Compositions and methods for treatment of mammalian skin

• US 8,652,534 B2
• Filed: 03/19/2010
• Issued: 02/18/2014
• Est. Priority Date: 10/14/2009
• Status: Active Grant

• Current Assignee: Berry Pharmaceuticals, LLC
• Original Assignee: Berry Pharmaceuticals, LLC
• Inventors: Berry, Don Wayne
• Primary Examiner(s): Justice, Gina C
• Assistant Examiner(s): Pallay, Michael B
• Application Number:
  US12/661,567
• Publication Number:
  US 20110086088A1
• Time in Patent Office: 1,432 Days
• Field of Search: 424/725
• US Class Current: 424/725
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/404 Indoles, e.g. pindolol
• CPC Class Codes: A61K 31/438 The ring being spiro-condensed with carbocyclic or heterocyclic ring systems
• CPC Class Codes: A61K 31/575 substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 36/74 Rubiaceae (Madder family)
• CPC Class Codes: A61K 8/46 containing sulfur A61K8/44 takes precedence
• CPC Class Codes: A61K 8/553 Phospholipids, e.g. lecithin
• CPC Class Codes: A61K 8/9789 Magnoliopsida [dicotyledons]
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/16 Emollients or protectives, e.g. against radiation
• CPC Class Codes: A61Q 19/004 Aftersun 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

1. A method for treating pre-cancerous lesions present in or on a mammalian subject which method comprises contacting a composition containing a hamelia patens extract to the skin of said subject in an effective amount and frequency for reducing symptoms of pre-cancerous lesions.

2. The 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, 2 E -3,7,11,15,19-pentamethyl-2-cicosane-1-ol, ephedrine, flavonones, 2′

-5-5′

-7-tetrahydroxy-7-o-rutinoside, isomaruquinc, 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, 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.

3. The method according to claim 2 wherein said composition comprises all of said materials recited in said group.

4. The 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, including all weight percentages and ranges of weight percentages therebetween.

5. The method according to claim 2, wherein said composition is in any form selected from the group consisting of:

salves, creams, ointments, and lotions.

6. The 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.

7. The method according to claim 1 wherein said composition comprises a nanoparticle.

8. The method according to claim 7 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.

9. The method according to claim 1 wherein said composition comprises a liposome.

10. The method according to claim 1 wherein said extract is an aqueous extract.

11. The method according to claim 1 wherein said extract is a non-aqueous extract.

12. A The method according to claim 1 wherein said composition comprises a pharmaceutically-acceptable carrier.