US2017216405A1PendingUtilityA1

Stabilization of fsh

52
Assignee: FERRING BVPriority: Jul 30, 2010Filed: Sep 6, 2016Published: Aug 3, 2017
Est. expiryJul 30, 2030(~4 yrs left)· nominal 20-yr term from priority
Inventors:Helen Ulrika SjögrenHeidi Louise Bagger
A61K 9/0019A61K 47/10A61P 15/00C07K 14/59A61K 47/12A61K 38/24A61K 47/02A61K 9/08A61P 15/08A61K 47/26A61K 47/20
52
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

The present invention, pertains in general to the field of stabilization of FSH formulations, in particular liquid FSH formulations. The stabilization is achieved by the addition of salts comprising pharmaceutically acceptable alkali metal cations, in preferred embodiments by the addition of pharmaceutically acceptable salts, i.e. sodium salts or potassium salts.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A liquid FSH formulation comprising:
 follicle stimulating hormone (FSH);   sodium chloride at a concentration that stabilizes the FSH;   a preservative selected from benzyl alcohol and phenol;   L-methionine;   polysorbate-20; and   phosphate buffer at a pH of 5.5 to 7.5.   
     
     
         17 . A liquid FSH formulation comprising:
 follicle stimulating hormone (FSH); and   a sodium salt at a concentration that stabilizes the FSH;   wherein the sodium salt is sodium acetate, sodium citrate, sodium iodide, sodium perchlorate, sodium sulfate or sodium tartrate.   
     
     
         18 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium acetate, sodium citrate, sodium iodide, sodium perchlorate, or sodium tartrate. 
     
     
         19 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium acetate. 
     
     
         20 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium citrate. 
     
     
         21 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium iodide. 
     
     
         22 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium perchlorate. 
     
     
         23 . The liquid FSH formulation of  claim 17 , wherein the sodium salt is sodium tartrate. 
     
     
         24 . A liquid FSH formulation comprising:
 follicle stimulating hormone (FSH); and   a potassium salt at a concentration that stabilizes the FSH.   
     
     
         25 . The liquid FSH formulation of  claim 24 , wherein the potassium salt is potassium chloride, potassium iodide or potassium sulfate. 
     
     
         26 . The liquid FSH formulation of  claim 24 , wherein the potassium salt is potassium chloride. 
     
     
         27 . The liquid FSH formulation of  claim 24 , wherein the potassium salt is potassium iodide. 
     
     
         28 . The liquid FSH formulation of  claim 24 , wherein the potassium salt is potassium sulfate. 
     
     
         29 . A method for stabilizing a liquid FSH formulation wherein the method comprises the step of an addition of sodium chloride to a liquid formulation containing FSH, wherein the stabilized formulation further comprises a preservative selected from benzyl alcohol and phenol; L-methionine; polysorbate-20; and phosphate buffer at a pH of 5.5 to 7.5. 
     
     
         30 . A method for stabilizing a liquid FSH formulation wherein the method comprises the step of an addition of a sodium salt to a liquid formulation containing FSH, wherein the sodium salt is selected from the group consisting of sodium acetate, sodium citrate, sodium iodide, sodium perchlorate, sodium sulfate or sodium tartrate. 
     
     
         31 . The method of  claim 30 , wherein the sodium salt is sodium acetate, sodium citrate, sodium iodide, sodium perchlorate, or sodium tartrate. 
     
     
         32 . A method for stabilizing a liquid FSH formulation wherein the method comprises the step of an addition of a potassium salt to a liquid formulation containing FSH. 
     
     
         33 . The method of  claim 32 , wherein the potassium salt is potassium chloride, potassium iodide or potassium sulfate. 
     
     
         34 . A method of treating infertility comprising administering a liquid FSH formulation according to  claim 16  to a subject in need thereof. 
     
     
         35 . A method of treating infertility comprising administering a liquid FSH formulation according to  claim 17  to a subject in need thereof. 
     
     
         36 . A method of treating infertility comprising administering a liquid FSH formulation according to  claim 24  to a subject in need thereof. 
     
     
         37 . The method of  claim 34 , wherein the potassium salt is potassium chloride, potassium iodide or potassium sulfate.

Join the waitlist — get patent alerts

Track US2017216405A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.