Claims for Patent: 11,103,463

Summary for Patent: 11,103,463

Title:	Methods for treating alzheimer's disease with donepezil transdermal system
Abstract:	A transdermal delivery system for systemic delivery of donepezil is described, where the system comprises an adhesive matrix drug reservoir layer comprised of a copolymer of acrylic acid/vinyl acetate, triethyl citrate, and donepezil base generated in situ by reaction of donepezil HCl and an alkaline salt. The system is provided for treatment of Alzheimer's disease, and achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally.
Inventor(s):	Lee; Eun Soo (Redwood City, CA), Jain; Amit K. (Milpitas, CA), Singh; Parminder (Union City, CA)
Assignee:	Corium, Inc. (Grand Rapids, MI)
Application Number:	16/392,513
Patent Claims:	1. A method for treating Alzheimer's disease, comprising: providing a transdermal delivery system comprising a drug reservoir comprising donepezil HCl and an alkaline salt selected from sodium bicarbonate and potassium bicarbonate, said donepezil HCl and said alkaline salt present in the drug reservoir in an equimolar or less than equimolar ratio of alkaline salt to donepezil HCl, and applying the transdermal delivery system to the skin of a subject, thereby administering to the subject donepezil base. 2. The method of claim 1, wherein the applying comprises applying once weekly. 3. The method of claim 1, wherein providing comprises providing a transdermal delivery system that comprises an amount of donepezil HCl that provides an amount of donepezil base that is between about 1-25 mg in 24 hours. 4. The method of claim 3, wherein donepezil base is administered to the subject for a period of at least about 3 days. 5. The method of claim 1, wherein the donepezil base is administered to the subject for a period of at least about 3 days. 6. The method of claim 1, wherein providing comprises providing a transdermal delivery system that further comprises an adhesive in the drug reservoir. 7. The method of claim 6, wherein the adhesive forms a matrix in which donepezil base is soluble. 8. The method of claim 1, wherein providing comprises providing a transdermal delivery system comprising between about 5-25 wt % donepezil HCl. 9. The method of claim 1, wherein donepezil base is administered to the subject in an amount to achieve a plasma concentration of donepezil that is bioequivalent to administration of donepezil hydrochloride orally at a dose of up to approximately 10 mg/day. 10. The method of claim 1, wherein donepezil base is administered to the subject in an amount to achieve a plasma concentration of donepezil for up to a 7-day period that is bioequivalent to daily administration of donepezil hydrochloride orally at a dose of up to approximately 10 mg/day.