Interference 102,413 Page 7
Pitha v. Muller
condensation of beta-cyclodextrin with propylene oxide. 8
Pitha presents Dr. Szente’s testimony (PR 172-175) to
establish the intrinsically amorphous nature of PBCD and
HPBCD.
Pitha describes the research he supervised performed by
Dr. W. Ciesielski which purportedly exhibit the synthesis of
intrinsically amorphous cyclodextrin derivatives which are
water soluble and capable of forming inclusion complexes with
drugs in water. The experiments W-11, W-14 and W-44 are said
to describe the synthesis of Poly-beta-cyclodextrin (PBCD)
cyclodextrin derivative. Pitha argues that the intrinsically9
amorphous nature of W-14 is shown by the absence of indication
of the formation of crystals. Pitha also argues the10
synthesis described in making of PBCD product W-14 was a
condensation reaction of beta-cyclodextrin with
epichlorohydrin which results in an intrinsically amorphous
product. The experiments W-17, W-22, W-38, W-48 and W-55 are11
said to describe the synthesis of HPBCD cyclodextrin
8PX-38 column 4, lines 44-47.
9PB page 17, lines 2-7.
10PB page 16, lines 12-18.
11PB page 16, lines 16-20.
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007