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|Title:||Oligopeptide lyophilisate, their preparation and use|
|Abstract:||A novel lyophilizate and method of preparation as well as the use of the lyophilizate to treat female infertility and for gonad protection. Cetrorelix is dissolved in acetic acid 30% v/v, the solution is transferred to water and freeze dried.|
|Inventor(s):||Engel; Jurgen (Alzenau, DE), Wichert; Burkhard (Bielefeld, DE), Sauerbier; Dieter (Halle, DE), Sauerbier, legal representative; Gudrun (Halle, DE), Reissmann; Thomas (Luneberg, DE)|
|Assignee:||AEterna Zentaris GmbH (Frankfurt, DE)|
1. A sterile Cetrorelix acetate-bulking agent lyophilisate prepared by a method comprising the steps of: (a) dissolving having the amino acid sequence of
Ac-D-Nal(2)-D-pCl-Phe-D-Pal(3)-Ser-Tyr-D-Cit-Leu-Arg-Pro-D-Ala-NH.sub.2 (SEQ ID NO: 1) in 30% (v/v) aqueous acetic acid to form a solution; (b) diluting the solution with water; (c) adding bulking agent to the solution, after which the solution has a
pH range between 2.5-3.0; (d) sterilizing the solution by filtration; and (e) lyophilizing the solution, producing a sterile Cetrorelix acetate lyophilisate-bulking agent thereby.
2. The sterile Cetrorelix acetate-bulking agent lyophilisate according to claim 1 wherein the bulking agent is a conventional pharmaceutical auxiliary selected from the group consisting of amino acids, polyvinylpyrrolidone, albumin, a hexitol, urea, and sodium chloride.
3. The sterile Cetrorelix acetate-bulking agent lyophilisate according to claim 2 wherein the hexitol is selected from the group consisting of mannitol, glucitol, sorbitol, D-sorbitol, dulcitol, allitol, and iditol, and wherein the bulking agent in the lyophilisate is in an amount from 0.1 to 17 parts by weight per 1 part by weight of the peptide.
4. The sterile Cetrorelix acetate-bulking agent lyophilisate according to claim 1 wherein 1 part by weight of the peptide is dissolved in 100-10,000 parts by weight 30% (v/v) aqueous acetic acid and wherein the solution is diluted with water to 3% (v/v) aqueous acetic acid and wherein the bulking agent is mannitol.
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