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US 10,603,352 B2Granted
Formulations of hepalatide
AssigneeShanghai Hep Pharmaceutical Co., Ltd.
InventorHongli Liu
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Abstract
The present disclosure provides a drug formulation for hepalatide, comprising hepalatide and a buffer salt, and containing or not containing an osmotic regulator and/or an excipient.
Claims18
A formulation comprising (i) a polypeptide having an amino acid sequence set forth in SEQ ID NO:1;
- (ii) a buffer salt;
- (iii) an osmotic regulator;
- and (iv) an excipient;
- wherein the drug formulation is formulated in water, the N terminus of the polypeptide is modified by myristic acid and the C terminus is modified by amidation;
- and
- wherein the osmotic regulator is NaCl, the excipient is mannitol and the concentration of the polypeptide is in a range of 0.25-8.0 mg/ml, and NaCl is in a molar concentration of 116˜154 mM and mannitol is in a concentration (W/V) of 1˜5%;
- or the osmotic regulator is glucose, the excipient is mannitol, dextran or sorbitol, and the concentration of the polypeptide is in a range of 0.25-1.0 mg/ml, wherein the concentration of glucose is 5% (W/V), and the concentration of mannitol, dextran or sorbitol is 4% (W/V).
4 more elements
Dependencies are inferred from the claim text.