METHOD OF DRUG DELIVERY FOR PTH, PTHrP AND RELATED PEPTIDES
The present invention provides compositions, devices, methods and processes related to the intradermal delivery of PTHrP and PTHrP analogues, particularly [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
1 - 55 . (canceled)
56 . A method of treating osteoporosis in a subject comprising the administration of an array to the subject, said array comprising a plurality of microprojections coated with a formulation comprising [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 and said administration results in a peak plasma concentration of between 419 and 933 pg/mL of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
57 . The method of claim 56 wherein said administration is to the thigh.
58 . The method of claim 56 wherein said subject is a post-menopausal woman.
59 . The method of claim 56 wherein said array has a pH of from between 3 and 8.
60 . The method of claim 59 wherein said array has a pH of from between 3 and 7.
61 . The method of claim 60 wherein said array has a pH of from between 3.5 and 6.5.
62 . The method of claim 61 wherein said array has a pH of from between 4 and 6.
63 . The method of claim 62 wherein said array has a pH of from between 4.5 and 5.5.
64 . The method of claim 56 wherein said microprojections are from between 400-600 microns in length.
65 . The method of claim 64 wherein said microprojections are about 500 microns in length.
66 . The method of claim 56 wherein said microprojections are made from carbon containing polymers and said microprojections have a flexural modulus of >1,000 MPa (ISO 178).
67 . The method of claim 66 wherein said flexural modulus is from between 3,000 MPa (ISO 178) and 15,000 MPa (ISO 178).
68 . The method of claim 67 wherein said flexural modulus is from between 5,000 MPa (ISO 178) and 12,000 MPa (ISO 178).
69 . The method of claim 68 wherein said flexural modulus is from between 8,000 MPa (ISO 178) and 12,000 MPa (ISO 178).
70 . The method of claim 69 wherein said flexural modulus is from between 9,000 MPa (ISO 178) and 10,000 MPa (ISO 178).
71 . The method of claim 56 , wherein said microprojection array comprises from 80 μg to 450 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 (SEQ ID NO.: 2).