Claims for Patent: 6,526,316

Summary for Patent: 6,526,316

Title:	Iontophoresis method
Abstract:	A method for transdermal administration of parathyroid hormone by iontophoresis, which comprises applying electric current at least 2 times a day, which method is repeated one to four times each week, or an apparatus for the iontophoresis can be widely applied for not only the prevention or treatment of osteoporosis but also for general bone diseases which require promotion of bone morphogenesis, for example, treatment of ordinary fractures. The method of the present invention produces excellent pharmacological effects such as few side effects and a high bioavailability in long term administration for the prevention and treatment of bone diseases.
Inventor(s):	Iga; Katsumi (Suita, JP), Suzuki; Yasuyuki (Nishinomiya, JP), Kawase; Masahiro (Inagawacho, JP)
Assignee:	Hisamitsu Pharmaceutical Co., Inc. (Saga, JP)
Application Number:	09/207,605
Patent Claims:	1. A method for transdermal administration of parathyroid hormone by iontophoresis, which comprises applying a patch containing parathyroid hormone to a patient's skin, and applying an electric current to the patch to transdermally deliver parathyroid hormone into the patient's body, wherein the electric current is applied for about 20 to 40 minutes per application, wherein the electric current is applied from 2 to about 10 times in one day, wherein there is a rest interval of about 20 to about 60 minutes between each successive application of electric current, wherein the administration is repeated one to four times each week, and wherein the method administers a therapeutic amount of parathyroid hormone effective to treat or prevent bone disease. 2. The method according to claim 1, wherein the electric current is applied from about 3 to about 5 times in one day. 3. The method according to claim 1, wherein the electric current is applied for about 30 minutes, and there is a rest interval of about 45 minutes between each successive application of electric current. 4. The method according to claim 1, wherein there is at least a one day rest period between repetitions of the method. 5. The method according to claim 1, wherein the method is repeated each week on the same days. 6. The method according to claim 1, wherein the method is repeated once every week. 7. The method according to claim 1, wherein the method is repeated twice every week. 8. The method according to claim 1, wherein the method is repeated three times every week. 9. The method according to claim 1, wherein the method is repeated four times every week. 10. The method according to claim 1, wherein the location of electric current application is varied every one to three applications. 11. The method according to claim 1, wherein the location of electric current application is the patient's arm. 12. The method according to claim 11, wherein the arm is forearm. 13. The method according to claim 11, wherein the arm is upperarm. 14. The method according to claim 11, wherein the arm is underarm. 15. The method according to claim 1, wherein the parathyroid hormone is hPTH(1-34). 16. A method for preventing or treating a bone disease, comprising applying a patch containing parathyroid hormone to a patient's skin, and applying an electric current to the patch to transdermally and iontophoretically deliver parathyroid hormone into the patient's body, wherein the electric current is applied for about 20 to 40 minutes per application, wherein the electric current is applied from 2 to about 10 times in one day, wherein there is a rest interval of about 20 to about 60 minutes between each successive application of electric current, wherein the administration is repeated one to four times each week, and wherein the method administers a therapeutic amount of parathyroid hormone effective to treat or prevent bone disease.

Details for Patent 6,526,316

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2017-12-12