# US 2014/0155488 A1 · Compositions and methods for stimulating hair growth

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- Number: US 2014/0155488 A1
- Document ID: US20140155488A1
- Status: Published application
- Kind: A1
- Application number: 14/175,972
- Filed: 2014-02-07
- Published: 2014-06-05
- Earliest claimed: 2009-11-09
- Assignees: Allergan, Inc.
- Applicants: Allergan, Inc.
- Inventors: KEVIN S. WARNER; KRISTIN B. PRINN; CHETAN P. PUJARA; PRAMOD SARPOTDAR; JOHN T. TROGDEN; ADNAN K. SALAMEH
- Web page: https://patentgrep.com/patent/US20140155488A1

## CPC

- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 8/0216: {Solid or semisolid forms}
- A61K 8/022: {Powders; Compacted Powders}
- A61K 8/042: {Gels}
- A61K 8/046: {Aerosols; Foams}
- A61K 8/34: Alcohols
- A61K 8/342: {Alcohols having more than seven atoms in an unbroken chain}
- A61K 8/345: {containing more than one hydroxy group}
- A61K 8/361: {Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof}
- A61K 8/37: Esters of carboxylic acids
- A61K 8/375: {the alcohol moiety containing more than one hydroxy group}
- A61K 8/39: Derivatives containing from 2 to 10 oxyalkylene groups
- A61K 8/41: Amines
- A61K 8/42: Amides
- A61K 8/8147: {Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers}
- A61K 8/86: Polyethers
- 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 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/12: Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)}
- A61K 9/122: {Foams; Dry foams (edible foams A61K9/0056)}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 31/16: Amides, e.g. hydroxamic acids
- A61K 47/08: containing oxygen, {e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides}
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61P 17/14: for baldness or alopecia
- A61Q 7/00: Preparations for affecting hair growth
- A61K 2800/592: Mixtures of compounds complementing their respective functions
- A61K 2800/74: Biological properties of particular ingredients
- A61K 2800/87: Application Devices; Containers; Packaging
- 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

Methods and compositions for stimulating the growth of hair are disclosed wherein said compositions include a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by the formula I wherein the dashed bonds represent the presence or absence of a double bond which can be in the cis or trans configuration and A, B, Z, X, R1 and R2 are as defined in the specification and a penetration enhancer. Such compositions are used in stimulating hair growth of human or non-human animals.

## Claims

### Claim 1

A composition for growing hair by topical application comprising:
bimatoprost in free form or a pharmaceutically acceptable salt thereof, wherein the bimatoprost is contained in an amount of about 0.3% w/w to about 4% w/w;
at least one first compound selected from a fatty acid, fatty acid alcohol and fatty ester,
wherein said composition is formulated for topical administration to the skin.

### Claim 2 (depends on 1)

The composition of claim 1, wherein the first compound is a fatty acid.

### Claim 3 (depends on 2)

The composition of claim 2, wherein the fatty acid is saturated.

### Claim 4 (depends on 2)

The composition of claim 2, wherein the fatty acid is unsaturated.

### Claim 5 (depends on 2)

The composition of claim 2, wherein the fatty acid is selected from the group consisting of stearic acid, oleic acid, linoleic acid, and mixtures thereof.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the first compound is a fatty ester.

### Claim 7 (depends on 6)

The composition of claim 6, wherein the fatty ester is saturated.

### Claim 8 (depends on 6)

The composition of claim 6, wherein the fatty ester is unsaturated.

### Claim 9 (depends on 6)

The composition of claim 6, wherein the fatty ester is selected from the group consisting of glyceryl monostearate, glyceryl monooleate, and ethyl ester of linoleic acid.

### Claim 10

The composition of any preceding claim, wherein the composition comprises at least two first compounds.

### Claim 11 (depends on 10)

The composition of claim 10, wherein the two first compounds comprise a mixture of at last one fatty acid and at least one fatty ester.

