Appeal 2007-1082
Application 10/327,383
1 “Non-dihydrate azithromycin” means all amorphous and crystalline
2 forms of azithromycin, other than the dihydrate form of azithromycin
3 (Form A). Specification, page 3:29-33.
4 The “granulating liquid” may be non-aqueous or aqueous.
5 Specification, page 7:27-28. A preferred non-aqueous granulating liquid
6 includes ethanol. Specification, page 8:16-17.
7 A “granulating amount” is an amount of liquid sufficient to permit
8 particle adherence or agglomeration without significant dissolution of the
9 azithromycin. Specification, page 7:23-26.
10 The method of the invention is said to result in particles, i.e., granules,
11 which are free flowing and have good characteristics for tableting.
12 Specification, page 22:7-9.
13 According to appellants, flow properties of a formulation may be
14 evaluated by a number of methods known in the art. Specification,
15 page 22:16-17.
16 One way of characterizing formulation properties of a powdered
17 material is by bulk density measurements. Specification, page 22:17-19.
18 A simple method to provide a description of flow characteristics by
19 bulk density measurement is Carr’s Compressibility Index. Specification,
20 page 22:19-22.
21 Carr’s Compressibility Index is said to be a simple test to evaluate
22 flowability by comparing both the initial and final (tapped) bulk volumes
23 and the rate of packing down. Specification, page 22:22-25.
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