Formula of neuregulin preparation
AssigneeZensun (Shanghai) Science & Technology, Co., Ltd.
InventorMingdong Zhou
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Abstract
The present invention provides a pharmaceutical preparation for treating a cardiovascular disease. Particularly, the present invention provides a formula of a neuregulin pharmaceutical preparation. The formula consist of neuregulin polypeptide, a buffer, a stabilizer, an excipient, a salt, and another component, can ensure the long-term stability of the neuregulin polypeptide, and can be used for treating a heart failure patient or a patient in a risk of the heart failure.
Claims30
A pharmaceutical formulation of neuregulin (NRG) comprising:
- (a) an NRG polypeptide, wherein the NRG polypeptide is comprises the amino acid sequence set forth in SEQ ID NO:
- 2;
- and (b) a buffering agent, wherein said formulation has a pH between 3 and 4.
A pharmaceutical formulation of NRG comprising:
- (a) an NRG polypeptide, wherein the NRG polypeptide is a polypeptide consisting of the amino acid sequence set forth in SEQ ID NO:
- 2 at a concentration of about 0.25 g/L, (b) a buffering agent, wherein the buffering agent is phosphate at a concentration of about 10 mM, wherein said his about 6.0, (c) a stabilizing agent, wherein the stabilizing agent is human serum albumin at a concentration of about 2 g/L, and (d) a salt, wherein the salt is sodium chloride at a concentration of about 150 mM.
A pharmaceutical formulation of NRG comprising (a) a polypeptide consisting of the amino acid sequence set forth in SEQ ID NO:
- 2, (b) phosphate as the buffering agent, (c) mannitol as the excipient, (d) human serum albumin as the stabilizing agent, and (e) sodium chloride as the salt, wherein after resuspension of about 60 mg of the formulation with 1 ml of a resuspension solution, (a) is at a concentration of about 0.25 g/L;
- (b) is at a concentration of about 10 mM, and wherein the pH is about 6;
- (c) is at a concentration of about 50 g/L, (d) is at a concentration of about 2 g/L, and (e) is at a concentration of about 150 mM.
Dependencies are inferred from the claim text.