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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 (Werter, DE), Reissmann; Thomas (Frankfurt am Main, DE)|
|Assignee:||Zentaris GmbH (Frankfurt, DE)|
|Filing Date:||Jun 06, 1995|
|Claims:||1. A method for the preparation of a sterile Cetrorelix lyophilizate, said method comprising the steps of: (a) dissolving Cetrorelix 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 aqueous acetic acid to form a solution, (b) diluting said solution with water for injection, (c) adding bulking agent to the solution, wherein said solution has a pH range between 2.5-3.0, and (d) sterile filtering, dispensing into injection vials and lyophilizing the solution thereby obtaining a sterile Cetrorelix lyophilizate. |
2. The method according to claim 1, wherein the bulking agent used is a hexitol.
3. The method according to claim 2, wherein the hexitol is selected from the group consisting of mannitol, glucitol, sorbitol, D-sorbitol, dulcitol, allitol, iditol, urea or sodium chloride in an amount from 10-500 parts by weight per one part by weight Cetrorelix.
4. The method according to claim 1, wherein 1 part by weight of cetrorelix acetate is dissolved in 100-10,000 parts by weight of a 30% strength (w/w) acetic acid solution and diluted with water to 3% strength aqueous acetic acid, and wherein the bulking agent is mannitol.
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