# US 9,433,616 B2 · Methods and compositions for decreasing saliva production

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- Number: US 9,433,616 B2
- Document ID: US9433616B2
- Status: Granted
- Kind: B2
- Application number: 14/945,804
- Filed: 2015-11-19
- Published: 2016-03-10
- Granted: 2016-09-06
- Earliest claimed: 2005-01-19
- Assignees: NeuroHealing Pharmaceuticals, Inc.
- Applicants: NeuroHealing Pharmaceuticals, Inc.
- Inventors: Marcelo Merello; Neal M. Farber; Eyal S. Ron
- Web page: https://patentgrep.com/patent/US9433616B2

## CPC

- A61K 31/4409: only substituted in position 4, e.g. isoniazid, iproniazid
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 31/00: Medicinal preparations containing organic active ingredients
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/38: Cellulose; Derivatives thereof
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention provides methods and compositions comprising an anti-cholinergic agent for decreasing saliva production and treating sialorrhea.

## Claims

### Claim 1

A solid composition comprising tropicamide and an excipient formulated for intra-oral administration of said tropicamide to an individual of an amount effective for decreasing saliva production in said individual wherein said tropicamide is present in said composition in an amount ranging from 0.01 to 200 milligrams, inclusive.

### Claim 2 (depends on 1)

The solid composition according to claim 1, wherein said composition includes an excipient selected from the group consisting of a pharmaceutically acceptable buffering agent, a plasticizing agent, a muco-adhesive agent, a stabilizing agent, a taste-masking agent, a flavoring agent, a breath freshening agent, a coloring agent, an antiseptic agent, an inert filler agent, a preserving agent, nonionic polymer, anionic polymer, softening agent, swelling agent, chelating agent, foaming agent, and combinations thereof.

### Claim 3 (depends on 2)

The solid composition according to claim 2, wherein said excipient is a muco-adhesive agent.

### Claim 4 (depends on 1)

The solid composition according to claim 1, wherein said solid composition is in a dosage form selected from the group consisting of a candy composition, film, gum, buccal patch, lingual tablet, sublingual tablet, and fast-dissolving tablet.

### Claim 5 (depends on 4)

The solid composition according to claim 4, wherein said dosage form is selected from the group consisting of a candy composition, a film, and a gum.

### Claim 6 (depends on 5)

The solid composition according to claim 5, wherein said dosage form is a film.

### Claim 7 (depends on 5)

The solid composition according to claim 5, wherein said dosage form is a candy composition.

### Claim 8 (depends on 7)

The solid composition according to claim 7, wherein said candy composition is a lozenge or a lollipop.

### Claim 9 (depends on 1)

The solid composition according to claim 1, wherein said tropicamide is present in said composition in an amount ranging from 0.01 milligrams to 50 milligrams, inclusive.

### Claim 10 (depends on 9)

The solid composition according to claim 9, wherein said tropicamide is present in said composition in an amount ranging from 0.1 milligram to 20 milligrams, inclusive.

### Claim 11 (depends on 1)

The solid composition according to claim 1, wherein said solid composition has a disintegration rate of 1-7200 seconds.

### Claim 12 (depends on 11)

The solid composition according to claim 11, wherein said disintegration rate is 60-1800 seconds.

### Claim 13 (depends on 12)

The solid composition according to claim 12, wherein said disintegration rate is 300-1800 seconds.

### Claim 14 (depends on 1)

The solid composition according to claim 1, wherein said solid composition is packaged in an easy open container.