### Claim 12

The composition of any preceding claim, wherein the first compound has 12-24 carbon atoms.

### Claim 13

The composition of any preceding claim, further comprising at least one second compound selected from the group consisting of ethanol, propylene glycol, diethylene glycol monoethyl ether, and benzyl alcohol.

### Claim 14

The composition of any preceding claim, further comprising at least one third compound selected from the group consisting of terpenes, occlusive agents, surface active agents, sulfoxides, cyclic ethers, amides, amines, and dimethylaminopropionic acid derivatives.

### Claim 15 (depends on 14)

The composition of claim 14, wherein the terpene is selected from the group consisting of terpinolene, limonene, nerol, and cineol.

### Claim 16 (depends on 14)

The composition of claim 14, wherein the occlusive agent is selected from the group consisting of silicones, mineral oils, and water insoluble polymers.

### Claim 17 (depends on 14)

The composition of claim 14, wherein the surface active agent is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, sodium dodecyl sulfate, sodium lauryl sulfate, DMSO, and docusate sodium.

### Claim 18 (depends on 14)

The composition of claim 14, wherein the dimethylaminopropionic acid derivative is 2-dimethylaminopropionic acid dodecyl ester.

### Claim 19

The composition of any preceding claim, wherein the composition comprises bimatoprost in an amount of about 1% w/w to about 4% w/w.

### Claim 20 (depends on 19)

The composition of claim 19, wherein the composition comprises bimatoprost in an amount of about 2.5% w/w to about 3.5% w/w.

### Claim 21 (depends on 20)

The composition of claim 20, wherein the composition comprises bimatoprost in an amount of about 3% w/w.

### Claim 22

The composition of any preceding claim, wherein the composition is in the form of one selected from the group consisting of solutions, gels, ointments, foams, films, liniments, creams, shampoos, lotions, pastes, jellies, sprays and aerosols.

### Claim 23

The composition of any preceding claim, wherein the composition is packaged in a kit with an applicator for application to the skin.

### Claim 24

A method for stimulating hair growth comprising administering to the skin of a patient an effective amount of a bimatoprost composition according to any preceding claim, wherein the administration causes increased hair growth.

### Claim 25 (depends on 24)

The method of claim 24, wherein the composition is applied to the scalp.

### Claim 26 (depends on 24, 25)

The method of any of claims 24-25, wherein the composition is applied at least once daily.

### Claim 27 (depends on 24, 25, 26)

The method of any of claims 24-26, wherein the composition is applied to the scalp for treatment of a condition selected from the group consisting of alopecia areata, telogen effluvium, anagen effluvium, cicatricial alopecia, scarring alopecia; hair shaft abnormalities, trichorrexis nodosa, loose anagen syndrome, trichotillomania, traction alopecia; infectious hair disorders, tiniea capitis, sebohorreic dermatitis, follicullitus of the scalp, and androgenetic alopecia.

### Claim 28 (depends on 24, 25, 26, 27)

The method of any of claims 24-27, wherein the composition is applied to one or both of the scalp and the eyebrows for patients experiencing hair loss due to chemotherapy, hormonal imbalance, fungal infection of the scalp, anti-coagulants, medicine for gout, depression, high blood pressure and heart disease.

### Claim 29

A composition for promoting the growth of hair, the composition comprising:
at least one penetration enhancer; and
bimatoprost in free form or a pharmaceutically acceptable salt thereof, wherein the bimatoprost is contained in an amount of about 1-4% w/w;
wherein said composition is formulated for topical administration to the skin.

### Claim 30 (depends on 29)

The composition of claim 29, wherein the penetration enhancer is selected from one or more of the group consisting of alcohols, glycols, fatty acids, fatty esters, fatty ethers, occlusive agents, surface active agents, dimethylaminopropionic acid derivatives, terpenes, sulfoxides, cyclic ethers, amides, and amines.