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 - 28 . (canceled)
29 . A microprojection array suitable for transdermal drug delivery wherein said microprojection array comprises a backing material with a plurality of attached microprojections wherein at least one of said microprojections comprises a coating of a formulation comprising [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
30 - 32 . (canceled)
33 . A microprojection array according to claim 29 wherein said microprojections comprise a polycarbonate polymer.
34 . A microprojection array according to claim 29 wherein said microprojections comprise a liquid crystal polymer.
35 . A microprojection array according to claim 29 wherein said microprojections comprise a base with a width greater than two times the width at the tip.
36 . A microprojection array according to claim 29 wherein said microprojections comprise a base with a width greater than four times the width at the tip.
37 . A microprojection array according to claim 29 wherein said microprojections comprise a base with a width greater than six times the width at the tip.
38 . A microprojection array according to claim 29 wherein said microprojections are microneedles.
39 . A microprojection array according to claim 29 wherein said microprojections are pyramidal in shape.
40 . A microprojection array according to claim 29 wherein said microprojections have a rectangular base and rectangular tip.
41 . A microprojection array according to claim 29 wherein said microprojections have a square base and square tip.
42 . A microprojection array according to claim 29 wherein said microprojections have a flexural modulus of greater than 1,000 MPa (ISO 178).
43 - 46 . (canceled)
47 . A microprojection array according to claim 29 wherein said microprojections have a flexural modulus from about 8,000 MPa and 12,000 MPa (ISO 178).
48 . A microprojection array according to claim 29 wherein said microprojections have a flexural modulus from about 9,000 MPa to about 10,000 MPa (ISO 178).
49 . A microprojection array according to claim 29 wherein said microprojections have a flexural modulus of between 9,000 MPa and 9,500 MPa (ISO 178).
50 . A microprojection array according to claim 29 wherein said microprojections are more than 100 microns and less than 1,000 microns in length.
51 . (canceled)
52 . A microprojection array according to claim 29 wherein said microprojections are more than 400 microns and less than 600 microns in length.
53 . A microprojection array according to claim 29 wherein said microprojections are about 500 microns in length.
54 - 56 . (canceled)
57 . A microprojection array according to claim 29 wherein said array comprises between 100 and 500 microprojections.
58 . A microprojection array according to claim 29 wherein said array comprises between 250 and 400 microprojections.
59 . A microprojection array according to claim 29 wherein said array comprises between 300 and 375 microprojections.
60 - 63 . (canceled)
64 . A microprojection array according to claim 29 wherein said array comprises from about 85 μg to about 115 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
65 . A microprojection array according to claim 64 wherein said array comprises about 100 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
66 . A microprojection array according to claim 29 wherein said array comprises from about 106.25 μg to about 143.75 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
67 . (canceled)
68 . A microprojection array according to claim 29 wherein said array comprises from about 127.5 μg to about 172.5 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
69 . A microprojection array according to claim 68 wherein said array comprises about 150 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
70 . A method of administering [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 to a mammal comprising contacting the skin of said mammal with a microprojection array according to claim 29 wherein said contacting occurs with sufficient force to cause penetration of one or more of said microprojections comprising a coating of said formulation into the skin of said mammal.
71 . The method of claim 70 wherein said mammal is a human.
72 . The method of claim 71 wherein said human has osteopenia or osteoporosis.
73 . The method of claim 71 wherein said human is a post-menopausal woman.
74 . The method of claim 71 wherein said human has glucocorticoid-induced osteopenia or osteoporosis.
75 - 144 . (canceled)
145 . A microprojection array according to claim 29 wherein said array comprises about 366 microprojections, wherein said microprojections comprise a polycarbonate polymer, and wherein said coating comprises from about 85 μg to about 230 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
146 . A microprojection array according to claim 29 wherein said array comprises about 316 microprojections, wherein said microprojections comprise a liquid crystal polymer, and wherein said coating comprises from about 85 μg to about 230 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
147 . A microprojection array according to claim 29 wherein said coating further comprises sucrose or hydroxyethyl cellulose.
148 . A microprojection array according to claim 29 wherein said coating further comprises histidine or potassium chloride.
149 . A microprojection array according to claim 29 wherein said array comprises at least 63.75 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
150 . A microprojection array according to claim 29 wherein said microprojection array comprises from about 80 μg to about 450 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
151 . A microprojection array according to claim 29 wherein said microprojection array comprises from about 85 μg to about 230 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
152 . A microprojection array according to claim 29 wherein said microprojection array comprises from about 20 μg to about 386 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .