Appeal 2007-1082
Application 10/327,383
1 formed by a wet granulation process using non-aqueous
2 granulating liquid; wherein said granule has a Carr’s
3 Compressibility Index of less than 34%; wherein said non-
4 dihydrate azithromycin is selected from the group consisting of
5 substantially pure azithromycin monohydrate hemi-ethanol
6 solvate and azithromycin sesquihydrate.
7
8 Tenengauzer
9 Tenengauzer relates to stabilized azithromycin compositions.
10 Col. 1:13-14; col. 3:1-2.
11 One suitable particular azithromycin is azithromycin ethanolate
12 monohydrate. Col. 3:2-6.
13 Pharmaceutical compositions comprising the stabilized azithromycins
14 include dosage forms such as granulates. Col. 4:35-37.
15 While other dosage forms are described, according to Tenengauzer
16 among the methods for forming preferred tablet dosage forms are wet
17 granulation and dry granulation. Col. 4:41-43.
18 Tenengauzer describes numerous formulations using azithromycin.
19 See, e.g., the formulations described in Table 2 (beginning at the bottom of
20 columns 9 and 10 and ending at the top of columns 11 and 12).
21 Preparation 7 is described in Table 2 as being azithromycin granulated
22 with an ethanolic solution of antioxidant.
23 A further description of Preparation 7 is: “Technical grade
24 azithromycin was recrystallized from ethanol. BHT [butylated
2 With respect to the italicized portion of claim 15, see n. 1, supra.
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