7. Further according to applicants, degradation is
more evident for proteins produced by recombinant DNA techniques
(specification, page 1, lines 8-9).
8. Still further according to applicants, the
proteins are usually stabilized with saccharides, such as
lactose, or with mannitol, or with other proteins or aminoacids
(specification, page 1, lines 10-12).
9. An hCG composition is administered as a
pharmaceutical in the form of an injectable formulation. The
specification (page 1, lines 13-16) tells us:
The injectable stabilised formulations of gonadotropins
are obtained with a process which includes always a step of
lyophilisation to obtain a dry powder; in such a way the
stabilised formulations are able to maintain a longer cycle
life, even if stored at room temperature.
10. Applicants acknowledge the PCT application as
prior art in their specification (specification, page 1,
line 17). Specifically, applicants note (specification, page 1,
lines 17-21):
WO 93/11788 [the PCT application] describes lyophilised
gonadotropin-containing pharmaceutical compositions
stabilised with sucrose, alone or in combination with other
stabilising agents. In said patent application it is shown
that the stability provided to the lyophilised compositions
under study by sucrose was better than that provided by
lactose or mannitol.
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Last modified: November 3, 2007