminishing the desire to tobacco, alcohol, and food, comprising an effective amount of a hydrophilic polymer in a solution or troche in the absence of a therapeutic agent.

2. The formulation of claim 1 wherein the hydrophilic polymer is selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, and combinations thereof.

3. The formulation of claim 2 comprising a troche containing PEG 3350, mannitol, sodium bicarbonate, citric acid, and sucrose.

4. The formulation of claim 2 comprising a troche containing polyethylene glycol MW 1450 and polyethylene glycol 4500.

5. The formulation of claim 4 further comprising a dispersant and sweetener or flavoring.

6. The formulation of claim 5 comprising PEG MW 1450 60 g, PEG MW 4500 11 g, silica gel 0.56 g, acacia 0.56 g, polysorbate 80 3.75 ml, and sweetener.

7. The formulation of claim 1 comprising polyvinylpyrrolidone dissolved in an aqueous solution.

8. The formulation of claim 1 further comprising one or more of colorants, sweeteners, flavorants, excipients, binders, coating agents and lubricants

9. The formulation of claim 1 wherein the hydrophilic polymer is in the form of a mouthwash or spray.

10. The formulation of claim 1 wherein the hydrophilic polymer is in the form of a chewing gum, mouth strip or mint.

11. The formulation of claim 1 wherein the hydrophilic polymer is provided in the form of a cigarette or pipe.

12. The formulation of claim 1 wherein the hydrophilic polymer is provided in the form of a nasal spray, aerosol or inhaler.

13. The formulation of claim 1 wherein the hydrophilic polymer is provided in the form of a transmucosal patch

14. The formulation of claim 1 comprising a mucoadhesive which adheres the formulation to nasal or oral mucose for an effective period of time.

16. A method of decreasing desire for tobacco, alcohol, drugs, or food, comprising administering an effective amount of the formulation of claim 1 prior to smoking or chewing tobacco, eating, drinking or taking drugs.

15. A kit comprising polyethylene glycol lozenges, spray, aerosol, inhaler or mouthwash, in combination with one or more of the group consisting of:

nicotine gum, nicotine inhaler, nicotine lozenges, nicotine nasal spray, transdermal nicotine patches, nicotine tablets and capsules, antidepressants, mood stabilizers, self help materials, hypnosis tapes and literature, anti-smoking, anti-obesity, anti-drug or anti-addiction literature, herbal preparations such as Kava Kava and Chamomile, artificial cigarettes, cigars and pipes, anti-smoking cigarette filters, antabuse, flagyl, naloxone (Narcan), silver acetate, clonidine, benzodiazepines, antipsychotics.