It is known that highly purified proteins are time-
unstable and are stabilized, for instance, in admixture with
saccharides, such as lactose and mannitol ***.
31. Further according to the PCT application (page 2,
lines 31-33):
Gonadotropins which are found on the market are stabilized
by means of saccahrides, for instance hCG is stabilized by
means of mannitol (ProfasiŽ, SERONO) ***.
32. Still further according to the PCT application
(page 3, lines 3-6):
We have now found that sucrose confers a better
stability to the formulation of gonadotropins and in
particular to the form of these glycoproteins which have
been prepared with the recombinant DNA technique.
33. An object of the invention described by the PCT
application (page 3, lines 12-22):
is to provide a process for the preparation of *** [a]
pharmaceutical composition, the step of lyophilising an
aqueous solution of the components. Another object is to
provide a presentation's form of *** [the] pharmaceutical
composition comprising the said solid mixture hermetically
closed in a sterile condition within a container suitable
for storage before use and suitable for reconstitution of
the mixture for injectable substances.
Another object is to provide a solution for said solid
mixture reconstituted into an injectable solution.
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