# US 2014/0193479 A1 · Compositions and methods for treatment of mammalian skin

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- Number: US 2014/0193479 A1
- Document ID: US20140193479A1
- Status: Published application
- Kind: A1
- Application number: 13/999,350
- Filed: 2014-02-12
- Published: 2014-07-10
- Earliest claimed: 2009-10-14
- Assignees: Berry Pharmaceuticals, L.L.C.
- Applicants: Berry Pharmaceuticals, L.L.C.
- Inventors: Don Wayne Berry
- Web page: https://patentgrep.com/patent/US20140193479A1

## CPC

- A61K 36/74: Rubiaceae (Madder family)
- A61K 8/46: containing sulfur (A61K8/44 takes precedence)
- A61K 8/553: {Phospholipids, e.g. lecithin}
- A61K 8/9789: Magnoliopsida [dicotyledons]
- 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 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/404: Indoles, e.g. pindolol
- A61K 31/438: The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin}
- A61P 17/00: Drugs for dermatological disorders
- A61P 17/16: Emollients or protectives, e.g. against radiation
- A61Q 19/004: {Aftersun preparations}
- 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

Compositions useful for treatment of a wide range of skin disorders including: pre-cancerous lesions, keratotic lesions, superficial basal cell carcinomae; squamous cell carcinomae; malignant melanoma, and radiation-induced burns. In some embodiments the treatments comprise contacting human or other mammalian skin with a composition according to the disclosure. In other embodiments, administration of compositions provided is by injection. Some embodiments provide for preventive use of compositions provided towards preventing some forms of skin cancer and skin cancer-related disorders by repeated application to healthy-looking skin. Methods for providing the compositions are disclosed.

## Claims

### Claim 1

Method for treating a disorder present in or on a mammalian subject, including tumors and disorders present on mammalian skin selected from the group consisting of: pre-cancerous lesions, keratotic lesions, superficial basal cell carcinomae; squamous cell carcinomae; Kaposi's sarcoma, cutaneous lymphomae, Merkel cell carcinomae, malignant melanomas, and radiation-induced burns, which method comprises contacting a composition containing a hamelia patens extract to said disorder in an effective amount and frequency for reducing symptoms of said disorder.

### Claim 2 (depends on 1)

Method according to claim 1 wherein said extract comprises an effective symptom-reducing amount of at least one material selected from the group consisting of: alkaloids, 2-alpha-hydroxyursolic acid, apigenin-7-o-beta d-glucuronide, aricine, catequine, 19-alphahydroxy Asiatic acid, 24-methylenecycloartane-3β-ol, 24-methylcycloart-24-en-3β-ol, 2E-3,7,11,15,19-pentamethyl-2-eicosane-1-ol, ephedrine, flavonones, 2′-5-5′-7-tetrahydroxy-7-o-rutinoside, isomaruquine, isopteropodine, maruquine, the methyl ester of maruquine, mitraphylline, narirutin, narirutin (2r), narirutin (2s), oxindole alkaloids, oxindole aricine, palmirine, pigenin-7-o-beta D-glucuronide, pomolic acid, pteropodine, rumberine, rosmarinic acid, rotundic acid, rumberine, rutin, seneciophylline, β-sitosterol, speciophylline, stigmast-4-en-3-3-dione, stigmast-4-en-3-6-dione, stigmasterol, tannins, tormentic acid, uncarine F, and ursolic acid, and including any mixtures thereof.

### Claim 3 (depends on 2)

Method according to claim 2 wherein said composition comprises all of said materials recited in said group.

### Claim 4 (depends on 2)

Method according to claim 2 wherein each material selected to be, present in said composition is independently present in any amount between 0.05% by weight and 30% by weight based on the total weight of said composition.

### Claim 5 (depends on 2)

Method according to claim 2, wherein said composition is in any form selected from the group consisting of: salves, creams, ointments, and lotions.

### Claim 6 (depends on 8)

Method according to claim 8 wherein said carrier comprises an emulsion.

### Claim 7 (depends on 1)

Method according to claim 1 wherein said composition comprises any carrier selected from the group consisting of: water; saline solution, any C1 to C4 alcohol; any glyceryl ester oil; and any mineral oil.

### Claim 8 (depends on 1)

Method according to claim 1 wherein said composition comprises a nanoparticle.

### Claim 9 (depends on 8)

Method according to claim 8 wherein said nanoparticle is selected from the group consisting of: solid core nanoparticles, hollow core nanoparticles, lipid nanoparticles, PEG nanoparticles, and chitosan nanoparticles, including mixtures thereof.

### Claim 10 (depends on 1)

Method according to claim 1 wherein said composition comprises a liposome.

### Claim 11 (depends on 1)

Method according to claim 1 wherein said extract is an aqueous extract.

### Claim 12 (depends on 1)

Method according to claim 1 wherein said extract is a non-aqueous extract.

### Claim 13 (depends on 12)

Method according to claim 12 wherein said composition comprises a pharmaceutically-acceptable carrier.

### Claim 14 (depends on 13)

Method according to claim 13 wherein said contacting comprises a method selected from the group consisting of: injection of said composition into the basal layer of the dermis of a mammalian subject, and injection of said composition directly into the mass of a tumor.