Interference 102,413 Page 9
Pitha v. Muller
Pitha presents Dr. Czajkowska’s testimony (PR 352-356) to
establish the intrinsically amorphous nature of C-70 PBCD.
The experiment C-116 is said to describe the solubilization of
testosterone with the product produced from C-70.
In order to establish the intrinsically amorphous nature
of HPBCD and PBCD products are well known in the art and to
help establish the intrinsically amorphous property as
inherent, Pitha cites exhibits PX-41 published September 1985,
PX-54 published February 1986 and MCX-4 published October
1987. 18
2. Solubilized drug/cyclodextrin derivatives complex
Pitha describes the research he supervised performed by
Dr. Lajos Szente and Dr. Teresa Czajkowska which purportedly
exhibit the synthesis of solubilized drug/cyclodextrin
derivatives complexes. Specifically, Pitha directs us to the
experiments appearing in Dr. Szente and Dr. Czajkowska’s
laboratory notebooks which are said to take the formed
cyclodextrin derivatives and lipophilic drugs and solubilize
them in aqueous media.
3. The Laboratory Notebook of Dr. Lajos Szente
18PB page 14, lines 8-19 and page 16, lines 17-21.
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