Method of drug delivery for bone anabolic protein

Abstract

The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.

1 - 48 . (canceled) 
     
     
         49 . A single or multi-dose sealed container, vial or cartridge that contains an aqueous solution comprising at least 80 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2  (SEQ ID NO: 2) wherein said aqueous solution comprises an effective amount of buffer to maintain the pH between 2 and 7. 
     
     
         50 . The container, vial or cartridge of  claim 49  wherein said buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers. 
     
     
         51 . The container, vial or cartridge of  claim 50  wherein said buffer is an acetate buffer. 
     
     
         52 . The container, vial or cartridge of  claim 51  wherein said buffer is acetic acid and sodium acetate. 
     
     
         53 . The container, vial or cartridge of  claim 49  wherein said pH is maintained between 3 and 6. 
     
     
         54 . The container, vial or cartridge of  claim 49  wherein said pH is maintained between 4 and 6. 
     
     
         55 . The container, vial or cartridge of  claim 49  wherein said pH is maintained between 4.5 and 5.6. 
     
     
         56 . The container, vial or cartridge of  claim 55  further comprising phenol. 
     
     
         57 . The container, vial or cartridge of  claim 56  wherein said phenol is present in a concentration from about 0.25 to about 5 mg/mL. 
     
     
         58 . A multi-dose sealed container, vial or cartridge that contains an aqueous solution comprising at least 160 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2  (SEQ ID NO: 2) wherein said aqueous solution comprises an effective amount of buffer to maintain the pH between 2 and 7. 
     
     
         59 . The container, vial or cartridge of  claim 58  wherein said buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers. 
     
     
         60 . The container, vial or cartridge of  claim 59  wherein said buffer is an acetate buffer. 
     
     
         61 . The container, vial or cartridge of  claim 60  wherein said buffer is acetic acid and sodium acetate. 
     
     
         62 . The container, vial or cartridge of  claim 58  wherein said pH is maintained between 3 and 6. 
     
     
         63 . The container, vial or cartridge of  claim 58  wherein said pH is maintained between 4 and 6. 
     
     
         64 . The container, vial or cartridge of  claim 58  wherein said pH is maintained between 4.5 and 5.6. 
     
     
         65 . The container, vial or cartridge of  claim 64  further comprising phenol. 
     
     
         66 . The container, vial or cartridge of  claim 65  wherein said phenol is present in a concentration from about 0.25 to about 5 mg/mL 
     
     
         67 . A multi-dose sealed container, vial or cartridge that contains an aqueous solution comprising at least 160 μg of [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2  (SEQ ID NO: 2) wherein said aqueous solution comprises an effective amount of a buffer to maintain the pH at about 5.1 and wherein said buffer is an acetate buffer and wherein said aqueous solution further comprises about 5 mg/mL of phenol. 
     
     
         68 . The container, vial or cartridge of  claim 67  wherein said [Glu 22,25 , Leu 23,28,31 , Aib 29 , Lys 26,30 ]hPTHrP(1-34)NH 2  is present in a concentration of about 2 mg/mL.