Interference 102,413 Page 33
Pitha v. Muller
Pitha has not directed us to evidence which establishes
that the product from Sz-42 comprised cyclodextrin derivatives
or was solubilized in water with a drug. Thus, this
experiment alone fails to meet all the requirements of the
count.
f. The product Sz-111
In Sz-111 (PR 189, PX-20-52), the experiment took place
no later than February 22, 1982, which is the date indicated
on the request for analytical services PX-20-51. The reaction
product of BCD and epichlorohydrin was said to be formed
during the experiment. The substance was freeze dried to form
a white powder substance. There is no indication whether
crystals were formed. The solubility of the substance in
water at 20 C is reported to be 13-14 g/100ml.o
Pitha has not directed us to evidence which establishes
that the product from Sz-111 comprised cyclodextrin
derivatives or was solubilized in water with a drug. Dr.
Szente’s declaration states the product of Sz-111 was
amorphous and a good solubilizer of lipophilic drugs. 44
However, we have not been directed to evidence which exhibits
(1) Sz-111 contained cyclodextrin derivatives or (2) the
44PR page 177, lines 2-11.
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