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US 12,403,182 B2Granted
Liquid pharmaceutical formulations of PTH conjugates
AssigneeAscendis Pharma Bone Diseases A/S
InventorsAnja R. H. Skands, Felix Cleemann, Michael Duelund Sørensen, Julia Baron, Eric Hoffmann, Kennett Sprogøe
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Abstract
A liquid pharmaceutical formulation, wherein the pharmaceutical formulation comprises a PTH conjugate, a buffering agent, an isotonicity agent, a preservative and optionally an antioxidant and wherein the PTH conjugate comprises a PTH moiety that is covalently and reversibly conjugated to a water-soluble carrier moiety.
Claims8
A liquid pharmaceutical formulation, wherein the pharmaceutical formulation comprises a PTH conjugate of formula
- or a pharmaceutically acceptable salt thereof,
- wherein
- the unmarked dashed line indicates attachment by an amide bond to an N-terminal amine of a PTH moiety, which is PTH1-34 (SEQ ID NO:51);
- and
- the dashed line marked with the asterisk indicates attachment to a moiety
- wherein m and p are independently an integer from 400-500,
- succinic acid, D-mannitol and m-cresol, wherein the PTH moiety is at about 0.3 mg/ml mg/ml, the succinic acid is at about 1.18 mg/ml, the D-mannitol is at about 41.7 mg/ml, and the m-cresol is at about 2.5 mg/ml and wherein the pH is about 4.0, wherein about indicates variation of +/−10% of a stated value.
4 more elements
Dependencies are inferred from the claim text.