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US 7,605,121 B2Granted
Oligopeptide lyophilisate, their preparation and use
AssigneeAEterna Zentaris GmbH
InventorsJürgen Engel, Burkhard Wichert, Dieter Sauerbier, Thomas Reissmann
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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.
Claims4
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-NH2 (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.
4 more elements
Dependencies are inferred from the claim text.