34. The PCT applications says that "biological tests
have been performed" (page 4, line 6) and that the results of
those tests (page 4, lines 12-15):
show that the most stable formulations among those tested
are those containing sucrose, i.e., formulations with
sucrose alone and with sucrose plus glycin.
35. One study is described as follows (page 19,
lines 5-16):
A study has been also performed on urinary hCG
formulations by using sucrose (formulation "a", 30 mg
sucrose), lactose (formulation "b", 10 mg lactose) or
mannitol (formulation "c", 20 mg mannitol) as stabilizers in
3 ml vials containing 500 I.U./vial hCG.
Tab. 10 gives the estimated values derived by the
biological assay performed at different times for said hCG
formulations stored at a temperature of 55°C.
Once again, sucrose is shown to be the most suited
excipient in order to preserve hCG stability ***.
36. Part of a table at Tab. 10 reveals the following
(page 20), where 3W means 3 weeks and 6W means 6 weeks:10
+ ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 0 ) ) ) ) ) ) ) ) 0 ) ) ) ) ) ) ) ) 0 ) ) ) ) ) ) ,
* Composition * T = 0 * 3W * 6W *
/ ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 3 ) ) ) ) ) ) ) ) 3 ) ) ) ) ) ) ) ) 3 ) ) ) ) ) ) 1
* a * 511 * 567 * 597 *
* * * * *
* b * 534 * 355 * 428 *
* * * * *
* c * 449 * 332 * 244 *
. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 2 ) ) ) ) ) ) ) ) 2 ) ) ) ) ) ) ) ) 2 ) ) ) ) ) ) -
We note that the ratio of hCG to sucrose is not the same as the ratio
of hCG to mannitol. Hence, we find it difficult to assess the weight to be
given the data set out in Tab. 10. See also Finding 25.
- 11 -
Page: Previous 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Next
Last modified: November 3, 2007