Interference 102,413 Page 28
Pitha v. Muller
In Sz-34 (PR 185, PX-19-46), the product produced from
Sz-11 was solubilized in water with beta-ionone. The
experiment took place on July 19, 1981, which is the date
indicated on PX-19-46.
In Sz-36 (PR 186, PX-19-49), the product produced from
Sz-11 was solubilized in water with beta-carotene. The
experiment took place no later than July 29, 1981, which is
the date indicated on the subsequently occurring page
PX-19-54.
In Sz-40 (PR 187, PX-19-56), the product produced from
Sz-11 was solubilized in water with beta-carotene. The
experiment took place no later than September 1, 1981, which
is the date indicated on the subsequently occurring page
PX-19-66.
The product Sz-11 is described as white, foam like and no
homogenous composition of product. There is no indication
that crystals are formed. There is no indication whether the
product of Sz-11 contained cyclodextrin derivatives. The
solubility of the substance in water was reported. Pitha
directed us to pages Sz-32, Sz-36 and Sz-40 which establishes
that a portion of the product from Sz-11 was solubilized in
water with a drug. Dr. Szente’s declaration states the
product of Sz-11 was amorphous and solubilized in water with
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