Abaloparatide formulations and methods of testing, storing, modifying, and using same
Provided herein are newly discovered methods of analyzing abaloparatide samples for abaloparatide isomers. Additionally, methods of storing and treating with abaloparatide in view of the newly discovered abaloparatide isomers are described.
1. An isomer of abaloparatide comprising beta-Asp10 abaloparatide as set forth in the sequence:
(SEQ ID NO: 2)
Ala-Val-Ser-Glu-His-Gln-Leu-Leu-His-b-Asp-Lys-
Gly-Lys-Ser-Ile-Gln-Asp-Leu-Arg-Arg-Arg-Glu-Leu-
Leu-Glu-Lys-Leu-Leu-Aib-Lys-Leu-His-Thr-Ala-NH 2 .
2. The isomer of abaloparatide of claim 1 , consisting of beta-Asp10 abaloparatide.
3. A pharmaceutical composition comprising the abaloparatide isomer of claim 2 .
4. The pharmaceutical composition of claim 3 , further comprising abaloparatide.
5. The pharmaceutical composition of claim 4 , comprising an aqueous buffer.
6. The pharmaceutical composition of claim 5 , having a pH from about 4 to about 6.
7. The pharmaceutical composition of claim 5 , having a pH from 4.5 to 5.5.
8. The pharmaceutical composition of claim 4 , wherein the pharmaceutical composition is a formulated drug product.