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Last Updated: December 22, 2024

Claims for Patent: 8,148,333

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Summary for Patent: 8,148,333

Title:	Stable composition comprising a PTHrP analogue
Abstract:	The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) analogue and methods of using a PTHrP analogue 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.
Inventor(s):	Dey; Michael J. (Sandbach, GB), Mondoly; Nathalie (Le Chesnay, FR), Rigaud; Benedicte (Oulins, FR), Henderson; Bart (Belmont, MA), Lyttle; C. Richard (Bala Cynwyd, PA)
Assignee:	Radius Health, Inc. (Cambridge, MA) Ipsen Pharma S.A.S. (Boulogne-Billancourt, FR)
Application Number:	12/311,418
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,148,333
Patent Claims:	1. A storage-stable composition suitable for administration to a subject comprising: a) a PTHrP analogue having the sequence [Glu.sup.22,25, Leu.sup.23,28,31, Aib.sup.29, Lys.sup.26,30] hPTHrP(1-34)NH.sub.2(SEQ ID NO.2); and b) an effective amount of a pH buffer to maintain the pH in a range of about 4.5 to about 5.6. 2. The storage-stable composition according to claim 1, wherein said pH is about 5.1. 3. The storage stable composition according to claim 1, wherein said pH buffer is selected from the group consisting of acetate, tartrate, phosphate and citrate buffers. 4. The storage-stable composition according to claim 3, wherein said pH buffer is an acetate buffer. 5. The storage-stable composition according to claim 4, wherein said acetate buffer is acetic acid and sodium acetate. 6. The storage-stable composition according to claim 5, wherein said buffer is present in a concentration range of about 1 mM to about 10 mM. 7. The storage stable composition according to claim 6 wherein said buffer is present in a concentration of about 6 mM. 8. The storage-stable composition according to claim 1, further comprising an effective amount of an anti-microbial agent. 9. The storage-stable composition according to claim 8, wherein said anti-microbial agent is phenol. 10. The storage-stable composition according to claim 9, wherein said phenol is present in a concentration from about 0.25 to about 5 mg/mL. 11. The storage-stable composition according to claim 10, wherein said phenol is present in a concentration of about 5 mg/mL. 12. The storage-stable composition according to claim 1, wherein said PTHrP analogue is present in a concentration of about 2 mg/mL. 13. The storage-stable composition according to claim 1, wherein said composition does not contain a chemical stabilizer.

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