# US 2014/0151255 A1 · Topical glycopyrrolate formulations

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- Number: US 2014/0151255 A1
- Document ID: US20140151255A1
- Status: Published application
- Kind: A1
- Application number: 14/084,010
- Filed: 2013-11-19
- Published: 2014-06-05
- Earliest claimed: 2007-10-18
- Assignees: Rose U, LLC
- Applicants: Rose U
- Inventors: Michael JOHNSTON; Robert James HOULDEN
- Web page: https://patentgrep.com/patent/US20140151255A1

## CPC

- A61K 8/0208: {Tissues; Wipes; Patches}
- A61K 8/4913: {having five membered rings, e.g. pyrrolidone carboxylic acid}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61P 7/00: Drugs for disorders of the blood or the extracellular fluid
- A61P 17/00: Drugs for dermatological disorders
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61Q 15/00: Anti-perspirants or body deodorants (deodorisation of air A61L9/00)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.

## Claims

### Claim 1

An individually packaged wipe for the treatment of hyperhidrosis comprising about 0.25 to about 6% w/w of a glycopyrrolate compound, wherein said wipe is contained within a pouch resistant to leakage.

### Claim 2 (depends on 1)

The individually packaged wipe of claim 1, wherein the pouch comprises an inner lining of linear low density polyethylene (LLDPE).

### Claim 3 (depends on 1)

The individually packaged wipe of claim 1, wherein the glycopyrrolate compound degrades by less than 1% when stored at 0 to 25° C. for 1 month, 2 months, 6 months, or 1 year.

### Claim 4 (depends on 1)

The individually packaged wipe of claim 1, further comprising an alcohol, a buffering agent and water.

### Claim 5 (depends on 4)

The individually packaged wipe of claim 4, wherein the alcohol is ethanol.

### Claim 6 (depends on 4)

The individually packaged wipe of claim 4, further comprising propylene glycol.

### Claim 7 (depends on 4)

The individually packaged wipe of claim 4, wherein the buffering agent comprises citric acid and sodium citrate to maintain a pH of about 3.5 to about 6.

### Claim 8 (depends on 4)

The individually packaged wipe of claim 4, wherein the buffering agent comprises citric acid and tromethamine to maintain a pH of about 3.5 to about 6.

### Claim 9 (depends on 4)

The individually packaged wipe of claim 4, wherein the buffering agent maintains a pH of about 4.5.

### Claim 10 (depends on 4)

The individually packaged wipe of claim 4, wherein the alcohol and water is in the weight ratio of about 40:60 to about 60:40.

### Claim 11 (depends on 4)

The individually packaged wipe of claim 4, wherein the alcohol is at about 53.7 to about 57.3% w/w, the buffering agent is at about 0.2 to about 0.5% w/w and the water is added to 100% w/w.

### Claim 12 (depends on 6)

The individually packaged wipe of claim 6, wherein the alcohol is at about 53.7 to about 57.3 w/w, the propylene glycol is at about 2 to about 4% w/w, the buffering agent is at about 0.2 to about 0.5% w/w; and the water is added to 100% w/w.

### Claim at position 13

13-21. (canceled)

### Claim 22 (depends on 1)

A method for alleviating hyperhidrosis in a mammal comprising the topical administration of the wipe of claim 1 to an area of the body such that the hyperhidrosis is substantially reduced.

### Claim at position 15

23-35. (canceled)