Claims for Patent: 6,080,395

Summary for Patent: 6,080,395

Title:	Method and composition for topical treatment of damaged tissue using histamine as active ingredient
Abstract:	A pharmaceutical composition of water, water soluble vinyl polymer gel, amine alcohol dispersant and IEP is used topically to treat herpes labialis and aphthous stomatitis lesions, and also to treat herpes genitalis, chicken pox, allergic conjunctivitis, giant papillary conjunctivitis, stomatitis secondary to chemotherapy, thermal burn, sunburn, and decubitus ulcers and shingles.
Inventor(s):	Jack; Bruce A. (Albuquerque, NM), White; B. Thomas (Albuquerque, NM)
Assignee:	Maxim Pharmaceutical, Inc. (San Diego, CA)
Application Number:	09/196,840
Patent Claims:	1. A method for treating a disorder of the skin, mucous membranes, or conjunctival membranes comprising topically delivering an effective dose of histamine to a subject having said disorder, wherein said histamine is not histamine phosphate. 2. The method of claim 1, wherein said disorder is a viral disease selected from the group consisting of herpes labialis, herpes genitalis, herpes zoster, and varicella zoster. 3. The method of claim 1, wherein said disorder is selected from the group consisting of aphthous stomatitis, oral mucositis, allergic conjunctivitis, and giant papillary conjunctivitis. 4. The method of claim 1, wherein said disorder results from injury to the skin selected from the group consisting of photodermatitis, thermal burns, and decubitus ulcers. 5. The method of claim 1, wherein said histamine is administered in the form of a histamine precursor, wherein said histamine precursor is not histamine phosphate. 6. The method of claim 1, wherein said histamine is administered in the form of a histamine prodrug, and wherein said histamine prodrug is not histamine phosphate. 7. The method of claim 1, wherein said effective dose is administered through a unidose dispenser. 8. A composition comprising an effective dose of histamine in a pharmaceutically acceptable carrier adapted for topical delivery, wherein said histamine is present in a range from approximately 0.00325 to 0.0067 percent by weight, and wherein said histamine is not histamine phosphate. 9. The composition of claim 8, wherein said histamine is in the form of a histamine precursor, and wherein said histamine precursor is not histamine phosphate. 10. The composition of claim 8, wherein said histamine is in the form of a histamine prodrug, and wherein said histamine prodrug is not histamine phosphate. 11. The composition of claim 8, further comprising a neutralizer and an emulsifying agent. 12. The composition of claim 11, wherein said emulsifying agent is an amino alcohol. 13. The composition of claim 8, further comprising a pharmaceutically acceptable preservative. 14. The composition of claim 13, wherein said preservative is selected from the group consisting of propylparaben or methlyparaben. 15. The composition of claim 8, wherein said composition is in the form of a lotion. 16. The composition of claim 8, wherein said composition is in the form of a gel. 17. The composition of claim 8, wherein said composition is in the form of a mouthwash. 18. A method for making a composition for the topical delivery of histamine comprising the steps of: providing a pharmaceutically acceptable carrier and histamine in a concentration from approximately 0.00325 to 0.0067 percent by weight, to treat a disorder of the skin selected from the group consisting of herpes labialis, herpes genitalis, herpes zoster, varicella zoster, aphthous stomatitis, oral mucositis, allergic conjunctivitis, giant papillary conjunctivitis, photodermatitis, thermal burns, and decubitus ulcers; and forming an emulsion containing the pharmaceutically acceptable carrier and the histamine, wherein said histamine is not histamine phosphate. 19. The method of claim 18, wherein said histamine is in the form of a histamine prodrug, and wherein said histamine prodrug is not histamine phosphate. 20. The method of claim 18, wherein said histamine is in the form of a histamine precursor, and wherein said histamine precursor is not histamine phosphate.

Details for Patent 6,080,395

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Alk-abello, Inc.	HISTATROL	positive skin test control-histamine	Injection	103754	09/29/1950		2011-06-14
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2011-06-14