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Oligopeptide lyophilisate, their preparation and use
| Details |
Inventors: Engel, Jurgen; Wichert, Burkhard; Sauerbier, Dieter; Reissmann, Thomas;
Assignee: Zentaris GmbH (Frankfurt, DE)
Primary Examiner: Minnifield; N. M.
Assistant Examiner:
Attorney, Agent or Firm: Pillsbury Winthrop LLP
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. |
|
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS The following Examples illustrate the invention.
EXAMPLE 1 Approx.
1.
5 liters of water for injection purposes are prepared in a suitable glass vessel.
210 g water for injection purposes are prepared in another glass vessel and 91.
17 g acetic acid are added.
The amount of cetrorelix acetate calculated (1.
62-1.
695 g, depending on the content of the batch used) is dissolved in the prepared 30% acetic acid with stirring.
This solution is transferred to the glass vessel with 1.
5 liters of water for injection purposes, 82.
2 g mannitol are added, dissolved and made up to 3039 g with water for injection purposes.
In-process checks:
pH value: 2.
5-3.
0
Density: 1.
009-1.
017 g/cm.
sup.
3 at 20.
degree.
C.
Refractive index: 1.
227-1.
340 at 440 nm and 20.
degree.
C.
The solution is sterilized by filtration through an appropriate membrane filter (pore size 0.
2 .
mu.
m) under aseptic conditions.
100 ml first runnings should be discarded.
The filters should be sterilized with superheated steam before sterile filtration.
Cetrorelix freeze-dried solution should be protected from recontamination during storage.
The solution is immediately filled into colorless injection bottles DIN 2R, hydrolytic class I under aseptic conditions and provided with sterile freeze-drying stoppers.
The nominal filling amount is 2.
0 ml=2.
026 g.
The 2 ml injection bottles were rinsed in an injection bottle washing machine, dried with hot air and sterilized.
The cleaned, freeze-drying stoppers were autoclaved.
The closed injection bottles were transferred to a freeze-drying installation and frozen at a plate temperature of -40.
degree.
C.
Drying was carried out using a drying program with a plate temperature of -40.
degree.
C.
rising to +20.
degree.
C.
The installation is then flooded with sterile nitrogen, the bottles are closed in the installation and the stoppers secured with crimped caps.
The injection bottles are checked visually for faulty closures and outer faults
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