TRANSDERMAL SYSTEM FOR THE DELIVERY OF ABALOPARATIDE AND METHOD OF USE FOR TREATING OSTEOPOROSIS
Provided herein are methods for treating osteoporosis and increasing bone mass density, that includes administering once a day, for about 5 minutes, a transdermal patch loaded with about 300 μg of abaloparatide, and ZnCl 2 at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide. Also provided are the single-use transdermal patches loaded with about 300 μg of abaloparatide, and ZnCl 2 at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide.
1 . A method for treating osteoporosis in a subject in need thereof comprising:
administering daily a trans dermal patch applied to the subject's thigh for about 5 minutes, the patch comprising: 300 μg of abaloparatide, and ZnCl 2 , at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide,
wherein the subject is treated for osteoporosis.
2 . A method of increasing bone mass density (BMD) in a subject in need thereof comprising:
administering daily a trans dermal patch applied to the subject's thigh for about 5 minutes, the patch comprising: 300 μg of abaloparatide, and ZnCl 2 , at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide,
wherein the subject achieves at least a 5% increase in BMD by 6 months.
3 . A method for transdermally delivering abaloparatide to a subject in an amount bioequivalent to subcutaneous injection of 80 mcg abaloparatide, the method comprising:
administering daily a trans dermal patch applied to the subject's thigh for about 5 minutes, the patch comprising: 300 μg of abaloparatide, and ZnCl 2 , at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide,
wherein an amount of abaloparatide is transdermally delivered to the subject that is bioequivalent to subcutaneous injection of 80 mcg abaloparatide.
4 . A once-daily trans dermal system for the delivery of abaloparatide comprising:
a plurality of single-use trans dermal patches, each loaded with about 300 μg of abaloparatide, and ZnCl 2 at a molar ratio of 2.2:1 of ZnCl 2 :abaloparatide; and
instructions to administer one of said trans dermal patches once daily to the thigh for about 5 minutes.
5 . An aqueous formulation suitable for coating a trans dermal patch wherein the aqueous formulation comprises 300 μg of abaloparatide, zinc at a molar ratio of 2.2:1 of Zn:abaloparatide.
6 . The method, system or formulation according to any of the preceding claims, wherein the patch or formulation further comprises hydrochloric acid.
7 . The method, system or formulation according to claim 6 , wherein the mole ratio of hydrochloric acid to zinc chloride is at least 0.025.
8 . The method, system or formulation according to any of the preceding claims, wherein the pH of the patch or formulation is about 4.5.
9 . The method, system or formulation according to any of the preceding claims, wherein the pH of the patch or formulation is between about 4 and 4.75.