Transdermal delivery system for dried particulate or lyophilized peptides and polypeptides
View Patent ↗The present invention provides a system for transdermal delivery of dried or lyophilized pharmaceutical compositions and methods using thereof. The system comprises an apparatus for facilitating transdermal delivery of a peptide or polypeptide that generates hydrophilic micro-channels, and a patch comprising dried therapeutically peptide or polypeptide. Particularly, the system of the present invention facilitates transdermal delivery of parathyroid hormone useful for preventing or treating bone disorders.
1. A method for treating a bone disorder or disease comprising: (a) generating a plurality of micro-channels in an area of the skin of a subject; (b) affixing a printed patch to the area of the skin of the subject, the printed patch comprising a non-adhesive liner and a dried pharmaceutical composition comprising a therapeutically effective amount of a parathyroid hormone (PTH) or a fragment thereof that has PTH activity, and wherein the non-adhesive liner is made of a material that is not permeable to the PTH, and thereby treating the bone disorder or disease.
2. The method according to claim 1 , wherein the PTH is a human PTH.
3. The method according to claim 2 , wherein the human PTH is the fragment human PTH (1-34).
4. The method according to claim 1 , wherein the pharmaceutical composition further comprises a stabilizer.
5. The method according to claim 4 , wherein the stabilizer is a simple or complex carbohydrate.
6. The method according to claim 5 , wherein the simple or complex carbohydrate is selected from the group consisting of mannose, glucose, galactose, raffinose, cellobiose, gentiobiose, sucrose and trehalose.
7. The method according to claim 1 , wherein the pharmaceutical composition further comprises an acidic component to yield a pH in the range from about 3 to about 6 in solution before drying.
8. The method according to claim 7 , wherein the acidic component is selected from the group consisting of acetic acid, citric acid, and tartaric acid.
9. The method according to claim 8 , wherein the pharmaceutical composition comprises hPTH (1-34), acetic acid, and trehalose at pH of about 4.0 in solution before drying.
10. The method according to claim 1 , wherein the bone disorder or disease is selected from the group consisting of bone fractures, osteoporosis, arthritis, osteoarthritis, and glucocorticoid osteoporosis.
11. The method according to claim 1 , wherein the subject is a human.
12. The method according to claim 1 , wherein the subject is a woman.
13. The method according to claim 1 , wherein the subject is a postmenopausal woman suffering from osteoporosis.
14. The method according to claim 1 , wherein the pharmaceutical composition further comprising an antiresorptive agent.
15. The method according to claim 14 , wherein the antiresorptive agent is selected from the group consisting of calcitonin, estrogen, bisphosphonates, fluoride, vitamin D, IGF-1, statins, and selective estrogen receptor modulators (SERMs).
16. The method according to claim 1 , further comprising a step of administering a pharmaceutical composition comprising a therapeutically effective amount of an antiresorptive agent before, concurrently, or after affixing the patch.
17. The method according to claim 16 , wherein the antiresorptive agent is selected from the group consisting of calcitonin, estrogen, bisphosphonates, fluoride, vitamin D, IGF-1, statins, and selective estrogen receptor modulators (SERMs).
18. The method according to claim 1 , wherein the bone disorder is osteoporosis, and the pharmaceutical composition further comprises trehalose as a stabilizer, acetic acid in an amount sufficient to yield a pH in the range from about 3 to about 6 in solution before drying, and vitamin D as an antiresorptive agent.
19. The method according to claim 18 , wherein the PTH peptide is human PTH (1-34) and the subject to be treated is a woman.
20. The method according to claim 1 , wherein the bone disorder is osteoporosis, and the pharmaceutical composition further comprises trehalose as a stabilizer, and acetic acid in an amount sufficient to yield a pH in the range from about 3 to about 6 in solution before drying.