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US 6,828,415 B2Granted
Oligopeptide lyophilisate, their preparation and use
AssigneeZentaris AG
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 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-NH2 (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 more elements
Dependencies are inferred from the claim text.