European Patent Application 0 448 146 A1
37. The PCT application mentions European Patent
Application 0 448 146 A1, published 25 September 1991 (EPO).
38. EPO describes the "State of the Art" partially as
follows (page 2, lines 10-24):
Relatively pure gonadotropin preparations are
commercially available. For example, compositions
containing naturally derived human menopausal gonadotropin
("HMG") and naturally derived human chorionic gonadotropin
("HCG") are available as freeze-dried preparations under the
trade designations "Humegon" and "Pregnyl," respectively,
from Organon International, bv of Oss, NL. Pregnant mare
gonadotropin is also available in freeze dried form from the
same company.
A bulking agent, e.g., mannitol, is added to these
preparation before lyophilization. They do not require the
addition of a stabilizer to ensure an adequate shelf-life.
Evidently whatever natural contaminants remain after the
purification process act to stabilize the preparations in
freeze-dried form.
Recently however, with the advent of more effective
production and purification techniques, preparations of
certain very pure gonadotropins are insufficiently stable.
They degrade in a relatively short time, losing activity.
In order to prevent or slow down this degradation, attempts
were made to freeze-dry (lyophilize) the preparations.
Lyophilization has only been partially successful however.
A need exists for a gonadotropin containing
pharmaceutical preparation which is stable over a sufficient
long period of time for the product to be manufactured,
shipped, and stored prior to use. The need is especially
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