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 - 144 . (canceled)
145 . A method of a method of stimulating bone formation in a subject in need thereof comprising administering [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 by contacting the skin of said subject with a microprojection array,
wherein said microprojection array comprises a backing material with a plurality of attached microprojections and a coating on at least a part of one of said microprojections,
wherein said coating comprises [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 , and
wherein said contacting occurs with sufficient force to cause penetration of one or more of said microprojections into the skin of said subject.
146 . The method of claim 145 wherein said subject has osteopenia.
147 . The method of claim 145 wherein said subject is characterized as having bone mineral density at one or more skeletal sites of more than 1 standard deviations below the norm.
148 . The method of claim 145 wherein said subject is characterized as having bone mineral density at one or more skeletal sites of more than 2 standard deviations below the norm.
149 . The method of claim 145 wherein said subject has osteoarthritis.
150 . The method of claim 145 wherein said subject has a bone fracture.
151 . A method of claim 150 wherein said bone fracture is selected from vertebral fracture, femoral fracture, and radial fracture.
152 . A method of claim 150 wherein said bone fracture is a traumatic bone fracture.
153 . A method of claim 150 wherein said bone fracture is a non-traumatic bone fracture.
154 . The method of claim 145 wherein said administering is a once-daily administration.
155 . The method of claim 145 wherein said microprojection array is left in place with one or more of said microprojections embedded in the skin after said contacting for a period of from about 3 seconds to about 10 minutes.
156 . The method of claim 145 wherein said microprojection array is left in place with one or more of said microprojections embedded in the skin after said contacting for a period of from about 5 seconds to about 30 minutes.
157 . The method of claim 145 wherein said microprojection array comprises from about 75 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
158 . The method of claim 145 wherein said microprojection array comprises from about 85 μg to about 115 μg [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
159 . The method of claim 145 wherein said microprojection 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 .
160 . The method of claim 145 wherein said microprojection 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 .
161 . The method of claim 145 wherein said microprojection array comprises from about 170 μg to about 230 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2 .
162 . The method of claim 145 wherein said stimulating bone formation results in increased bone mineral density in said subject.
163 . The method of claim 145 wherein said stimulating bone formation results in increased levels of serum P1NP in said subject.