Interference 102,413 Page 6
Pitha v. Muller
from Dr. Lajos Szente and Dr. Teresa Czajkowska. Pitha’s
exhibits do not include a declaration or transcript of oral
testimony from Dr. Winicjusza Ciesielski.
1. Intrinsically amorphous cyclodextrin derivatives.
Pitha describes the research he supervised performed by
Dr. Lajos Szente which purportedly exhibited the synthesis of
intrinsically amorphous cyclodextrin derivatives which are
water soluble and capable of forming inclusion complexes with
drugs in water. The experiments Sz-8, and Sz-111 are said to
describe the synthesis of Poly-beta-cyclodextrin (PBCD)
cyclodextrin derivative. PBCD is said to be formed by the4
condensation of beta-cyclodextrin with epichlorohydrin. 5
Pitha argues the absence of indication of crystals upon
purification and the reaction described on Sz-8 is recognized
to indicate amorphous-type characteristics. The experiments 6
Sz-20, Sz-28, Sz-35, Sz-42 and Sz-49 are said to describe the
synthesis of Hydroxypropyl-beta-cyclodextrin (HPBCD)
cyclodextrin derivative. HPBCD is said to be formed by the7
4PB page 17, lines 2-7.
5PX-38 column 4, lines 44-47.
6PB page 15, 14-23.
7PB page 15, lines 1-9.
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