# US 8,784,872 B2 · Formulation for decreasing tobacco, alcohol, drug or food consumption

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- Number: US 8,784,872 B2
- Document ID: US8784872B2
- Status: Granted
- Kind: B2
- Application number: 11/942,414
- Filed: 2007-11-19
- Published: 2009-05-21
- Granted: 2014-07-22
- Earliest claimed: 2007-11-19
- Assignees: ComgenRx, Inc.
- Applicants: Bryan T. Oronsky; Neil C. Oronsky; Arnold L. Oronsky
- Inventors: Bryan T. Oronsky; Neil C. Oronsky; Arnold L. Oronsky
- Web page: https://patentgrep.com/patent/US8784872B2

## CPC

- 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)
- A24B 15/16: of tobacco substitutes
- A61K 47/02: Inorganic compounds
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A24B: MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 1

A method of decreasing a subject's desire for tobacco, alcohol, or drugs, comprising administering orally to the subject a formulation comprising an effective amount of a hydrophilic polymer composition, as the only active ingredient, selected from the group consisting of a polyalkylene oxide, polyvinylpyrrolidone, poloxamer, combination of polyethylene glycol and polyvinylpyrrolidone, and combination of two polyethylene glycols having different molecular weights; wherein the formulation is administered to the subject prior to smoking or chewing tobacco, drinking alcohol or taking drugs, to thereby decrease the subject's desire for tobacco, alcohol, or drugs.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

The method of claim 1 wherein the formulation comprises polyethylene glycol 3350 as the only active ingredient, mannitol, sodium bicarbonate, citric acid, and sucrose.

### Claim 4 (depends on 1)

The method of claim 1 wherein the only active ingredient in the formulation is a mixture of polyethylene glycol 1450 and polyethylene glycol 4500.

### Claim 5 (depends on 4)

The method of claim 4 wherein the formulation further comprises a sweetener or flavoring.

### Claim 6 (depends on 5)

The method of claim 5 wherein the formulation comprises a mixture of polyethylene glycol 1450 and polyethylene glycol 4500 as the only active ingredient, silica gel, acacia, polysorbate 80, and sweetener.

### Claim 7 (depends on 1)

The method of claim 1 wherein the formulation further comprises one or more of colorants, sweeteners, flavorants, excipients, binders, coating agents, and lubricants.

### Claim 8 (depends on 1)

The method of claim 1 wherein the formulation further comprises a mucoadhesive which adheres the formulation to nasal or oral mucosa for an effective period of time.

### Claim 9 (depends on 1)

The method of claim 1 wherein the method is to decreasing a subject's desire for tobacco; and the formulation is administered to the subject prior to smoking or chewing tobacco, to thereby decrease the subject's desire for tobacco.

### Claim 10 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is polyethylene glycol, polyvinylpyrrolidone, or a combination thereof.

### Claim 11 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is polyethylene glycol.

### Claim 12 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is polyethylene glycol 3350.

### Claim 13 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is a combination of two polyethylene glycols having different molecular weights.

### Claim 14 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is a mixture of polyethylene glycol 1450 and polyethylene glycol 4500.

### Claim 15 (depends on 9)

The method of claim 9 wherein the hydrophilic polymer composition is polyvinylpyrrolidone.

### Claim 16 (depends on 11)

The method of claim 11 wherein the formulation is in the form of a sublingual troche.

### Claim 17 (depends on 13)

The method of claim 13 wherein the formulation is in the form of a sublingual troche.

### Claim 18 (depends on 1)

The method of claim 1 wherein the method is to decreasing a subject's desire for alcohol; and the formulation is administered to the subject prior to drinking alcohol, to thereby decrease the subject's desire for alcohol.

### Claim 19 (depends on 18)

The method of claim 18 wherein the hydrophilic polymer composition is polyethylene glycol, polyvinylpyrrolidone, or a combination thereof.

### Claim 20

A method of decreasing a subject's desire for food, comprising administering orally to the subject a formulation comprising an effective amount of a hydrophilic polymer composition, as the only active ingredient, selected from the group consisting of a polyalkylene oxide, polyvinylpyrrolidone, poloxamer, combination of polyethylene glycol and polyvinylpyrrolidone, and combination of two polyethylene glycols having different molecular weights; wherein the formulation is administered to the subject prior to eating or drinking, to thereby decrease the subject's desire for food.

### Claim 21 (depends on 20)

The method of claim 20 wherein the hydrophilic polymer composition is polyethylene glycol, polyvinylpyrrolidone, or a combination thereof.

### Claim 22 (depends on 20)

The method of claim 20 wherein the hydrophilic polymer composition is polyvinylpyrrolidone.
