Claims for Patent: 8,211,872

Summary for Patent: 8,211,872

Title:	Method and composition for treatment of multiple sclerosis and related neurodegenerative conditions
Abstract:	A method for treating the symptoms of multiple sclerosis and related neurodegenerative conditions, using a histamine compound that is methylated in vitro prior to being introduced into the body of the patient. The histamine compound is suitably histamine diphosphate, and may be methylated in vitro by mixing in combination with at least one thiol compound in the presence of at least one methyl group donor compound. The thiol compound is suitably L-reduced glutathione and the methyl group donor is suitably betaine hydrochloride. The compounds are mixed vigorous in an acid environment, to create a shearing force that facilitates exchange of the methyl group from the donor compound to the histamine diphosphate. The resulting methylated histamine compound is suitably administered to the patient by transdermal application. The method also provides a medicament for treatment the symptoms of multiple sclerosis and related neurodegenerative conditions, and a method for preparation of such a medicament.
Inventor(s):	Delack; Elaine A. (Stanwood, WA)
Assignee:	MedDEV, Inc. (Bellingham, WA)
Application Number:	12/290,036
Patent Claims:	1. A method for treating multiple sclerosis, said method comprising the steps of: providing a selected histamine compound; methylating said selected histamine in vitro to form a methylated histamine compound; and administering to a patient an effective amount of said methylated histamine compound. 2. The method of claim 1, wherein said selected histamine compound is histamine diphosphate. 3. The method of claim 2, wherein the step of methylating said histamine compound in vitro comprises: combining said histamine diphosphate with at least one thiol compound in the presence of at least one methyl group donor compound. 4. The method of claim 3, wherein said at least one thiol compound is selected from the group consisting of: N-acetylcystiene; glutathiones; L-reduced glutathione; and combinations thereof. 5. The method of claim 4, wherein said methyl group donor compound is selected from the group consisting of: betaine hydrochloride; S-adenosylmethionine; methionine; and combinations thereof. 6. The method of claim 5, wherein the step of methylating said histamine compound in vitro further comprises the step of: vigorously mixing said histamine diphosphate, said thiol compound, and said methyl group donor compound under pressure in an acid environment so as to create a shearing force that facilitates exchange of a methyl group from said methyl group donor compound to said histamine diphosphate. 7. The method of claim 6, wherein said acid environment has a pH less than about 3.0. 8. The method of claim 5, wherein said thiol compound is L-reduced glutathione. 9. The method of claim 8, wherein said methyl group donor compound is betaine hydrochloride. 10. The method of claim 9, wherein said betaine hydrochloride is included in an amount in the range from about 15 gm to about 30 gm per each 500 gm of said histamine diphosphate, and said L-reduced glutathione is included in an amount in the range from about 1 gm to about 10 gm per each 15 gm-30 gm of said betaine hydrochloride. 11. The method of claim 10, wherein the step of methylating said histamine compound in vitro further comprises the step of: vigorously mixing said histamine diphosphate, said L-reduced glutathione, and said betaine hydrochloride under pressure in an acid environment so as to create a shearing force that facilitates exchange of a methyl group from said methyl group donor compound to said histamine diphosphate. 12. The method of claim 11, wherein said acid environment has a pH less than about 3.0. 13. The method of claim 10, wherein the step of administering an effective amount of said methylated histamine compound to a patient comprises: administering an effective amount of said methylated histamine compound to a patent by transdermal application. 14. The method of claim 13, wherein the step of administering an effective amount of said methylated histamine compound to a patient by transdermal application comprises: administering said methylated histamine compound by transdermal application twice daily, in an amount in the range from about 0.2 mg to about 5.5 mg per dose. 15. The method of claim 13, wherein the step of administering an effective amount of said methylated histamine compound to a patient by transdermal application comprises: administering said methylated histamine compound by transdermal application twice daily, in an amount of about 1.65 mg per dose.

Details for Patent 8,211,872

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Jubilant Hollisterstier Llc	N/A	positive skin test control-histamine	Injection	103891	03/13/1924		2027-10-24